Bsi bs en 30011 3 1993 (1998) iso 10011 3

00374230 PDF BRITISH STANDARD BS EN 30011 3 1993 ISO 10011 3 1991 Incorporating Amendment No 1 to BS 7229 3 1991 (renumbers BS as BS EN 30011 3 1993)Guidelines for auditing quality systems — Part 3 Ma[.]

BRITISH STANDARD BS EN

30011-3:1993 ISO 10011-3: 1991

Incorporating Amendment No 1 to

BS 7229-3:1991 (renumbers BS as

BS EN 30011-3:1993)

Guidelines for auditing

quality systems —

Part 3: Management of audit

programmes

The European Standard EN 30011-3:1993 has the status of a

British Standard

UDC 658.562(035)

This British Standard, having

been prepared under the

direction of the Quality,

Management and Statistics

Standards Policy Committee,

was published under the

authority of the Standards Board

and comes into effect on

31 July 1991

© BSI 10-1998

The following BSI references

relate to the work on this

standard:

Committee reference QMS/25

Draft for comment 89/97803 DC

ISBN 0 580 19844 8

Committees responsible for this British Standard

The preparation of this British Standard was entrusted by the Quality, Management and Statistics Standards Policy Committee (QMS/-) to Technical Committee QMS/25, upon which the following bodies were represented: Association of Consulting Engineers

Association of Consulting Scientists British Paper and Board Industry Federation British Photographic Association

British Quality Association British Telecommunications plc Chemical Industries’ Association Computing Services Association EEA (the Association of Electronics, Telecommunications and Business Equipment Industries)

Energy Industries Council Engineering Equipment and Materials Users’ Association GAMBICA (BEAMA Ltd.)

Guildford County College of Technology Institute of Quality Assurance

Loughborough University of Technology National House-building Council Production Engineering Research Association of Great Britain Solvents Industry Association Ltd

Amendments issued since publication

1993 Renumbered as BS EN 30011-3:1993

BS EN 30011-3:1993

Contents

Page

National foreword

This Part of BS 7229 has been prepared under the direction of the Quality, Management and Statistics Standards Policy Committee It is identical with

ISO 10011-3 “Guidelines for auditing quality systems, Part 3: Management of audit programmes”, published by the International Organization for

Standardization (ISO)

In 1993 the European Committee for Standardization (CEN) accepted ISO 10011-3:1991 as European Standard EN 30011-3:1993 As a consequence of implementing the European Standard this British Standard is renumbered as

BS EN 30011-3 and any reference to BS 7229-3 should be read as a reference to

BS EN 30011-3

BS 7229 is published in three Parts as follows:

— Part 1: Auditing;

— Part 2: Qualification criteria for auditors;

— Part 3: Managing an audit programme.

A British Standard does not purport to include all the necessary provisions of a contract Users of British Standards are responsible for their correct application

Compliance with a British Standard does not of itself confer immunity from legal obligations.

Cross-references

International standard Corresponding British Standard

ISO 8402:1986 BS 4778 Quality vocabulary

Part 1:1987 International terms

(Identical)

BS 7229 Quality systems auditing

ISO 10011-1:1990 Part 1:1991 Auditing

(Identical) ISO 10011-2:1991 Part 2:1991 Qualification criteria for auditors

(Identical)

Summary of pages

This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 2 to 6, an inside back cover and a back cover

This standard has been updated (see copyright date) and may have had amendments incorporated This will be indicated in the amendment table on the inside front cover

EUROPEAN STANDARD

NORME EUROPÉENNE

EUROPÄISCHE NORM

EN 30011-3

April 1993

UDC 658.562(035)

Descriptors: Quality, quality assurance, quality assurance programme, quality audit, management

English version

Guidelines for auditing quality systems — Part 3: Management of audit programmes

(identical with ISO 10011-3:1991)

Lignes directrices pour l’audit des systèmes

qualité —

Partie 3: Gestion des programmes d’audit

(identique à ISO 10011-3:1991)

Leitfaden für das Audit von Qualitätssicherungssystemen — Teil 3: Management von Auditprogrammen (identisch mit ISO 10011-3:1991)

This European Standard was approved by CEN on 1993-04-05 CEN members

are bound to comply with the CEN/CENELEC Internal Regulations which

stipulate the conditions for giving this European Standard the status of a

national standard without any alteration

Up-to-date lists and bibliographical references concerning such national

standards may be obtained on application to the Central Secretariat or to any

CEN member

This European Standard exists in three official versions (English, French,

German) A version in any other language made by translation under the

responsibility of a CEN member into its own language and notified to the

Central Secretariat has the same status as the official versions

CEN members are the national standards bodies of Austria, Belgium,

Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,

Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and

United Kingdom

CEN

European Committee for Standardization Comité Européen de Normalisation Europäisches Komitee für Normung

Central Secretariat: rue de Stassart 36, B-1050 Brussels

© 1993 Copyright reserved to CEN members Ref No EN 30011-3:1993 E

Following the resolution BT 221/1991

ISO 10011-3:1991 Guidelines for auditing quality

systems — Part 3: Management of audit

programmes was submitted to the Unique

Acceptance Procedure

The result of the Unique Acceptance Procedure was

positive

This European Standard shall be given the status of

a national standard, either by publication of an

identical text or by endorsement, at the latest by

October 1993, and conflicting national standards

shall be withdrawn at the latest by October 1993

According to the CEN/CENELEC Internal

Regulations, the following countries are bound to

implement this European Standard: Austria,

Belgium, Denmark, Finland, France, Germany,

Greece, Iceland, Ireland, Italy, Luxembourg,

Netherlands, Norway, Portugal, Spain, Sweden,

Switzerland, United Kingdom

Contents

Page

Annex ZA (normative) Normative references to international publications with their relevant

EN 30011-3:1993

1 Scope

This part of ISO 10011 gives basic guidelines for

managing quality systems audit programmes

It is applicable to the establishment and

maintenance of an audit programme management

function when performing quality systems audits in

accordance with the recommendations given in

ISO 10011-1

2 Normative references

The following standards contain provisions which,

through reference in this text, constitute provisions

of this part of ISO 10011 At the time of publication,

the editions indicated were valid All standards are

subject to revision, and parties to agreements based

on this part of ISO 10011 are encouraged to

investigate the possibility of applying the most

recent editions of the standards indicated below

Members of IEC and ISO maintain registers of

currently valid International Standards

ISO 8402:1986, Quality — Vocabulary.

ISO 10011-1:1990, Guidelines for auditing quality

systems — Part 1: Auditing.

ISO 10011-2:1991, Guidelines for auditing quality

systems — Part 2: Qualification criteria for quality

systems auditors.

3 Definitions

For the purposes of this part of ISO 10011, the

definitions given in ISO 8402 and ISO 10011-1 and

the following definition apply

audit programme management

organization, or function within an organization,

given the responsibility to plan and carry out a

programmed series of quality systems audits

4 Managing an audit programme

4.1 Organization

Any organization which has an ongoing need to

carry out audits of quality systems should establish

a capability to provide overall management of the

entire process This function should be independent

of direct responsibility for implementing the quality

systems being audited

4.2 Standards

Audit programme management should determine

the quality system standards they may be expected

to audit against and develop capabilities to enable

them to audit effectively against such standards

4.3 Qualification of staff 4.3.1 Audit programme management

Management of the audit programme should be carried out by those who have practical knowledge

of quality audit procedures and practices

4.3.2 Auditors

Audit programme management should employ auditors who comply with the recommendations given in ISO 10011-2 Such auditors should be approved by an evaluation panel, acceptable to audit programme management, which complies with the recommendations given in ISO 10011-2

4.4 Suitability of team members

Audit programme management should consider the following factors when selecting auditors and lead auditors for particular assignments in order to ensure that the skills brought to each assignment are appropriate:

— the type of quality system standard against which the audit is to be conducted (for example, manufacturing, computer software or service standards);

— the type of service or product and its associated regulatory requirements (for example, health care, food, insurance, computers,

instrumentation, nuclear devices);

— the need for professional qualifications or technical expertise in a particular discipline;

— the size and composition of the audit team;

— the need for skill in managing the team;

— the ability to make effective use of the skills of the various audit team members;

— the personal skills needed to deal with a particular auditee;

— the required language skills;

— the absence of any real or perceived conflict of interest;

— other relevant factors

4.5 Monitoring and maintenance of auditor performance

4.5.1 Performance evaluations

Audit programme management should continually evaluate the performance of their auditors, either through observation of audits or other means Such information should be used to improve auditor selection and performance and to identify unsuitable performance

Audit programme management should make this information available to evaluation panels, where required

4.5.2 Consistency of auditors

Audits conducted by different auditors should arrive

at similar conclusions when the same operation is

audited under the same conditions Audit

programme management should establish methods

to measure and compare auditor performance to

achieve consistency among auditors Such methods

should include:

— auditor training workshops;

— auditor performance comparisons;

— reviews of audit reports;

— performance appraisals;

— rotation of auditors between audit teams

4.5.3 Training

Audit programme management should regularly

assess the training needs of auditors and take

appropriate action to maintain and improve audit

skills

4.6 Operational factors

4.6.1 General

Audit programme management should consider the

following factors and, where necessary, establish

procedures to ensure that their staff can operate in

a consistent manner and are adequately supported

4.6.2 Commitment of resources

Procedures should be established to ensure that

adequate resources are available to accomplish

audit programme objectives

4.6.3 Audit programme planning and

scheduling

Procedures should be established for planning and

scheduling the programme of audits

4.6.4 Audit reporting

Audit report formats should be formalized to the extent practicable

4.6.5 Corrective action follow-up

Procedures should be established to control corrective action follow-up, if audit programme management are requested to do so

4.6.6 Confidentiality

Audit programme management should establish procedures to safeguard the confidentiality of any audit or auditor information that they may hold

4.7 Joint audits

There may be instances when several auditing organizations cooperate to audit jointly a quality system Where this is the case, agreement should be reached on the specific responsibilities of each organization, particularly in regard to lead auditor authority, interfaces with the auditee, methods of operation and distribution of audit results before the audit commences

4.8 Audit programme improvement

Audit programme management should establish a method of continuously improving the audit programme through feedback and

recommendations from all parties concerned

5 Code of ethics

Audit programme management should consider the need to include a code of ethics into the operation and management of the audit programmes

EN 30011-3:1993

Annex ZA (normative)

Normative references to international publications with their relevant

European publications

This European Standard incorporates by dated or undated reference, provisions from other publications These normative references are cited at the appropriate places in the text and the publications are listed hereafter For dated references, subsequent amendments to or revisions of any of these publications apply

to this European Standard only when incorporated in it by amendment or revision For undated references the latest edition of the publication referred to applies (including amendments)

Publication Year Title EN/HD Year

ISO 10011-1 1990 Guidelines for auditing quality systems —

Part 1: Auditing

30011-1 1993

ISO 10011-2 1991 Guidelines for auditing quality systems —

Part 2: Qualification criteria for quality systems auditors

30011-2 1993

BS EN 30011-3:1993

© BSI 10-1998

Publication(s) referred to

See national foreword

389 Chiswick High Road

London

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