D 50v22 - ISO 15189 internal audit medical laboratory management system version 2022 - Set of documents
This set of 16 documents, specifically designed for auditing a medical biology laboratory (MBL) management system against the ISO 15189:2022 standard, is a key resource for conducting internal audits in accordance with management system auditing guidelines (ISO 19011). The documents are ready-to-use and editable (in Word format) to suit your specific context and needs. These documents serve as supplementary materials for the "ISO 15189 internal audit version 2022" online training course and include, among other items: training materials (support), the audit program, the audit procedure, process and management system (MS) audit plans, process and MS audit questionnaires, the audit report, ISO 15189 audit multiple-choice tests (MCTs), case studies, and true stories.
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See the online training T 50v22 Internal audit ISO 15189 soon See the set of documents D 65v22 ISO 15189 readiness See the set of documents D 90v22 ISO 15189 package soon |
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
Main Content
- 16 documents specifically designed to prepare for and conduct high-value internal audits of a medical laboratory management system (MS) according to ISO 15189:2022, following the guidelines of ISO 19011
- these documents are provided as annexes in the online training course Internal audit ISO 15189 version 2022. Examples of included documents:
- training materials
- audit program
- audit procedure
- audit plan (process and MS)
- audit questionnaire (process and MS)
- audit report
- multiple-choice tests on ISO 15189 requirements
- good and bad practices
- case studies
- true stories
These documents allow the audit to be approached with a pre-structured framework and to better link field observations to the requirements of the medical laboratory standard.
Advantage
- the documents are ready to use and editable (Word format) to adapt to the specific needs of each organization
They can also be useful to companies wishing to link the system preparation phase with audit checks, in a logic consistent with ISO 15189 accreditation.
Target audience
- internal auditors, quality managers, biologists, technicians and laboratories wishing to conduct internal audits of a MS accredited ISO 15189:2022
Other documents procedures and instructions ISO 15189 version 2022 medical laboratories are in the set D 010v22.
Free quiz without registration on the requirements of the ISO 15189 standard that you can exercise by clicking on the "QUIZ" button:
See also the free pack "Oxebridge Totally Free ISO 9001:2015 QMS Documentation Template Kit"
| D 50v22 Medical laboratory management system ISO 15189 version 2022 internal audit set of documents | |||
| Codification | Title | Pages | |
| PQBD50v22S | ISO 15189 internal audit training module (support), example first 11 pages in pdf | 56 | |
| PQBD50v22A01 | Audit program (example) | 1 | |
| PQBD50v22A02 | Internal audit procedure (example) | 5 | |
| PQBD50v22A03 | ISO 15189 process internal audit plan (example) | 3 | |
| PQBD50v22A04 | ISO 15189 MS internal audit plan (example) | 3 | |
| PQBD50v22A05 | ISO 15189 MS internal audit questionnaire, 512 questions | 37 | |
| PQBD50v22A06 | Glossary | 14 | |
| PQBD50v22A07 | ISO 15189 process internal audit questionnaire, 164 questions | 9 | |
| PQBD50v22A08 | Good practices ISO 15189 | 7 | |
| PQBD50v22A09 | Bad practices ISO 15189 | 8 | |
| PQBD50v22A10 | Scoring method for audit findings | 1 | |
| PQBD50v22A11 | ISO 15189 internal audit report (template) | 2 | |
| PQBD50v22A12 | Auditor competence | 1 | |
| PQBD50v22A13 | MCT ISO 15189 | 12 | |
| PQBD50v22A14 | Audit case studies | 10 | |
| PQBD50v22A15 | Audit true stories | 5 | |
| PQBD50v22List | List of ISO 15189 internal audit documents | 1 | |
| Total | 173 | ||
