D 13v16 - ISO 13485 Medical devices procedures and instructions version 2016 - Set of documents
Document set - 107 editable procedures and instructions for your medical devices quality management system ISO 13485 version 2016
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$52.73
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See the set of documents D 22v16 ISO 13485 Readiness See the set of documents D 42v16 ISO 13485 Internal audit See the set of documents D 72v16 ISO 13485 package |
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.
Description
All these documents can be modified to adapt to your needs and your context.
Some procedures are like quality procedures and some instructions are like quality instructions.
They will help you assimilate the online trainings:
- T 22v16 ISO 13485 readiness
- T 42v16 ISO 13485 internal audit
- T 72v16 ISO 13485 package
Other documents are in the set D 22v16 version 2016 and D 42v16 version 2016.
See also documents in set D 54v19 Risk Management DM ISO 14971 (soon).
Documents included in the package: D 72v16 medical devices ISO 13485 version 2016
| D 13v16 Procedures and instructions medical devices version 2016 | |||
| 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 |
| PQBD13v1627 | Post-market surveillance | 8.2; 8.4;8.5 | 5 |
| PQBD13v1628 | Regulatory watch | 0.1; 7.2 | 3 |
| PQBD13v1629 | UDI-DI codes | MDR 2017/745 | 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 | |
| PQBD13v160801 | 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 | |
| PQBD13v161004 | Product realization plan | 2 | |
| 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 | |
| PQBD13v162204 | Benefit/risk ratio | 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 | |
| PQBD13v162701 | Post-market surveillance plan | 2 | |
| PQBD13v162702 | Post-market surveillance report | 2 | |
| PQBD13v162703 | Safety periodic update report | 2 | |
| PQBD13v162801 | Legislation review | 1 | |
| PQBD13v162802 | Inventory of legal requirements | 2 | |
| PQBD13List | List of MD documents | 3 | |
| Total | 302 | ||
