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| Implementing and Auditing an ISO 9000:2000 Quality System Return to Our Services This course focuses on a complete review of the ISO 9000:2000 standard, the 14 implementation steps, creating several level I policy statements and level II procedures and a full day of examining the audit process and working with auditing through a case study. Who Should Attend Personnel responsible for developing, implementing and auditing an ISO quality management system. Learning Outcomes -Understand the ISO 9000:2000 standard and how to create necessary policy, procedures, and work instructions. -Know how to conduct an internal audit. -Understand a quality system. -Link the three levels of documentation. -Know the 14 steps to implementing the ISO 9000:2000 standard. -Develop policy and procedure documents. -Understand the registration process. -Be familiar with the audit cycle (using a case study). OUTLINE I.What is a quality system? A.Prevention B.Implementation C.Effectiveness D.ISO 9001 E.ISO 19011 II.Understanding the ISO 9000 Series of Standards III.Hierarchy of documentation A.The policy statement B.The operating procedure C.The work instructions D.Quality records E.The quality plan IV.An in-depth look at ISO 9001 A.Section 4.2 B.Linkage of requirements V.ISO 9001 Review A.A look at the remaining segments VI.Implementing the ISO 9000 quality system A.14 steps to registration B.Developing the team structure C.The importance of top management involvement and the steering committee VII.Developing the necessary documentation A.Level I quality manual B.Level II procedures C.Level III work instructions VIII.Workshop: developing documentation IX.What is an audit? A.Different types of audits B.Personnel involved in audits C.The human side of auditing X.The audit cycle A.Initiation of audit (ref. ISO 19011,5.1) 1.Authority to conduct internal audits 2.Independence of auditing authority B.Developing the audit plan 1.Working documents C.Preparing for the audit 1.Developing audit plan/assignments for internal audit D.Executing the internal audit 1.Opening meeting with department supervisor/manager 2.Collecting evidence/audit observations 3.Closing meeting 4.Audit report 5.Corrective action follow-up a.Establishing time line for action b.Verification of effectiveness of actions Return to Our Services |
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