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Tips and Tricks to understand ISO 9001

#1
Hi All!!
I will preface this by saying I am totally new to the world of ISO 9001, etc... I come from the world of Strength and Conditioning so I am very much learning on the fly. I work for a small (9 employee) company that produces two products. I am wondering if anyone has any tips or tricks to help me wrap my head around everything that is ISO 9001.

Thanks in advance!!

Adam
 
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Mike S.

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#2
We need some more context to give a good answer. Is the company already ISO 9001 certified? What will be your responsibilities with respect to ISO 9001?
 
#3
We need some more context to give a good answer. Is the company already ISO 9001 certified? What will be your responsibilities with respect to ISO 9001?

We are not yet certified so I am tasked with preparing us for our first audit in a few months time. And essentially, I am in charge of making sure we are ISO compliant in regards to 9001. We are already 13485 compliant for another product that we make. But just trying to grasp all that is ISO at the moment.
 

yodon

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#5
There's plenty of overlap between ISO 13485:2016 and ISO 9001:2015. The biggest difference is that ISO 13485:2016 chose to NOT follow the common high-level structure (Annex SL). 13485 focuses "risk based thinking" at the product level (risk to patients, users, etc.). 9001 risk-based thinking is more business-based (with all the context of the organization and risks and opportunities stuff). Many of the 'fundamentals' (quality policy / objectives, document control, etc.) are pretty common. 9001 doesn't require (but doesn't prohibit) a quality manual. 9001 eliminated "preventive actions' (from CAPA). The management review in 9001 is a bit broader.

Bottom line is that there are substantial differences. No doubt the resources @Mike S. cited will be helpful but at least you have a pretty high jumping off point.

P.S. The whole "context of the organization" and "risks and opportunities" stuff challenged a lot of companies just transitioning to 9001:2015. I'm sure a good search of the archives here would be quite helpful in seeing what other folks did.
 

Sidney Vianna

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#8
I am wondering if anyone has any tips or tricks to help me wrap my head around everything that is ISO 9001.
I understand that that you had no malice when you asked the question, but, EXACTLY BECAUSE ISO 9001 has been trivialized, dumbed-down and commoditized, it has lost it's value for the most part. An example of a "trick" that inflicted enormous disservice to quality practitioners was the idea that ISO 9001 is nothing more than DO-WHAT-YOU-SAY-SAY-WHAT-YOU-DO.

ISO 9001 only brings value with a bespoke implementation and profound knowledge. Short of that, you have a façade.
 

Mike S.

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#9
Unless I am understanding you wrong, I disagree with that premise, Sidney. My understanding is that the OP is trying to better understand ISO9001. Been there, done that, still get confused myself sometimes. The average person (or even above-average person) can read ISO9001 and still be confused and unsure about the meaning and intent - heck this forum is built largely to help those kinda people!

Lots of books are written on the subject, lots of training sold. Even the "experienced" and "experts" on here often debate and disagree on its content and meaning. If it has been so dumbed-down, why all the questions and confusion?

Einstein once said "If you can't explain it simply, you don't understand it well enough." I think that by and large standards writers have failed to create adequately simplified standards, either via ignorance and inability or intentionally.
 

Tagin

Trusted Information Resource
#10
In addition to TS9002:2016, I also found it helpful to visualize how the clauses of 9001:2015 are arranged in PDCA sequence. Attached are some examples of such images that I found. Note that clause 7 is sometimes considered as PLAN, and sometimes as DO. In any case, it helped to orient me in comprehending the overall flow, intent and relationships among the clauses.
 

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