Process Map Transition from ISO9001:2008 to ISO9001:2015

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cbhigdon3

All - lots of different ways to handle the identification of processes with regards to the newly revised standard. Since I like the simplicity of a 1:1 translation (and we still get auditors that like to see a matrix between our QMS and the clauses of the standard), our new process map matrix - for 2015 - is set up similarly what we put together a while back for ISO9001:2008 compliance. In our "old" system, our Management Responsibility process was denoted a 5 placeholder for all documents, procedures, forms, and records. Similarly, CAPA activities were identified with an 8 placeholder. For each of the main processes in our old, 2008-compliant system, we put together a defined set of inputs, outputs, records/documents, objectives and measures of effectiveness, and required resources. For the revised 2015 standard, we are keeping these for each process and are adding "Context of the organization" - essentially where these line up to our interested parties (internal or external) - and "Risks/Opportunities". That way, everything ties nicely together and it would give our auditor(s) (internal and external) immediate visibility that we've thought through these items.

All of our procedures, work instructions, and forms will be updated to reflect the new numbering system of the 2015 revised standard so that Leadership-related items are now assigned to a 5 designation and, in turn, auditing, MR, and other performance-assessment related activities get a 9 designation.

Curious to see how others are handling this. Since one of our facilities is supposed to be audited against the 2015 revision this coming summer, we're already neck-deep in updates.
 

Attachments

  • Process Maps - Current.pdf
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  • Process Maps - ISO9001-2015.pdf
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S

Stuart Powell

All - lots of different ways to handle the identification of processes with regards to the newly revised standard. Since I like the simplicity of a 1:1 translation (and we still get auditors that like to see a matrix between our QMS and the clauses of the standard), our new process map matrix - for 2015 - is set up similarly what we put together a while back for ISO9001:2008 compliance. In our "old" system, our Management Responsibility process was denoted a 5 placeholder for all documents, procedures, forms, and records. Similarly, CAPA activities were identified with an 8 placeholder. For each of the main processes in our old, 2008-compliant system, we put together a defined set of inputs, outputs, records/documents, objectives and measures of effectiveness, and required resources. For the revised 2015 standard, we are keeping these for each process and are adding "Context of the organization" - essentially where these line up to our interested parties (internal or external) - and "Risks/Opportunities". That way, everything ties nicely together and it would give our auditor(s) (internal and external) immediate visibility that we've thought through these items.

All of our procedures, work instructions, and forms will be updated to reflect the new numbering system of the 2015 revised standard so that Leadership-related items are now assigned to a 5 designation and, in turn, auditing, MR, and other performance-assessment related activities get a 9 designation.

Curious to see how others are handling this. Since one of our facilities is supposed to be audited against the 2015 revision this coming summer, we're already neck-deep in updates.
Hi, No need to re-number, re-structure, or adopt any apparently "new" terminologies...please read Annex A of ISO9001:2015...most people haven't done this...it could save you a lot of grief.
 
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