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T 22v16D - Free demo course - E-Learning ISO 13485 readiness medical devices management system 2016
Presentation T 22
MCT Beginning T 22
1 Quality approach T 22
2 Principles and steps T 22
MCT Quality approach T 22
3 Process approach T 22
Case: Interested parties T 22
MCT Process approach T 22
4 QMS T 22
Case: New risk T 22
Case: Risk register T 22
Case: Change T 22
Case: Document control T 22
Case: Risk treatment T 22
Summary of clause 4
MCT QMS T 22
5 Management responsibility
Case: Quality policy
Case: Management review
Summary of clause 5
6 Resource management
Case: Customer and need
Case: Importance of work
Case Clean room
Summary of clause 6
MCT Management ...
7 a Product realization
Case: Communication
Case Priority tasks
Case: Design review
Summary of clause 7a
MCT Planning
7 b Product realization
Case: Process stability
Case: Selecting suppliers
Case: New line
Summary of clause 7b
MCT Purchasing and ...
8 Improvement
Case: Nonconformities
Case: Audit readiness
Case: Auditor question
Case: Audit program
Case: Audit report
Case: Kaizen & problem
Summary of clause 8
MCT Improvement
MCT End
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Documents
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