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Document Control for ISO 15189.2012

Open Espurna opened this issue 4 years ago • 1 comments

The following statements are not meet by Senaite Health during the creation of Reports of Results:

The ISO stands that: The laboratory shall control documents required by the quality management system and shall ensure that unintended use of any document is prevented.

All documents are identified to include: — a title -> Can it be the Sample ID? — a unique identifier on each page; — the date of the current edition and/or edition number; — page number to total t edition and/or edition number; — page number to total number of pages (e.g. “Page 1 of 5,” “Page 2 of 5,”);

"Obsolete controlled documents are dated and marked as obsolete." -> Does it mean that Results Reports has to be marked as "obsolete" when a new report is created for the same Sample?

Espurna avatar Jan 20 '20 11:01 Espurna