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quality_manual [2025/09/27 03:41]
admin [8.2 Management system documentation] |
quality_manual [2025/09/27 03:43] (current)
admin [8.4 Control of records] |
| ===8.3.1 General=== | ===8.3.1 General=== |
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| The laboratory will control the documents (internal and external) that relate to the fulfilment of this | The laboratory will control the documents (internal and external) that relate to the fulfilment of this document. |
| document. | |
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| **NOTE:** In this context, "document" can be policy statements, procedures and related job aids, flow charts, instructions for use, specifications, manufacturer's instructions, calibration tables, biological reference intervals and their origins, charts, posters, notices, memoranda, software documentation, drawings, plans, agreements, and documents of external origin such as laws, regulations, standards and textbooks from which examination methods are taken, documents describing personnel qualifications (such as job descriptions), etc. These can be in any form or type of medium, such as hard copy or digital. | **NOTE:** In this context, "document" can be policy statements, procedures and related job aids, flow charts, instructions for use, specifications, manufacturer's instructions, calibration tables, biological reference intervals and their origins, charts, posters, notices, memoranda, software documentation, drawings, plans, agreements, and documents of external origin such as laws, regulations, standards and textbooks from which examination methods are taken, documents describing personnel qualifications (such as job descriptions), etc. These can be in any form or type of medium, such as hard copy or digital. |
| ===8.3.2 Control of documents=== | ===8.3.2 Control of documents=== |
| The laboratory will ensure that: | The laboratory will ensure that: |
| {{ https://docs.google.com/spreadsheets/d/1FgPYEGFZ7v3LObAUIYsLXDp8zg1cFdjT/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true | Master list of documents }} | |
| {{ https://docs.google.com/document/d/10j2wNoTWdooTE-QhwIaZTn3Jg5YG5uv_/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true | Documentary Procedure for Control of Documents }} | |
| - Documents are uniquely identified; | - Documents are uniquely identified; |
| - Documents are approved for adequacy before issue by authorized personnel who have the expertise and competence to determine adequacy; | - Documents are approved for adequacy before issue by authorized personnel who have the expertise and competence to determine adequacy; |
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| ====8.4 Control of records==== | ====8.4 Control of records==== |
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| {{ https://docs.google.com/document/d/172kNPn_W_NldSaDGKfGr9sT5TAv3LOqw/edit?usp=drive_link&ouid=105726813387160537689&rtpof=true&sd=true | Documentary Procedure for Control of Records | |
| }} | |
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| ===8.4.1 Creation of records=== | ===8.4.1 Creation of records=== |