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Systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled.
ISO 9000:2000 - Clause 3.9.1Fundamentals and Vocabulary
Clause 8.2.2 Documented procedure for internal audits Verification of conformity and effectiveness Planned on status; importance; prior audits Auditors selected for impartiality; objectivity Results reported and records maintained Corrective action taken without undue delay Follow-up audit to verify corrective action
Clause 8.2.1.3: Establish effective and efficient internal audits Assess strengths and weaknesses of the QMS Use as management tool for independent view Obtain objective evidence that requirements met Judge effectiveness and efficiency of
Clause 8.2.1.3: Ensure improvement actions are taken on results Establish flexible audit plans for internal audits Permit changes in emphasis based on evidence Develop plans with input from areas to be audited Consider planning input from interested parties
Clause 8.2.1.3: Effective and efficient process implementation Opportunities for continual improvement Capability of processes Effective and efficient use of statistical
techniques Use of information technology Analysis of quality cost data Effective and efficient use of resources Process and product performance results
8.2.2.1 Quality Management System Audit Audit the QMS to verify compliance with ISO/TS 16949 and
any additional quality management system requirements.
8.2.2.2 Manufacturing Process Audit Audit the effectiveness of each manufacturing process.
8.2.2.3 Product Audit Audit products at appropriate stages of production and
delivery to verify conformance to all specified requirements, such as product dimensions, functionality, packaging, and labeling at a defined frequency.
Missing direct coverage of these ISO 9001:2000 requirements:
ISO 9001:2000 - Management responsible for area being audited must ensure actions are taken without undue delay to eliminate detected nonconformities and their causes.
ISO 14001:2004 - Not included.
ISO 9001:2000 - Follow-up activities must include verification of actions taken and the reporting of verification results.
ISO 14001:2004 - Not included.
Addressed indirectly by ISO 14001:2004, clause 4.5.3, on Nonconformity, Corrective Action, and Preventive Action.
Perform internal audits to identify opportunities for improvement in environmental system
Establish an audit program to direct the planning and conduct of audits and identify the audits needed to meet the program's objectives
Base program on the nature of operations, in terms of its environmental aspects and potential impacts, the results of past audits, and other relevant factors
Each internal audit need not cover entire system, so long as audit program ensures all organizational units and functions, system elements, and full scope of the EMS are audited periodically
Plan and conduct audits by objective and impartial auditors, aided by technical experts, as appropriate, selected from within organization or from external sources
Collective competence of auditors should be sufficient to meet objectives and scope of the particular audit and provide confidence as to the degree of reliability that can be placed on results
Results of an internal EMS audit can be provided in the form of a report and used to:
– Correct or prevent specific nonconformities
– Fulfill one or more objectives of the audit program
When software organizations separate their work into projects, internal audit planning should:
Define a selection of projects Cover all stages and all processes Assess compliance of project quality plan to QMS Assess project compliance to project quality plan
ISO 19011 provides guidance and examples US decided additional guidance was neededPublished ANSI/ISO/ASQ QE19011S:2004 QE19011S includes ISO 19011 guidanceQE19011S adds guidance and examples for:
– First-party (internal) audits – Second-party (external) audits– Small organizations
Request: (RFI-036 for Clause 8.2.2) Clause 8.2.2: “An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, ...”.
Is it a requirement of this clause that the criteria to determine the status and the importance of the processes and areas to be audited have to be documented?
Background: There is divergence with the auditor regarding a requirement for documentation of “status and importance criteria” despite the fact that evidence was provided that the planning of the audit program has taken the status and importance of the processes and areas to be audited into consideration.
http://www.iso.org/tc176/ISO9001AuditingPracticesGroup 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 audit of a task, activity or process to overall system Auditing continual improvement 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, QMS, and certification How to add value during the audit process Auditing competence and effectiveness of actions taken Auditing statutory and regulatory requirements Auditing the quality policy and quality objectives Auditing 7.6 Control of monitoring and measuring devices Making effective use of ISO 19011 Auditing customer feedback processes
Documenting a nonconformity Guidance for reviewing and closing nonconformities Auditing internal communications Auditing preventive action Auditing service organizations Third party auditor impartiality and conflict of interest Auditing the effectiveness of the internal audit Auditing electronic-based management systems Auditing the management of resources Auditing customer communications