Is ISO 9001:2015 certification worth it for a company that does only contract manufacturing?

[greenlantern]

I am implementing a QMS at my company. I am curious to hear your opinions on if ISO 9001:2015 certification is even applicable for our company that only does contract manufacturing. The contract manufacturer is ISO 9001:2015 certified and has a fairly robust QMS. However, I realized the need to develop standards for processes that happen within the company. I am trying to find out if it is applicable to pursue ISO 9001:2015 or even just a complete QMS for our company as well. There are tentative plans for verticalization so that may factor into the decision. Anyways, thanks for reading!

 

[Dr. IJ Arora]

My thought is aligned to you. I would say go ahead and implement the standard, after all why re-invent the wheel. Once you have say done two cycles of internal audits and management review and are happy and satisfied, go ahead and self-declare you confirm to ISO 9001. Your interest is in running an efficient organization, why waste money on certification. If at a later date you need to get certified it will be simple and easy because your system will be already ready and aligned to the standard. good luck.

 

[qualprod]

I am implementing a QMS at my company. I am curious to hear your opinions on if ISO 9001:2015 certification is even applicable for our company that only does contract manufacturing. The contract manufacturer is ISO 9001:2015 certified and has a fairly robust QMS. However, I realized the need to develop standards for processes that happen within the company. I am trying to find out if it is applicable to pursue ISO 9001:2015 or even just a complete QMS for our company as well. There are tentative plans for verticalization so that may factor into the decision. Anyways, thanks for reading!

First you need to define what you need.
-Is it a customer requirement?
-do you want to improve your business?
What is your thinking?
Do you really believe ISO can help you?
do you have a mess in your company?, maybe you already have some organization tools in your company, and is not needed.
As an example Toyota doesn't have ISO, however they have other tools to manage the business.
hope it helps

 

[Deli88]

I am implementing a QMS at my company. I am curious to hear your opinions on if ISO 9001:2015 certification is even applicable for our company that only does contract manufacturing. The contract manufacturer is ISO 9001:2015 certified and has a fairly robust QMS. However, I realized the need to develop standards for processes that happen within the company. I am trying to find out if it is applicable to pursue ISO 9001:2015 or even just a complete QMS for our company as well. There are tentative plans for verticalization so that may factor into the decision. Anyways, thanks for reading!

ISO can be cumbersome particularly if you are a small company. If you are only getting certified to have the piece of paper and pay lip service to the standards there is little point getting certified. I would recommend you get a copy of the ISO9001:2015 standard and read through it. There is plenty of very helpful sections in it to start you off at the very least.

 

[John Broomfield]

greenlantern,

Determine if certification is necessary for your company to realize its strategic plan. New markets and new customers may open to you if your system is certified.

Meanwhile, study closely the extent to which your organization, working as a system, already conforms. Never presume that it does not conform. Having respected the system (as it is) your colleagues should be more inclined to help you to develop this system.

That word “implement” may worry your colleagues because it suggests you’ll be in your office writing procedures around clauses in the standard.

Best wishes,

John

 

[greenlantern]

First you need to define what you need.
-Is it a customer requirement?
-do you want to improve your business?
What is your thinking?
Do you really believe ISO can help you?
do you have a mess in your company?, maybe you already have some organization tools in your company, and is not needed.
As an example Toyota doesn't have ISO, however they have other tools to manage the business.
hope it helps

It is not yet a customer requirement, however we anticipate that it may become one in the next few years. My thoughts are moving to be in a better position to pursue certification in case it is needed but in the meantime have an actual QMS for the benefit it offers the company in general in terms of reducing waste and improving efficiency. It is a relatively small start up so there is not much structure and very few tools to manage the business from a quality aspect. There is a doc control system and a system for tracking CAPAs, SCARs and NCRs however not much in terms of procedures or quality manual. I think at the very least it is worth it to create the QMS aligned with ISO.

 

[greenlantern]

ISO can be cumbersome particularly if you are a small company. If you are only getting certified to have the piece of paper and pay lip service to the standards there is little point getting certified. I would recommend you get a copy of the ISO9001:2015 standard and read through it. There is plenty of very helpful sections in it to start you off at the very least.

Thanks for the feedback. Yes I am lead auditor certified for ISO so pretty familiar with the standard. I just haven't worked at any companies that only do contract manufacturing before so not certain how it applies in this case

 

[hogheavenfarm]

I would agree with Dr. Arora, get an ISO 9001 compliant system up and running first, like the others have said, you probably have most of what you need already, and no need for a quality manual either. We self certify we are complaint and have no issues, and our customers audit us to ISO 9001 and we have not had any problems arise. We essentially run an ISO 9001 system without any of the expense, and we reap the benefits of the structure.
Should we wish to go "full ISO", virtually no additional work would be required, as we are ready to do so at a moments notice.

 

[greenlantern]

greenlantern,

Determine if certification is necessary for your company to realize its strategic plan. New markets and new customers may open to you if your system is certified.

Meanwhile, study closely the extent to which your organization, working as a system, already conforms. Never presume that it does not conform. Having respected the system (as it is) your colleagues should be more inclined to help you to develop this system.

That word “implement” may worry your colleagues because it suggests you’ll be in your office writing procedures around clauses in the standard.

Best wishes,

John

Haha yes implement is a heavy word. Thanks for the insights. My approach so far is to create procedures of process that are already well defined and thought out but had not yet been committed to paper mainly so if there is turnover some of that knowledge can be retained. Also, creating procedures that mainly apply to the small quality department has been a good place to start.

I was thinking to build the barebones of a QMS with the following SOPs: control of documents, control of records, audits, control of nonconforming product, corrective action and preventive action. Any thoughts on that as a starting point?

 

[greenlantern]

I would agree with Dr. Arora, get an ISO 9001 compliant system up and running first, like the others have said, you probably have most of what you need already, and no need for a quality manual either. We self certify we are complaint and have no issues, and our customers audit us to ISO 9001 and we have not had any problems arise. We essentially run an ISO 9001 system without any of the expense, and we reap the benefits of the structure.
Should we wish to go "full ISO", virtually no additional work would be required, as we are ready to do so at a moments notice.

Thanks for your insights. Yeah I think that's the best route right now. Does your company outsource all manufacturing? That's kind of the situation I am trying to figure out since some of the typical ISO compliant procedures are tricky since we don't own the manufacturing process