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Bretta Kelly

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Published: Thursday, December 20, 2018 – 12:03

Back in January 2009, I wrote an commodity for Affection Digest blue-blooded “ISO 9001 Affidavit Is Like a Box of Chocolates.” Here we are, about 10 years later, all of the ISO 9001 and accompanying standards accept been updated, yet companies still misunderstand what to document, how to document, or why to certificate procedures for their affection administration systems (QMS).

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Bretta Kelly is the owner/operator of Business Administration Systems Consulting LLC (BMSC). Kelly began consulting in 1999, implementing, managing, training, and auditing ISO 1994, ISO 9001:2000, and AS 9100 programs for semiconductor, aerospace, chemical, cosmetic, and administration companies. Currently Kelly conducts third-party audits for several registrars; she conducts centralized audits and facilitates administration reviews as well. Kelly additionally provides seminars for centralized action auditing and how to conduct administration reviews and set assessable objectives. Kelly holds bachelor’s and master’s degrees in automated engineering, and certifications for Exemplar-QMS Lead Auditor, Probitas-AS 9100 Auditor, HACCP, and SQF 1000 and 2000 auditing and able training.

Hi Bretta,

Seeking your admonition on how to do almanac identification no.

For e.g certificate no was set – OP-QMS-001

How about record?

Thanks in advance.

Venantius

In what commodity of  ISO 9001 advertence the minimum years to absorb the record? Is it accessible I would accumulate it alone for 3 years?

Hi Bretta

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We had an ISO 27001 analysis yesterday, and one of our accessory non-conformities was that I hadn’t included what we do with abstracts of alien origin. The accessory was absolutely that it was missing from the procedure, not that we didn’t ascendancy these documents.

I asked the accountant why it mattered accustomed that I didn’t allegation a action at all action by the accepted and he said it was because we had set the rules and there was again a gap in our rules. I said if we hadn’t done a action again it wouldn’t accept mattered, to which he replied yes, we would aloof be testing to see if you accommodated the standards requirements.

What is your assessment on this? Is he right, or is this absolutely picky?

So… we actualy do not allegation to accept Adept List of Documents. I accept a lot of adept lists. Form, Procedure, File, Assignment Apprenticeship alike Obselete Document.

My aggregation application Certificate Administration Arrangement (DMS). If I appetite to get rid all the adept lists can I say if its on the DMS again its current? Or do you accept bigger abstraction on

how I can get rid all the adept lists?

Thanks in beforehand 🙂

You can absolutely annihilate your Adept Lists, abnormally if you accept a DMS. The account you accept “Most accepted adaptation of abstracts is on DMS” is perfect.

Hi Bretta,

It sounds basal but i am not abiding if it is.

Say, I accept a certificate update. In the afterlight history, the afterlight agreeable exists but approver’s name is empty.

The accompanying affiliate say that they can’t trace as the aftermost afterlight was 11 years ago.

Does it breach the ISO 9001 accepted or not? i am aggravating to articulation it to a specific ISO clause.

The afterlight agreeable would be the best important part, there is no ISO 9001 requiremetn to apperceive who was the approver 11 years ago back the above-mentioned change was made. What is important and appropriate is the approver of the accepted change and are they accustomed to accomplish the change.

I would like to ask if what can we do with the abstracts ( drawing/work instructions) that is already 9 years on book , afterwards 9 years our applicant ordered for the aforementioned account , my catechism is are we action to amusement it as new certificate and affair new cartoon or we can still use the old cartoon on file? 

It is about the afterlight of the book against how old it is. So, if the adjustment calls out the aforementioned afterlight of the orint that you accept on book from 9 years ago again it is accomplished to use. If the afterlight does not bout you allegation get an adapted print. Achievement this helps.

Bretta

But abstracts and annal are all the aforementioned thing, now, alleged collectively “documented information.” So….

Hi,

I accept captured addition abeyant abashing in this Extract below:

“”…The latest standard, ISO 9001:2015, does not authorization any appropriate procedures or manual;

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AS9100D and ISO 9001:2015 authorization alone one action for ascendancy of adverse outputs and a affection manual….

So, chiral and procedures are required/mandated or not? what do you beggarly absolutely ?

thanks for your feedback.

Cheers

Nathalie

Hi Nathalie,

In the AS9100D Accepted there are adventurous requirements that accommodate a claim for a Affection Chiral and a action for Ascendancy of Nonconfoirning Outputs. In the ISO 9001:2015 Accepted Alone there is no claim for a chiral or procedure. Sorry if that came out ambagious achievement this clears it up.

Bretta

Hi Breta, 

Great commodity BTW… 

There are requirements for accurate advice for organisational activity, about the alarm for a affection chiral is a ‘note’ and these are not auditable right? 

plus the affection chiral ‘can’ be compiled, and ‘can’ indicates a achievability or adequacy right? 

I’m currently charwoman up an AS9100D organisation BMS and I am attractive to present a Business Chiral to accommodate action maps, turtles etc to explain how they accommodated the requirements of 4.4. Its not allowable to be alleged a ‘quality manual’ per say, as far as I apprehend the commodity or accept I missinterpreted the clause. 

Thanks

Paul

Yes, the new accepted refers to abstracts and annal as accurate information. Area it says advance accurate advice it is apropos to abstracts and area it says retains accurate advice it is apropos to records. Achievement this helps!

Would you apprehend to see training absolute controlled as accurate information? Or would that be absolutely separate?

For instance we adjudge on our adjustment of authoritative documents, does training absolute allegation to chase this aforementioned system, or can it be absolutely removed from the administration system?

If it’s allotment of the administration system, does it still calculation as commodity that doesn’t allegation to be followed 100%?

There is no claim to ascendancy training absolute the aforementioned as how you would afterlight ascendancy a procedure or assignment instruction. I absolutely accept a agenda in the Affection Chiral in my templated arrangement that says:

Note: Procedures, breeze archive and assignment instructions articular as training or advertence abstracts are acclimated for training and auditing purposes and are not appropriate to be followed absolutely as written.

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I achievement this helps!

Bretta

I’m a little afflictive with this.. 

I get the no claim affair for assignment instructions and all that, however… in AS9100D 8.1.2 b we accept to ensure that accurate advice is constant with the absolute attributes of the articles and services.. which relates to the identification and traceability 8.5.2 to ensure we shall advance the identification of the configuration.. amid absolute agreement and the appropriate configuration. 

How can you do that after afterlight controlled abstruse accurate information? 

You do accept to afterlight ascendancy those blazon of docuemnts, my animadversion and acknowledgment was about advertence training abstracts acclimated for training purposes to abutment competency, not confirguration ascendancy or any added docuemnted informtaion acclimated for ascendancy of assembly and account operations.

You’re conflating two issues. First, do training abstracts allegation to be controlled? Answer: probably. There’s annihilation in the accepted that excludes “training documents” as allotment of a QMS, and instead the accepted says ALL QMS abstracts allegation be controlled. Suggesting abstracts as analytical as those acclimated to TRAIN bodies are NOT allotment of the QMS is a austere stretch. I accept you can do this if you are absorbed on ensuring your training sucks.

Next, the additional affair is whether training abstracts allegation to be followed. To advance they do NOT allegation to be followed is additionally a very, actual big stretch. What’s the point of training, then? Why accommodate training abstracts if the end aftereffect is “you can do whatever you like, this absolute affair has been one continued suggestion.” Again, this is a answerable way of ensuring really, absolutely bad training.

Finally, the appellation “reference materials” is baneful in any QMS. There’s an industry-wide bad addiction that suggests if you mark commodity “reference only” you aback don’t allegation to ascendancy it. This is wholly false, and is not accurate by ISO 9001. Again, ISO 9001 acutely states that QMS abstracts allegation be controlled. There’s no allowance for “reference” materials, and this is absolutely fabricated concept. I appetite to be clear: ALL QMS abstracts are for “reference” because that’s LITERALLY WHAT YOU USE THEM FOR. There’s no arrangement of “referencing” commodity — either you use the advice to drive your assignment or you don’t. Slapping “reference only” on some abstracts because you don’t appetite to ascendancy them creates abundant arena for analysis nonconformities, bold the accountant knows what they are doing.

If I book a affection analysis action and slather “reference only” on it, I don’t accept to amend the action afterwards back I acquisition it was abounding with errors? I can let my bodies abide to use it? What if they are authoritative pacemakers or airplanes? Acceptance them to use anachronistic abstracts is accept because I formed “reference only” on the cover?

“Reference only” was invented by apathetic bodies who didn’t appetite to do certificate control, and again accustomed to bolster by apathetic auditors who never activated any analytic cerebration to the concept. THERE IS NO SUCH THING AS “REFERENCE ONLY” DOCUMENTS IN A QMS. Simple.

There was absolutely a confounding of my acknowledgment to training materials. Any QMS affidavit acclimated for managing your arrangement or processes is controlled per you action of authoritative accurate information. Analysis documents, action instructions, affection manual, procedures for how to ascendancy adverse outputs, etc. allegation be controlled and audited to ensure they are actuality followed as written. Performance to objectives and action expectations admeasurement capability of training and competency. My acknowledgment was talking about guideline abstracts produced for the absorbed of training, that is what I anticipation the catechism was pertaining to. Training absolute can be accounting beautifully, and afterlight controlled but already accomplished if the agent is not able to accommodated expectations of the process, the adequacy needs to be addressed not the afterlight ascendancy of the training documents. I still angle by account that accurate advice appropriate by the affection administration arrangement and by the International Accepted requires analysis and ascendancy and that abstracts acclimated for training can be controlled or advertence or guideline purposes, because it is about the adequacy of the being who had the training not the architecture or controls of the training materials.

I anticipate I accept accepted you correctly.

What I am planning is to accept a ambit of training absolute (these are acutely detailed, too abundant for a action I analysis in my opinion). These are all certificate controlled the aforementioned as aggregate abroad but I accept acclaimed them as ‘training guide’.

I am still planning action breeze diagrams for the aerial akin processes that these guides support, so we can see absolutely how aggregate fits together, and can again be audited to to ensure we are accomplishing the accepted outputs.

What I appetite to see is, for instance, if footfall 4 is achieved, does the action again move to the abutting amenable aggregation affiliate or department, and do we accept the annal adored about at this point. I appetite to analysis to see that the key credibility in the arrangement are working.

What I don’t appetite to do is be auditing to see if addition clicked a assertive affair afore beat the abutting one and again beat ‘next’ etc.

That’s what I aggregate from what you said anyway.

Yes, I anticipate you absolutely get it! Good luck with your training and auditing.

Bretta

Thank you, this accomplished commodity was a big admonition actually!

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Thank you, animated it helped.

Bretta

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