Implementing and Auditing an ISO 9000:2000 Quality System

OUTLINE (Return to Main)

1. What is a quality system?
   1. Prevention
   2. Implementation
   3. Effectiveness
   4. ISO 9001
   5. ISO 19011
2. Understanding the ISO 9000 Series of Standards
3. Hierarchy of documentation
   1. The policy statement
   2. The operating procedure
   3. The work instructions
   4. Quality records
   5. The quality plan
4. An in-depth look at ISO 9001
   1. Section 4.2
   2. Linkage of requirements
5. ISO 9001 Review
   1. A look at the remaining segments
6. Implementing the ISO 9000 quality system
   1. 14 steps to registration
   2. Developing the team structure
   3. The importance of top management involvement and the steering committee
7. Developing the necessary documentation
   1. Level I quality manual
   2. Level II procedures
   3. Level III work instructions
8. Workshop: developing documentation
9. What is an audit?
   1. Different types of audits
   2. Personnel involved in audits
   3. The human side of auditing
10. The audit cycle
    1. Initiation of audit (ref. ISO 19011,5.1)
       1. Authority to conduct internal audits
       2. Independence of auditing authority
    2. Developing the audit plan
       1. Working documents
    3. Preparing for the audit
       1. Developing audit plan/assignments for internal audit
    4. 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
          1. Establishing time line for action
          2. Verification of effectiveness of actions

Course Content/Main Topics	% of Time Spent on Topic
The standards and associated documentation	40%
Implementation	20%
Internal auditing	40%

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