Document: ISO/TC 176/SC 2/N

524R3

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Secretariat of ISO/TC 176/SC 2

Date:

13 February 2002

ISO 9000 Introduction and Support Package: Guidance on ISO 9001:2000 clause 1.2 'Application'
In conjunction with the publication of the International Standards ISO 9001:2000 and ISO 9004:2000, ISO/TC 176/SC 2 has published a number of guidance modules: Guidance on ISO 9001:2000 clause 1.2 'Application' Guidance on the Documentation requirements of ISO 9001:2000 Guidance on the Process Approach to quality management systems Guidance on the Terminology used in ISO 9001:2000 and ISO 9004:2000 _1)
(1) This module was developed jointly with ISO/TC 176/SC1/WG2. ISO/TC 176/SC1 was responsible for the development of ISO 9000:2000 Quality management systems - Fundamentals and vocabulary)

Together these are being made available as the ISO/TC 176/SC 2 'ISO 9000 Introduction and Support Package. Feedback from users of the standards will be used to determine whether additional modules should be developed, or if these published modules should be revised. The modules, and further information on the year 2000 ISO 9000 standards, may be downloaded from web site:

http://www.bsi.org.uk/iso-tc176-sc2
This particular module has become a point of focus in the discussions between the International Accreditation Forum (IAF), the ISO Policy Committee on Conformity Assessment (ISO/CASCO), and ISO/TC 176, on harmonizing the application of the ISO 9000 standards. A copy of the "IAF Guidance on the Application of ISO 9001:2000" is given in annex C. Reference should be made to web site: http://www.iaf.nu for details of further IAF documents. The changes in this document, when compared to the earlier N524R2 version, are solely due to changes in the IAF Guidance, given in annex C. C Corrie for BSI Secretariat ISO/TC 176/SC 2

BSI Standards, 389 Chiswick High Road, London W4 4AL Telephone: + +44 208 996 9000 Fax: + +44 208 996 7400

ISO 9000Product Introduction and Support Package: Guidance on ISO 9001:2000 clause 1.2 'Application'

1 Introduction
One objective of the Year 2000 revisions to the ISO 9000 family of standards is to simplify the structure and reduce the number of standards within the family. The replacement of ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 by a single quality management system (QMS) requirements standard, ISO 9001:2000, supports this objective. ISO 9001:2000 is intended to be generic, and applicable to all organizations, regardless of type, size and product category. It is recognised, however, that not all the requirements of this new standard will necessarily be relevant to all organizations. Under certain circumstances, an organization may exclude some specific ISO 9001:2000 requirements from its QMS. ISO 9001:2000 makes allowance for such organizations, through clause 1.2 Application. This module from the ISO 9000 Introduction and Support Package has been developed by ISO/TC 176/SC 2 to provide users with information regarding the intent of ISO 9001:2000 clause 1.2 Application, including some typical examples of its use in practical situations.

The scope of a quality management system

ISO 9001:2000 clause 1 Scope defines the scope of the standard itself. This should not be confused with the scope of the QMS, which is a term commonly used within the context of QMS certification/registration to describe the organization and products to which the QMS applies. The remainder of this guidance document will refer to the scope of the QMS. The scope of the QMS should be based on the nature of the organization's products and their realization processes, the result of risk assessment, commercial considerations, and contractual, statutory and regulatory requirements. If an organization chooses to implement a QMS with a limited scope, this should be clearly defined in the organisation's Quality Manual and any other publicly available documents to avoid confusing or misleading customers and end users (this includes, for example, certification/registration documents and marketing material).

Application of ISO 9001:2000

It is intended that organizations seeking to implement ISO 9001:2000 will comply with all the requirements of the standard that are applicable to the products within the scope of the QMS. However, even when an organization includes all its products in the scope of its QMS, it may be found that some of the requirements of ISO 9001:2000 clause 7 Product realization cannot be applied. This could be due to the nature of the organization, andor that of its products or realization processes. In such circumstances, the organization may limit the application of the requirements of ISO 9001:2000, in accordance with clause 1.2. Clause 1.2 of ISO 9001:2000 states:1.2 Application All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

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ISO 9000Product Introduction and Support Package: Guidance on ISO 9001:2000 clause 1.2 'Application'
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that fulfils meets customer and applicable regulatory requirements. It should be noted that clause 1.2 of ISO 9001:2000 applies to specific requirements of this International Standard. There may, however, be circumstances where an entire clause or subclause can be excluded. An example would be clause 7.3 Design and development, which could be excluded in its entirety if no part of the design and development process is performed by the organization and it has no responsibility for this process.

Justification of exclusions

Where an organization finds that it cannot apply certain requirements of ISO 9001:2000, this has to be defined and justified in the organization's Quality Manual. Any publicly available documents, such as certification/registration documents or marketing materials, should be carefully phrased in order to avoid confusing or misleading customers and end users regarding the application of ISO 9001:2000 requirements within the organizations QMS. ISO 9001:2000 clause 4.2.2(a) Quality manual requires that: The organization shall establish and maintain a quality manual that includes: a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2);. "

5 Claims of conformity, and requirements that may not be excluded

If an organization excludes from its QMS ISO 9001:2000 requirements that do not meet the criteria established in clause 1.2 Application, then conformity to ISO 9001:2000 may not be claimed or implied. This includes the following situations:

Where an organization fails to comply with the requirement in clause 4.2.2(a) Quality manual to provide justification for the exclusion of specific clause 7 Product realization requirements. Where requirements in clause 7 have been excluded because they are not required by regulatory bodies, but the requirements affect the organizations ability to meet customer requirements. Where an organization decides not to apply a requirement in clause 7 based only on the justification that this was not a requirement of either ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994, and had not been previously included in the organizations QMS.

Outsourced processes

ISO 9001:2000 clause 4.1 General requirements states that: Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. Where the overall responsibility for product realization belongs to an organization, the fact that a specific product realization process (such as product design and development or manufacturing) is outsourced (or sub-contracted) to an external organization is not an adequate justification for the exclusion of this process from the QMS. Instead, the organization has to be able to demonstrate that it exercises sufficient control to ensure that such processes are performed according to the relevant requirements of ISO 9001:2000. The nature of this control will depend on the nature of the outsourced

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process and the risk involved. It may include, for example, the specification and/or validation of processes as part of the contractual agreement with the supplier, requirements for the suppliers QMS, on-site inspections or verifications, and/or audits. ISO 9001:2000 clause 7.4 Purchasing should be applied to monitor the output of these outsourced or subcontracted processes. In these circumstances, the organization should include such processes in the scope of its QMS and make it clear in its Quality Manual and any other publicly available documents that the QMS covers the management of these outsourced or subcontracted activities for which the organization retains overall responsibility.

Regulated industries and other regulatory situations

For organizations with products or realization processes that are subject to regulation, Annex B to this guidance document gives broad comparisons between ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 requirements and the new requirements of ISO 9001:2000. It is emphasized, however, that if the organization excludes requirements of ISO 9001:2000 beyond those permitted in clause 1.2 of the standard, claims of conformity to ISO 9001:2000 are not valid, even if such exclusions are allowed by the regulatory body.

Certification / registration

A clear description of the scope of an organization's QMS, and the application of the requirements of ISO 9001:2000 within that scope, is of increased importance for certification/registration purposes, since there will no longer be the option to issue certificates to ISO 9002 or ISO 9003 beyond 15 December 2003.

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Annex A
Examples of the Application of ISO 9001:2000 Requirements
Given below are a number of examples designed to show the reasoning used to determine which requirements of ISO 9001:2000 are applicable to an organization. It is stressed that these are only hypothetical examples, and that in reality each organizations particular circumstances will have to be analysed carefully. Although the standard allows for the exclusion of individual requirements, the examples given here refer to entire sub-clauses, for simplicity. Situations will occur in which organizations may justifiably exclude other ISO 9001:2000 requirements from their QMS, either individually, or as entire sub-clauses. In all examples, it is assumed that the exclusions mentioned do not affect the organizations ability, or responsibility, to provide product that fulfils customer and applicable regulatory requirements.

Example 1
ABC Bank provides a variety of services to its customers, but chooses to implement a QMS only for its on-line internet banking services. This is acceptable, provided that any associated documentation (Quality Manual, any eventual QMS Certification and promotional material) makes it clear which services are covered by the QMS. The bank applies all the requirements of ISO 9001:2000 for the realization of its internet banking service, without any exclusions. Initially the bank had excluded clause 7.5.4 Customer property from its QMS, but then realized that its customers do indeed provide important personal information in confidence, when signing up for the service, and that this constitutes Customer property.

Example 2
The DEF Bottling Company is a manufacturing facility that produces soft drinks according to product and packaging specifications provided by its parent company. It also manufactures products under license according to full product and packaging specifications provided by another independent company. These two sets of specifications meet all regulatory requirements and have not changed for years. DEF Bottling Company excluded ISO 9001:2000 clause 7.3 Design and development, from its QMS because the responsibility for product design and development belongs to the parent company and the licensor. Full justification for this decision is provided in DEFs Quality Manual, and neither DEFs claim of conformity, nor any associated publicity materials imply that the manufacturing plant has any design activity relating to its products. The fact that the design has not changed for years is irrelevant to the exclusion of clause 7.3 for this specific case. Changing regulatory requirements may necessitate changes to the product design and the application of clause 7.3 by the organisation responsible for the design, which in this case is not DEF Bottling Company. DEFs QMS. The corporate purchasing division of DEFs parent company negotiates all raw material and packaging purchases, in order to negotiate better prices. The organization recognizes that, even though the manufacturing unit does not carry out the operational part of purchasing, it has an important input into the process, particularly for the initiation of orders for raw material and packaging and the verification of the purchased product. DEF therefore does not exclude clause 7.4 Purchasing from its QMS and explains in its documented QMS the way in which the purchasing process operates, including a description of the interfaces between the manufacturing plant and its corporate purchasing division. It also applies the requirements of clause 7.4 to other purchased products and services, which are managed locally.

Example 3
HIJ & Partners is a firm of international lawyers that has implemented a QMS based on ISO 9001:2000. The QMS includes the design and development of new services such as international tax planning, as well as changes to the design of existing services to take advantage of worldwide electronic databases of applicable legislation. HIJ also designs and develops customised services to meet specific customer requirements. Purchasing control includes the selection of computer hardware and software, as well as the subcontracting of specialist lawyers as needed. The only exclusions to ISO 9001:2000 (justified in the Quality Manual) relate to the requirements for measuring equipment in

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clause 7.6 Control of monitoring and measuring devices, since this specific law firm does not need to use monitoring equipment in order to provide a service that meets all customer and applicable regulatory requirements.

Example 4
XYZ Electronics is building a new factory to assemble three distinct families of products: mobile phones, pagers and personal computers. The top management decides to implement a QMS based on the ISO 9000 family of standards. It has only one customer for mobile phones, and this customer requires all suppliers to demonstrate conformity to ISO 9001:2000. Presently there is no such requirement for the other products. The organization decides, therefore, to implement a QMS that focuses initially on the realization processes associated with mobile phones and to include the other products at a later stage. The scope of the QMS and all the organizations marketing material makes it clear that the QMS addresses only activities related to mobile phones. The customer of mobile phones maintains responsibility for the product design, so XYZ Electronics excludes from its QMS the requirements of ISO 9001:2000 clause 7.3 Design and development. XYZ Electronics considers the design specifications as a customer supplied product and therefore controls this according to ISO 9001:2000 clause 7.5.4 Customer property. The exclusion of design and development requirements is detailed and justified in XYZ Electronics quality manual. When XYZ decides to seek certification/registration of its QMS the Certification Body (Registrar) reviews the validity of these exclusions prior to and during the certification/registration process. The QMS certificate states what is included within the scope of the certification.

Example 5
KML Medical designs and produces medical devices according to strict product codes and regulations. KML Medical has a QMS that was originally certified/registered according to ISO 9002:1994 because the regulations did not require the QMS to include design for the risk class of devices KML produces. The regulatory authority has not yet revised its rules to take into account the new ISO 9001:2000, but has confirmed that it will continue not to require the QMS to include the design activity for this risk class of devices. KML Medical decides not to exclude clause 7.3 Design and development from its QMS, however, because it does in fact carry out this activity and the activity does affect its ability to meet customer requirements. Also, KML wants to be able to claim conformity with ISO 9001:2000, and the exclusion of the design and development activity would not allow it to do so.

Example 6
NOP Ltd operates a network of passenger trains and has a number of individual workshops at different geographical locations to provide maintenance services for the trains. There are centralized maintenance planning, general engineering and purchasing functions, at NOPs corporate headquarters as well as a spare parts store. The individual maintenance workshops supply their services to the train operations department and have no direct interaction with NOP Ltds external customers (train passengers). One of the workshops is planning to implement a QMS in compliance with ISO 9001:2000 ahead of the rest of the NOP organization. Originally, the workshop management was considering the exclusion of the requirements of clauses 7.2 Customer-related processes, 7.3 Design and development, 7.4 Purchasing and clause 7.5.4 Customer property, on the basis that it has no direct contact with the external customer, and the corporate headquarters carries out the other processes. It soon realized, however, that this interpretation was incorrect and decided to analyse more closely its products, its customers and the interfaces of the workshop with the rest of NOP Ltd. As a result of such determination the following were established:

Product - is the service of trains according to NOPs technical specifications, centrally approved maintenance plans and requests from the Train Operations department of NOP. Customer - is the Train Operations department. Interfaces - with the Procurement department, the Central Store (material control and inventory) and the Central Engineering office for provision of technical specifications.

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Regarding clause 7.2 Customer related processes, it was apparent that it is applicable as Train Operations is the Customer and the requirements have to be identified, reviewed and communicated. In the case of clause 7.4 Purchasing the application of the requirements is limited because the Workshop is not responsible for selection of major suppliers (this function is performed by NOPs corporate purchasing department). The Workshop is responsible for the provision of information to the Purchasing Department and for the verification of all purchased goods delivered to the Workshop. Additionally, some minor local purchasing is done by the Workshop. The requirements of clause 7.5.4 Customer property are also applicable because the customer (NOP Ltd) owns the trains and the component parts that are supplied for service. The Workshop finally decided therefore only to exclude from its QMS the requirements of clause 7.3 Design and development, which are not applicable to Workshop activities as the Central Engineering office controls them.

Example 7
TCH Enterprise has decided to launch a new product. Although TCH owns the conceptual design, the detailed design calculations are outsourced to HT&T Inc., who provides detailed product specifications as HT&T s output to TCH Enterprise. These specifications are, in turn, passed on to CBB Construction for the manufacture of the product. In this case the requirements of clause 7 of ISO 9001:2000 are applicable as follows: Sub-clause 7.1(Planning of product realization) 7.2 (Customerrelated processes) 7.3 (Design and development) 7.4 (Purchasing) 7.5 (Production and service provision) 7.6 (Control of monitoring and measuring devices) TCH Enterprise Applicable Applicable Applicable Applicable Applicable Applicable HT&T Applicable Applicable Applicable Applicable Applicable Applicable CBB Construction Applicable Applicable Not Applicable Applicable Applicable Applicable If measuring equipment is used. Comments

Example 8
CDH Construction Ltd designs, develops and constructs buildings but does not have an in-house design capability. This company employs a project manager who is responsible for the management of design activities, which are subcontracted to TPL Engineering Ltd, an engineering consulting company. The appointment and activities of the subcontracted company is managed through the application of the requirements of clause 7.4 Purchasing. The project manager of CDH Construction Ltd oversees the design activities and is involved in design review meetings and design verification and validation activities. In addition, the project manager is responsible for ensuring that the design activities are carried out in accordance with the requirements of ISO 9001:2000 clause 7.3 Design and development. In this case, CDH Construction Ltd retains the responsibility for the design and is able to demonstrate that the management of subcontracted design is a part of its QMS.

Example 9
AKP Corp. is a factory that manufactures electric motors. Traceability of the component parts of the product is not an internal requirement of this company. For a specific type of electric motor, however, one of their customers requires full traceability. In this specific case, AKP Corps quality management system has to apply the full requirements of clause 7.5.3 Identification and traceability.

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Annex B
Comparisons for regulatory purposes
It is recognized that there may be instances where regulatory bodies are not able to revise their quality management system requirements concurrently with the publication of ISO 9001:2000. Consequently, regulations may continue to state requirements in terms of conformance to ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994, for some time after these have been withdrawn. In these cases, it may be appropriate for regulatory bodies to base their requirements on the broad comparisons of the 1994 and 2000 versions of the standard shown in the following table. Table B1 Comparison of ISO 9001:2000 to ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 for regulatory purposes Standard Basis for comparison ISO 9001:1994 All clauses of ISO 9001:2000 ISO 9002:1994 All clauses of ISO 9001:2000, except: ISO 9003:1994 All clauses of ISO 9001:2000, except: Clause 7.1: Planning of product realization Sub-clause 7.2.3: Customer communication Clause 7.3: Design and development Clause 7.4: Purchasing Sub-clause 7.5.1: Control of Pproduction and service provision operation control Sub-clause 7.5.2: Validation of processes for production and service provision Sub-clause 7.5.3: Identification and traceability Sub-clause 7.5.2: Validation of processes

Clause 7.3: Design and development

It is emphasized, however, that these are not to be used as direct equivalents, since some requirements of the 1994 standards have been simplified or removed in ISO 9001:2000. Specific guidance from individual regulatory bodies should always be sought. In addition, it should be noted that ISO 9001:2000 contains additional requirements to the 1994 version of ISO 9001, 9002 and 9003, particularly those relating to the concepts of customer satisfaction and continual improvement. Important: Some exclusions that are allowed by regulatory bodies may not be permitted by ISO 9001:2000 clause 1.2 Application. In these situations the QMS shall not be stated to be in conformity with ISO 9001:2000

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ISO 9000Product Introduction and Support Package: Guidance on ISO 9001:2000 clause 1.2 'Application'

ISO 2002 All rights reserved

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ISO 9000Product Introduction and Support Package: Guidance on ISO 9001:2000 clause 1.2 'Application'

Annex C IAF Guidance on the Application of ISO 9001:2000

Issue 2 Approved by Members Issue Date: December 2001 Issue No: 1 Prepared by: JWG of Representatives of IAF, ISOITCI 76 and CASCO Approved by IAF Members Issue Date: 22 February 2001 Name for Enquiries: Contact Phone: +612 6257 1962 Email: Date: 8 November 2000 Date: 16 February 2001 Application Date: 15 December 2000 Noel Matthews, Secretary IAF FAX: +612 6222 2761 21 October 2001 Application Date: 1 December 2001

<secretary@accreditationforum.com>

IAF expects that all Accreditation Body Members will ensure that all accredited certificates issued under their accreditations will comply with the guidance below as from the date of issue of lSO 900l :2000.

IAF Guidance on the Application of ISO 9001:2000

1.

Background

Industry expects that the introduction of the new ISO 9000 Family of standards will be a coordinated effort between the developers of the standards, certification / registration bodies and accreditation bodies. As a starting point to achieve this objective an International Accreditation Forum (IAF) ISO/TC 176 ISO/CASCO joint session was held on September 26, 1999 in Vienna, Austria to establish common and consistent messages to ensure a smooth transition to the new standards. The results were published in a joint communiqu dated September 27, 1999. Of the agreements reached in Vienna, Item 5 of the communiqu states that: Certification I Registration Bodies will need to take particular care in defining the scope of certificates issued to ISO 900 1:2000, and the permissible exclusions to the requirements of that standard.

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2.

Scope of the current work

To develop consistent guidance on the application of ISO 9001:2000, and on the scope statements for any resulting certification/registration, for: organizations already certified / registered to ISO 9001, ISO 9002 or ISO 9003 :1994 organizations presently not certified / registered to ISO 9001, ISO 9002 or ISO 9003 :1994 certification / registration bodies

3.

Guidance on ISO 9001 :2000 Application

Guidance I
All requirements of ISO 9001:2000 are generic in nature, and intended to apply to all organizations. The situations in which specific requirements may be excluded are clearly defined in ISO 9001:2000, clause 1.2 (Application). A guidance document on the application of ISO 9001:2000 has been published by ISOITCI76/SC2, as ISO/TC176/5C2/N524R, and is endorsed by this group. It is emphasized that this guidance from ISO/TC176 is a living document, and may be subject to further revision. The latest version of the guidance may be found on the ISO/TC176/SC2 website (http://www.bsi.org.uk/iso-tcl76-sc2). Since ISO 9001:2000 will replace the 1994 editions of ISO 9001, ISO 9002 and ISO 9003, particular care must be given in addressing the requirements of clause 7.3 of ISO 9001 :2000 (Design and Development), since the inclusion or exclusion of this process will no longer be self-evident from the title and number of the standard used for certification purposes.

Guidance 2
If the organization has responsibility for, and performs or outsources the design and development of the products that are within the scope of its certification, then clause 7.3 of ISO 9001:2000 shall be included in the quality management system. When assessing the validity of requests for the exclusion of clause 7.3 of ISO 9001:2000, attention shall be given to the definition of Design and development given in ISO 9000:2000 clause 3.4.4, as it relates to the product: Set of processes that transforms requirements into specified characteristics or into the specification of a product.. ISO 9000:2000 also defines Requirement as a need or expectation that is stated, generally implied or obligatory If the organization is not provided with the product characteristics necessary to plan its product realization processes and has to define those characteristics based on customer and/or regulatory body requirements, this is, by definition, product design and development. This process shall be addressed in the QMS, according to the requirements of clause 7.3 of ISO 9001:2000. NOTE: i) Design and development has traditionally tended to focus on tangible products, but is equally applicable where the product of an organization is a service.

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ii) The organization may choose to outsource its design and development process, in which case clause 4.1 of ISO 9001 :2000 shall apply. iii) An organization may not be responsible for the design and development of all the products within the scope of its quality management system. iv) An organization may have the responsibility and authority to make changes to the product specification or to the characteristics of the product, even though it was not responsible for the original design and development process. In these circumstances, some requirements of the sub-clauses of clause 7.3 may not be applicable, but clause 7.3 shall not be excluded in its entirety.

Guidance 3
Certificates issued to ISO 9001:2000 shall state clearly in words the scope of the quality management system (QMS) in a way that will not mislead customers, and shall ensure that information is available for the user to determine which categories of product and product realization processes are included within the scope of certification/registration. In particular, scope statements shall be explicit in stating the responsibility for product design and development and other principal realization processes such as manufacturing, sales, and service. a) The exclusion of clause 7 requirements may relate to all or only some of the product categories that are within the scope of the organizations QMS. Justification for the exclusion of any requirement must be given in the organizations quality manual, and the certification /registration body shall review the validity of any such exclusion during certification and surveillance audits. b) If the organization has responsibility for and realises or outsources the design and development process, the scope statement for certification/registration shall include the words Design of...., Development of..., or Design and development of.....

End of IAF Guidance on the Application of ISO 9001:2000. ________________________________________________________________________ __ IAF-PL-01-012

Issue Date: December 2001 Application Date: 1 December 2001 FG_1S09001_2000.doc Printed 14 December, 2001

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