What Every Employee Needs to Know About ISO 9001:2000 A Pocketguide to the Basics QMS Documentation: Module 2

1. What Every Employee Needs to Know About ISO 9001:2000A Pocketguide to the BasicsQMS Documentation: Module 2 ISO 9001:2000

2. What Every Employee Needs to Know About ISO 9001:2000 Module 2 Contents • Types of QMS Documentation • Documentation System Structure • The Value of Documentation • Your Roles and Responsibilities • Documentation that Applies to Your Job

3. The Documentation System • What Are The Different Types of Documentation? • Quality Manual • Quality Procedures • Quality Work Instructions • Records and Forms See pages 12 - 13 in your pocket guide

4. Quality Manual The Quality Manual Describes: • Your company’s structure • The scope and processes of the QMS • The QMS approach to meeting customers’ needs • The QMS documentation structure • The policy & responsibilities for meeting the requirements of the various ISO 9001 clauses See page 12 in your pocket guide

5. Quality Procedures Quality Procedures: • Describe the steps each person or department must follow to meet the policies described in the quality manual. • Specify who does what, when (and possibly where) it is done, and what documentation is used or produced as a result of the activity. See pages 12 - 13 in your pocket guide

6. Quality Work Instructions Work Instructions : • Cover the specific “how-to” instructions for certain tasks specified in the procedures. • Contain detailed instructions in the form of written statements, diagrams, checklists, etc. • Are usually written with input from the process owners. See page 13 in your pocket guide

7. Records and Forms Records & Forms Provide: • Evidence that the required product or service quality was achieved. • Proof that the company’s QMS was implemented correctly. • A systematic way to collect information that can serve as records. See page 13 in your pocket guide

8. Records and Forms • Examples of Records include: • Inspection reports • Shipping documents • Purchase orders • Employee training records Joe Bahr Certificate of Achievement Internal Audit Training John Smith Certificate of Achievement

9. How Is The Documentation System Structured?

10. What’s The Value Of All This Documentation? A Good Documentation System Should: • Remove uncertainty & make your job easier. • Allow for new & better ways to perform your job. See page 17 in your pocket guide

11. What’s The Value Of All This Documentation? • Ensures key tasks can be carried out consistently - even when the personnel who normally do them are absent. • Increases quality awareness. • Reduces the costs of poor quality.

12. What’s The Value Of All This Documentation? • Improves communication within & between departments. • Aids in the training of personnel. See page 17 in your pocket guide

13. What’s The Value Of All This Documentation? • Provides correct, complete, & consistent ways to perform work & maintain high levels of quality. • Provides assurance of adequate control in meeting customer needs.

14. How Will The Documentation System Affect You And Your Job? • The implementation of ISO 9001 will affect different jobs in different ways. • You may be asked to do new things. • If your company already has a complete system in place, your job may not be affected at all. See pages 17 - 18 in your pocket guide

15. What Are Some Roles You Might Be Expected to Take On? • Be familiar with the documentation that affects you. • Consistently follow the QMS documentation. • Maintain complete and accurate records when necessary. • Ensure that the documentation in your area is complete, correct and effective.

16. What Are Some Roles You Might Be Expected to Take On? • Educate & guide others to use the ISO 9001 QMS correctly. • Identify ways to improve the ISO 9001 QMS. • Participate in internal audits of the QMS. What can we do to improve?

17. Procedures That Apply To My Job • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________

18. Work Instructions That Apply To My Job • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________

19. Forms & Records That Apply To My Job • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________ • _______________________________________