D 13v16 - Set of documents - Medical devices - Procedures and instructions version 2016
Document set - 97 editable procedures and instructions for your medical devices quality management system ISO 13485 version 2016
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See the set of documents D 22v16 ISO 13485 Readiness |
You have an unlimited access for one year to the whole set of documents. This includes access to all the modifications (improvements) which could be made during that period.
| D 13v16 Procedures and instructions medical devices | |||
| Codification | Title | Sub-clause ISO 13485 version 2016 | Pages |
| Procedures (* mandatory) | |||
| PQBD13v1601 | Software validation*(first 3 pages) | 4.1.6; 7.5.6; 7.6 | 5 |
| PQBD13v1602 | Documents and records* | 4.2.4; 4.2.5 | 6 |
| PQBD13v1603 | Management review* | 5.6 | 5 |
| PQBD13v1604 | Work environment* | 6.4.1 | 4 |
| PQBD13v1605 | Feedback* | 7.2.3; 8.2.1 | 4 |
| PQBD13v1606 | Complaint handling* | 7.2.3; 8.2.2 | 4 |
| PQBD13v1607 | Advisory notices* | 7.2.3; 8.2.3; 8.3.3 | 4 |
| PQBD13v1608 | Design and development* | 7.3 | 5 |
| PQBD13v1609 | Purchasing* | 7.4 | 5 |
| PQBD13v1610 | Production* | 7.5.1; 8.2.6 | 4 |
| PQBD13v1611 | Servicing* | 7.5.4 | 3 |
| PQBD13v1612 | Process validation* | 7.5.6; 7.5.7; 8.2.5 | 6 |
| PQBD13v1613 | Identification and traceability* | 7.5.8; 7.5.7 | 5 |
| PQBD13v1614 | Product preservation* | 7.5.11 | 4 |
| PQBD13v1615 | Monitoring and measurement* | 7.6 | 5 |
| PQBD13v1616 | Reporting to regulatory authorities* | 8.2.3 | 3 |
| PQBD13v1617 | Internal audit* | 8.2.4 | 6 |
| PQBD13v1618 | Nonconforming product* | 8.3.1; 8.3.2 | 5 |
| PQBD13v1619 | Rework* | 8.3.4 | 3 |
| PQBD13v1620 | Analysis of data* | 8.4 | 9 |
| PQBD13v1621 | Corrective and preventive actions* | 8.5.2 ; 8.5.3 | 5 |
| PQBD13v1622 | Risk management | 4.1; 7.1; 7.3; 7.4; 7.5; 7.6; 8.2 | 5 |
| PQBD13v1623 | Medical device file | 4.2.3 | 4 |
| PQBD13v1624 | Training | 6.2 | 4 |
| PQBD13v1625 | Disinfection and sterilization | 7.5.2; 7.5.5; 7.5.7 | 5 |
| PQBD13v1626 | Contamination | 6.4.2; 7.5.2; 7.5.11 | 5 |
| Instructions | |||
| PQBD13v160101 | Software list | 1 | |
| PQBD13v160102 | Validation report | 1 | |
| PQBD13v160201 | Quality manual | 22 | |
| PQBD13v160202 | List of documents ofexternal origin | 1 | |
| PQBD13v160203 | List of standards | 1 | |
| PQBD13v160204 | Procedure | 1 | |
| PQBD13v160205 | Instruction | 1 | |
| PQBD13v160206 | List of procedures | 1 | |
| PQBD13v160207 | List of instructions | 3 | |
| PQBD13v160208 | Codification of documents | 2 | |
| PQBD13v160301 | Management review report | 3 | |
| PQBD13v160401 | Air cleanliness | 1 | |
| PQBD13v160501 | Satisfaction survey | 3 | |
| PQBD13v160502 | Feedback register | 1 | |
| PQBD13v160601 | Complaint register | 1 | |
| PQBD13v160701 | Advisory notice | 1 | |
| PQBD13v160702 | Advisory notice register | 1 | |
| PQBD13v160801 | Design and development stages | 1 | |
| PQBD13v160802 | Design and development inputs | 1 | |
| PQBD13v160803 | Design and development outputs | 1 | |
| PQBD13v160804 | Design and development review | 1 | |
| PQBD13v160805 | Design and development verification | 1 | |
| PQBD13v160806 | Design and development validation | 1 | |
| PQBD13v160807 | Design and development transfer | 1 | |
| PQBD13v160808 | Roles and competence of project members | 1 | |
| PQBD13v160809 | Design and development resources | 1 | |
| PQBD13v160810 | Design and development changes | 1 | |
| PQBD13v160811 | Design and development file | 1 | |
| PQBD13v160901 | List of approved suppliers | 1 | |
| PQBD13v160902 | Supplier evaluation questionnaire | 3 | |
| PQBD13v160903 | Product specifications | 2 | |
| PQBD13v160904 | Verification of purchased product | 1 | |
| PQBD13v160905 | Reception anomaly | 1 | |
| PQBD13v160906 | Supplier quality complaint | 1 | |
| PQBD13v161001 | Work instruction | 1 | |
| PQBD13v161002 | Maintenance intervention report | 2 | |
| PQBD13v161003 | Production report | 1 | |
| PQBD13v161101 | Servicing report | 1 | |
| PQBD13v161201 | List of processes | 1 | |
| PQBD13v161202 | Process validation report | 2 | |
| PQBD13v161301 | Follow-up form | 1 | |
| PQBD13v161302 | Output traceability | 1 | |
| PQBD13v161401 | Special conditions | 1 | |
| PQBD13v161501 | Equipment list | 1 | |
| PQBD13v161502 | Verification range | 1 | |
| PQBD13v161503 | Verification certificate | 1 | |
| PQBD13v161601 | Reporting register | 1 | |
| PQBD13v161701 | List of internal auditors | 1 | |
| PQBD13v161702 | Internal audit plan | 3 | |
| PQBD13v161703 | Internal audit program | 2 | |
| PQBD13v161704 | Internal audit report | 2 | |
| PQBD13v161705 | Process audit questionnaire | 9 | |
| PQBD13v161706 | QMS audit questionnaire | 31 | |
| PQBD13v161801 | Nonconforming treatment form | 1 | |
| PQBD13v161802 | Customer concession | 1 | |
| PQBD13v161901 | Rework form | 1 | |
| PQBD13v162001 | Capability study | 1 | |
| PQBD13v162002 | Machine capability | 1 | |
| PQBD13v162003 | R&R study | 1 | |
| PQBD13v162101 | Customer return | 1 | |
| PQBD13v162102 | Quality alert form | 1 | |
| PQBD13v162103 | Action plan | 1 | |
| PQBD13v162201 | List of risks | 6 | |
| PQBD13v162202 | Risk level | 2 | |
| PQBD13v162203 | Risk management plan | 1 | |
| PQBD13v162301 | List of medical device file | 1 | |
| PQBD13v162401 | Certificate of attendance | 1 | |
| PQBD13v162402 | Evaluation of training | 1 | |
| PQBD13v162501 | Daily cleaning | 1 | |
| PQBD13v162502 | Sterilization form | 1 | |
| PQBD13v162601 | Filter follow-up form | 1 | |
| PQBD13List | List of MD documents | 3 | |
| Total | 281 | ||
