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Document Pyramid ISO 13485:2016 Select

4.1.1 - Roles undertaken by the organization under applicable regulatory requirements QM


4.1.5 - Outsourcing process QM
4.2.2 - Quality Manual QM
5.3 - Quality Policy QM
5.5.1 - Responsibilities and authorities QM
4.1.6 - Validation of the application of computer software used in the Quality Management
System P
4.2.4 - Control of documents P
4.2.5 - Control of records P
5.6.1 - Management Review P
6.2 - Training P
6.3 - Requirements for infrastructure and maintenance activities P
6.4.1 - Monitor and control the work environment P

6.4.2 - Arrangements for control of contaminated or potentially contaminated product P


7.3.1 - Design and Development P
7.3.8 - Transfer of design and development output P
7.3.9 - Control design and development changes P
7.4.1 - Purchasing process P
7.5.4 - Servicing procedure P

7.5.6 - Procedure and records of production and service provision process validation P

7.5.7 - Validation of processes: Sterilization and sterile barrier systems P


7.5.8 - Identification P
7.5.8 - Product identification from normal production P
7.5.9.1 - Traceability P
7.5.11 - Preservation of product P
7.6 - Control of Monitoring and measuring equipment P
7.6 - Validation of the application of computer software used for the monitoring and
measurment of requirements P
8.2.1 - Feedback process P
8.2.2 - Complaint handling P
8.2.3 - Vigilance Control P
8.2.4 - Internal audit P
8.3.1 - Control of non-conforming product P
8.3.4 - Rework P
8.4 - Analysis of data P
8.5.2 - Corrective Action P
8.5.3 - Preventive Action P
7.1 - Process for risk management in product realization P*
8.2.1 - Post-Market Surveillance (PMS) P*
8.2.1 - Post-Market Clinical Follow-up (PMCF) P*
8.2.1 - Clnical evaluation P*
5.4.1 - Quality Objectives D
4.2.3 - Medical Device File D
7.2.3 - Arrangements for communication with customers D
7.3.10 - Design and development file D
7.5.2 - Requirements for cleanliness of product D
7.5.3 - Requirements for medical device installation acceptance criteria for verification of
installation D
7.1 - Outputs of product realization planning R
7.2.2 - Records of the results of the customer requirements review and actions araising
from it R
7.3.2 - Design and development planning R
7.3.4 - Design and development outputs R
7.3.5 - Records of design and development review R
7.3.6 - Design verification plans, results and conclusions R
7.3.6 - Design validation plans, results and conclusions R
7.4.3 - Record of verification of purchased product R
7.5.1 - Record for each medical device or batch that provides traceability R
7.5.3 - Record for medical device installation and verification of installation R
7.5.5 - Records of sterilization process R

7.5.9.2 - Records of traceability and name and address of the shipping package consignee R
7.5.10 - Report on changes on customer property R
7.6 - Record of calibration R
8.2.4 - Record of audits and their results R
8.2.6 - Identity of the person authorizing release of product R
8.2.6 - Monitoring and measurment of product R
8.3.3 - Advisory notices in accordance with applicable regulatory requirements R