Iso_guide_72 3m293j

GUIDE 72

Guidelines for the justification and development of management system standards

First edition 2001 © ISO 2001

ISO GUIDE 72:2001(E)

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Contents

Page

Foreword.....................................................................................................................................................................iv Introduction .................................................................................................................................................................v 1

Scope .............................................................................................................................................................. 1

2

Normative references .................................................................................................................................... 2

3

and definitions ................................................................................................................................... 2

4

Abbreviated ......................................................................................................................................... 4

5

General principles ......................................................................................................................................... 4

6 6.1 6.2 6.3

Justification study process and criteria...................................................................................................... 5 General............................................................................................................................................................ 5 Justification study process .......................................................................................................................... 5 Justification study criteria ............................................................................................................................ 6

7 7.1 7.2 7.3

Guidance on the development process and structure of an MSS............................................................ 6 General............................................................................................................................................................ 6 MSS development process ........................................................................................................................... 7 Management system standard model, structure and common elements ............................................. 11

Annex A (informative) Justification criteria questions.......................................................................................... 13 Annex B (informative) Common elements of ISO MSSs ....................................................................................... 16 Bibliography .............................................................................................................................................................. 18

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Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Guides are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3. Draft Guides adopted by the responsible Committee or Group are circulated to the member bodies for voting. Publication as a Guide requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this Guide may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO Guide 72 was prepared by the ad hoc group on Management System Standards of the ISO Technical Management Board. Annexes A and B of this Guide are for information only.

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Introduction ISO management system standards are increasingly being used worldwide by organizations of all types and sizes. For them to remain useful, authoritative and respected, it is of key importance that they reflect demonstrated market needs and that they are mutually compatible to facilitate their t implementation. The ISO Technical Management Board has recognized the need to ensure market relevance of and compatibility between management systems standards and has acknowledged that this could be facilitated by a common methodology for drafting such standards and by covering issues such as the economic cost and benefits of such standards. As a result, this Guide on the justification and development of management systems standards has been developed as additional guidance to the ISO/IEC Directives. The objective of this Guide is to assist those involved in the writing of management system standards, whether new or revised, to ensure that these standards meet the above-mentioned key criteria of market relevance and compatibility. Use of these guidelines should result in the development of management system standards that meet demonstrated market needs, and should avoid the development of management system standards that cause unnecessary burden and complexity in the market. Use of these guidelines should also help ensure compatibility and enhance alignment between management system standards with a view to facilitating the combined application of the standards by organizations that wish to do so. The ISO technical committees responsible for generic management system standards are responsible for maintaining the integrity of their standards. These technical committees can establish a sector policy and provide further guidance and procedures for the development of sector-specific standards related to their scope. Such guidance is additional to that provided in this Guide (as has already been done by ISO/TC 176).

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Guidelines for the justification and development of management system standards

1

Scope

This Guide provides 

guidance for justifying and evaluating a proposed management system standard project with a view to assessing market relevance,



guidance on the methodology (process) of developing and maintaining (i.e. reviewing and revising) management system standards with a view to ensuring compatibility and enhancing alignment, and



guidance on the terminology, structure and common elements of management system standards with a view to ensuring compatibility as well as enhancing alignment and ease of use.

This guidance is in addition to the procedures for technical work and the methodology for the development of International Standards established by the ISO/IEC Directives. This Guide makes a distinction between three different types of management system standard (MSS), as follows. 

Type A: management system requirements standards, both generic and sector-specific.



Type B: management system guidelines standards, both generic and sector-specific.



Type C: management system related standards.

Whilst this Guide is aimed primarily at Type A MSSs, it is equally applicable to Type B. This Guide is also applicable to Type C with the exception of 7.3 relating to the MSS structure and common elements. This Guide is intended to be used by all ISO bodies involved in the development of management system requirements and guidelines standards, and management system related standards. It can also be used by nonISO standards development organizations at the international, regional or national level that are considering or are in the process of developing management system standards and/or comparable documents. It should be emphasized that this Guide does not serve as an integrated management system standard. It is intended to be used by standards writers. It is not intended to be used by organizations implementing management system standards, nor used for certification purposes. NOTE 1 Whenever in this Guide the term "standard" is used, the whole range of ISO deliverables is meant [i.e. International Standards, ISO(/IEC) Guides, Technical Specifications, Technical Reports, Publicly Available Specifications and International Workshop Agreements] unless a specific type of document is referred to. NOTE 2

Throughout this Guide the abbreviation MSS is used to cover a Type A, B and C standard.

NOTE 3

Whenever in this Guide the term technical committee (TC) is used, all ISO bodies developing MSSs are included.

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2

Normative references

The following normative documents contain provisions which, through reference in this text, constitute provisions of this Guide. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this Guide are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. of ISO and IEC maintain s of currently valid International Standards. ISO/IEC Directives, Part 1, 2001, Procedures for the technical work ISO/IEC Directives, Part 2, 2001, Rules for the structure and drafting of International Standards ISO/IEC Guide 2:1996, Standardization and related activities — General vocabulary ISO 9000:2000, Quality management systems — Fundamentals and vocabulary ISO 14050:1998, Environmental management — Vocabulary

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and definitions

For the purposes of this Guide, the and definitions given in ISO/IEC Guide 2, ISO 9000, ISO 14050 and the following apply. 3.1 management system system to establish policy and objectives and to achieve those objectives [ISO 9000:2000, definition 3.2.2] NOTE 1 Management systems are used by organizations to develop their policies and to put these into effect via objectives and targets, using — an organizational structure where the roles, responsibilities, authorities, etc. of people are defined, — systematic processes and associated resources to achieve the objectives and targets, — measurement and evaluation methodology to assess performance against the objectives and targets, with of results used to plan improvements to the system, and — a review process to ensure problems are corrected and opportunities for improvement are recognized and implemented when justified. NOTE 2 Every organization possesses (whether consciously or not, and whether documented or not) an overall management system through which the organization’s objectives are set, executed and controlled.

3.2 Management system standards 3.2.1 Type A: management system requirements standard standard that is intended to provide the market place with relevant specifications for the management system of an organization to demonstrate its capability to meet internal and external requirements (e.g. by assessment of that capability by internal or external parties) EXAMPLES — Management system requirements standards (specifications). — Management system sector-specific requirements standards.

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3.2.2 Type B: management system guidelines standard standard that is intended to assist an organization to implement and/or to enhance its management system by providing additional guidance to the elements of a management system requirements standard, or stand-alone guidance with no equivalence to a management system requirements standard EXAMPLES — Guidance on the use of management system requirements standards. — Guidance on the establishment of a management system. — Guidance on the improvement/enhancement of a management system. — Management system sector-specific guidelines standards.

3.2.3 Type C: management system related standard standard that is intended to provide further information on specific parts of the management system or guidance on related ing techniques, in addition to management system standards EXAMPLES — Management system terminology documents. — Standards on auditing, documentation, training, monitoring, measurement and performance evaluation. — Standards on labelling and life-cycle assessment.

3.3 management system standard family MSS family set of management system requirements and guidelines standards (3.2.1 and 3.2.2) and related standards (3.2.3) developed by the same technical committee 3.4 management system standard project MSS project project to develop initially, review, revise or add new parts to management system requirements and guidelines standards (3.2.1 and 3.2.2) and related standards (3.2.3) 3.5 compatibility ⟨of standards⟩ suitability of similar standards for use together under specific conditions to fulfil relevant requirements without causing unacceptable interactions NOTE 1

Based on ISO/IEC Guide 2.

NOTE 2 In the case of an MSS, “compatibility” means that common elements of the standards can be implemented by organizations in a shared manner, in whole or in part, without unnecessary duplication or the imposition of conflicting requirements. “Compatibility” does not mean that the text of the common elements of the standards needs to be identical, although it should be whenever this is possible in practice. See ISO/TAG 12, Report to the ISO/TMB on ISO 9000 and ISO 14000 compatibility.

3.6 justification study process JS process process for justifying and evaluating the market relevance of MSS projects (3.4) NOTE The initial justification study is carried out by the proposer of an MSS project. Following evaluation, and if necessary amendment, it forms the input to the subsequent assessment and recommendation report (see 6.2).

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4

Abbreviated

For the purposes of this Guide, the following abbreviated apply. CASCO

ISO Committee on Conformity Assessment

CD

committee draft

DIS

draft International Standard

JS

justification study

MSS

management system standard(s) (being Type A, B and C as described in 3.2.1 to 3.2.3)

MSS family

management system standard family (3.3)

MSS project

management system standard project (3.4)

NWI

new work item

PDCA

Plan-Do-Check-Act

SC

subcommittee

TC

technical committee

TMB

ISO Technical Management Board

WD

working draft

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General principles

The following general principles provide guidance to assess the market relevance of proposed new work (clause 6) and to the standard development processes carried out by the assigned body (clause 7) once the new work has been accepted. The justification criteria questions in annex A are based on these principles which provide the criteria against which the answers to the questions should be assessed. The processes described in clause 7 are similarly based on these principles which provide the criteria for the verification and validation of the resulting MSS. An MSS should be initiated, developed and maintained only when all of the following principles are observed. Market relevance

Any MSS should meet the needs of, and add value for, the primary s and other affected parties.

Compatibility

Compatibility between various MSSs and within an MSS family should be maintained.

Ease of use

It should be ensured that the can easily implement one or more MSS.

Topic coverage

An MSS should have sufficient application coverage to eliminate or minimize the need for sector-specific variances.

Flexibility

An MSS should be applicable to organizations in all relevant sectors and cultures and of every size. An MSS should not prevent organizations from competitively adding to or differentiating from others, or enhancing their management systems beyond the standard.

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Technically sound basis

An MSS should be based on proven management practices or existing scientifically validated and relevant data.

Easily understood

An MSS should be easily understood, unambiguous, free from cultural bias, easily translatable, and applicable to businesses in general.

Free trade

An MSS should permit the free trade of goods and services in line with the principles included in the WTO Agreement on Technical Barriers to Trade.

Applicability of conformity assessment

The market need for first-, second- or third-party conformity assessment, or any combination thereof, should be assessed. The resulting MSS should clearly address the suitability of use for conformity assessment in its scope. An MSS should facilitate t audits.

Exclusions

An MSS should not include directly related product (including services) specifications, test methods, performance levels (i.e. setting of limits) or other forms of standardization for products produced by the implementing organization.

6 6.1

Justification study process and criteria General

This clause describes the justification study (JS) process for justifying and evaluating the market relevance of proposals for an MSS. Annex A provides a set of questions to be addressed in the justification study.

6.2

Justification study process

The JS process applies to any MSS project and consists of the following: a)

the conduct of the JS by (or on behalf of) the proposer of an MSS project;

b)

an independent evaluation to consider whether the justification study is sufficient or whether further work is needed;

c)

an independent assessment of the JS and preparation of a recommendation report; this will include the following information to accompany the proposal during the subsequent ballot: 

recommendations with summary of rationale, including preferred scope and type of document;



methods of conformity assessment, if any, against the proposed standard that are believed to suit the standard s best;



summary of the JS assessment, including considered significant factors for and against;



relevant geography, sector and information made and gathered during the assessment;



identification of the authors of the report.

The JS process is followed by the normal ISO balloting procedure for a new field of activity or new work item approval as appropriate. The objective of the independent assessment is to provide unbiased and objective information as a basis for the recommendation report. It should provide additional useful objective information in a report form for the ISO Member Bodies to make well-informed decisions in the approval process.

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In the initial phase of any review of an MSS, a new JS should be conducted; the results and subsequent recommendations should accompany a review enquiry. The scale of the JS may vary from minor to major depending on the expected changes in management practices since publication of the MSS in question. The JS assessment should consider the principles in clause 5 and questions in annex A, and can be compared against the previous JS and design specification. This process should help to identify continued market need for the standard and areas to be considered for possible modifications. The JS recommendation report should indicate one of the following: 

withdrawal;



confirmation; or



revision.

6.3

Justification study criteria

Based on annex C of the ISO/IEC Directives, Part 1, 2001, and the general principles stated in clause 5, annex A lists a set of questions that should be used as criteria for justifying and assessing a proposed MSS project. The proposer of an MSS project should consider the principles in clause 5 and address the questions in annex A when preparing the justification study. This list is not exhaustive and any additional information that is relevant to the case should be provided. The significance and relevance of the different questions in annex A will vary according to the nature of the MSS project. The JS should demonstrate that all questions have been considered. If it is decided that they are not relevant or appropriate to a particular situation, then the reasons for this decision should be clearly stated. A proposal for a new Type C MSS or a minor revision of an existing standard will require less rigorous answers to the questions than a proposal for a new Type A MSS. The entity responsible for assessing the JS should also use these principles and the criteria questions in annex A but is not limited to these. The unique aspect of a particular JS may require consideration of additional questions in order to assess objectively the market relevance of the proposed MSS project. In the process of JS assessment, the proposer may be asked to clarify answers or to provide additional information.

7 7.1

Guidance on the development process and structure of an MSS General

The development of an MSS will have effects in relation to 

the far-reaching impact of these standards on business practice,



the importance of worldwide for the standards,



the practical possibility for involvement by many, if not all, ISO Member Bodies, and



the market need for compatible and aligned MSSs.

This clause provides guidance in addition to the procedures laid down in the ISO/IEC Directives, in order to take these effects into . The development and revision of all MSSs should follow the processes described in 7.2. When developing management systems requirements or guidelines standards (3.2), the guidance given in 7.3 should also be followed. Where a draft document is already available and is accepted as the basis for a proposed MSS, the extent to which the recommendations of 7.2 and 7.3 apply should be established, based on the maturity of the document.

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All MSSs should use consistent terminology so that they are easy to use and compatible with each other. Where applicable, MSSs should use common elements that are preferably arranged in the same sequence (see 7.3). The architecture of any MSS family should be carefully designed and the role of each document in the family defined. Any management system related standards (Type C) within an MSS family should be fully in line with the management system requirements standards (Type A). Type B and C standards should not introduce additional management system requirements. When developing MSS family standards on ing techniques, appropriate use should be made of the guidance given in 7.2. These documents are independent and do not need to have their structure aligned with those of Type A or B. However, if there are similar documents from another or the same MSS family, due consideration should be given to these and every effort should be made to achieve alignment. Where management system guidelines are involved, it is important that their functions be clearly defined together with their relationship with the management system requirements standard, for example: 

guidance on the use of the requirements standard;



guidance on the establishment/implementation of the management system;



guidance on improvement/enhancement of the management system.

When related to a Type A management system requirements standard, the guidelines should have a structure aligned with that standard. Where the proposed MSS is sector specific, the following applies in addition to the guidance given in 7.2 and 7.3: 

the sector-specific MSS should be compatible and aligned with the generic MSS;



the relevant technical commitee or subcommittee responsible for the generic MSS may have additional requirements to be met or procedures to be followed;



other technical commitees or subcommittees may need to be consulted, as well as CASCO on conformity assessment issues.

In the case of sector-specific documents, their function and relationship with the generic MSS should be clearly defined (e.g. additional sector-specific requirements; elucidation; or both as appropriate). Sector-specific documents should always show clearly (e.g. by using different typographical styles) the kind of sector-specific information being provided.

7.2 7.2.1

MSS development process General

Most of the additional guidance provided in this subclause concerns the preparatory stage (stage 2) of standards development (ISO/IEC Directives, Part 1, 2001, 2.4) which covers the preparation of a working draft. NOTE Wherever in the following reference is made to a technical committee, this can also mean a subcommittee as appropriate.

7.2.2

Design specification

To ensure that the intention of the standard, as demonstrated by the justification study, will be maintained, a design specification should be developed and approved before a working draft is prepared. The responsible technical committee should decide upon the format and content of the design specification that is appropriate for each type of MSS and should set up the necessary organization to carry out the task.

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The design specification should typically address the following. needs

The identification of the s of the standard and their associated needs, together with the costs and benefits for these s.

Scope

The scope and purpose of the standard, the title and the field of application.

Compatibility

How compatibility within this and with other MSS families will be achieved, including identification of the common elements with similar standards, and how these will be included in the recommended structure (see 7.3).

Consistency

Consistency with other documents (to be) developed within the MSS family.

NOTE 1

Most, if not all of the information on needs and scope will be available from the justification study.

In the case of development of a management system requirements or guidelines standard (3.2), the design specification should also address the following. Model

The features of the model to be used for the standard (see 7.3).

Structure

The structure should follow the recommendations in 7.3. If there are reasons for not following the recommended structure, these should be explained.

The design specification should ensure that a)

the outputs of the justification study are translated correctly into requirements for the MSS,

b)

the issues of compatibility and alignment with other MSSs are identified and addressed,

c)

a basis for verification of the final MSS exists at appropriate stages during the development process,

d)

the approval of the design specification provides a basis for ownership throughout the project by the of the TC/SC(s),

e)

is taken of comments received through the NWI ballot phase, and

f)

any constraints are taken into .

NOTE 2 If more than one standard is called for by the justification study, it may be necessary to prepare a design specification for each.

7.2.3 7.2.3.1

Producing the deliverables Project management

The technical committee should establish a project plan indicating how the project is to be organized and managed, the time frame for the project, and how the key dates are to be met. In committees that make the decisions during this process (in general TCs and SCs), all member bodies should be welcome to participate, to assure common . The technical committees should also endeavour to ensure that there is adequate representation from organizations expected to implement the proposed MSS. For the sake of this , it may be necessary to have additional stages of comment and decision-making beyond those prescribed in the ISO/IEC Directives. Experience has shown that because of the nature and application of MSSs, many countries want to be involved and committees can be very large. This may be managed by distinguishing between operational tasks (e.g. drafting) and decision making. The technical committees should find the right balance between a desire for the involvement of all interested parties and the size of drafting groups for effective working.

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7.2.3.2

Human resources

The success of any MSS project will depend to a large extent on 

the composition of drafting groups, which should consist of experts both in the subject field and in standards writing, as well as have a balanced representation of the various affected parties, and



the continuity of group hip and therefore the commitment of to continuity of attendance.

The TC Secretariat should ensure that convenors and secretariats have the necessary skills for the task. Convenors should make sure that people in their group (e.g. SC, WG, drafting group) know what the task is and provide or arrange for if required. 7.2.3.3

Monitoring output

In the drafting process, the output should be monitored for compatibility and ease of use with other MSSs, by covering issues such as 

vocabulary and definitions,



the inclusion of agreed common elements,



the use of agreed structure and topics to be addressed in each section,



the need for clarity (both in language and presentation), and



avoiding overlap and contradiction.

7.2.3.4

Managing deviations

Any deviation from the schedule, from the recommended structure (see 7.3) and/or from the design specification should be agreed upon and recorded to enable ISO and the technical committee to for these deviations. Adequate procedures for corrective actions on deviations should be established. This is the responsibility of the technical committee carrying out the work and secretaries should remind committee of this. 7.2.3.5

Verification and validation

As part of its planning process, the technical committee should establish the stages at which verification (against the design specification) and validation (against the intended use) is appropriate and the methodology to be applied. NOTE

Definitions of verification and validation are given in ISO 9000.

By its nature, the verification process cannot start before the design specification has been approved but, in order to benefit from its results, it is important that it be carried out as early as possible, and at least at the design specification and committee draft stages. Verification and/or validation may take place at a number of stages, as follows: 

verification of the design specification against the JS;



verification of a “mature” working draft against the design specification;



verification and/or validation at the CD stage;



verification and/or validation at the DIS stage;



validation of the final MSS.

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Verification is carried out by the technical committee itself. Validation techniques may include 

surveys of organizations to obtain their response on the likely benefits, impacts, problems, etc., of the new MSS,



pilot projects with selected organizations in member countries to test the new MSS and report on benefits and problems, and



balloting of documents by national member bodies.

Where validation indicates that the project is not meeting interested parties’ expectations, the draft MSS should be reviewed and amended, or the design specification may be amended, and even the JS revisited. 7.2.4

Transparency of the MSS development process

MSSs have a broader scope than most other types of standard. They cover a large field of human endeavour and have an impact on a wide range of interests. Technical committees preparing MSSs should accordingly adopt a highly transparent approach to the development of the standards, ensuring that 

possibilities for participation in the process of developing standards are clearly identified, and



the development processes being used are understood by all parties.

Technical committees should provide information on progress throughout the life cycle of the project, including 

the status of the project to date (including items under discussion),



points for further information,



communiqués and press releases on plenary meetings, and



regular listings of frequently asked questions and answers.

In doing this, needs to be taken of the distribution facilities available in the participating countries. Where it may be expected that s of an MSS are likely to demonstrate conformity (through self-declarations, second-party contracts or certification/registration), particular attention should be paid to any guidance given in the standard on how this can be achieved. Maximum use should be made of the resources of the ISO Central Secretariat to facilitate the transparency of the project and the technical committee should, in addition, consider the establishment of a dedicated open-access website. Technical committees should involve the national member bodies to build up a national awareness of the MSS project, providing drafts as appropriate for different interested and affected parties, including accreditation bodies, certification bodies, enterprises and the community, together with additional specific information as needed. The technical committee should ensure that technical information on the content of the MSS under development is readily available to participating , especially those in developing countries. 7.2.5

Process for interpretation of a standard

The technical committee should establish a process to handle interpretation questions related to their standards from the s, and should make the resulting interpretations available to others in an expedient manner. Such a

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mechanism can effectively address possible misconceptions at an early stage and identify issues that may require improved wording of the standard during the next revision cycle.

7.3

Management system standard model, structure and common elements

7.3.1

General

This subclause is only applicable to management system requirements and guidelines standards as defined in 3.2.1 and 3.2.2. Compatibility between management system requirements or guidelines standards and ease of use can be improved by increasing commonality between standards. Factors such as the overall management system model applied, the structure of the standard, and the number of common elements together with their wording and the terminology used, should all be considered. There are various ways to address these factors when drafting standards for different subjects, ranging from harmonized terminology to a completely integrated management system standard. It is recommended that management system requirements and guidelines standards for different subjects apply harmonized terminology and use an identified set of common elements. In this way they will provide organizations that are implementing the standards with a sound basis to do this in an integrated manner if they so wish. 7.3.2

Model and structure

The overall structure of a management system requirements or guidelines standard should be based on a recognized model and a logical arrangement of the management system requirements following that model. The model chosen should represent the underlying principles applied to the management system standard in order a)

to assist s in understanding those principles and so assist the in the implementation of management systems, and

b)

to assist standard writers in establishing a consistent and logical structure.

Management system related standards (3.2.3) may also need to be structured in a similar manner where there is obvious benefit in having a common structure. Existing models for MSSs will evolve over time, and new models may emerge. It is therefore not appropriate to favour any particular MSS model. Currently in International Standards there are two recognized models: PDCA and the process model. ISO technical committees that develop management system standards and who intend to adopt a different model should ensure compatibility with MSSs developed by other technical committees. NOTE

7.3.3

Examples of the use of these models can be found in ISO 9001, ISO 9004 and ISO 14001.

Common elements

Experience with MSSs produced by ISO shows that a number of common elements exist. These common elements can be arranged under the following main subjects: a)

policy;

b)

planning;

c)

implementation and operation;

d)

performance assessment;

e)

improvement;

f)

management review.

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Table B.1 in annex B shows the common elements of ISO management system requirements and guidelines standards listed according to this structure. It is recommended that this arrangement of elements be followed to facilitate ease of use of the standard and also t implementation of an MSS. It is recognized that the common arrangement of elements may only be practical at the high element level, i.e. main clause and subclause level. ISO technical committees who develop management system requirements and guidelines standards and who intend to adopt a different sequence of elements should demonstrate how ease of use and t implementation with MSSs developed by other technical committees can be achieved. For communication with the Technical Management Board and other technical committees as appropriate, the technical committee should provide a table giving the cross-references between the arrangement of their own management system standard and Table B.1. If a technical committee chooses a sequence of elements which differs significantly from that in Table B.1, crossreference tables to other MSSs should be included in their document to assist ease of use. When drafting text for common elements of management system requirement standards, the same wording should be used when the same meaning is expressed.

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Annex A (informative) Justification criteria questions

A.1 General The following list of questions to be addressed in the justification study is not exhaustive. Additional information not covered by the questions should be provided if it is relevant to the case. The answers to the questions listed under A.2.3 to A.2.8 should be differentiated according to those parties that may be affected by the proposed MSS if the answers differ significantly.

A.2 Questions A.2.1 Basic information on the MSS proposal a)

What is the proposed purpose and scope of the MSS?

b)

Would the proposed MSS work item result in an International Standard (IS), an ISO(/IEC) Guide, a Technical Specification (TS), a Technical Report (TR), a Publicly Available Specification (PAS), or an International Workshop Agreement (IWA)?

c)

Does the proposed purpose or scope include product (including service) specifications, product test methods, product performance levels, or other forms of guidance or requirements directly related to products produced or provided by the implementing organization?

d)

Is there one or more existing ISO technical committee or non-ISO organization that could logically have responsibility for the proposed MSS? If so, identify.

e)

Have relevant reference materials been identified, such as existing guidelines or established practices?

f)

Are there technical experts available to the standardization work? Are the technical experts direct representatives of the affected parties from the different geographical regions?

g)

What efforts are anticipated as being necessary to develop the document in of experts needed and number/duration of meetings?

h)

What is the anticipated completion date?

A.2.2 Affected parties a)

Have all the affected parties been identified? For example: 1)

organizations (of various types and sizes): the decision-makers within an organization who approve work to implement and achieve conformance to the MSS;

2)

customers/end-s, i.e. individuals or parties that pay for or use a product (including service) from an organization;

3)

Supplier organizations, e.g. producer, distributor, retailer or vendor of a product, or a provider of a service or information;

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4)

MSS service provider, e.g. MSS certification bodies, accreditation bodies or consultants;

5)

regulatory bodies;

6)

non-governmental organizations.

b) Is the MSS intended to be a guidance document, contractual specification or regulatory specification for an organization?

A.2.3 Need for an MSS a)

What is the need? Does the need exist at a local, national, regional or global level? Does the need apply to developing countries? Does it apply to developed countries? What is the added value of having an ISO document (e.g. facilitating communication between organizations in different countries)?

b)

Does the need exist for a number of sectors and is thus generic? If so, which ones? Does the need exist for small, medium or large organizations?

c)

Is the need important? Will the need continue? If yes, will the target date of completion for the proposed MSS satisfy this need? Are viable alternatives identified?

d)

Describe how the need and importance were determined. List the affected parties consulted and the major geographical or economical regions in which they are located.

e)

Is there known or expected for the proposed MSS? List those bodies that have indicated . Is there known or expected opposition to the proposed MSS? List those bodies that have indicated opposition.

A.2.4 Sector-specific MSS proposals a)

Is the MSS for a single specific sector?

b)

Will the MSS reference or incorporate an existing, non-industry-specific ISO MSS (e.g. from the ISO 9000 series of quality management standards)? If yes, will the development of the MSS conform to the ISO/IEC Sector Policy (see 6.8.2 of ISO/IEC Directives, Part 2, 2001), and any other relevant policy and guidance procedures (e.g. those that may be made available by a relevant ISO technical committee)?

c)

What steps have been taken to remove or minimize the need for particular sector-specific deviations from a generic MSS?

A.2.5 Value of an MSS A.2.5.1

Value to an organization implementing the MSS

a)

What are the expected benefits and costs to organizations, differentiated for small, medium and large organizations if applicable?

b)

Describe how the benefits and the costs were determined. Provide available information on geographic or economic focus, industry sector and size of the organization. Provide information on the sources consulted and their basis (e.g. proven practices), premises, assumptions and conditions (e.g. speculative or theoretical), and other pertinent information.

c)

Will the MSS allow an organization competitively to add to, differentiate or encourage innovation of its management system beyond the standard?

d)

If the intended use is for contractual or regulatory purposes, what are the potential methods to demonstrate conformance (e.g. first party, second party or third party)? Does the MSS enable organizations to be flexible in choosing the method of demonstrating conformance, and to accommodate for changes in its operations, management, physical locations and equipment?

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ISO GUIDE 72:2001(E)

e)

If third-party registration/certification is a potential option, what are the anticipated benefits and costs to the organization? Will the MSS facilitate t audits with other management system standards or promote parallel assessments?

A.2.5.2

Value to other affected parties

a)

What are the expected benefits and costs to other affected parties (including developing countries)?

b)

Describe how the benefits and the costs were determined. Provide any information regarding the affected parties indicated.

c)

What will be the expected value to society?

A.2.6 Risk of trade barriers a)

How would the MSS facilitate or impact global trade? Could the MSS create or prevent a technical barrier to trade?

b)

Could the MSS create or prevent a technical barrier to trade for small, medium or large organizations?

c)

Could the MSS create or prevent a technical barrier to trade for developing or developed countries?

d)

If the proposed MSS is intended to be used in government regulations, is it likely to add to, duplicate, replace, enhance or existing governmental regulations?

A.2.7 Risk of incompatibility, redundancy and proliferation a)

Is there potential overlap or conflict with other existing or planned ISO or non-ISO international standards, or those at the national or regional level? Are there other public or private actions, guidance, requirements and regulations that seek to address the identified need, such as technical papers, proven practices, academic or professional studies, or any other body of knowledge?

b)

Is the MSS or the related conformity assessment activities (e.g. audits, certifications) likely to add to, replace all or parts of, harmonize and simplify, duplicate or repeat, conflict with, or detract from the existing activities identified above? What steps are being considered to ensure compatibility, resolve conflict or avoid duplication?

c)

Is the proposed MSS likely to promote or stem proliferation of MSSs at the national or regional level, or by industry sectors?

A.2.8 Other risk factors Have any other risks been identified (e.g. timeliness or unintended consequences to a specific business)?

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Annex B (informative) Common elements of ISO MSSs

Table B.1 — Common elements of ISO MSSs Main subjects that are common to all MSSs

Common elements

Policy and principles

Typical issues to be covered

B.1 Policy

B.1

B.1

Policy to demonstrate an organization’s commitment to meeting the requirements related to the management system standard and to establish an overall sense of direction and principles for action. The policy should provide a framework for setting objectives and targets.

B.2 Planning

B.2.1 Identification of needs, requirements and analysis of critical issues

B.2.1 Identification of the issues which have to be controlled and/or improved in order to satisfy the relevant interested party(ies). The term “requirements” includes legal requirements.

B.2.2 Selection of significant issues to be addressed

B.2.2 Prioritization of the issues identified as a result of B.2.1.

B.2.3 Setting of objectives and targets

B.2.3 Identification of clear objectives and targets (including time frames) based on the output of B.2.2, an organization’s policy and the results of management review (B.6).

B.2.4 Identification of resources

B.2.4 Identification of resources needed and the availability of adequate human, infrastructure and financial resources.

B.2.5 Identification of organizational structure, roles, responsibilities and authorities

B.2.5 Identification of the roles, responsibilities, authorities and their interrelationships within the organization as far as needed to ensure effective and efficient operations.

B.2.6 Planning of operational processes

B.2.6 The planning arrangements for the operational processes that may include actions effecting how the objectives and targets defined in B.2.3 are achieved.

B.2.7 Contingency preparedness B.2.7 The arrangements that need to be in place to manage for foreseeable events foreseeable emergencies. B.3 Implementation B.3.1 Operational control and operation

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B.3.1 The operational control measures needed to implement the plan(s) and maintain control of activities against defined targets.

B.3.2 Management of human resources

B.3.2 The management of employees, contractors, temporary staff, etc. (including qualifications and activities such as awareness building and training).

B.3.3 Management of other resources

B.3.3 The operational management and maintenance of infrastructure, plant, facilities, finance, etc. which have an impact on the organization’s performance.

B.3.4 Documentation and its control

B.3.4 The management of those documents which are essential to the successful implementation and operation of the management system.

B.3.5 Communication

B.3.5 The arrangements for communications both within the organization and to/from external sources.

B.3.6 Relationship with suppliers and contractors

B.3.6 The formalizing of arrangements for those who supply and contract their services to the organization which have an impact on the organization’s performance.

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ISO GUIDE 72:2001(E)

Table B.1 (continued) Main subjects that are common to all MSSs B.4 Performance assessment

B.5 Improvement

B.6 Management review

Common elements

Typical issues to be covered

B.4.1 Monitoring and measuring

B.4.1 The mechanisms by which the organization assesses its performance on an ongoing basis.

B.4.2 Analysing and handling nonconformities

B.4.2 The determination of nonconformities and the manner in which these are dealt with.

B.4.3 System audits

B.4.3 The audit of the management system.

B.5.1 Corrective action

B.5.1 The mechanism for eliminating the causes of detected nonconformities both in the management system and the operational processes.

B.5.2 Preventive action

B.5.2 The mechanism for instigating action to eliminate potential causes of nonconformities in both the management system and the operational processes.

B.5.3 Continual improvement

B.5.3 The provisions made for continual improvement of the management system.

B.6

B.6

Management review

© ISO 2001 – All rights reserved

Management review of the system to determine its current performance, to ensure its continuing suitability, adequacy and effectiveness, and to instruct improvements and new directions when found necessary.

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Bibliography

[1]

ISO/IEC Guide 7:1994, Guidelines for drafting of standards suitable for use for conformity assessment

[2]

ISO 9001:2000, Quality management systems — Requirements

[3]

ISO 9004:2000, Quality management systems — Guidelines for performance improvements

[4]

ISO 14001:1996, Environmental management systems — Specification with guidance for use

[5]

ISO 14004:1996, Environmental management systems — General guidelines on principles, systems and ing techniques

[6]

ISO/TAG 12 report to ISO TMB on ISO 9000/ISO 14000 compatibility

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© ISO 2001 – All rights reserved

International Organization for Standardization Case postale 56 • CH-1211 GENEVA 20 • Switzerland Ref. No.: ISO GUIDE 72:2001(E) ICS 01.120; 03.100.01 Price based on 18 pages © ISO 2001 – All rights reserved