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ISO13485:2003

input

ISO13485:2003

output

ISO13485:2003

top management

ISO13485:2003

quality policy

- 87 -

ISO13485:2003 system

quality management

ISO13485:2003

review

ISO13485:2003

resource

ISO13485:2003

infrastructure

ISO13485:2003

traceablity

ISO13485:2003

advisory notices

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ISO13485:2003

4.1 General requirements

ISO13485:2003

process

- 90 -

ISO13485:2003

4.2.1 Documentation requirements ­ General

- 91 -

- 92 -

ISO13485:2003 shall be implemented and maintained

4.2.1

- 93 -

ISO13485:2003

4.2.2 Quality manual

ISO13485:2003

4.2.3 Control of documents

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- 95 -

ISO13485:2003

4.2.4 Control of records - 96 -

- 97 -

ISO13485:2003

5.1 Management commitment

ISO13485:2003 commitment ISO13485:2003 customer

ISO13485:2003

5.2 Customer

- 98 -

ISO13485:2003

5.3 Quality policy

ISO13485:2003

5.4.1 Quality objectives

ISO13485:2003

5.4.2 Quality management system planning

- 99 -

ISO13485:2003

5.5.1 Responsibility and authority

ISO13485:2003

5.5.2 Management representative

ISO13485:2003

management representative

ISO13485:2003

5.5.3 Internal communication

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5

ISO13485:2003

5.6.1 Management review ­ General

ISO13485:2003

5.6.2 Review input

- 101 -

ISO13485:2003

5.6.3 Review output

ISO13485:2003

6.1 Provision of resources

ISO13485:2003

6.2.1 Human resources - General

ISO13485:2003

6.2.2 Competence, awareness and training

- 102 -

ISO13485:2003

6.3 Infrastructure

ISO13485:2003 associated utilities

ISO13485:2003

6.4 Work environment

- 103 -

ISO13485:2003

7.1 Planning of product realization

ISO13485:2003 to the product

7.2.1 Determination of requirements related

- 104 -

ISO13485:2003 product

7.2.2 Review of requirements related to the

ISO13485:2003

7.2.3 Customer communication

ISO13485:2003

7.3.1 Design and development planning

ISO13485:2003

7.3.2 Design and development inputs

- 105 -

ISO13485:2003

7.3.3 Design and development outputs

ISO13485:2003

7.3.4 Design and development review

- 106 -

ISO13485:2003

7.3.5 Design and development verification

ISO13485:2003

7.3.6 Design and development validation

ISO13485:2003 changes

7.3.7 Control of design and development

- 107 -

ISO13485:2003

7.4.1 Purchasing process

ISO13485:2003

7.4.2 Purchasing information

- 108 -

ISO13485:2003

7.4.3 Verification of purchased product

ISO13485:2003 provision

7.5.1 Control of production and service

ISO13485:2003

7.5.1.2.1 Cleanliness of product and

- 109 -

contamination control

ISO13485:2003

7.5.1.2.2 Installation activities

- 110 -

ISO13485:2003

7.5.1.2.3 Servicing activities

ISO13485:2003 medical devices

7.5.1.3 Particular requirements for sterile

- 111 -

( )

ISO13485:2003 7.5.2.1 Validation of processes for production and service provision ­ General requirements

ISO13485:2003 medical devices

7.5.2.2 Particular requirements for sterile

- 112 -

ISO13485:2003

7.5.3.1 Identification

ISO13485:2003

7.5.3.2.1 Traceability ­ General

ISO13485:2003 7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices

ISO13485:2003

- 113 -

ISO13485:2003

7.5.3.3 Status identification

ISO13485:2003

7.5.4 Customer property

ISO13485:2003

7.5.5 Preservation of product

- 114 -

ISO13485:2003 devices

7.6 Control of monitoring and measuring

ISO13485:2003 ­ General

8.1 Measurement, analysis and improvement

ISO13485:2003

8.2 Feedback

(

- 115 -

ISO13485:2003

8.2.2 Internal audit

ISO13485:2003 processes

8.2.3 Monitoring and measurement of

ISO13485:2003 product

8.2.4 Monitoring and measurement of

- 116 -

ISO13485:2003 8.2.4.2 Particular requirements for active implantable medical devices and implantable medical devices

ISO13485:2003

8.3 Control of nonconforming product

ISO13485:2003

8.4 Analysis of data

- 117 -

ISO13485:2003

8.5.1 Improvement ­ General

ISO13485:2003

8.5.2 Corrective action

- 118 -

ISO13485:2003

8.5.3 Preventive action

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(

)

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( )

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10-6

SAL Sterility Assurance Level 10

-n

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-

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i (i) (ii) ii

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14 ( )

( ( (

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