D 42v16 - ISO 13485 internal audit medical devices quality management system version 2016 - Set of documents
This set of 17 documents, specifically designed for auditing a medical device Quality Management System (QMS) according to ISO 13485: 2016, is a key resource for conducting internal audits according to the ISO 19011 guidelines for auditing management systems. The documents are ready to use and editable (Word format) to adapt to your specific context and needs. These documents are annexes to the online training course "ISO 13485 audit version 2016" and include, among other things, training materials, an audit program, an audit procedure, a process and QMS audit plan, a process and QMS audit questionnaire, an audit report, multiple-choice tests (MCTs) for ISO 13485 audits, case studies, and true stories.
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See the online training T 42v16 Internal audit ISO 13485 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.
Description
Documents provided as annexes in the training course Internal audit ISO 13485 version 2016.
See also the training package ISO 13485 version 2016.
Other documents procedures and instructions ISO 13485 version 2016 medical devices are in the set D 13v16.
| D 42v16 Medical devices quality management system ISO 13485 version 2016 internal audit | |||
| Codification | Title | Pages | |
| PQBD42v16S | ISO 13485 internal audit training module (support), example first 11 pages in pdf | 54 | |
| PQBD42v16A01 | Audit program (example) | 1 | |
| PQBD42v16A02 | Internal audit procedure (example) | 5 | |
| PQBD42v16A03 | ISO 13485 process internal audit plan (example) | 3 | |
| PQBD42v16A04 | ISO 13485 QMS internal audit plan (example) | 3 | |
| PQBD42v16A05 | ISO 13485 QMS internal audit questionnaire, 419 questions | 29 | |
| PQBD42v16A06 | Glossary | 13 | |
| PQBD42v16A07 | ISO 13485 process internal audit questionnaire, 165 questions | 9 | |
| PQBD42v16A08 | MD questionnaire | 4 | |
| PQBD42v16A09 | Good practices QMS ISO 13485 | 5 | |
| PQBD42v16A10 | Bad practices QMS ISO 13485 | 6 | |
| PQBD42v16A11 | Scoring method for audit findings | 1 | |
| PQBD42v16A12 | ISO 13485 internal audit report (template) | 2 | |
| PQBD42v16A13 | Auditor competence | 1 | |
| PQBD42v16A14 | MCT ISO 13485 | 12 | |
| PQBD42v16A15 | Audit case studies | 10 | |
| PQBD42v16A16 | Audit true stories | 4 | |
| PQBD42v16List | List of ISO 13485 internal audit documents | 1 | |
| Total | 163 | ||
