Identifying context for every process in an organization

[LUV-d-4UM]

My company just went through the upgrade to 2015. This is the CB auditors first audit to that standard. Needless to say the journey was rather bumpy but we had a discussion about the findings. There was not issue about Context because we read that clause several times, understood it and had gotten some guidance from Elsmar Cove moderators. As I said the CB auditors are not perfect. But we got through the finish line without going through an appeal process. IMHO, I had to be very familiar with the standard before going through this upgrade. The Training was not enough.

 

[Randy]

The Training was not enough.

Training is never enough. When I received my A&P License 30 some odd years ago the FAA examiner said I was now licensed to "learn", and the same holds true for ISO type courses.

 

[BoardGuy]

Sorry, as an actual user, and not a register auditor or employee (direct hire or contractor), there is the issue of CB auditors not understanding the actual standard they are auditing. Had one auditor insist during a medical device audit that the note reference to ISO 14971 (Risk) formed a requirement that had to be implemented for registration. As we know, notes are for guidance, they do not form requirements of the standard.

 

[LUV-d-4UM]

Sorry, as an actual user, and not a register auditor or employee (direct hire or contractor), there is the issue of CB auditors not understanding the actual standard they are auditing. Had one auditor insist during a medical device audit that the note reference to ISO 14971 (Risk) formed a requirement that had to be implemented for registration. As we know, notes are for guidance, they do not form requirements of the standard.

Under TS16949 and ISO9001:2015, notes are important.

 

[BoardGuy]

Yes notes are important because they provide guidance in understanding or clarifying the associated requirement. They do not form requirements of ISO9001:2015 and ISO/TS 16949 which is the issue we hand with the medical device auditor.

[FONT=&quot]Also you should note that in Clause/Section 0.1 of ISO 9001:2015 it is clearly stated that “It is not the intent of this International Standard to imply the need for uniformity in the structure of… quality management systems, alignment of documentation to the clause structure of this International Standard or the use of the specific terminology of this International Standard within the organization”. Will the CB auditor understand this or fall back to old audit habits?[/FONT]

 

[LUV-d-4UM]

CB auditors are just starting to audit to the new standard. Sometimes they fall back to the old habits. It is important that the clients know the standards so at least they can ask questions during the audit process. CB auditors should have an open mind.

 

[BoardGuy]

I would add that they should know the full standard and not the requirements starting Clause 1, Scope and ending at Clause 10.3, Continual improvement.

 

[Colin]

CB auditors are just starting to audit to the new standard. Sometimes they fall back to the old habits. It is important that the clients know the standards so at least they can ask questions during the audit process. CB auditors should have an open mind.

Agreed. they are new to it and it will take some time to rub off the sharp edges but as Randy mentions, training does not necessarily mean learning, or competence.

I have recently been involved with 3 different CB's and whilst they have all done some training, most of it has been remote i.e. by webinars. Where is the interaction with their peers and the opportunity to sit down together and discuss scenarios? I was heavily involved with the re-training of the auditors from 1 of the larger CB's when there was a major overhaul of the standard (2000) and all the auditors agreed that they achieved greater understanding by this method than any other - all to save money (see my signature for my thoughts on the matter.

 

[JoShmo]

Some think "training" is someone going through a powerpoit slides presentation and telling someone something. HA! They know nothing of adult learning styles and instructional design so it's not training. No skillz were developed and as a result it's a waste of time! Webinars aren't training, without clear learning objectives or a means to learn by doing. As a reslt the auditors don't get to practice before they involve their customer and it's live. How many registers actually emply (even by contract) someone with instructional design experience? I'd bet very few...

 

[LUV-d-4UM]

Agreed. they are new to it and it will take some time to rub off the sharp edges but as Randy mentions, training does not necessarily mean learning, or competence.

I have recently been involved with 3 different CB's and whilst they have all done some training, most of it has been remote i.e. by webinars. Where is the interaction with their peers and the opportunity to sit down together and discuss scenarios? I was heavily involved with the re-training of the auditors from 1 of the larger CB's when there was a major overhaul of the standard (2000) and all the auditors agreed that they achieved greater understanding by this method than any other - all to save money (see my signature for my thoughts on the matter.

My company has taken its management system to a new path-Continuous Improvement. Would you recommend that I contact the CB and ask for an auditor with a LEAN and six sigma background- in addition to the ISO9001:2015 Lead Auditor training to conduct the surveillance audit next year?
Thanks.