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ISO 9001: documents, records and competency

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Guest user Created:   Dec 27, 2018 Last commented:   Dec 27, 2018

ISO 9001: documents, records and competency

"In particular, the main area of interest I have is in relation to management of Education Course Material. Specifically, I am trying to learn and understand specific information about what “validates” a system that stores this type of data such as what requirements it must meet to be validated and also what other processes are required around the system to ensure compliance. I recently became aware that Course material must be document controlled and recorded, as well, distribution of this data must be recorded to ensure that only the latest material is provided but to also prove that the latest data was provided to, and received by the Student.
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ISO 9001 DOCUMENTATION TOOLKIT

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ISO 9001 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Carlos Pereira da Cruz Dec 27, 2018

My understanding in this area and efforts to understand so far have not been very successful. ISO 9001 is huge whereas I am only interested and trying to focus in one particular area. I am not responsible for everything and the person that is, is not well versed in technology. The information and material I have found so far has not explained or communicated this well – or let’s say it’s not focused on the “technology” that supports the systems being used to meet ISO requirements. The information is more in relation to the people and processes that surround it. Any other information or suggestions you could provide me with would be very greatly appreciated."

Answer:
As far as I understood your concerns my answer is:

Independently of the media used there are some ISO 9001 requirements to consider:
a) Who has the authority to approve Education Course Material?
b) Who has the responsibility to keep Education Course Material updated?
c) Who must attend the course where that Education Course Material is used?
d) Can you show evidences that people attended the course?
e) Was the course effective, did people become competent after the course? Can you prove it?

About a) it is related with ISO 9001:2015 clause 7.5
Education Course Material must be a controlled document. Someone with authority must approve the document after ensuring that it is complete, updated and according to requirements (laws, regulations, standards, internal practices and know-how, …)

About b)
Laws, regulations and standards are relevant documents of external origin that can affect the content of Education Course Material. Periodically, someone should be responsible for checking if there are revisions and/or new documents that can affect the content of Education Course Material. Retaining records that show evidence of that “checking” is a good practice although not mandatory.
If revisions and/or new documents are found the organization needs to get them, study them and incorporate changes in the Education Course Material and update it with a new version that requires a new approval, removal of obsoletes and retaining a copy for historic purposes.
After approval of the updated version of the Education Course Material it must be distributed to users. A good practice is having a register that summarizes for each document: what is the current version; where it is used or who must have access to it
Internal changes must be handled in the same way.

About c) it is related with ISO 9001:2015 requirements 7.1.6 and 7.2
7.1.6 is about the competency profile for each position in the organization
7.2 is about the competency level of each employee
If the actual competency level of someone is bellow the required by the organization and/or law/regulation that person must take the course where the Education Course Material is used

About d) and e) it is related with ISO 9001:2015 clause 7.2
Retaining records of the course realization, of who participated, and about any documentation distributed is a good practice
Retaining evidence that the course was effective and people became competent is mandatory

You can find more information about documented information at New approach to document and record control in ISO 9001:2015 - https://advisera.com/9001academy/blog/2015/06/30/new-approach-to-document-and-record-control-in-iso-90012015/

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Dec 27, 2018

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