Is it possible to merge 8.2 and 8.3?

[TamurRizwan]

Hello,

I am currently completing my internship and have been tasked with the process of obtaining ISO 9001 certification for the company I'm working for.

The company primarily manufactures order specific products, based on their standard products, and does not engage in research and development (R&D) activities very often. The company makes emergency equipment for oil spill so the standard products always have modified specifications from customers.

I am considering the possibility and feasibility of creating a standard that encompasses both Clause 8.2 (Requirements for Products and Services) and Clause 8.3 (Design and Development) of the ISO 9001 standard. My concern is whether such a combined standard would be acceptable during an audit without raising red flags.
I hope this makes sense.

Please keep in mind I am still studying so I do not have much experience with ISO9001.

Your insights and advice on this matter would be greatly appreciated. Thank you.

 

[Kronos147]

Consider the process approach. If your organization addresses the requirements of 8.2 & 8.3 with one of your processes, and all of the requirements are met, then yes, they can be "combined".

The standard doesn't say how you accomplish your goals, only what requirements you must address in the process.

 

[Jen Kirley]

Welcome to the Cove!

8.2 is an input to 8.3, but that isn't the only place where it is used. Your Design process would certainly include 8.2.2 and 8.2.3 as inputs but I wouldn't want to see 8.2 "swallowed up" in Design. 8.2.1 is also about the Customer Service process, Customer Returns, and Process design (realization). 8.2.1 and 8.2.2 are part of 6.3 change management via customer changes to specifications.

I am sorry if I make this look complicated. ISO is not a recipe where you add this clause, mix and move on to the next. It's about processes where clauses are relevant over and over again.

I hope this makes sense.

 

[Jen Kirley]

You say you are still studying. Have you read the book "ISO 9001:2015 In Plain English"? I often recommend it for those new to the standards.

 

[Dazzur]

6.3 change management via customer changes to specifications.

Hi Jen,

What do you mean by this? My understanding of 6.3 was change management for the QMS and not customer requirements? Unless I'm misunderstanding something here?

 

[Michael_M]

Hello,

The company primarily manufactures order specific products, based on their standard products, and does not engage in research and development (R&D) activities very often. The company makes emergency equipment for oil spill so the standard products always have modified specifications from customers.

What do you mean "very often". If your company only takes orders that are modified by the customer and your company does not do any engineering on the item you are making, you might be able to exclude 8.3. Before you exclude 8.3, you really need to make sure you do not do any actual design and development (drawing up prints, having engineers design a part from scratch, etc.), but from my experience, 8.3 is the most excluded section of ISO 9001.

 

[Jen Kirley]

Hi Jen,

What do you mean by this? My understanding of 6.3 was change management for the QMS and not customer requirements? Unless I'm misunderstanding something here?

6.3 is for the QMS, but can have (not always) 8.2.2 as an input as per 6.2 a), consider the purpose of the changes.

 

[Randy]

Do whatever you want, if it works for you, fine, if not, change it.

But if you're building a clause based MS, as a clause based system prepare for the "F" word, and not the one you think, prepare to Fail.

 

[TamurRizwan]

Welcome to the Cove!

8.2 is an input to 8.3, but that isn't the only place where it is used. Your Design process would certainly include 8.2.2 and 8.2.3 as inputs but I wouldn't want to see 8.2 "swallowed up" in Design. 8.2.1 is also about the Customer Service process, Customer Returns, and Process design (realization). 8.2.1 and 8.2.2 are part of 6.3 change management via customer changes to specifications.

I am sorry if I make this look complicated. ISO is not a recipe where you add this clause, mix and move on to the next. It's about processes where clauses are relevant over and over again.

I hope this makes sense.

Hello Jen,

now that you mention it, it totally makes sense. I hadn't considered that until now. Thanks!

 

[TamurRizwan]

You say you are still studying. Have you read the book "ISO 9001:2015 In Plain English"? I often recommend it for those new to the standards.

Thank you for that recommendation I will look into it!