ISO 13485:2003 Process/Clause MATRIX

ISO13485:2003 Requirements PROCESS

Management

Purchas-ing
Customer

Monit &
Planning &
Production

Service

Service

R&D
Meas.
Field

QA
4 Quality Management System

4.1 General Requirements X

4.2.1 General X

4.2.2 Quality manual X

4.2.3 Control of Documents X X X

4.2.4 Control of Quality records X X

5.2 Customer focus X

5.3 Quality policy X X X

5.4.1 Quality objectives X X X

5.4.2 Quality management system planning X

5.5.1 Responsibility and authority X X

5.5.2 Management representative X

5.5.3 Internal communication X

5.6.1 General X X X

5.6.2 Review input X X

5.6.3 Review output X X

6.2.1 General X

6.2.2 Competence, awareness and training X X

6.3 Infrastructure X

6.4 Work environment X

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 ISO13485:2003 Requirements PROCESS

Management

Purchas-ing
Customer
Planning &
Production

Monit &
Service

Service

R&D
Meas.
Field

QA
7 Product Realization
7.1 Planning of product realization X
7.2.1 Determination of requirements related to the product X X
7.2.2 Review of requirements related to the product X
7.2.3 Customer communication X
7.3.1 Design and development planning X
7.3.2 Design and development inputs X
7.3.3 Design and development outputs X
7.3.4 Design and development review X
7.3.5 Design and development verification X
7.3.6 Design and development validation X
7.3.7 Control of design and development changes X
7.4.1 Purchasing process X
7.4.2 Purchasing information X
7.4.3 Verification of purchased product X X
7.5.1 Control of production and service provision X
7.5.2 Validation of processes for production and service provision X X
7.5.3 Identification and traceability X
7.5.4 Customer property X
7.5.5 Preservation of product X
7.6 Control of monitoring and measuring devices X
8 Measurement, analysis, and Improvement
8.1 General X
8.2.1 Customer feedback X X X
8.2.2 Internal audit X
8.2.3 Monitoring and measurement of processes X
8.2.4 Monitoring and measurement of product X
8.3 Control of nonconforming product X
8.4 Analysis of data X
8.5.1 Improvement- General X X
8.5.2 Corrective action X
8.5.3 Preventive action X

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