ISO 9001 Standard / ISO 9001 Standards – ISO 9000 Standard / ISO 9000 Standards Certification & Implementation

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.

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.

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.

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.

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 Coordinator
The 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 analysis
A 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 resources
After 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 Team
Top 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 policy
The 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.

Elements Of The Six Sigma Framework

Management strategies, such as TQC, TQM, and Six Sigma, are distinguished from each other by their underlying rationale and framework. As far as the corporate framework of Six Sigma is concerned, it embodies the five elements of top-level management commitment, training schemes, project team activities, measurement system and stakeholder involvement. 

Stakeholders include employees, owners, suppliers and customers. At the core of the framework is a formalized improvement strategy with the following five steps: define, measure, analyse, improve and control (DMAIC) which will be explained in detail in Section 2.3. The improvement strategy is based on training schemes, project team activities and measurement system. Top-level management commitment and stakeholder involvement are all inclusive in the framework. 

Without these two, the improvement strategy functions poorly. All five elements support the improvement strategy and improvement project teams.  Most big companies operate in three parts: R&D, manufacturing, and non-manufacturing service. Six Sigma can be introduced into each of these three parts separately. In fact, the color of Six Sigma could be different for each part. Six Sigma in the R&D part is often called “Design for Six Sigma (DFSS),” “Manufacturing Six Sigma” in manufacturing, and “Transactional Six Sigma (TSS)” in the non-manufacturing service sector. All five elements are necessary for each of the three different Six Sigma functions. However, the improvement methodology, DMAIC, could be modified in DFSS and TSS. These points will be explained in detail in Sections 2.6 and 2.7.2.2 Top-level Management Commitment and Stakeholder Involvement 

(1) Top-level management commitment

Launching Six Sigma in a company is a strategic management decision that needs to be initiated by top-level management. All the elements of the framework, as well as the formalized improvement strategy, need top-level management commitment for successful execution. Especially, without a strong commitment on the part of top-level management, the training program and project team activities are seldom successful. Although not directly active in the day-to-day improvement projects, the role of top-level management as leaders, project sponsors and advocates is crucial. Pragmatic management is required, not just lip service, as the top-level management commits itself and the company to drive the initiative for several years and into every corner of the company.

There are numerous pragmatic ways for the CEO (chief executive officer) to manifest his commitment. First, in setting the vision and long-term or short-term goal for Six Sigma, the CEO should play a direct role. Second, the CEO should allocate appropriate resources in order to implement such Six Sigma programs as training schemes, project team activities and measurement system. Third, the CEO should regularly check the progress of the Six Sigma program to determine whether there are any problems which might hinder its success. He should listen to Six Sigma reports and make comments on the progress of Six Sigma. Fourth, he should hold a Six Sigma presentation seminar regularly, say twice a year, in which the results of the project team are presented and good results rewarded financially. Finally, he should hold a Champion Day regularly, say once in every other month, in which Champions (upper managers) are educated by specially invited speakers and he should discuss the progress of Six Sigma with the Champions.

It is also the responsibility of top-level management to set “stretch goals” for the Six Sigma initiative. Stretch goals are tough and demanding, but are usually achievable. Some companies set the stretch goal for process performance at 6 sigma or 3.4 DPMO for all critical-to-customer characteristics.  

However, the goals can also be set incrementally, by stating instead the annual improvement rate in process performance.

The industry standard is to reduce DPMO by 50% annually.

(2) Stakeholder involvement

 Stakeholder involvement means that the hearts and minds of employees, suppliers, customers, owners and even society should be involved in the improvement methodology of Six Sigma for a company. In order to meet the goal set for improvements in process performance and to complete the improvement projects of a Six Sigma initiative, top-level management commitment is simply not enough. The company needs active support and direct involvement from stakeholders.

 Employees in a company constitute the most important group of stakeholders. They carry out the majority of improvement projects and must be actively involved. The Six Sigma management is built to ensure this involvement through various practices, such as training courses, project team activities and evaluation of process performance. Suppliers also need to be involved in a Six Sigma initiative.

 A Six Sigma company usually encourages its key suppliers to have their own Six Sigma programs. To support suppliers, it is common for Six Sigma companies to have suppliers sharing their performance data for the products purchased and to offer them participation at in-house training courses in Six Sigma. It is also common for Six Sigma companies to help small suppliers financially in pursuing Six Sigma programs by inviting them to share their experiences together in report sessions of project team activities. The reason for this type of  involvement is to have the variation in the suppliers’ products transferred to the company’s processes so that most of the process improvement projects carried out on suppliers’ processes would result in improvement of the performance.

Customers play key roles in a Six Sigma initiative. Customer satisfaction is one of the major objectives for a Six Sigma company. Customers should be involved in specific activities such as identifying the critical-to-customer (CTC) characteristics of the products and processes. CTC is a subset of CTQ from the viewpoint of the customers. Having identified the CTC requirements, the customers are also asked to specify the desired value of the characteristic, i.e., the target value and the definition of a defect for the characteristic, or the specification limits. This vital information is utilized in Six Sigma as a basis for measuring the performance of processes. In particular, the R&D part of a company should know the CTC requirements and should listen to the voice of customers (VOC) in order to reflect the VOC in developing new products.

ISO 14001 Environmental Aspects And Impacts

The fundamental purpose of the EMS is to control and reduce the environmental impacts of your facility’s processes and products. For this reason, a critical element of the EMS involves identifying and prioritizing the environmental aspects and impacts associated with your facility. An environmental aspect is an element of an organizations activities, products, or services that can interact with the environment. For example, chrome plating is a metal finishing activity and an associated aspect is chrome air emissions.
This aspect may have an impact on the environment in several ways, for example, ambient air quality degradation.
The environmental aspects and impacts of your metal finishing operations can be identified, prioritized, and documented in several ways. This Template includes two approaches, either of which can be used during EMS implementation. Use the approach that works best for your circumstances. This process is important because high-priority environmental aspects and impacts will be considered when environmental objectives and targets are established.

Aspects and Impacts Form A — The first approach uses the experience and judgment of
employees familiar with facility processes to identify the top five environmental issues
currently facing the facility. These issues and their specific aspects and impacts should
be summarized using Aspects and Impacts Form A.

Aspects and Impacts Form B — The second approach uses detailed, structured matrices
to list and prioritize environmental aspects and impacts according to the following
categories:
• Environmental Aspects and Impacts: Wastewater
• Environmental Aspects and Impacts: Air Emissions
• Environmental Aspects and Impacts: Hazardous and Solid Waste
• Environmental Aspects and Impacts: Raw Materials
• Environmental Aspects and Impacts: Water and Energy

The matrices that comprise Form B will help facility staff identify and document environmental aspects and impacts. The matrices also provide criteria for prioritizing environmental aspects and impacts; this process is important because high-priority environmental aspects and impacts will be considered when environmental objectives and targets are established. One possible way to prioritize environmental aspects and impacts using Form B is described as follows:
Step 1:
For each aspect and impact, score each prioritization criterion on a scale from 1 to 5, where 1 indicates the criterion is very important or relevant to that aspect (for example, the aspect is strictly regulated, is the subject of compliance violations, or is a waste generated in large uantities), and 5 indicates the criterion is relatively unimportant or irrelevant to that aspect (for example, the aspect is an unregulated waste, is generated infrequently, and is inexpensive to manage).
Step 2:
Add the scores of all criteria for each aspect and write the total in the right-most column of the form.
This number indicates the relative priority of the aspect compared to other aspects and impacts in the same category. The lower the total score, the higher the priority.
Purpose Of This procedure is used to identify, document, and update the environmental aspects and impacts of facility processes and operations.

Step 1 The environmental manager and other facility personnel selected by the environmental manager are responsible for identifying and prioritizing the environmental aspects and impacts of facility operations during EMS planning and development.
Environmental aspects are characteristics of facility processes and products that interact with the environment. Only environmental aspects the company can control or influence will be considered. Environmental impacts are the effects of an organization’s activitie , products or services on the environment.

Step 2 Environmental aspects and impacts will be documented and prioritized.
Environmental aspects and impacts will be associated with the following categories:
• Wastewater
• Air emissions
• Hazardous and solid waste
• Raw materials
• Water and energy
High-priority environmental aspects and impacts will be considered when environmental
objectives and targets are set.

Step 3 The environmental manager and other facility personnel will review and update
the environmental aspects and impacts documentation annually.

Step 4 Environmental aspects and impacts documentation will be retained at the facility
for at least 2 years.

Responsible Person: _____________________________________
Signature and Date: ______________________________________

ISO 14001 ENVIRONMENTAL POLICY

The intent of an environmental policy is to state the organization’s commitment to continuous improvement in environmental performance. A strong, clear environmental policy can serve as both a starting point for developing the EMS and a reference point for maintaining continuous improvement.
The policy should be evaluated regularly and modified, as necessary, to reflect changing environmental priorities.
The policy should function in two ways: (1) within the company, the policy should focus attention on environmental issues associated with company activities, products, and services; and (2) outside the company, the policy is a public commitment to addressing environmental issues and continuously improving environmental performance.
The environmental policy must address:
• Commitment to compliance with relevant environmental legislation and
regulations
• Pollution prevention
• Continuous improvement

Tips for Developing an Environmental Policy:
1. Develop a policy that reflects perspectives of various employees within the company (for example, line worker, owner, wastewater treatment operator, quality inspector, compliance/legal manager, production manager).
2. Display the policy statement in view of all employees; the policy should be available to the public and customers if requested and be printed in languages other than English, as appropriate.
3. Include top management signatures on the policy to demonstrate understanding and commitment.
Purpose This procedure is used to develop and write the company’s environmental policy.

Step 1 The environmental manager will form a policy development team responsible for developing and writing the environmental policy. The policy will address, at a minimum, compliance, pollution prevention, and continuous improvement.

Step 2 The policy development team will review other relevant documents to ensure consistency with other company policies and guide the content and phrasing of the policy. Example documents include the company mission statement and the example environmental policies included in this EMS element.

Step 3 The policy will be displayed in view of all employees and introduced to new employees; the policy will be available in languages other than English, as appropriate, and to the public (on request) and customers (as appropriate).
Step 4 The environmental manager will review the environmental policy at least annually, and update it if needed.

Responsible Person: _____________________________________
Signature and Date: ______________________________________

Environmental Policy Example 1

It is the policy of COMPANY NAME to conduct its operations in a manner that is environmentally responsible and befitting a good corporate neighbor and citizen.
In accordance with this policy, COMPANY NAME complies with all environmental laws and manages all phases of its business in a manner that minimizes the impact of its operations on the environment.
To further this policy, COMPANY NAME shall:
1. Include environmental requirements in planning and design activities
2. Comply with applicable environmental laws and regulations
3. Eliminate, or reduce to the maximum practical extent, the release of contaminants into the environment, first through pollution prevention (material substitution and source reduction), then recycling, and finally through treatment and control technologies
4. Effectively communicate with company employees, suppliers, regulators, and customers, as well as the surrounding community, regarding the environmental impact of company operations
5. Periodically review and demonstrate continuous improvement in the company’s environmental management system

SIGNATURE___________________

Responsible Person
______________________

Environmental Policy Sample 2

Effective Date

ENVIRONMENTAL POLICY

_________________________ IS COMMITTED TO IMPROVE THE HEALTH, SAFETY AND ENVIRONMENT FOR OUR EMPLOYEES, NEIGHBORS, AND FAMILIES.

WE WILL MEET AND OR EXCEED LAWFUL COMPLIANCE THROUGH POLLUTION PREVENTION PRACTICES AND CONTINUOUS IMPROVEMENT.

TO IMPLEMENT THIS POLICY WE WILL CREATE AN ENVIRONMENTAL MANAGEMENT SYSTEM TO IDENTIFY GOALS, SYSTEMS, MEASUREMENTS AND SAMPLING METHODS.
TO SUPPLEMENT THIS POLICY WE WILL INCORPORATE SOURCE REDUCTION THROUGH REUSE, RECYCLING, MATERIAL SUBSTITUTION, NEW AND IMPROVED TECHNOLOGIES, CREATIVE MANAGEMENT AND OPERATIONAL PRACTICES.

TO MAINTAIN THIS POLICY WE WILL PERFORM MANAGEMENT REVIEW, REVENTATIVE MAINTENANCE, EMPLOYEE TRAINING, AND A COMMITMENT AND INVOLVEMENT FROM OUR EMPLOYEES AND MANAGEMENT TO SUPPORT THIS POLICY.

ISO 9001 Quality Policy

The standard requires the quality policy to be appropriate to the purpose of the organization.

The purpose of an organization is quite simply the reason for its existence and as Peter Drucker so eloquently put it there is only one valid definition of business purpose: to create a customer”(Drucker, Peter F., 1977)2 . In ensuring that the quality policy is appropriate to the purpose of the organization, it must be appropriate to the customers the organization desires to create. It is therefore necessary to establish who the customers are, where the customers are, what they buy or wish to receive and what these customers regard as value. As stated above, the quality policy is the corporate policy and such policies exist to channel actions and decisions along a path that will fulfil the organization’s purpose and mission. A goal of the organization may be the attainment of ISO 9001 certification and thus a quality policy of meeting the requirements of ISO 9001 would be consistent with such a goal, but goals are not the same as purpose as indicated in the box to the right. Clearly no organization would have ISO 9001 certification as its purpose because certification is not a reason for existence – an objective maybe but not a purpose.

Policies expressed as short catchy phrases such as “to be the best” really do not channel actions and decisions. They become the focus of ridicule when the organization’s fortunes change. There has to be a clear link from mission to quality policy.

Policies are not expressed as vague statements or emphatic statements using the words may, should or shall, but clear intentions by use of the words ‘we will’

– thus expressing a commitment or by the words ‘we are, we do, we don’t, we have’ expressing shared beliefs. Very short statements tend to become slogans which people chant but rarely understand the impact on what they do. Their virtue is that they rarely become outdated. Long statements confuse people because they contain too much for them to remember. Their virtue is that they not only define what the company stands for but how it will keep its promises.

In the ISO 9001 definition of quality policy it is suggested that the eight quality management principles be used as a basis for establishing the quality policy.

One of these principles is the Customer Focus principle. By including in the quality policy the intention to identify and satisfy the needs and expectations of customers and other interested parties and the associated strategy by which this will be achieved, this requirement would be fulfilled. The inclusion of the strategy is important because the policy should guide action and decision. Omitting the strategy may not ensure uniformity of approach and direction.

The standard requires that the quality policy include a commitment to comply with requirements and continually improve the effectiveness of the quality management system.

A commitment to comply with requirements means that the organization should undertake to meet the requirements of all interested parties. This means meeting the requirements of customer, suppliers, employees, investors, owners and society. Customer requirements are those either specified or implied by customers or determined by the organization and these are dealt with in more detail under clauses 5.2 and 7.2.1. The requirements of employees are those covered by legislation such as access, space, environmental conditions, equal opportunities and maternity leave but also the legislation appropriate to minority groups such as the disabled and any agreements made with unions or other representative bodies. Investors have rights also and these will be addressed in the investment agreements. The requirements of society are those obligations resulting from laws, statutes, regulations etc.

An organization accepts such obligations when it is incorporated as a legal entity, when it accepts orders from customers, when it recruits employees, when it chooses to trade in regulated markets and when it chooses to use or process materials that impact the environment.

The effectiveness of the management system is judged by the extent to which it fulfils its purpose. Therefore improving effectiveness means improving the capability of the management system. Changes to the management system that improve its capability i.e its ability to deliver outputs that satisfy all the interested parties, are a certain types of change and not all management system changes will accomplish this. This requirement therefore requires top management to pursue changes that bring about an improvement in performance.

Scope Of  The Quality Management System

The ISO 9001 standard requires the quality manual to include the scope of the quality management system including details of justification for any exclusion. The standard addresses activities that may not be relevant or applicable to an organization. The permissible exclusions are explained in section 1.2 of ISO 9001. Here it states that the organization may only exclude requirements that neither affect the organization’s ability, nor its responsibility to provide product that meets customer and applicable regulatory requirements. The requirements for which exclusion is permitted are limited to those in section 7 of the standard.

Under ISO 9001:2008, it was possible for organizations to exclude functions and processes of their organization that may have been difficult to control or were not part of the order fulfilment cycle. Organizations that designed their own products but not for specific customers could escape bringing these operations into the management system. Marketing was omitted because it operated before placement of order. Accounting, Administration, Maintenance, Publicity, Public Relations and After Sales Support functions were often omitted because there were no requirements in the standard that specifically dealt with such activities. As there is no function in an organization that does not directly or indirectly serve the satisfaction of interested parties, it is unlikely that any function or process will now be excluded from the quality management system.

It is sensible to describe the scope of the quality management system so as to ensure effective communication. The scope of the quality management system is one area that generates a lot of misunderstanding particularly when dealing with auditors, consultants and customers. When you claim you have a management system that meets ISO 9001 it could imply that you design, develop, install and service the products you supply, when in fact you may only be a distributor. Why you need to justify specific exclusions is uncertain because it is more practical to justify inclusions.

The scope of the quality management system is the scope of the organization. There is no longer any reason to exclude locations, activities, functions or processes for which there is no requirement in the standard. The reason is because the ISO 9000 family now serves customer satisfaction and is not limited to quality assurance as were the 1994 versions of ISO 9001, ISO 9002 and ISO 9003.

It is not appropriate to address exclusions by inserting pages in the manual corresponding to the sections of the standard and adding justification if not within the scope of the management system – such as ‘We don’t do this!’.

It is much more appropriate to use an appendix as indicated previously in the manual contents list. By describing the nature of the business, you are establishing boundary conditions. If in doing so you do not mention that you design products, it will be interpreted that design is not applicable.

For exclusions relative to detail requirements, the Compliance Matrix may suffice but for an unambiguous solution, it is preferable to produce an exposition that addresses each requirement of the standard.