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EN
ISO 13485: 2003 Medical devices -
Quality management systems- Requirements for regulatory purposes |
1 Scope
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1.1 General
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1.2 Application
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2 Normative reference
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3 Terms and definitions
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4 Quality management system [title only]
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4.1 General requirements
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4.2 Documentation requirements [Title
only] |
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4.2.1 General
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4.2.2 Quality manual
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4.2.3 Control of documents |
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4.2.4 Control of records
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5 Management
responsibility [title only]
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5.1 Management commitment
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5.2 Customer focus |
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5.3 Quality policy
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5.4 Planning [title only]
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5.4.1 Quality objectives |
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5.4.2 Quality management system
planning |
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5.5 Responsibility, authority and
communication [title only] |
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5.5.1 Responsibility and authority |
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5.5.2 Management representative |
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5.5.3 Internal communication |
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5.6 Management review [title only] |
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5.6.1 General |
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5.6.2 Review input
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5.6.3 Review output |
6 Resource management
[title only]
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6.1 Provision of resources |
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6.2 Human resources [title only] |
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6.2.1 General
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6.2.2 Competence, awareness and
training |
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6.3 Infrastructure
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6.4 Work environment
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7 Product realization
[title only]
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7.1 Planning of product realization |
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7.2 Customer-related processes [title
only] |
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7.2.1 Determination of requirements
related to the product |
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7.2.2 Review of requirements related
to the product |
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7.2.3 Customer communication |
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7.3 Design and development [title
only]
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7.3.1 Design and development planning |
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7.3.2 Design and development inputs |
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7.3.3 Design and development outputs |
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7.3.4 Design and development review
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7.3.5 Design and development
verification |
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7.3.6 Design and development
validation |
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7.3.7 Control of design and
development changes |
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7.4 Purchasing [title only] |
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7.4.1 Purchasing process
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7.4.2 Purchasing information
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7.4.3 Verification of purchased
product |
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7.5 Production and service provision
[title only]
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7.5.1 Control of production and
service provision |
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7.5.1.1 General requirements |
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7.5.1.2 Control of production and service provision -
Specific requirements |
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7.5.1.2.1 Cleanliness of product and contamination
control |
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7.5.1.2.2 Installation activities |
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7.5.1.2.3 Servicing activities |
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7.5.1.3 Particular requirements for sterile devices |
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7.5.2 Validation of processes for
production and service provision |
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7.5.2.1 General requirements |
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7.5.2.2 Particular requirements for sterile medical
devices |
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7.5.3 Identification and traceability |
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7.5.3.1 Identification |
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7.5.3.2 Traceability |
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7.5.3.2.1 General |
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7.5.3.2.2 Particular requirements for active implantable
medical devices and implantable medical devices |
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7.5.3.2.3 Status identification |
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7.5.4 Customer property
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7.5.5 Preservation of product |
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7.6 Control of monitoring and
measuring devices |
8 Measurement, analysis
and improvement [title only]
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8.1 General
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8.2 Monitoring and measurement [title
only] |
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8.2.1 Feedback
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8.2.2 Internal audit
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8.2.3 Monitoring and measurement of
processes |
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8.2.4 Monitoring and measurement of
product |
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8.2.4.1 General Requirements |
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8.2.4.2 Particular requirement for active implantable
medical devices and implantable medical devices |
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8.3 Control of nonconforming product
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8.4 Analysis of data
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8.5 Improvement [title only]
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8.5.1
General |
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8.5.2 Corrective action
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8.5.3 Preventive action
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