ISO 13485 readiness free online course medical devices version 2016

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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: Risk treatment T 22

MCT QMS T 22

5 Management responsibility

Case: Management review

6 Resource management

Case: Customer and need

Case Clean room

MCT Management responsibility

7 a Product realization

Case: Communication

Case Priority tasks

Case: Design review

MCT Planning

7 b Product realization

Case: Process stability

Case: Selecting suppliers

Case: New line

MCT Purchasing and production

8 Improvement

Case: Nonconformities

Case: Audit readiness

Case: Auditor question

Case: Audit program

Case: Audit report

Case: Kaizen & problem

MCT Improvement

MCT End

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MCT Quality approach T 22

Let's continue with this MCT (multiple-choice test) to see what you have learned about quality approach
(One or more correct answers are possible)

1. A supplier is:

An organization or a person that receives a product
The result of a process
An organization or a person that provides a product

2. ISO stands for:

International Standard Organization
International Organization for Standardization
International Superior Organization

3. In the PDCA cycle, the A stands for:

Analyse data
Act
Bring support
Adapt

4. The first edition of the ISO 9000 family of standards appeared in:

1947
1980
1987

5. The following examples are medical devices:

Sunglasses
Medical gloves
Syringe
Nurse apron
Diagnostic help software

2 Principles and steps T 22

3 Process approach T 22

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