INTERNATIONAL ISO STANDARD 19011

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ISO 19011 2011 E,TC1 ibited,t o 12 2 king proh,COPYRIGHT PROTECTED DOCUMENT URC. 011 networ,e n s ed b ownloadpying an,Lic D ly co,ISO 2011 o n. All rights reserved Unless otherwise specified, le of this publication may be reproduced or utilized in any form or by any means. electronic or mechanical including photocopying and microfilm without permission in writing from either ISO at the address below or ISO s. member body in the country of the requester,ISO copyright office. Case postale 56 CH 1211 Geneva 20,Tel 41 22 749 01 11.
Fax 41 22 749 09 47,E mail copyright iso org,Web www iso org. Published in Switzerland,ii ISO 2011 All rights reserved. ISO 19011 2011 E,Contents Page,Foreword iv,Introduction v. 2 Normative references 1,3 Terms and definitions 1. 4 Principles of auditing 4,5 Managing an audit programme 5.
5 1 General 5,5 2 Establishing the audit programme objectives 6. 5 3 Establishing the audit programme 7,5 4 Implementing the audit programme 10. 5 5 Monitoring the audit programme 13, 5 6 Reviewing and improving the audit programme 14. 6 Performing an audit 14,6 1 General 14,6 2 Initiating the audit 15. 6 3 Preparing audit activities 16,6 4 Conducting the audit activities 18.
6 5 Preparing and distributing the audit report 23. 6 6 Completing the audit 24,6 7 Conducting audit follow up 24. 7 Competence and evaluation of auditors 24,7 1 General 24. 7 2 Determining auditor competence to fulfil the needs of the audit programme 25. 7 3 Establishing the auditor evaluation criteria 29. 7 4 Selecting the appropriate auditor evaluation method 29. 7 5 Conducting auditor evaluation 29, 7 6 Maintaining and improving auditor competence 29. Annex A informative Guidance and illustrative examples of discipline specific knowledge and skills of. auditors 31, Annex B informative Additional guidance for auditors for planning and conducting audits 37. Bibliography 44,TC1 ibited,E t o 12 2 king proh,URC 011 networ.
y SO ed 2 d,e n s ed b ownloadpying an,Lic D ly co. ISO 2011 All rights reserved iii,ISO 19011 2011 E, 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. International Standards are drafted in accordance with the rules given in the ISO IEC Directives Part 2. The main task of technical committees is to prepare International Standards Draft International Standards. adopted by the technical committees are circulated to the member bodies for voting Publication as an. International Standard 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 document may be the subject of patent. rights ISO shall not be held responsible for identifying any or all such patent rights. ISO 19011 was prepared by Technical Committee ISO TC 176 Quality management and quality assurance. Subcommittee SC 3 Supporting technologies, This second edition cancels and replaces the first edition ISO 19011 2002 which has been technically revised. The main differences compared with the first edition are as follows. the scope has been broadened from the auditing of quality and environmental management systems to the. auditing of any management systems, the relationship between ISO 19011 and ISO IEC 17021 has been clarified. remote audit methods and the concept of risk have been introduced. confidentiality has been added as a new principle of auditing. Clauses 5 6 and 7 have been reorganized, additional information has been included in a new Annex B resulting in the removal of help boxes.
the competence determination and evaluation process has been strengthened. illustrative examples of discipline specific knowledge and skills have been included in a new Annex A. additional guidelines are available at the following website www iso org 19011auditing. TC1 ibited,E t o 12 2 king proh,URC 011 networ,y SO ed 2 d. e n s ed b ownloadpying an,Lic D ly co,iv ISO 2011 All rights reserved. ISO 19011 2011 E,Introduction, Since the first edition of this International Standard was published in 2002 a number of new management. system standards have been published As a result there is now a need to consider a broader scope of. management system auditing as well as providing guidance that is more generic. In 2006 the ISO committee for conformity assessment CASCO developed ISO IEC 17021 which sets out. requirements for third party certification of management systems and which was based in part on the guidelines. contained in the first edition of this International Standard. The second edition of ISO IEC 17021 published in 2011 was extended to transform the guidance offered in. this International Standard into requirements for management system certification audits It is in this context. that this second edition of this International Standard provides guidance for all users including small and. medium sized organizations and concentrates on what are commonly termed internal audits first party. and audits conducted by customers on their suppliers second party While those involved in management. system certification audits follow the requirements of ISO IEC 17021 2011 they might also find the guidance in. this International Standard useful, The relationship between this second edition of this International Standard and ISO IEC 17021 2011 is shown. in Table 1, Table 1 Scope of this International Standard and its relationship with ISO IEC 17021 2011.
Internal auditing External auditing,Supplier auditing Third party auditing. For legal regulatory and similar, Sometimes called first party audit Sometimes called second party audit. For certification see also the,requirements in ISO IEC 17021 2011. This International Standard does not state requirements but provides guidance on the management of an. audit programme on the planning and conducting of an audit of the management system as well as on the. competence and evaluation of an auditor and an audit team. Organizations can operate more than one formal management system To simplify the readability of this. International Standard the singular form of management system is preferred but the reader can adapt the. implementation of the guidance to their own particular situation This also applies to the use of person and. persons auditor and auditors, This International Standard is intended to apply to a broad range of potential users including auditors. organizations implementing management systems and organizations needing to conduct audits of management. systems for contractual or regulatory reasons Users of this International Standard can however apply this. guidance in developing their own audit related requirements. O Tused ited, The guidance in this International Standard can also be.
o IS 2 for pthe,rohibpurpose of self declaration and can be. R CE t 011 12 tworking, useful to organizations involved in auditor training. U 2 personnel,ne certification,se ownlo opying,Licen D ly c. The guidance in this International Standard, er li c ence is intended to be flexible As indicated at various points in the text. the use of this guidance canSdiffer, ingle depending on the size and level of maturity of an organization s management.
system and on the nature and complexity of the organization to be audited as well as on the objectives and. scope of the audits to be conducted, This International Standard introduces the concept of risk to management systems auditing The approach. adopted relates both to the risk of the audit process not achieving its objectives and to the potential of the. audit to interfere with the auditee s activities and processes It does not provide specific guidance on the. organization s risk management process but recognizes that organizations can focus audit effort on matters of. significance to the management system,ISO 2011 All rights reserved v. ISO 19011 2011 E, This International Standard adopts the approach that when two or more management systems of different. disciplines are audited together this is termed a combined audit Where these systems are integrated into a. single management system the principles and processes of auditing are the same as for a combined audit. Clause 3 sets out the key terms and definitions used in this International Standard All efforts have been taken. to ensure that these definitions do not conflict with definitions used in other standards. Clause 4 describes the principles on which auditing is based These principles help the user to understand the. essential nature of auditing and they are important in understanding the guidance set out in Clauses 5 to 7. Clause 5 provides guidance on establishing and managing an audit programme establishing the audit. programme objectives and coordinating auditing activities. Clause 6 provides guidance on planning and conducting an audit of a management system. Clause 7 provides guidance relating to the competence and evaluation of management system auditors and. audit teams, Annex A illustrates the application of the guidance in Clause 7 to different disciplines. Annex B provides additional guidance for auditors on planning and conducting audits. TC1 ibited,E t o 12 2 king proh,URC 011 networ,y SO ed 2 d.
e n s ed b ownloadpying an,Lic D ly co,vi ISO 2011 All rights reserved. INTERNATIONAL STANDARD ISO 19011 2011 E,Guidelines for auditing management systems. This International Standard provides guidance on auditing management systems including the principles of. auditing managing an audit programme and conducting management system audits as well as guidance on. the evaluation of competence of individuals involved in the audit process including the person managing the. audit programme auditors and audit teams, It is applicable to all organizations that need to conduct internal or external audits of management systems or. manage an audit programme, The application of this International Standard to other types of audits is possible provided that special. consideration is given to the specific competence needed. 2 Normative references, No normative references are cited This clause is included in order to retain clause numbering identical with.
other ISO management system standards,3 Terms and definitions. For the purposes of this document the following terms and definitions apply. systematic independent and documented process for obtaining audit evidence 3 3 and evaluating it. objectively to determine the extent to which the audit criteria 3 2 are fulfilled. NOTE 1 Internal audits sometimes called first party audits are conducted by the organization itself or on its behalf for. management review and other internal purposes e g to confirm the effectiveness of the management system or to obtain. information for the improvement of the management system Internal audits can form the basis for an organization s self. declaration of conformity In many cases particularly in small organizations independence can be demonstrated by the. freedom from responsibility for the activity being audited or freedom from bias and conflict of interest. NOTE 2 External audits include second and third party audits Second party audits are conducted by parties having an. interest in the organization such as customers or by other persons on their behalf Third party audits are conducted by. independent auditing organizations such as regulators or those providing certification. NOTE 3 When two or more management systems of different disciplines e g quality environmental occupational. health and safety are audited together this is termed a combined audit. O T 2 audit p C176, NOTE 4 When two or more auditing organizations cooperate. to IS 2 to g arosingle auditee 3 7 this is termed a joint audit. URC 0 twork,d b y SOloaded 2g and ne,NOTE 5 Adapted from ISO 9000 2005. Licen definition,se own o3 9 1,D ly c pyin,3 2 u s er lic. audit criteria, set of policies procedures or requirements used as a reference against which audit evidence 3 3 is compared.
NOTE 1 Adapted from ISO 9000 2005 definition 3 9 3. NOTE 2 If the audit criteria are legal including statutory or regulatory requirements the terms compliant or non. compliant are often used in an audit finding 3 4,ISO 2011 All rights reserved 1. ISO 19011 2011 E,audit evidence, records statements of fact or other information which are relevant to the audit criteria 3 2 and verifiable. NOTE Audit evidence can be qualitative or quantitative. ISO 9000 2005 definition 3 9 4,audit findings, results of the evaluation of the collected audit evidence 3 3 against audit criteria 3 2. NOTE 1 Audit findings indicate conformity or nonconformity. NOTE 2 Audit findings can lead to the identification of opportunities for improvement or recording good practices. NOTE 3 If the audit criteria are selected from legal or other requirements the audit finding is termed compliance or. INTERNATIONAL STANDARD ISO 19011 2011 E Guidelines for auditing management systems 1 Scope This International Standard provides guidance on auditing management systems including the principles of auditing managing an audit programme and conducting management system audits as well as guidance on the evaluation of competence of individuals involved in the audit process including the person

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