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 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) BS EN 30011-3:1993 ISO 10011-3: 1991 Incorporating Amendment No to BS 7229-3:1991 (renumbers BS as BS EN 30011-3:1993) BS EN 30011-3:1993 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 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 580 19844 Amendments issued since publication Amd No Date Comments 7924 September 1993 Renumbered as BS EN 30011-3:1993 BS EN 30011-3:1993 Contents Committees responsible National foreword Foreword Text of EN 30011-3 Publication(s) referred to © BSI 10-1998 Page Inside front cover ii Inside back cover i BS EN 30011-3:1993 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 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 Part 1:1991 Auditing (Identical) Part 2:1991 Qualification criteria for auditors (Identical) ISO 10011-1:1990 ISO 10011-2:1991 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 Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN title page, pages 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 ii © BSI 10-1998 EN 30011-3 EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM 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 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 EN 30011-3:1993 Foreword 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 Foreword Scope Normative references 3 Definitions Managing an audit programme Code of ethics Annex ZA (normative) Normative references to international publications with their relevant European publications © BSI 10-1998 EN 30011-3:1993 Scope 4.3 Qualification of staff 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 4.3.1 Audit programme management 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 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 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 © BSI 10-1998 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 EN 30011-3:1993 4.5.2 Consistency of auditors 4.6.4 Audit reporting 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 Audit report formats should be formalized to the extent practicable 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 4.6.5 Corrective action follow-up Procedures should be established to control corrective action follow-up, if audit programme management are requested to 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 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 Procedures should be established for planning and scheduling the programme of audits © BSI 10-1998 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 © BSI 10-1998 blank BS EN 30011-3:1993 Publication(s) referred to See national foreword © BSI 10-1998 BSI 389 Chiswick High Road London W4 4AL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BSI Ð British Standards Institution BSI is the independent national body responsible for 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