Document Control for ISO 15189.2012

[Espurna]

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?

[xispa]

Some comments:

• The unique identifier can already be achieved using the idserver. At the moment, there is no specific configuration for sample attachments (so their ids look similar to attachment-1345). Still, this id could be considered as the unique id. There is the need to display this ID on each page though.
• The pagination criterias, as well as the date of current edition can be addressed by adding a footer in the report template. There is no need of changes in the codebase.
• In health's and impress' default templates there is no specific title. Adding a header <h1> with the text "Certificate of Analysis" in the report template would be enough.
• The revision ID can be also configurable via IDServer so the ID of the sample is prefixed and the revision number is a sequentially generated number. E.g. DBS200139-C01, were DBS200139 represents the ID of the sample and C01 is the first revision (the first report created for this sample). If a new revision is created, the revision ID would become DBS200139-C02. Note this revision ID becomes the report unique id too.