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ISO-9001-2000 Audit Checklist

ISO-9001-2000 Audit Checklist



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Published by: OmFaris on Nov 04, 2009
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Guidance to auditor(s)
This document is intended to provide structured assistance to conduct the audit. To fit that purpose it containskey questions related to each standard clause. It shall not to be part of the audit report.
1.2ApplicationAre any exclusions to requirements of ISO9001:limited to clause 7?not customer and/or regulatory requirements?4.2.2 a)defined and justified in the Quality Manual?4.2.1 b)Quality Manual4.2.2a)Does the Quality Manual define:the scope of the quality management system (products and processes)?b)documented QMS procedures, or reference to them?c)a description of the interaction between the processes of the quality managementsystem?4.1General requirementsIs the QMS:DOCUMENTED, implemented, and maintained?Is the Quality Management System’s effectiveness continually improved (see8.5.1)?4.1a)b)c)d)e)f)Has the organisation:Identified the processes needed?Determined the sequence and interaction of these processes?Determined criteria and methods for effective operation and control?Made supporting resources and information available?Measured, monitored and analysed these processes (see 8.2.3)?acted to achieve planned results and continual improvement of these processes(see 8.5.1)?4.1Are any outsourced processes controlled and identified within the QMS?4.2.1Documentation requirementsa)b)c)d)e)Does the quality management system documentation include:Policy and objectives?A quality manual?Required documented procedures?Process related documentation?Required quality records?NOTE 2Is the QMS documentation appropriate to:a)the organisations size and activities?b)its complexity?c)competency of personnel?5.1Management responsibility
Is there evidence of top management commitment to the QMS and its continualimprovement by:a)communicating the importance of meeting customer, statutory and regulatoryrequirements?b)establishing the quality policy?c)ensuring that quality objectives are established?d)conducting management reviews?e)ensuring the availability of resources?5.2focussing on meeting customer requirements and enhancing customesatisfaction (see 7.2.1 and 8.2.1)?5.3Quality policya)Appropriate to the purpose of the organisation?b)Commits to comply with requirements and continually improve the effectiveness of the quality management system?c)Provides a framework for establishing and reviewing quality objectives?d)Communicated and understood within the organisation?e)Reviewed for continuing suitability?5.4.1Quality objectivesAre objectives established at relevant functions and levels?Do they include product requirements (see 7.1 a)?8.5.1Are they measurable?Are they consistent with the quality policy?Do they improve the effectiveness of the QMS?5.4.2Quality management system planninga)Does the QMS meet the general requirements in clause 4.1 AND the qualityobjectives (5.4.1)?b)Does it maintain its integrity when changes are planned and implemented?5.5Responsibility, authority & communication5.5.1Are responsibilities and authorities defined and communicated by topmanagement?5.5.2Management representativeIs there a member of the management team responsible for:a)ensuring that QMS processes are established implemented and maintained?b)reporting performance of the QMS to management, including any need for improvement?c)promoting awareness of customer requirements throughout the organisation?5.5.3Internal communicationAre internal communication processes established, including the effectiveness of the QMS?5.6.1Management review – GeneralDo top management review the quality management system:at planned intervals?to ensure continuing suitability, adequacy and effectiveness?
to assess improvement opportunities and the need for changes to the QMS, policyand objectives?Are RECORDS maintained?5.6.2Review inputIncludes information from:a)Audit resultsb)Customer feedback?c)Process performance and product conformity?d)Preventive and corrective actions?e)Follow-up from previous reviews?f)Changes?g)Improvement recommendations?5.6.3Review outputIncludes decisions and actions for:a)Improved effectiveness of the QMS and processes?b)Improved product related to customer requirements?c)Resource needs?4.2.3a)Control of documentsFor QMS documents, is there a DOCUMENTED PROCEDURE and controls for:issue approval?b)review, update, and re-issue approval?c)change and revision status?d)distribution?e)legibility and identification?f)external documents?g)obsolete documents?4.2.4Control of recordsAre records maintained to provide evidence of the effective operation of QMS inaccordance with a DOCUMENTED PROCEDURE?Are controls defined for:Identification?Storage protection & retrieval?Retention time and disposition?Are records:Legible?Identifiable?Retrievable?6.1Provision of resourcesHave resources been determined and provided:a)to implement, maintain, and continually improve the effectiveness of the QMS?b)to meet customer requirements?

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