ISO 14000 Standards

ISO 9001 Standard - ISO 9001:2008 Standards

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Quality Management

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There are two schools of thought on quality management. One views quality
management as the management of success and the other the elimination of
failure. They are both valid. Each approaches the subject from a different
angle:

The ‘success’ school is characterized by five questions (Hoyle, David and
Thompson, John, 2001)3 :
1 What are you trying to do?
2 How do you make it happen?
3 How do you know it’s right?
4 How do you know it’s the best way of doing it?
5 How do you know it’s the right thing to do?

The ‘failure elimination’ school is characterized by five different questions
1 How do you know what is needed?
2 What could affect your ability to do it right?
3 What checks are made to verify achievement?
4 How do you ensure the integrity of these checks?
5 What action is taken to prevent a recurrence of failure?

In an ideal world, if we could design products, services and processes that
could not fail we would have achieved the ultimate goal. Success means not
only that products, services and processes fulfil their function but also that the
function is what customers’ desire. Failure means not only that products,
services and processes would fail to fulfil their function but also that their
function was not what customers desired. A gold-plated mousetrap that does
not fail is not a success if no one needs a gold-plated mousetrap!
The introductory clause of ISO 9001:1994 contained a statement that the aim
of the requirements is to achieve customer satisfaction by prevention of
nonconformities. (This was indicative of the failure school of thought.) The
introductory clause of ISO 9001:2000 contains a statement that the aim is to
enhance customer satisfaction through the effective application of the quality
management system and the assurance of conformity to customer and
applicable regulatory requirements. (This is indicative of the success school of
thought.)

In reality you cannot be successful unless you know of the risks you are
taking and plan to eliminate, reduce or control them. A unification of these
approaches is what is therefore needed for organizations to achieve, sustain
and improve quality. You therefore need to approach the achievement of
quality from two different angles and answer two questions. What do we need
to do to succeed and what do we need to do to prevent failure?

Quality does not appear by chance, or if it does it may not be repeated. One
has to design quality into the products and services. It has often been said that
one cannot inspect quality into a product. A product remains the same after
inspection as it did before, so no amount of inspection will change the quality
of the product. However, what inspection does is measure quality in a way that
allows us to make decisions on whether or not to release a piece of work. Work
that passes inspection should be quality work but inspection unfortunately is
not 100% reliable. Most inspection relies on human judgement and this can be
affected by many factors, some of which are outside our control (such as the
private life, health or mood of the inspector). We may also fail to predict the
effect that our decisions have on others. Sometimes we go to great lengths in
preparing organization changes and find to our surprise that we neglected
something or underestimated the effect of something. We therefore need other
means to deliver quality products – we have to adopt practices that enable us
to achieve our objectives while preventing failures from occurring.

Quality Management

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Establishing a ISO 9001 records procedure

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ISO 9001:2008 Documentation Requirements
ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”
ISO 9001:2008 Clause 4.2.1 General explains that the quality management system documentation shall include:
documented statements of a quality policy and quality objectives;
a quality manual
documented procedures required by this International Standard
documents needed by the organization to ensure the effective planning, operation and control of its processes, and
records required by this International Standard;
The notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure”, the procedure has to be established, documented, implemented and maintained. It also emphasizes that the extent of the QMS documentation may differ from one organization to another due to:
the size of organization and type of activities;
the complexity of processes and their interactions, and
the competence of personnel.
All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4.
Guidance on Clause 4.2 of ISO 9001:2008
The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.
a) Documented statements of a quality policy and objectives:
Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3.Note: Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).
Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.
b) Quality Manual:
Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS
A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.
The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.
c) Documented procedures:
ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:4.2.3 Control of documents4.2.4 Control of records8.2.2 Internal audit8.3 Control of nonconforming product8.5.2 Corrective action8.5.3 Preventive action
These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3
Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable.
Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.
Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented.
d) Documents needed by the organization to ensure the effective planning, operation and control of its processes:
In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are:- Quality policy (clause 4.2.1.a)- Quality objectives (clause 4.2.1.a)- Quality manual (clause 4.2.1.b)
There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:- Process maps, process flow charts and/or process descriptions- Organization charts- Specifications- Work and/or test instructions- Documents containing internal communications- Production schedules- Approved supplier lists- Test and inspection plans- Quality plans
All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable
e) Records:
Examples of records specifically required by ISO 9001:2008 are presented in Annex B.
Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system.
Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008.

Establishing a ISO 9001 records procedure

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The standard requires records to remain legible, readily
identifiable and retrievable and that a procedure defines
the controls needed for the identification, storage,
protec- tion, retrieval, retention time and disposition of records.
Records have a life cycle. They are generated during
which time they acquire an identity and are then
assigned for storage for a prescribed period. During
use and storage they need to be protected from
inadvertent or malicious destruction and as they
may be required to support current activities or
investigations, they need to be brought out of storage
quickly. When their usefulness has lapsed, a decision is made as to whether to
retain them further or to destroy them.
Readily retrievable means that records can be obtained on demand within a
reasonable period (hours not days or weeks) Readily identifiable means that
the identity can be discerned at a glance.
Although the requirement implies a single procedure, several may be
necessary because there are several unconnected tasks to perform. A procedure
cannot in fact ensure a result. It may prescribe a course of action which if
followed may lead to the correct result, but it is the process that ensures the
result not the procedure.
The revised requirement omits several aspects covered in clause 4.16 of the
1994 version.
Collection of records is now addressed by Analysis of data (clause 8.4)
Indexing of records is a specific form of identification and is therefore
already addressed
Access is now addressed by the requirement for record retrieval
Filing is a specific form of storage and is therefore already addressed
You may only need one procedure which covers all the requirements but this
is not always practical. The provisions you make for specific records should be
included in the documentation for controlling the activity being recorded. For
example, provisions for inspection records should be included in the inspection
procedures; provisions for design review records should be included in the
design review procedure. Within such procedures you should provide the
forms (or content requirement for the records), the identification, collection/
submission provisions, the indexing and filing provisions. It may be more
practical to cover the storage, disposal and retention provisions in separate
procedures because they may not be type-dependent. Where each department
retains their own records, these provisions may vary and therefore warrant
separate procedures.
Unlike prescriptive documents, records may contain handwritten elements and
therefore it is important that the handwriting is legible. If this becomes a
problem, you either improve discipline or consider electronic data capture.
Records also become soiled in a workshop environment so may need to be
protected to remain legible. With electronically captured data, legibility is often
not a problem. However, photographs and other scanned images may not
transfer as well as the original and lose detail so care has to be taken in
selecting appropriate equipment for this task.
Whatever the records, they should carry some
identification in order that you can determine what
they are, what kind of information they record and
what they relate to. A simple way of doing this is to
give each record a reference number and a name or
title in a prominent location on the record.

1994 –2000 Differences

Previously the standard
covered retrieval in four
ways. It required:
(a) that quality records be

made available for
evaluation by the
customer or his
representative for an
agreed period, where
agreed contractually

Records can take various forms – reports contain-

ing narrative, computer data, and forms containing
data in boxes, graphs, tables, lists and many others.
Where forms are used to collect data, they should
carry a form number and name as their identifica-
tion. When completed they should carry a serial
number to give each a separate identity. Records
should also be traceable to the product or service
they represent and this can be achieved either within
the reference number or separately, provided that the
chance of mistaken identity is eliminated. The
standard does not require records to be identifiable
to the product involved but unless you do make such
provision you will not be able to access the pertinent
records or demonstrate conformance to specified
requirements.

Retention of ISO 9001 records

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It is important that records are not destroyed before their useful life is over.
There are several factors to consider when determining the retention time for
records.

The duration of the contract – some records are only of value whilst the
contract is in force.

The life of the product – access to the records will probably not be needed for
some considerable time, possibly long after the contract has closed. On
defence contracts the contractor has to keep records for up to 20 years and
for product liability purposes, in the worst-case situation (taking account of
appeals) you could be asked to produce records up to 17 years after you
made the produc
The period between management system assessments – assessors may wish to see
evidence that corrective actions from the last assessment were taken. If the
period of assessment is three years and you dispose of the evidence after 2
years, you will have some difficulty in convincing the assessor that you
corrected the deficiency.
While the ISO 9001 requirement applies only to records, you may also need to
retain tools, jigs, fixtures, test software – in fact anything that is needed to repair
or reproduce equipment in order to honour your long-term commitments.
Should the customer specify a retention period greater than what you
prescribe in your procedures, special provisions will need to be made and this
is a potential area of risk. Customers may choose not to specify a particular
time and require you to seek approval before destruction. Any contract that
requires you to do something different creates a problem in conveying the
requirements to those who are to implement them. The simple solution is to
persuade your customer to accept your policy. You may not want to change
your procedures for one contract. If you can’t change the contract, the only
alternative is to issue special instructions. You may be better off storing the
records in a special contract store away from the normal store or alternatively
attach special labels to the files to alert the people looking after the archives.

Retention of ISO 9001 records

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Disposition of ISO 9001 records

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Disposition in this context means the disposal of records once their useful life
has ended. The requirement should not be confused with that on the retention
of records. Retention times are one thing and disposal procedures quite
another.
The standard does not specifically require records to be authenticated, certified
or validated other than product verification records in clause 8.2.4. A set of
results without being endorsed with the signature of the person who captured
them or other authentication lacks credibility. Facts that have been obtained by
whatever means should be certified for three reasons:

They provide a means of tracing the result to the originator in the event of
problems.
They indicate that the provider believes them to be correct.
They enable you to verify whether the originator was appropriately
qualified.
They give the results credibility.

If the records are generated by computer and retained in computerized form,
a means needs to be provided for the results to be authenticated. This can be
accomplished through appropriate process controls by installing provisions for
automated data recording or preventing unauthorized access.

Control of ISO 9000 records

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The standard requires records to be established and
maintained to provide evidence of conformity to require-
ments and the effective operation of the quality manage-
ment system.
A record is defined in ISO 9000 as a document stating
results achieved or providing evidence of activities
performed.

Although a record is a document, the document

control requirement of clause 4.2.3 do not apply to

records primarily because records are not issued,
neither do they exhibit revision status simply
because they are results that are factual when
recorded. If the facts change, a new record is usually
created rather than the previous record revised. Even
where a record is revised and new facts added, the
old facts remain identified as to their date. The only reason for revising facts
contained in a record without changing the identity of the record or the date
when they were collected is where the facts were incorrectly recorded. This
subtle difference demands different treatment for documents that are classed
as records to those that are classed as informative. As with other types of
documents, records result from processes and may be used as inputs to other
processes.
Records required by the management system means records used or
generated by the management system. There is therefore no requirement to
produce records solely to satisfy an auditor. The records required are those for
the effective operation of the organization’s processes (see clause 4.1d of ISO
9001). If a record has no useful purpose within the management system there
is no requirement that it be established or maintained.
This does not mean that a record is required to prove conformity with every
single requirement for every product and service. There are those records
required by the standard (see below) that are required for every product and
service where applicable and in all other cases, audit records showing
compliance on a sample of operations would be sufficient.
Compliance with many requirements can be demonstrated by observation,
analysis, interview or examination of documentation. If a result or an activity
is not required to be recorded in order to manage the organization effectively
and satisfy the interested parties, it is not necessary to maintain records of it.

Changes to ISO 9000

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Changes in titles
The titles have changed – moving away from models to requirements andguidance.

Changes in scope
The scope of the standard has changed from those activities that impact theproduct to embrace all activities
in an organization that serve the satisfaction of customers. This leaves little if any activity of an organization that would be
outside the scope of the quality management system.

Changes in structure

By far the most significant change is the change in structure – away from 20elements to a model based on five elements.
The ISO 9000:2000 family of standard is based on a process model.
Changes in content
The content has changed from 20 elements organized on the basis of whatcould go wrong to four groups of requirements
that focus on elements of process management. It is however, not the fact that the original elements have
been placed onto a new structure, but that the principles upon which the standard has been based have changed.
Changes in intent
The intent of ISO 9001 has changed from a model for quality assurance to a setof requirements for an effective quality
management. The standard is now based on eight management principles not on what requirements were
necessary to prevent failures that experience had shown led to poor product quality.
The forgotten standard ISO 8402 is brought into the family of ISO 9000 thus making it more likely that people will use it.
However, in the author ’s opinion, all three standards should have been merged into one standard thus
ensuring that everyone who possessed the requirements also possessed the concepts, terminology and
guidelines to refer to as necessary.
Much damage can be done when the requirements of ISO 9000 are taken out
of context, taken in isolation and taken literally. ISO 9000 is not a productstandard therefore it is subject to
interpretation as appropriate to the conditions
in which it is being used. Whatever the initial understanding of a requirement
of ISO 9001 might be, the intent is that:
organizations design and manage their processes effectively to achievecorporate objectives, not that they create functional
silos that compete for resources.
organizations choose the right things to do based on an objective analysis of
the environment in which they operate, not slavishly follow procedures that
serve no practical purpose.
management create an environment in which people will be motivated, not
create bureaucratic systems of documentation that stifle initiative and
creativity.
Changes in language
The language in ISO 9000 has changed to reflect pressure from the usercommunity for a user-friendlier standard.
In some cases the changes are insignificant but in others the changes have a wider impact as indicated
below:
Subcontractor has changed to supplier and supplier changed to organizationso that there is now a supply
chain represented by customer – organization – supplier.
In ISO 9001 the term customer is used but in ISO 9004 the term, interested party
is used in order to embrace customers, employees, investors and otherparties.
Executive management has been changed to Top Management indicating thatwhen the standard uses
the term management responsibility it is the people who direct the organization that should address
these requirements.
Specified requirements have changed to customer and regulatory require-ments or product requirements
depending on the context.
Procedures have not exactly been changed to processes but presented in adifferent way that makes
procedures only one element of managing an effective process. Procedures have lost their dominance in
the standard to be replaced by the concept of managed processes.
Changes in requirement
ISO 9001 still contains 136 ‘shall’ statements, 2 less than the 1994 version so insome respects it is no different.
There were roughly 323 requirements in ISO 9001:1994 (Hoyle, David, 1996)6 . In ISO 9001:2000 there are roughly 250
requirements. This is still too many especially if we are trying to get across the
fundamental requirements of the standard. The following summarizes the
requirement of ISO 9001 at two levels: firstly as a single requirement, secondly
as a series of generic requirements.

Environmental Aspects (ISO 14001:2004, ?4.3.1)

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The requirement of ?4.3.1 of ISO 14001 is to establish and maintain procedures 1) for identifying the environmental aspects of the organization’s activities, products, and services that it can control and those that it can influence and 2) for determining which of those aspects have or can have a significant impact on the environment. Understanding the requirement of this element of ISO 14001 is central to understanding the concept of an environmental management system.
1 .A single manufacturing facility has potentially hundreds of environmental aspects. How far must it go in identifying its environmental aspects to satisfy the terms of the requirement? ISO 14001 specifies that the organization is to identify those aspects that it can control and those that it can influence and that it must also take into account planned or new developments and new or modified activities, products, and services. These stipulations in the requirements, without actually drawing boundaries on how far the organization must go in identifying environmental aspects, at least establish some categories of aspect that must be considered. Beyond this principle, each organization must identify its aspects comprehensively enough so as to not fail to identify a significant aspect or a legal requirement. An objection to comprehensive identification of aspects is that the organization may become so immersed in aspects identification that it loses sight of the end objective of the procedure, which is to determine significance.
2. Significant impact is not a stand-alone term in ?4.3.1.
It is accompanied by the phrase impact on the environment_ and environment_ is a defined term (see definition of environment, ?3.5). Significant aspects, then, are those environmental aspects that have or can have significant impacts on air, water, land, natural resources, flora, fauna, and humans. The organization determines, using its own criteria, what magnitude of impact on these seven environmental receptors constitutes a significant impact. Whether an aspect is regulated is not intended to be a factor in determining significance.
3. Proper execution of the environmental aspects procedure is important, in part, because it lifts environmental management out of the regulatory compliance mode and into the mode of systematically identifying environmental aspects and impacts and considering their consequences for the environment, irrespective of regulation. The organization that rigorously applies the environmental aspects procedure discovers many opportunities to improve environmental performance that regulation does not address, including:
• Use of energy
• Consumption of materials
• Environmental impacts of employee activities
•Environmental impacts of products and by-products post-manufacture, including distribution, use, reuse, and disposal
• Environmental impacts of services
• Unregulated waste streams such as carbon dioxide
Aspects vs. Impacts – Environmental aspects and environmental impacts differ by definition from one another in that an aspect is an element of an organization’s activities, products or services that can interact (emphasis added) with the environment_ while an impact is any change (emphasis added) to the environment_ resulting from an organization’s environmental aspects._ An aspect, then, is a precursor to an impact and an impact occurs when the aspect interacts with and changes the environment.
When identifying its aspects and impacts, the organization may find that there are more than one potential impacts associated with any given aspect. For example, an environmental aspect of a coal-fired power generation facility is stack emissions containing sulfur dioxide, nitrogen oxides, mercury, and carbon. These emissions change the environment and become impacts by contaminating plants, soil, and surface waters; contributing to the formation of ground-level ozone; causing or exacerbating heart and lung disease in humans; entering the aquatic food chain and impairing reproductive, immune, and endocrine systems; and contributing to the increase in atmospheric carbon dioxide leading to global warming. One aspect, stack emissions, then can generate at least five impacts.
Other organizations, applying benefit/cost analyses to their corrective actions, may discover that creation of a beneficial impact provides a greater environmental benefit than elimination of an adverse impact.
The introduction of the beneficial environmental impact concept into the ISO 14001 Terms and Definitions suggests that it was considered by some of the ISO 14001:1996 drafters as a placeholder for the future possibility of offsetting adverse impacts with beneficial and, on balance, achieving an environmentally neutral organization.
Control and Influence – The environmental aspects procedure requires the organization to identify those environmental aspects that it can control and those that it can influence._ Circumstances where control and influence are considered separately can occur where the environmental aspects of products or services are concerned. Some examples illustrate the case:
1. No control, no influence – When an organization manufactures a product, such as lumber, and sells it to a customer that can use the product in any way that it wishes, the organization has no control over the environmental aspects of the product’s use. The customer could use the product benignly as in the manufacture of a table or to damage the environment by burning the lumber and releasing its carbon into the atmosphere. In this case, the organization would not be expected to have either control or influence over the environmental aspects of the product.
2. Control, no influence – When an organization’s environmental aspect is the use of electric power generated from coal, it may be able to control its use of electric power by using less, by buying from a different, less environmentally damaging source, or by generating its own power. Rarely, however, does the organization have influence over the power generator to an extent that it could influence it to reduce the environmental impacts of power production.
3. Influence, no control – When an organization manufactures a product, such as an automobile, which is sold to the customer without restrictions on its use, the organization may be said to have no control over the environmental aspects of the product’s use. The organization may, however, be able to assert influence with the inclusion of owner’s manuals containing instructions for low impact use of the product.
4. Control and influence – When an organization buys a product built to its specifications, it has control over the products’ environmental aspects in the sense that it can determine the environmental aspects of the product. In this case, control also includes influence.
Significant Impacts – ISO 14001 does not provide guidance as to what constitutes a significant impact on the environment_, leaving that determination to the organization.
Many organizations ignore the qualifying phrase, impact on the environment_, and add additional criteria to what they determine to be significant impacts. For example, many organizations decide that aspects that are the subject of regulation, irrespective of impact to the environment, or that can cause damage to business reputation, are significant. Legal requirements, however, are identified in ?4.3.2 and legal requirements and business requirements are specifically considered when the organization establishes its objectives and targets (?4.3.3). Adding criteria that are not relevant to impact on the environment in the determination of significance distorts the outcome of procedures for environmental aspects and objectives and targets by giving these criteria undue weight in the determination of significance. For example, an environmental aspect that is significant only because its disclosure might affect the organization’s reputation is best dealt with in the Public Relations Department rather than as an environmental aspect.
Determination of significance is a yes or no question, not a determination of relative value. It is possible, therefore, that the execution of the environmental aspects procedure will result in the determination that the organization has no significant aspects. While the organization may elect to rank its aspects from most significant to least significant, that does not necessarily mean that any rise to the level of significant impact on the environment.
Where the impact occurs can be material to determination of significance. For example, a coal-fired power plant’s air emissions can interact with the environment; these emissions are clearly environmental aspects. Whether they significantly impact the environment may depend upon where the interaction with the environment occurs.
Part of the importance of establishing significance lies in the fact that the potentially significant environmental impacts become a focus of Objectives and Targets (?4.3.3), Competence (?4.4.2), Operational Controls (?4.4.6), and Monitoring and Measurement (?4.5.1) requirements.
An organization that determines that aspects are significant because of regulation or business reputation increases the amount of work it must do in these areas.
ISO 14001 does not require the organization to establish objectives and targets for each significant environmental aspect. On the one hand, the absence of a requirement to set objectives and targets for all significant aspects gives organizations latitude to conform to the requirements of ISO 14001 while not presently dealing, for example, with the significant environmental aspects of products. On the other, a requirement to establish objectives and targets for all identified significant aspects could easily overwhelm an organization having many significant aspects. Without this latitude, organizations might choose to ignore the existence of significant aspects that they believe are insurmountable or even decide not to implement ISO 14001. As it is, many organizations choose to deny the existence of significant aspects about which they feel they can do nothing.

Key Elements of ISO 14001

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The Resources, Roles, Responsibility, and Authority; Legal and Other Requirements; Evaluation of Compliance; and Nonconformity, Corrective Action and Preventive Action elements of ISO 14001 are all essential to the ongoing effectiveness of the EMS. This section describes how they function within the overall scheme.
1. Resources, Roles, Responsibility, and Authority (ISO 14001:2004, ?4.4.1)
?4.4.1 of ISO 14001 establishes three important requirements:
1. That management ensure the availability of resources to establish, implement, maintain, and improve the EMS;
2. That roles, responsibilities, and authorities be defined, documented, and communicated in order to facilitate effective environmental management; and
3. That top management appoint a management representative(s) who, irrespective of other responsibilities, will have responsibility and authority for implementing and maintaining the EMS and for reporting to top management on the performance of the EMS.
Ensuring Availability of Resources – Provision of resources for the EMS is almost always an issue within organizations. Although top management usually understands and accepts, at least in principle, the requirement to provide resources, the level of management that makes decisions on capital deployment and operating budgets often does not subscribe to the same requirement. Making the case for resources typically requires the implementation team or management representative to quantify intangibles such as the avoided cost of regulatory fines or the value to the environment of reducing environmental impacts.
When considering the requirement to provide resources, especially financial resources, it may be important to recognize that ISO 14001 requires the provision of resources for the establishment, implementation, maintenance, and improvement of the EMS, not necessarily resources to correct or prevent environmental impacts or to register to ISO 14001. When contemplating the cost of implementing ISO 14001, organizations, again, should think in terms of three separate cost categories:
1) Internal labor and external consultant costs to establish, implement, maintain, and improve the policy and procedural elements of ISO 14001;
2) Capital costs for correction or prevention of environmental impacts; and
3) Costs of registration to ISO 14001, if the organization elects to register.
Roles, Responsibilities, and Authorities – In the past, some organizations have employed a practice of not delegating responsibility and authority for environmental affairs to specific management representatives, reasoning that if the responsibility was diffused throughout the organization, no one person could become personally accountable for non-compliance with regulations or for environmental liabilities. §4.4.1 of ISO 14001 limits such ‘willful ignorance’ by requiring top management of the organization to appoint “specific management representative(s)” to ensure that the EMS is implemented and that top management be apprised of EMS performance. It also requires that the delegation of responsibility and authority be documented and communicated, thus eliminating circumstances where responsibility and authority for the EMS are diffuse or uncertain.
When §4.4.1 is read together with the requirement of the Environmental Policy for a commitment to comply with applicable legal requirements, §4.3.2, Legal and Other
Requirements, requiring a procedure for identifying legal requirements (following), and §4.5.2, Evaluation of Compliance, requiring a procedure for evaluating regulatory compliance, it is evident that the management representative is also responsible for ensuring that the organization is in compliance with applicable regulations. While this responsibility and authority can be delegated, the chain of delegation begins with top management and is passed to the management representative, effectively eliminating any uncertainty as to who is responsible and authorized to ensure regulatory compliance.
EMS Organizational Structure – There is an almost universal norm for the management structure of the EMS organization under ISO 14001. It begins with the top management position, proceeds to the top manager’s leadership team, and then to an EMS implementation team that is generally chaired by the management representative. The departments making up the relevant functions and levels of the organization and environmental, safety, and health professionals comprise the typical implementation team.
Defining Roles, Responsibilities, and Authorities for the EMS – In defining, documenting, and communicating EMS roles, responsibilities, and authorities, it makes sense to begin with top management and proceed through all of the positions having EMS responsibilities. Following is a generic example of how roles, responsibilities, and authorities might be documented and communicated in an EMS Procedures Manual:
Plant Manager
Authority: The Plant Manager has the authority, responsibility, and accountability for managing all aspects of ABC Company’s activities, products, and services at the Anytown facility.Source: Senior Vice President, Manufacturing, ABC Company, Inc.
EMS Responsibilities: Under the requirements of ISO 14001, the Plant Manager shall be specifically responsible for:
1) Defining the Environmental Policy;
2) Delegating authority and responsibility for the establishment, implementation, maintenance, and improvement of the EMS;
3) Providing human, technological, infrastructure, and financial resources and specialized skills; and
4) Periodically reviewing the EMS for suitability, adequacy, and effectiveness and directing changes as necessary to achieve the goals for an EMS and the commitment to continual improvement.
Leadership Team
EMS Responsibilities: The Leadership Team shall advise the Plant Manager on the exercise by
the Plant Manager of his/her responsibilities for the EMS.
Management Representative, Implementation and Maintenance Responsibilities
EMS Authority: The Plant Manager delegates to the Manager, ______ _______, the authority
to establish, implement, maintain, and improve the Environmental Management System and to
ensure that it conforms to the requirements of ISO 14001. In the context of ISO 14001, the
Manager, _____ _________, shall be the Management Representative.

Environment Policy In ISO 14001:2004

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Environment Policy In ISO 14001:2004
To develop a successful and effective EMS, five key tasks that must be undertaken by management:a. Select an EMS CoordinatorThe selection of an EMS Coordinator is crucial to the success of your EMS. This person will be responsible for developing and implementing the environmental policy and the EMS. Great care must be taken to ensure that the person chosen is well qualified to handle the responsibilities associated with the EMS.b. Perform a gap analysisA gap analysis determines the differences, or gaps, between one system and another. Not only will this analysis identify the gaps, but it also should etermine the size of the gaps. These findings will lead to recommendations, project plans, and the identification of necessary resources for filling the gaps.
c. Prepare a budget, and obtain the appropriate resourcesAfter conducting a gap analysis, the EMS Coordinator will develop a budget that covers the necessary resources to complete an EMS that conforms with ISO 14001. For some organizations, this may mean establishing a budget for the entire process; other organizations may only need to update certain portions of their existing management system.
ISO 14001 Section 4.4.1 requires top management to provide the essential resources to implement, control, and manage the EMS.
d. Select an EMS TeamTop management and the EMS Coordinator may consider creating an EMS Team to assist in developing and implementing the system. This decision should be based on the size of the organization or facility that will be implementing the EMS.
This team should consist of key individuals from various divisions, departments, and operating work areas within the organization who are familiar with the facility, the various processes, and its environmental requirements. Diversity among team members will bring together a pool of expertise and ideas from which to develop and implement the EMS.
e. Develop an environmental policyThe environmental policy is an essential part of an organization’s EMS. The environmental policy must establish the overall direction of the organization in terms of its commitment to environmental responsibility. A policy should also set the foundation and framework for meeting the environmental objectives and targets for the organization.
The ISO 14001 standard establishes certain requirements that an organization’s environmental policy must meet. If your organization already has an environmental policy, review this section to ensure it meets the ISO 14001 requirements.
The first requirement is that top management must establish and define the environmental policy. Note that ISO 14001 does not specifically state that top management must write the policy, only that it be committed to the policy and ensure its implementation.
These actions are essential in constructing a firm foundation for an effective EMS.

ENVIRONMENTAL and HEALTH & SAFETY COMPLIANCE CHECKLIST

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Self-Audit Procedures
The following checklist should be used as an aid in reviewing your facility’s compliance with industry environmental and health & safety regulations and requirements.
Additional Information: This checklist is based on the current laws and regulations as of the date of publication. Regulations frequently change.
Therefore, you should review current laws and regulations for any recent changes in the requirements. Some of the items you should check include:
Additional Requirements: In addition to recent changes in the requirements, you should also consider additional Cal/OSHA standards that might apply to your facility.
These might include any of the following:
Employer postings; ergonomics; process safety management; use of asbestos, formaldehyde, or lead containing substances; blood borne
pathogens; welding operations; use of compressed air and gases; boiler operations; use of power tools, hoists and grinding equipment; spray coating; elevated platforms; aisle way, ramp, door and exit requirements; fire sprinkler requirements; and seismic requirements.
Legal Authority : The compliance requirements provided on the following pages are taken from the respective laws and regulations, as indicated in the references column. In addition to the statutory and regulatory requirements, some compliance items that reflect improved and accepted management practices have been included. These management practices have been included because of their overall industry acceptance and their potential to reduce environmental risk and improve compliance.

ISO 14001 – Specifications With Guidance for Use

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ISO 14001 – Specifications with Guidance For Use
Given the number of international participants involved in the process of developing the ISO 14001 Specifications, it is amazingly brief, consisting of five pages. This includes a Scope, Definitions, and EMS requirements.
The heart of the specification is in the EMS Requirements, the principles of which are summarized below:
Principle #1 – Commitment and Policy Top management must make a commitment to the program.
Principle #2 – Planning To be successful, the program must be organized. This includes an organizational structure, open communications, both internal and external, and a mechanism for identifying issues.
Principle #3 Implementation Program must be undertaken, including training, writing process descriptions, and establishing prevention programs.
Principle #4 Measurement and Evaluation Create a mechanism for assessing performance and progress toward goals.Principle #5 Review and Improvement? ISO 14004, Section 4, Environmental Management System (EMS)
Reference: ISO 14004, Section 4, Environmental Management System (EMS) Principles and Elements.

ISO 14001 – Certification/Registration

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ISO 14001 – Certification/Registration
Similar to the organized approach to problem solving contained in ISO 9000
and ISO 14000, an organized approach is necessary to achieve certification. Although the written requirements contained in ISO 14001 are straightforward and brief, the level of effort required to conform with the requirements should not be underestimated.
If an environmental review of the facility‘s operations has not been conducted, it is important to retain a qualified consultant to conduct the review. which should focus on the requirements of ISO 14000 versus programs currently in use. This activity is known as a Gap Analysis.?E After the Gap Analysis is completed, the environmental status of the operation should be known and the level of effort necessary to develop the ISO 14000 program understood.
It can easily take six months to a year to develop a program that meets EMS requirements. Staff should develop the EMS program as they will ultimately be required to manage it. If staff is inadequate to develop the program, a consultant can be retained to provide guidance to staff as the program is being developed.
But, retaining a consultant will not resolve the problem of long term program maintenance. The ultimate goal of developing the EMS is to obtain certification/registration. Aside from the internal benefits offered by the ISO 14000 series of standards, external benefits may be derived through the certification/registration process. The certification/registration process only applies to ISO 14001, and this is the only standard to which the audit process applies. For the purposes of certification/registration, all other ISO 14000 standards are considered guidance. Certification can either be by a self declaration?Eor by an independent registrar.
Obviously the use of an independent registrar would give more credibility to those looking at an organization from outside.
Registrars have individual preferences about how the requirements should be administered. A registrar should be selected early in the process to help ensure that the program being developed is consistent with the registrars preferences. When the program is fully prepared and implemented, the registrar will be notified and a formal program audit undertaken. This audit will not result in a denial of ISO 14000 certification, but it may result in either approval or a list of deficiencies that must be corrected before certification.

ESTABLISHING THE INITIAL STATE OF THE QMS For SME

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Establishing The Initial State of The ISO 9001 QMS For SME
The implementation of an ISO 9001 conformant system must recognize that it is but a step in a long-term development of a continually improving QMS. Unfortunately, it is often the case that ISO 9001 is taken as a means to an end, where the implementation of a QMS is not the primary objective, rather certification is. As a result, SMEs may end up with stacks of documentation waiting to be processed that adds no value, but cost.
According to the requirements of ISO 9001, an organization must develop only six documented procedures: (1) control of documents, (2) control of quality records, (3) internal audits, (4) control of non-conformities, (5) corrective action, and (6) preventative action. A quality manual and several records are also required. The development of other procedures, work instructions, and
other documents is largely at the discretion of the organization. From the very beginning of the process, it is therefore essential that SMEs establish a balanced view between a short-term focus (marketing/sales) and a long-term focus (achieving company-wide quality awareness through TQM). ISO documentation should be considered as an enabler along that way and SMEs must guard against the creation of unnecessary documentation.
However, even when such a view is adopted, many SMEs struggle to move from their initial state to a fully functional ISO 9001 QMS. Over the last several years, we have been involved in ISO 9001 implementation projects in seven different SMEs. The SMEs have ranged in size from approximately 20 employees to 500 employees. The SMEs have been drawn from a variety of sectors in Virginia, including manufacturing, distribution, and services. Based on our experience, we developed a schematic of initial states of an organization in terms of the existence and functionality of the ISO 9001 QMS . Throughout this paper, existence is equated with the documentation required by the standard while functionality is equated with an effectively operated QMS that leads to increased customer satisfaction and continuous improvement of business results.
A successful QMS must be fully functional and appropriately documented. With that in mind, there are four main states in which SMEs can be located in the beginning of the implementation process:
1. Complete Death: No documentation, no functioning.
This is the state in which there is no indication of the existence and functionality of the QMS. No documentation exists and no processes are in place to help ensure the quality of the product.
Relatively few companies will find themselves in this situation.
2. Informally Alive: No documentation, some level of functioning.
Many SMEs exhibit an organic structure characterized by an absence of standardization and the prevalence of loose and informal working relationships. SMEs operating in this state are more likely to rely on people rather than a system. In such situations, key personnel may resist documentation for two key reasons “(1) documentation is considered a waste of time and (2) documentation of processes and procedures makes the individual less dependable” [2]. SMEs in this state perform some or all of the processes required by ISO 9001 and the QMS may function fairly well. However, they are not willing and ready to document those processes unless there is a cultural change lead by top management.
3. Formally Death: Some level of documentation, no functioning.
SMEs categorized in this state have documented processes and procedures at some degree, however, the documents are generally not followed and do not necessarily reflect the actual manner in which the organization undertakes its operations and management. This situation highlights the fact that the mere existence of documentation does not necessarily lead to a functional QMS. Moreover, such a situation may help perpetuate the view that ISO 9001 is a way for SMEs to market their products and services but that implementation of the standard requires stacks of documents that offer no value.
4. Formally Alive: Some level of documentation, some level of functioning.
Each SME considered in this state, achieves a unique combination of the existence and functionality of processes and procedures that may or may not be required by ISO 9001. This situation is closest to the desired state of full functionality (100%) of the ISO 9001 QMS and full documentation (100%) of this functionality.

The Benefits To Integrate ISO 14001:2004 and ISO 9001:2008

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The Benefits To Integrate ISO 14001:2004 and ISO 9001:2008
Reduce the time and cost of implementing the new specification by acquiring a concise, yet thorough understanding the scope of ISO 14001:2004 and key terms.
Avoid spinning your wheels by learning precisely which modifications and additions to ISO 14001:2004 require your attention for compliance with ISO 9001:2008.
Get a quick handle, through hands-on activities, on the environmental aspects of ISO 14001:2004, including how to:- Develop an environmental policy statement appropriate for your company- Integrate processes for identifying environmental aspects and impacts- Identify environmental objectives, set related targets, and establish programs for achieving results- Integrate environmental responsibilities and authorities into a management system- Outline an environmental awareness and training program- Establish environmental metrics and indicators for monitoring performance- Integrate requirements on non-conformance and corrective and preventive actions into your existing system- Understand the purpose and scope of the environmental management review- Integrate document control requirements of ISO 14001:2004 into your current system- Identify those operations that need to be controlled under EMS and identify emergency operations and contingencies that must be considered as part of EMS
Get off to a running start by learning to use a versatile prioritization matrix to identify and prioritize significant environmental aspects and impacts.
Optimize understanding and retention with the Plexus Learning Model- Multiple learning channels through lecture, coaching, group activities, innovative learning exercises and case studies.- Hands-on insights. Lecturing is minimized so learning is maximized.- Learn by doing. Connect the lessons learned to your real world by using your current circumstances as examples for activities.

Demonstrating conformity with ISO 9001:2008

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Demonstrating conformity with ISO 9001:2008
For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.
Organizations may be able to demonstrate conformity without the need for extensive documentation.
To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective
evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”
Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d)
Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.
Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.

Guidance on Clause 4.2 of ISO 9001:2008

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Guidance on Clause 4.2 of ISO 9001:2008
The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.
a) Documented statements of a quality policy and objectives:
Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3.
Note: Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).
Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.
b) Quality Manual:
Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS
A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.
Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.
The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.
c) Documented procedures:
ISO 9001:2008 specifically requires the organization to have “documented procedures” for the following six activities:
4.2.3 Control of documents
4.2.4 Control of records
8.2.2 Internal audit
8.3 Control of nonconforming product
8.5.2 Corrective action
8.5.3 Preventive action
These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3 Some organizations may find it convenient to combine the procedure for several activities into a single documented procedure (for example, corrective action and preventive action). Others may choose to document a given activity by using more than one documented procedure (for example, internal audits). Both are acceptable.
Some organizations (particularly larger organizations, or those with more complex processes) may require additional documented procedures (particularly those relating to product realization processes) to implement an effective QMS.
Other organizations may require additional procedures, but the size and/or culture of the organization could enable these to be effectively implemented without necessarily being documented. However, in order to demonstrate compliance with ISO 9001:2008, the organization has to be able to provide objective evidence (not necessarily documented) that its QMS has been effectively implemented.
d) Documents needed by the organization to ensure the effective planning, operation and control of its processes:
In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are:
- Quality policy (clause 4.2.1.a)
- Quality objectives (clause 4.2.1.a)
- Quality manual (clause 4.2.1.b)
There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples
may include:
- Process maps, process flow charts and/or process descriptions
- Organization charts
- Specifications
- Work and/or test instructions
- Documents containing internal communications
- Production schedules
- Approved supplier lists
- Test and inspection plans
- Quality plans
All such documents have to be controlled in accordance with the requirements of clause 4.2.3 and/or 4.2.4, as applicable
e) Records:
Examples of records specifically required by ISO 9001:2008 are presented in Annex B.
Organizations are free to develop other records that may be needed to demonstrate conformity of their processes, products and quality management system.
Requirements for the control of records are different from those for other documents, and all records have to be controlled according to those of clause 4.2.4 of ISO 9001:2008

ISO 9001:2008 Documentation Requirements

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SUMMARY OF CHANGES TO ISO 14001:2004

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SUMMARY OF CHANGES TO ISO 14001:2004
ISO 14001:2004 aims to clarify the 1996 edition and align it more closely with the ISO 9001:2000 standard. Some clauses have not been modified for content but have been rewritten to align ISO 14001:2004 with the format, wording, and layout of ISO 9001:2000 and to enhance the compatibility between the two standards.
References in Annex A of the standard are aligned with the numbering in the standard for ease of use. Annex B of the standard identifies similarities and associations between ISO 9001:2000 and ISO 14001:2004.
An important change in wording throughout the revised standard appears in requirements that previously stated that an organisation shall “establish and maintain”; these have now been changed to “establish, implement and maintain”.
Throughout the standard the word “personnel” in the original standard is replaced with “persons working for or on behalf of the organisation” in the revised standard. This is included to ensure that external contractors and applicable suppliers are included under the requirements of certain clauses.
In developing, implementing and maintaining the organisation’s EMS, significant environmental aspects, applicable legal requirements and other requirements to which the organisation subscribes must be considered, and management must ensure the availability of resources.
There are additional paragraphs in the introduction, which generally cover:
• the aim of the ISO 14001:2004 standard is to enhance compatibility with ISO 9001:2000;
• alignment is improved between clause references and supporting Annexes. For example, 4.3.3 and A.3.3 both deal with objectives, targets and programme(s), and 4.5.5 and A.5.5 both deal with internal audit;
• an explanation of the Plan-Do-Check-Act (PDCA) model used in ISO 9001:2000;
• the use of the process approach is promoted in alignment with ISO 9001:2000;
• possible alignment and integration with other management systems is reviewed.

Change In ISO 14001:2004 – Documentation

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Change In ISO 14001:2004 – Documentation
This clause has been updated to align it with ISO 19001:2004, but has not changed in intent. The listed EMS documentation now includes:
• the environmental policy,
• objectives and targets,
• a description of the scope of the EMS,
• a description of the main elements of the EMS and their interaction and reference to related documents, documents and records
• required by the standard, • documents and records determined by the organisation as necessary to ensure the effective planning, operation and control of processes that relate to the significant environmental aspects.
Formatting changes help align Clause 4.4.5 of ISO 14001:2004 with ISO 9001:2000. An additional clarification has been made to define records as a special type of document requiring control under Clause 4.5.4. A new addition to the requirements aims to ensure documents of external origin, (i.e. MSDS, permits) that are necessary to the system, are identified and their distribution is controlled.
Formatting changes help align Clause 4.4.5 of ISO 14001:2004 with ISO 9001:2000. An additional clarification has been made to define records as a special type of document requiring control under Clause 4.5.4. A new addition to the requirements aims to ensure documents of external origin, (i.e. MSDS, permits) that are necessary to the system, are identified and their distribution is controlled.
The revised standard requires documents required by the EMS and the standard to be controlled documents.
Note that “document” is included in the definitions, and includes its supporting medium which can be paper, magnetic, electronic or optical computer disc, photograph or master sample, or a combination thereof.

ISO 14001:2004 Evaluation of compliance

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ISO 14001:2004 Evaluation of compliance
This clause has been separated from 4.5.1 and includes two sub-clauses, as well as clarification and an addition to the ISO 14001:1996 standard. Included in Clause 4.5.1 of ISO 14001:1996 was a requirement for the organisation to periodically evaluate compliance with relevant (now applicable) environmental legislation and regulations. This requirement has been retained in Clause 4.5.2.1 of the revised standard. In Clause 4.5.2.2, ISO 14001:2004 includes evaluation of compliance with other requirements to which the organisation subscribes, which was not specifically required by ISO 14001:1996. This clarification also includes a requirement for records of periodic evaluations of compliance to be kept.
The UK-based Institute of Environmental Management and Assessment (IEMA) has published an opinion that this means that compliance against each and every piece of legislation / regulation relating to an organisation’s environmental aspects will need to be evaluated before it can be considered to be in conformity with ISO 14001: 2004; it will not be acceptable for organisations to claim that the periodic evaluation will be covered by their internal EMS audit program at some future date.
This has always been one of the most difficult issues in ISO 14001:2004, and organisations will need to review and revise their compliance procedures to ensure that they meet these new requirements.

KEY CONSIDERATIONS IN IMPLEMENTING ISO 9001 IN SMEs

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KEY CONSIDERATIONS IN IMPLEMENTING ISO 9001 IN SMEs
There are many issues that must be addressed in moving the QMS from the initial state to the desired state. For example, all organizations implementing ISO 9001 will need to consider the unique culture within the organization, its size, and the resources available. Beyond those widely discussed points, three issues that merit particular attention are (1) consideration of the QMS as a parallel function, (2) training, and (3) auditing. Key points associated with these issues are discussed below.
Consideration of QMS as Parallel Function
In the case of all of the transitions depicted, real benefits from the QMS are more likely to be experienced if the QMS is implemented directly into the core structure of the organization. SMEs must be cautious against establishing a QMS that is run separately in parallel to its other systems. In SMEs, the parallel subsystem most commonly exhibits itself as a separate Quality Assurance, or in some cases, ISO 9001 department. Possible reasons for this may include the existence of rigid departmental boundaries in some SMEs or overemphasis on core activities. As Yauch and Steudel [10] note, SMEs tend to focus their attention on “…necessary routine activities (such as sales, production, shipping, etc.) rather than activities aimed at improving processes or systems.” If a SME insists on establishing a separate quality department, its level of effectiveness can be increased by embedding the QMS in widely-used organizational systems where practical. The integration is largely a function of how well the QMS manages to share information with other subsystems and its ability to align with the policies, norms, goals, and values in place throughout the organization.
Training
In SMEs, training and staff development is more likely to be ad hoc and small scale because of modest human and financial resources and the absence of a specific training budget. To prevent the problems arising from lack of education and training, two things must be done:
1. Education of Top Management: The centralization of decision-making processes within many SMEs means that the management can either be the main stumbling block to change or the main catalyst for change. Therefore, any approach to ISO 9001 implementation must involve considerable education for the top management of the organization to create awareness and understanding of the implementation process as a change initiative. Implementing a fully functional and documented QMS requires motivation by top management to appreciate, achieve, and implement the necessary measures to meet the standards’ criteria.
2. Education and Training of Employees: SMEs are often under pressure to quickly gain ISO 9001 registration. Meeting the requirements of the standard in a short period of time can prove a formidable obstacle for a small company. Since most SMEs do not possess the needed expertise internally, they may be inclined to hire external experts to provide the necessary technical expertise and manpower. However, having a functioning and documented QMS requires more than that. It requires ensuring that all employees in the organization clearly know what is expected of them and how they can contribute to the attainment of their organizations’ goals. This will likely require the preparation and implementation of a training plan tailored specifically to the unique characteristics and maturity level of the SME.
Auditing
As emphasized throughout the paper, a QMS is not going to produce the expected results unless it is fully functional. While auditing must therefore verify the existence of the necessary documentation, it must also focus on the functionality of the QMS. The measurement of the functionality and the qualitative and financial impacts of a QMS have been the subject of several studies, including Kaynak [11]. Among the categories used to measure functionality and performance improvement, two are particularly noteworthy for our purposes: management commitment and employee involvement. A QMS cannot be functional in the absence of those two characteristics. Therefore, as a minimum, internal and external auditors should continually verify top management’s commitment to increased company-wide quality awareness and improvement in addition to employee involvement in the design, implementation, operation, and improvement of quality related processes and procedures.

IMPLEMENTATION GUIDANCE FOR ISO 9001:2008

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IMPLEMENTATION GUIDANCE FOR ISO 9001:2008
This Implementation Guidance has been developed to assist users in understanding the issues that need to be considered during the co-existence period between ISO 9001:2000 and ISO 9001:2008.
While the changes between ISO 9001:2000 and ISO 9001:2008 are expected to have a limited impact on users, some arrangements regarding implementation are needed.
Note: To reflect the limited scope of the changes the term “implementation” is now being used to make a clear distinction with the former “transition” from ISO 9001:1994 to ISO 9001:2000, when there were significant changes throughout the standard.
A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2000, given in Annex B to ISO 9001:2008.
ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.
Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008 No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.
Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:
- the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004
- feedback from the ISO/TC 176/Working Group on “Interpretations”
- the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004″ by ISO/TC 176/SC 2/WG 18 and similar national surveys.
The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.
The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO14001:2004.
A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:
1) No changes with high impact would be incorporated into the standard;
2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;
3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.
The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:
- No changes or minimum changes on user documents, including records
- No changes or minimum changes to existing processes of the organization
- No additional training required or minimal training required
- No effects on current certifications
The benefits identified for the ISO 9001:2008 edition fall into the following categories:
- Provides clarity
- Increases compatibility with ISO 14001.
- Maintains consistency with ISO 9000 family of standards.
- Improves translatability.

Role of Governments in ISO 14001 Standards

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Role of Governments in ISO 14001 Standards
Although ISO 14001 is a set of voluntary standards that individual companies may or may not choose to adopt, governments can clearly have a role in providing information, establishing the necessary framework and infrastructure, and, in some cases, helping companies to develop thebasic capabilities to adopt ISO 14001. There are wo particular areas in which government action would be useful:(a) providing information on he sectors and markets where ISO 14001 certification s a significant issue and assisting sector rganizations to develop appropriate responses, and(b) helping to establish a certification framework, ased on strengthening national standards organizations and encouraging competitive private sector provision of auditing and certificationservices. At present, the World Bank is having discussions with a number of countries about how assistance could be provided with these issues.
Governments should see EMS approaches as part of a broad environmental strategy that includes regulatory systems, appropriate financial incentives, and encouragement of improved industrial performance. Such encouragement can really only be effective where there is cooperation at the government level between the relevant departments, including industry and trade, as well as environment. There is a growing interest in integrating environmental management issues into productivity or competitiveness centers designed to promote SME performance, but little information exists on experience to date.

ISO 9001 Standards & ISO 14001 Standards Related Blogs

2009-10-08T19:21:00.001-07:00

ISO 14001 Template

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The ISO 14001Template were created to help you to prepare the ISO 14001Quality Manual, ISO 14001 Operating Procedure & ISO 14001 Forms. This ISO 14001 Template contains prewritten Quality Manual, Operating Procedure along with sample forms and checklists included as Microsoft Word & Excel format. It provides sample practical documentation in the proper ISO format required by the latest ISO 14001:2004.
The ISO 14001 Template features:-
• Specifically designed to be very easy to customize so that the entire documentation that is required by ISO 14001 : 2004 can be quickly and easily developed.• Professional design and layout.• It is designed to fulfill the ISO 14001 : 2004 requirements. .• Easy to read, easy to understand, and easy to implement.• Easy to audit as it follows the structure of ISO 14001: 2004..• Includes the required Process Flowchart.
The ISO 14001 Template series itself is generic, and is designed to be applicable to any manufacturing or service process. The ISO 14001 Environmental Management System (EMS) Template are consist of:
a. ISO 14001 EMS Manual TemplateThe Policy is fundamental to meeting the needs of ISO 14001. It essentially defines the rules and requirements of the organization with respect to the standard/EMS and as such is a central plank of the initiative.ISO 14001 Manual Template Consist of:• Section 1: General EMS Requirement• Section 2: Environment Policy – Objectives, Targets & Programmes• Section 3: EMS Planning• Section 4: Implementation & Operation• Section 5: Checking & Monitoring• Section 6: Management Review
b. ISO 14001 Operating ProcedureThe ISO 14001 Operating Procedure Template includes and integrates ISO 14001 EMS requirements, thus containing the most difficult part of the ISO 14001 documentation. The ISO 14001 Operating Procedure Template include the detailed samples of the Operating Procedures to fulfill the ISO 14001 : 2004 requirements for the procedures, making the customization process even easier. The entire manual follows the structure of ISO 14001 : 2004.
ISO 14001 Operating Procedures Consist Of:• Objective & Targets Procedure• Environmental Management Program Procedure• Environmental Aspect & Impact Identification & Evaluation Procedure• Environmental Monitoring & Measuring Procedure• Legal & Others Requirement & Evaluation Of Compliance Procedure• Emergency Preparedness & Response Procedure• Chemical Control Procedure• Waste Management Procedure• 5S House Keeping Procedure
c. ISO 14001 FormsISO 14001 Forms Consist Of :• Environmental Non-Conformance Master List• Environmental Non-Conformance Notice Form• Environmental Management Program Form• Environmental Aspect & Impact Identification Form• Green Environment Internal Audit Master Plan• Green Environment Plan & Activities Form• Green Environment Material Purchase Master List• ISO 14001:2004 Internal Audit Summary Report• Equipment Monitoring Master List• Environment Preventive Action Report (PAR) Master List• Environment Preventive Action Report (PAR) Form.• Environmental Responsible Form• EMS Organization Chart.• Waste Management Schedule Form• Totally Abolish Banned Substances & Target Deadline For Total Abolishment Form
For more information, please visit us at:
http://www.e-wia.com http://www.iso-consults.com http://www.iso9000-software.com

How To Implement ISO 9001 Standards Using Template & Softwares

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There are few ways of implementing the ISO 9000 in a particular organization. One of the easy way is hiring a ISO 9000 consultant in a turn key project basis. This definitely will incur cost. However, some of the organization will appoiint an employee to start up the ISO 9000, by learning thru seminar, preparing the ISO 9000 Quality Manual, Procedure & Form by using some of the ISO 9000 Template sell at internet. Some of the provider such as http://www.iso-consults.com & http://www.quality-template.com are providing such services.
Normally, the template provide will provides the ISO 9000 Quality Manual Template, Standand Procedure & also sample form for the ISO 9000 implementation. One of the provider like http://www.e-wia.com give a very complete set of the ISO 9000 Templates, which will help an organization to implement the ISO 9000 easily.
There are also some ISO 9000 Softwares which helps the organization in the ISO 9000 implementation. Some of the ISO 9000 Software are listed below:
a. Document Control Software – Software which Helps the organization to keep track & control of the ISO 9000 Documents.
b. Audit Control Software – Software which helps the organization to keep track of internal & external audit events.
c. Training Record Management Software – Software which helps the organization to keep track of Training records in a system.
d. Calibration Software – Software to maintain the calibration records for tool & machinery.
More Sites on ISO 9001 Standards Template & Softwares are as below:
http://www.iso9001store.com
http://www.iso14000store.com

Hidden Businees Opportunities

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The ISO 9001:2000 Standard has been revised after eight years. And the buzz is rapidly reaching a crescendo. We continue to receive numerous emails and phone calls regarding the impact of the new release. First, let me dispel any anxiety about the November 15, 2008 official “2008” release. There are no new requirements. The changes are largely interpretive, and focus on terminology clarifications. The changes to the ISO 9001 amendment, however, will have considerable benefit.As a back drop, keep in mind that ISO 9001 is not just an International Standard for a Quality Management System. It is the world’s most recognized business management standard. And it makes a strong business case. It focuses attention on leadership, business planning, organizational business processes, your customers (internal and external), measurement and reporting, and continual improvement. That translates to improved business results and a sustainable competitive advantage.
Overview of the Changes
The points of clarification focus on outsourcing, documentation, management representative, employee competence, design verification and validation, process monitoring, control of nonconforming product and corrective and preventive action. But bear in mind, no “shalls” (requirements) were added or removed.Examples of select changes include: In an attempt to clarify the term “outsourcing,” notes were added that require the organization to identify processes (and the control of these) to be completed by an external party. With respect to documentation, the changes focus on improving the compatibility between ISO 9001 and ISO 14001.The only significant addition to the management representative sub clause was to require that the MR be a member of the organization’s management team. This means a contracted person could serve in this role as long as he or she is also considered part of management. The management representative does not have to be full-time.With regard to competence of employees, a note was added to make training more pervasive throughout the organization. Training applies to all employees directly or indirectly responsible for delivering a service or producing a product (everyone that is part of the quality chain). A complete listing of changes can be found in Annex B (Table B.1) of the Standard. Also, note that there is better alignment with ISO 14001:2004.

Understand Quality Management

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Quality Management may be defined as the process through which organizations apply statistical process control mechanisms in order to improve the quality and standards of goods and services that are manufactured. Closely related to Quality Management is tqm, also known as total quality management. This is basically a management strategy that is applied in businesses in order to create awareness of high quality in most organizational processes. Quality Management features three main components including quality assurance, quality improvement and quality control. Quality management is focused not only on the quality of products and services but also on continuous improvement of quality standards.
Most methods that are now being used for Quality Management, quality system and quality manufacturing system take into consideration the need for high quality as an essential attribute in services and products that are manufactured by companies and organizations. Quality Management usually involves the successful improvement of quality of services and products. This is usually done through quality training processes where one can also acquire lessons on quality process and process management. One tool that is used for ensuring auditing quality in Quality Management is the MasterControlQAAD(TM) software. Besides using tools to carry out Quality Management successfully, one can also consider applying project management. This will help ensure continuous quality improvement.
The other way through which organizations can improve quality of process and service output is by using six sigma. This is basically a business management strategy that helps identify and remove defects and variations in the manufacturing process. It also helps guarantee Quality Management. It works by using a set of high quality business management and overall management methods to ensure quality and guarantee Quality Management. Most products and services to which Quality Management is applied are certified with iso certificates. Some of the iso certificates that guarantee that a product or service has undertaken Quality Management, change management and process improvement is iso 9001.
iso 9001 and iso 14001:2004 set down specific guidelines for environmental management systems and Quality Management. Other guidelines can be found in other generic process management philosophies such as the lean management that follows iso 9000 quality improvement standards aimed at guaranteeing total quality to its quality systems. The other mode through which organizations guarantee Quality Management is by use of a quality plan that meets iso 14000 and iso 14001 iso certification requirements. The other iso certification that guarantees product quality in Quality Management include iso 9001 2000.
In order to meet supplier quality in Quality Management systems, there are several iso training sessions that are offered. These meet iso standards. An organization that is in need of Quality Management for its products and services may also consider using a quality manual for its day to day Quality Management plans. Such a manual will usually have guidelines for iso quality. However, when applying the guidelines in the manual, regard must be had to quality audit measures aimed at guaranteeing Quality Management for the organization. Quality Management also involves knowledge of as9100 and iso 13485 that are commonly applicable in supplier management.
Quality Management programs that are iso certified help offer quality policy to existing iso 9001 certifications and quality management system that meet iso 9000 and ts16949 requirements. Quality companies that are aimed at ensuring Quality Management for the products and services that they manufacture also use quality management software that guarantees managing quality. In order to enhance Quality Management, the software guarantees quality procedures through its high rate of functionality. Besides such software, an organization can adopt quality assurance training and also offer quality consulting to its members in order to guarantee Quality Management to its products and services.
There are also several quality project management plans, which meet iso standards such as iso 9002 that are available today. Such plans are usually developed with a view to developing flexible, affordable and scalable management solutions to companies that seek to uphold Quality Management for their products and services. Such plans feature quality management systems that offer quality control management and quality assurance management through quality a management plan. Other quality objectives that can be obtained through iso 9001 training thus meeting iso 9000 certification use project management skills to improve Quality Management for the manufactured products and services.

ISO 14001 Standards – Complying with Environmental Laws and Regulations

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One of the most commonly cited reasons for implementing an ISO 14001 environmental management system is that it helps an organization comply with environmental laws and regulations.
ISO 14001 registration will provide additional assurance to City Council, senior management, regulators and key stakeholders that appropriate procedures have been implemented to identify, track, and communicate environmental laws and regulations. ISO 14001 registration will also provide assurance that our Administration is controlling, monitoring, and improving performance, relative to these laws/regulations.
A strong environmental management system, aimed at legal/regulatory compliance, will serve the City of Edmonton by increasing the likelihood of avoiding convictions, fines and judgments; avoiding internal legal costs; and promoting positive relations with regulators.

IS0 14001 – HISTORICAL DEVELOPMENT

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Firstly ISO 14000 environment system standards was prepared in June of 1992 year in Rio at world apex and this standard brooks decisions of this world apex and Rio contract principles. After 1 year, ISO established one technique committee which is yielded by 50 different country representatives to prepare international environment management system in 1993 year. ISO 14001 environment management system standard was issued in September of 1996 year with works of this committee. ISO 14001 standard is used as voluntary now but ISO 14001 will be burden by coercions of societies, international organizations, states in the future. Levels which environment management system passed are the following briefly:
= Europe community countries issued I action plan in 1973 year (to practice protecting preventions of environment )= BS 7750 Standard in 1992= Rio Declaration in 1992 year= ISO/TC 207. Environmental management technique committee was established in 1993 year to develop ISO 14000 family standards= TS 9719 standard (environment management system – General features) in 1994 year= ISO 14001 standard in 1996 year= ISO 14001 current version in April of 2005 Nisan 2005

ISO 14001 and The Environment

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The ISO 14000 family of International Standards on environmental management is a relative newcomer to ISO’s portfolio – but enviroment-related standardization is far from being a new departure for ISO.
In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.
On the one hand, it offers a wideranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards (out of a total morethan 12000) for the monitoring of such aspects as the quality of air, water and soil. These standards are means of providing business and government with scientifically valid data on the environmental effects of economic activity.
They also serve in a number of countries as the technical basis for environmental regulations.
ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sectors (companies, administration, public utilities). To spearhead this strategic approach, ISO establish a new technical commitee, ISO /TC 207, Environmental management, in
1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.
ISO’s direct involvement in environmental management stemmed from an intensive consultation process, carried out within the framework of a Strategic Advisory Group on Environment (SAGE),set up in 1991, in which 20 countrie, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.
This pioneering work was consolidated with ISO’s commitment to support the objective of “sustainable development” dicussed at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992.
Today, delegations of business and government experts from 55 countries have participate actively within TC 207,
and another 16 countries have observer status. These delegations are chosen by the national standars institute concerned and they are required to bring to TC 207 a national consensus on issue being addressed by the commitee.
This national consensus is derived from a process of consultation with interested parties.
From its beginning, it was recognized that ISO/TC 207 should have close cooperation with ISO/TC 176, Quality management and quality assurance, in the areas of management systems, auditing and related terminology. Active efforts are under way to ensure compatibility of ISO environmental management and quality management standards, for the benefit of all organizations wishing to implement them.

ISO 14001 ENVIRONMENTAL MANAGEMENT SYSTEM AUDIT

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In order to be in conformance with this provision of ISO 14001 an organization must be able to answer the overall question: “How does the organization conduct environmental audits of the EMS?”. In order to answer that question four specific tasks must be addressed under the Management System Audit section of the standard.
First, the organization must develop a program and related procedures that define an audit plan of the environmental management system. In addition the program must define frequency of the audit process. Second, the procedures must specify the methodology of the audit process, including the qualifications of the auditors. Third, the audit reports must be submitted to top management. Fourth, the audit reports must provide recommendations directed at correcting any reported nonconformance that was discovered in the audit process.
The audit process discussed in this section of the standard is directed at internal audits. The standard is silent on the frequency issue. Generally accepted practice with a mature ISO 14001 system is a total audit of the system once a year. In the implementation phase of an environmental management system a more frequent audit process might be appropriate. In addition any part of the environmental management system that has been previously determined to be in nonconformance should be audited with an increased frequency. The methodology of the audit process required by the standard requires two distinct steps:
A. determine whether the environmental management system conforms to the requirements of ISO 14001, andB. that the system has been managed as described in the Environmental Policy statement, the Environmental Objectives and Targets, and the related work descriptions and procedures.
It is critical that an audit report that relates a nonconformance be forwarded to top management promptly. The internal audit staff must be competent with respect to the requirements of ISO 14001.

Reasons a Company Becomes Certified in ISO 9001 Standards

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ISO 9000 certification or registration can be an expensive process. A company must consider the reasons and promised benefits for going through this process. If a company decides to seek certification, they should consider making sure their suppliers are certified or at least compliant to the ISO 9000 standards.
Major reasonsIn the early 1990s, companies seemed to be jumping on the certification bandwagon without seriously considering the rationale for doing so. Often they did so because competitors or “everybody else” is getting registered. Today companies seriously look at the reasons and benefits for becoming registered.
The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.
Improved businessA company can maintain a relationship with customers, as well as get increased business through complying to the ISO 900 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.
Finally, some companies want to become certified, so they can advertise that fact and give the impression of being better than their competitors.
You have seen ads with a logo stating the company is certified at some ISO 9000 level. It apparently gives those companies a leg up on competitors not registered.
Again, this seemed more important in the 1990s, but you don’t see that many companies using ISO 9000 certification as an advertising tool.
ISO 9000 is supposed to make sure your business is run in an orderly manner that will assure continued success.
One would think that a goal such as being run effectively and able to deliver goods consistently and reliably would also be desirable for a company’s own operation. Surprisingly, many companies do not consider that as a goal.

What is ISO 14000?

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ISO 14000 is a series of international standards that have been developed to incorporate environmental aspects into business operations and product standards. ISO 14001 is a specific standard in the series for a management system that incorporates a set of interrelated elements designed to minimize an organization’s impact on the environment. Similar to the ISO 9001 Quality Management System (QMS), ISO 14001 defines the implementation of an Environmental Management System (EMS). In addition, ISO14001 incorporates the QMS ISO 9001 management system philosophy, terminology, and requirement structure, providing system compatibility.
What Does ISO 14001 Require?
Originally issued in 1996 and later revised in 2004, the ISO 14001 EMS standard is intended to address the identification, evaluation, and continual improvement of an organization’s activities, products, or services that interact with the environment. The ISO 14001 methodology is a systematic approach for continually improving environmental management through identification and evaluation of aspects and impacts, development of objectives and measurable targets, implementation of programs, and on-going monitoring and review.

Understanding the ISO 14001 Standard

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ISO 14001 is an international voluntary standard that specifies the minimum elements for an environmental management system. It was published in 1996 by the International Organization for Standardization and is being taken up by organizations throughout the world at varying speeds.
The above is accepted as true by most people who are aware of the standard. Beyond these simple facts, however, there are many misconceptions about ISO 14001. For instance:
ISO 14001 will be a requirement for all companies.As with ISO 9000, conformance to ISO 14001 may become a condition of doing business in certain countries, regions or markets. This process already has begun in some industrial sectors, such as the automotive and electronics markets. However, there are still a tremendous number of companies in business today that do not conform to ISO 9000, even though that standard is now 13 years old. Thus it is too early to tell how widely ISO 14001 will be required in the future.
Implementing ISO 14001 means getting a registration.Many suppliers choose to demonstrate conformance to ISO 14001 through third-party certification. Some customers may require this. However, the standard itself considers a company’s self-declaration of conformance as an acceptable alternative. Further, some companies simply use the ISO 14001 model for internal purposes as a means to enhance their environmental performance.
ISO 14001 is just paperwork and won’t really help my company.ISO 14001 is like many things in life – you get out of it what you put into it. The way a company implements the standard determines what benefits it receives. Many companies that have implemented ISO 14001 report a variety of benefits, including improved environmental performance, greater operating efficiency, cost reduction, improved employee awareness and enhanced public image, among others.
Implementing ISO 14001 means throwing out our current environmental programs.ISO 14001 criteria specify “what to do,” not “how to do it.” Implementation approaches vary widely. There is no reason to think that your existing approach to environmental management must be put aside to satisfy ISO 14001.

ISO 14001:2004 Document Control System

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Documents required by the environmental management system and by this international standard shall be controlled. Records are a special type of document and shall be controlled in accordance with the requirements given in 4.5.4 (Control of Records).
The organization shall establish, implement, and maintain a procedure(s) to
a) approve documents for adequacy prior to issue;
b) review and update as necessary and re-approve documents;
c) ensure that changes and the current revision status of documents are identified;
d) ensure that relevant versions of applicable documents are available at points of use;
e) ensure that documents remain legible and readily identifiable;
f) ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the environmental management system are identified and their distribution controlled; and
g) prevent the unintended use of obsolete documents and apply suitable identification to them if they are retained for any purpose. [ISO 14001, 4.4.5]
http://www.iso-consults.com
http://www.e-wia.com

Implementing ISO 14001

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ISO 14001 is an internationally recognised standard that provides a framework for a strategic approach to corporate environmental management. This standard gives organisations the means to identify and control their environmental impacts, improve performance and achieve their objectives and targets. The standard is independently audited, giving it great strength and integrity.
Due to its widespread adoption (e.g. Barclays, Credit Suisse and UBS in the financial sector), it now acts as a common reference for communication about environmental issues. ISO 14001 provides assurance to stakeholders on environmental claims and helps organisations meet requirements laid down by clients and investors.
Adoption of ISO 14001 is being driven by stakeholder concerns as well as the significant benefits on offer to adopters. Few companies are now exempt from government, client and investor demands for accountability and improved environmental performance. With brand and reputation on the line, it is a risky strategy to ignore these concerns.
However, choosing how to act is not a straightforward decision. Companies that rushed to announce their green credentials without independent verification and transparency fell foul of greenwash accusations and suffered perhaps more damage to their reputation than had they not acted in the first place. In response to this, many companies are now choosing to implement internationally recognised and independently audited environmental management systems such as ISO 14001.
The benefits of implementing ISO 14001 are extensive:
It immediately enhances corporate reputation and sends a clear signal of commitment to corporate responsibility. Accusations of greenwash are prevented by the transparent and robust approach of the standard.
Proactive environmental management increases attractiveness to investors, especially for Socially Responsible Investment (SRI), an area already accounting for £9 billion investment per year in the UK alone.
ISO 14001 accreditation may also bring financial benefits through increased market share. Firms can differentiate themselves from competitors as responsible companies as well as securing the rewards of first mover advantage in new markets. In addition, many buyers are now implementing sustainable procurement codes and stipulating conditions in Requests for Information (RFIs) where suppliers are required to have environmental credentials. Gaining ISO 14001 accreditation ensures access to environmentally demanding but high reward markets.
Financial benefits are not limited to increased investment and sales. Implementation of an EMS may produce significant cost savings that actually negate the initial outlay. With energy and waste prices rising sharply, environmental responsibility can produce a win:win opportunity.
Perhaps the most significant benefit for many will be the positive effect on attracting and retaining staff. With intense competition for the best staff, corporate responsibility is becoming a key criterion against which employers are judged.
Finally, responsible environmental management is quickly becoming a necessary condition for business, a socially accepted norm of behaviour. Those who fail to follow these norms risk damage to their reputation and the possibility of their social licence to operate being revoked.
A standard as thorough and robust as ISO 14001 has an equally thorough implementation process with extensive requirements for procedures and auditable document trails. Implementation follows the Plan-Do-Check-Review cycle and key required procedures are detailed in the diagram below. Implementation will entail the creation of at least 20 procedures and supporting documents. The procedures are all company-specific and must be tailored to suit individual operations. It is this level of detail that gives the standard such strength and integrity.

The ISO 14000 Challenge

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The building blocks of an environmental management system is an understanding of aspects and impacts.
Implementing ISO 14001 begins with identifying how an organisation’s business activities impact on the
environment.
Many organisations believe they are already aware of the significant aspects and impacts of their operations.
The process of implementing ISO 14001 may uncover significant impacts not previously identified and allows
for a consistent approach to analysis.
Generally this analysis is done department by department or centre by centre.
It is best if it is a team approach that involves the employees who do the activity. An employee’s
familiarity with a task is essential for both the identification of the environmental impacts of business
activities and the determination or implementation of control measures.
An aspect is any element of an organisation’s activities, products or services that can interact with the
environment.
An impact is the change caused to the environment.
Impacts may occur during normal and abnormal operating conditions, such as accidents and
emergencies.
Aspects can often be isolated by analysing the inputs and outputs of an activity.
EVALUATION OF IMPACTS
Once the impacts have been determined they have to be evaluated.
Criteria for evaluation include environmental concerns such as the severity of the impact, and business
concerns such as potential regulatory and legal exposure, the probability of the impact occurring, the
cost of changing the impact and effect on public image.
This type of evaluation highlights the significant impacts. These, in turn, determine the significant
aspects. Once the significant aspects have been determined, targets and objectives can be set.

Please visit http://www.iso9001-standard.us for more information

What Is an Environment Management System (EMS) ?

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An EMS can be described as a program of continuous environmental improvement that follows a defined sequence of steps drawn from established project management practice and routinely applied in business
management. In simple terms these steps are as follows:
• Review the environmental consequences of the operations.
• Define a set of policies and objectives for environmental performance.
• Establish an action plan to achieve the objectives.
• Monitor performance against these objectives.
• Report the results appropriately.
• Review the system and the outcomes and strive for continuous improvement.
Not every system will present these steps in exactly the same way, but the basic principles are clear and easily understandable.
The ISO 14000 series is a series of standards for different aspects of environmental management. A number of these standards relating to environmental management systems have been adopted formally by
the members of the ISO, while others are in different stages of preparation.
The standards that have been adopted are (as of early 1997):
ISO 14001-1996 Environmental management systems:
specification with guidance for use
ISO 14004-1996 Environmental management systems:
general guidelines on principles, systems, and supporting techniques
ISO 14010-1996 Guidelines for environmental auditing:
general principles of environmental auditing
ISO 14011-1996 Guidelines for environmental auditing:
audit procedures; auditing of environmental management systems.
ISO 14012-1996 Guidelines for environmental auditing:
qualification criteria for environmental auditors Standards currently available as draft international standards:
ISO 14021 Environmental labels and declarations:
self-declaration environmental claims; guidelines and definition and usage of terms.
ISO 14040 Environmental management: life cycle assessment; principles and framework
ISO 14050 Environmental management: vocabulary More than half a dozen others in this series have been drafted and are under discussion.

Quality Planning

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Whenever the term “product” is used within the ISO 9001 standard, it refers to both tangible goods and intangible services. The ISO 9001 standard is meant to be generic which means that it is suitable for all kinds of organization, whether commercial or otherwise. The purpose of the quality management system model that is being propagated by the standard is the fulfillment of customer requeirements and expectations in order to induce high levels of customer satisfaction. An unsatisfied customer is essentially a customer whose requirements or needs, and expectations of the level of services being granted upon him/her have not been met. We are all customers because we buy products all the time. So we know what it means to be a dissatisfied customer. The common reaction is to never to go back to that seller and look for other alternatives. A successful organization is one which understands what it takes to meet customer requirements in order to satisfy their needs and expectations. A specific process is thus necessary to resolve any customer complaint or dispute. This process should be geared towards satisfying the customer’s needs and expectations. The parameters of this process should be referenced from the terms of the sale and purchase. This is why it is necessary to review the customer’s requirements before committing to the sales contract. It is necessary that the customer understands what he/she is paying for and it is equally necessary for the organization to understand what it is supposed to deliver. When your organization has these processes in place, then the only thing to do next is to continually measure the effectiveness and subsequently take actions to continually improve the whole process.