TC176/IAF ISO 9001:2000 Auditing Practices Group
The ISO 9000 Advisory Group identified auditor competence as a critical issue when ensuring the credibility of ISO 9001:2000 certification. Auditing Practices Group established in February 2003.
Participants Experts nominated by:- IAF (CRBs, ABs, Industry) ISO TC/176(WG Int, SC1, SC2, SC3) ISO CASCO
Aims of the Group 1. Development of examples of good auditing practices related to requirements of ISO9001: 2000 and guidelines of ISO19011: 2002 2. Development of a website where papers and examples of auditing practice against the requirements of ISO 9001:2000 are posted and available to the public without charge. 3. The information provided by the Group does not constitute IAF or ISO endorsed benchmarks or interpretations of the preferred way conformance to ISO 9001:2000 is audited. APG-Introduction.doc
Topics The need for a 2-stage approach to auditing Measuring QMS effectiveness and improvements Identification of processes Understanding the process approach Determination of the where appropriate processes Auditing the where appropriate requirements Demonstrating conformity to the standard Linking an audit of a particular task, activity or process to the overall system
Topics Auditing a QMS which has minimum documentation How to audit top management processes The role and value of the audit checklist Scope of ISO 9001:2000, scope of quality management system and defining scope of certification How to add value during the audit process Auditing competence of personnel and the effectiveness of actions taken Auditing statutory and regulatory requirements
Topics Auditing quality policy and quality objectives Auditing the control of monitoring and measuring devices Effective use of ISO 19011:2002 Auditing customer feedback processes Documenting a nonconformity Reviewing and closing a nonconformity Auditing preventive action Auditing continual improvement
Topics Auditing service organizations Auditing Internal Communication Third party auditor impartiality and conflict of interest Auditing the effectiveness of the internal audit Auditing Electronic-Based Management Systems (EBMS)
Topics Auditing the Design and Development Process Auditor Code of Conduct and Ethics Auditing the Management of Resources
Accreditation Auditing Practices Group (AAPG) Topics The Witnessing of CRB Audits by an Accreditation Body Process approach" based accreditation audits Auditing the competence of quality management system certification/registration body auditors and audit teams
The need for a 2 stage approach to auditing Auditing to ISO 9001:2000 requires a good understanding of the business and QMS The primary purpose of the 1 st stage audit Activities performed during the 1 st stage audit APG-2stage.doc
Measuring QMS effectiveness and improvements (Open presentation) Microsoft owerpoint Presentatio
Identification of Processes Can the auditee distinguish between processes and activities? Be able to adapt to the auditee s situation Determine if there is a problem with difference in terminology Determine if there is a real lack of implementation of the process approach APG-IdentifyProcesses.doc
Understanding the process approach (1) The Auditor should realise several steps are needed Determine the processes and responsibilities needed to attain objectives Determine and provide adequate resources and information Establish and apply methods to monitor and analyse processes Establish and apply a process for continual improvement
Understanding the process The Auditor also needs to:- approach (2) Be aware that application of the process approach will be different from organization to organization Understand the process approach to a level beyond the terminology of the standard Consider small & medium enterprises who may not need many processes Ensure that misunderstandings are identified and resolved during the 1 st stage audit
Understanding the process approach (3) The Auditee needs to consider:- Establishment of process objectives Process planning Availability of suitable records Redefinition of processes during the 1 st stage audit can identify activities incorrectly described as processes APG-UnderstandProcessApproach.doc
Determination of the where appropriate processes Terminology Definition of process Exclusions APG-DetermineWhereAppropriate.doc
Auditing where appropriate requirements (1) Determine the application of ISO 9001:2000 Ensure where appropriate requirements are appropriate Does the requirement add value? Does it increase the risk of not meeting customer requirements?
Auditing where appropriate requirements (2) Need for experience to make a judgement on a technical issue Sector knowledge Competence Auditing skills Knowledge of the processes Objective evidence APG-AuditWhereAppropriate.doc
Demonstrating conformity to the standard Auditing processes versus auditing to the standard's clauses Audit checklists may not be sufficient What is adequate sampling? APG-DemonstrateConformity.doc
Linking an audit of a particular task, activity or process to the overall system Overall direction of the audit Interaction of processes Importance of processes Take samples APG-AuditofTasktoSystem.doc
Auditing continual improvement How much improvement is enough? What sort of information is relevant and where can we find it? Improvement of the process or improvement of the QMS? APG-AuditContinualImprovement.doc
Auditing a QMS which has minimum documentation The necessity for any documentation should be evaluated in the light of: the observed need for consistency the role that any documentation could play in avoiding any significant, identified risks. APG-MinDocumentation.doc
How to audit top management processes Identifying top management processes Conducting the audit Audit reporting APG-AuditTopManagement.doc
The role and value of the audit checklist Need for checklists The use of audit checklists Advantages Disadvantages Conclusion APG-Checklist.doc
Scope of ISO 9001:2000, Scope of Quality Management System (QMS) and Defining Scope of Certification ISO 9001:2000 clause 1 Scope defines the scope of the standard, not to be confused with QMS scope The scope of a QMS should be based on the: nature of products and realization processes result of risk assessment commercial considerations contractual, statutory and regulatory requirements ISO 9001:2000 clause 1.2 Application Scope of registration/certification APG-Scope.doc
How to add value during the audit process (1) Value-added quality management systems Value-added auditing Maturity of QMS Non Non-conforming Conforming Zone 3 Zone 4 Zone 1 Zone 2 Low High Maturity of Quality culture
How to add value during the audit process (2) Some tips for Value-added auditing Audit planning Audit technique Analysis and decision Report and follow-up APG-HowtoAddValue.doc
Auditing 'competence' and 'effectiveness of actions taken' (1) An organization will need to: Identify what competencies are required Identify which personnel already are competent Decide what additional competencies are required Decide how these are to be obtained Train, hire or reassign personnel review competence of personnel
Auditing 'competence' and 'effectiveness of actions taken (2) Auditor would seek evidence of: Identification of competencies required Assignment of competent personnel Evaluation of the effectiveness of actions taken Maintenance of competence APG-AuditingCompetence.doc
Auditing statutory and regulatory requirements An organization must identify and control the statutory and regulatory requirements applicable to its products (including services). Evidence should be obtained that these requirements are being satisfied APG-StatutoryRegulatory.doc
Auditing quality policy and objectives (1) Auditing quality policy Interview top management to verify that the organization s overall quality objectives have been defined Evaluate commitment and involvement Have management disseminated the policy throughout the organization? Determine awareness among personnel at all levels
Auditing quality policy and Auditing quality objectives objectives (2) Verify that the organization s overall quality objectives have been defined Do they reflect the quality policy? Are they coherent, aligned and compatible with the overall business objectives, including customer expectations? APG-QualityPolicyandObjectives.doc
Auditing the control of monitoring and measuring devices It is important for the auditor to understand the differences between:- monitoring and measurement, and equipment and devices. The different sub-clauses of the standard refer to all of these in isolation and together so clause 7.6 should be read carefully. APG-ISO9001Clause7.6.doc
Effective use of ISO19011:2002 The standard contains guidance on:- The principles of auditing Managing an audit programme Audit activities Competence and evaluation of auditors APG-EffectiveUseofISO19011.doc
Auditing customer feedback processes What are the requirements? What should be addressed when auditing customer feedback processes? Prior to the audit of the customer feedback process (preparation stage) During the process assessment APG-CustomerFeedback.doc
Documenting a nonconformity What is a nonconformity? Identify and document the audit evidence Determine the requirement Write the statement of nonconformity APG-DocumentNonconformity.doc
Reviewing and closing a nonconformity Auditors not only write nonconformities but are also responsible for the review of the response to the nonconformity Correction Determination of cause Corrective action Objective evidence Closing nonconformities APG-ReviewNonconformity2.doc
Auditing preventive action How the organization: Determines potential nonconformities & causes Evaluates the need for preventive action Determines action required & how it is implemented Records results of actions taken Reviews preventive actions taken Philosophical discussion - auditor and auditee APG-ReviewNonconformity2.doc
Auditing service organizations Design and development of the service Validation of processes for production and service provision 2 types of Services - those involving the customer in the realization of the service itself (real time delivery) and - those in which the output is delivered to the customer after the realization of the process Control of nonconforming product
Auditing Internal Communication Identification of the people between whom the communication is to occur Information to be communicated Means by which this is to be achieved Methods selected to monitor its effectiveness Documentation and records necessary to verify it has occurred
Third party auditor impartiality and conflict of interest CRB commitment to impartiality Threats to auditor impartiality Safeguards to auditor impartiality Assessing the level of impartiality risk Determining the acceptability of the level of impartiality risk Organizational and structural issues
Auditing the effectiveness of the internal audit Issues to evaluate : the competencies that are needed for and applied to the audit the risk analysis performed by the organization (if any) in planning internal audits the degree of management involvement in the internal audit process the way the outcome of the internal audit process is used by the organization to evaluate the effectiveness of its QMS and to identify opportunities for improvements.
Auditing Electronic-Based Management Systems (EBMS) Audit Initiation and Planning Document Review On-Site Realization Activities Auditing the Control of Electronic Documents Auditing the Control of Electronic Records Organizational Resources Internal and External Electronic Communication Multi-Site Management Systems Auditor Competence
The Witnessing of CRB Audits by an Accreditation Body Pre-audit preparations During the audit Feedback and reporting of results
Process approach" based accreditation audits CRB objectives Typical processes of CRBs Example of questions to be asked by an AB during a process based audit
Auditing the competence of quality management system CRB auditors and audit teams Evaluation of auditor qualifications and competence Personal attributes Generic knowledge and skills Processes and products Size of Organizations Culture and Language Legal, statutory, and regulatory requirements Evaluation of competence requirements Deployment of a team of competent auditors
Copies of the guidance documents referred to in this presentation can be obtained from: www.iaf.nu www.iso.org/tc176/iso9001auditingpracticesgroup Comments on the papers or presentations can be sent to the following email address: charles.corrie@bsi-global.com Feedback from users will be used by the ISO 9001 Auditing Practices Group to determine whether additional guidance documents should be developed, or if these current ones should be revised.
Disclaimer These papers have not been subject to an endorsement process by the International Organization for Standardization (ISO), ISO Technical Committee 176, or the International Accreditation Forum (IAF). The information contained within them is available for educational and communication purposes. The ISO 9001 Auditing Practices Group does not take responsibility for any errors, omissions or other liabilities that may arise from the provision or subsequent use of such information.
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