ISO 9001 - How to decide if a company needs or will benefit from certification?

#1
Forgive my ignorance and lack of research, but how do you decide if your company needs or will benefit from this certification?
We're a third-party reseller of mostly consumable medical devices. We recently had a potential customer ask if we were certified.
I'm going to do some more research, but thought I'd post here for some additional info.

Thanks!
 
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Emmyd

Involved In Discussions
#2
One of the first questions I would ask would be if you could gain additional business if you were certified or if you are in danger of losing customers because you aren't certified. ISO 9001 certification is not cheap and doesn't make sense for every company.

If you don't want to be certified, then you can implement a QMS that is ISO 9001 compliant but not certified. Good luck!
 

dsanabria

Quite Involved in Discussions
#3
Forgive my ignorance and lack of research, but how do you decide if your company needs or will benefit from this certification?
We're a third-party reseller of mostly consumable medical devices. We recently had a potential customer ask if we were certified.
I'm going to do some more research, but thought I'd post here for some additional info.

Thanks!
1. Ask the customer if they have an alternative to ISO 9001.
2. Can you get other customers if you get this certificate.
3. Do you have a system in place that is equal or better than ISO 9001.

Start with those question and then we can continue.... and how much time, effort or money are you willing toinvest into this process.
 
#4
Thank You for the replies! We most definitely have procedures in place that are equal to ISO 9001. At this time - I do not think it would be beneficial, as this was the first time we were asked.
 

Golfman25

Trusted Information Resource
#5
Yeah, how long have you been around. If you have gone a long time without being asked, it's probably not worth it.
 

Raffy

Quite Involved in Discussions
#6
Basically in my own experience, what I do recommend is evaluate your capability or capacity, do some SWOT or PESTLE Analysis by scanning the environment. (Clause 4.1 of ISO9001:2015 Standard) Then a gap might be identified and I think that will be a good start.
Hope this helps.
Best,
Raffy
 

John Broomfield

Staff member
Super Moderator
#7
An excellent question.

Even if you decide against certification do not ignore your national management system standards.

These standards define the minimum duty of care for every organization that is committed to protecting its customers and other stakeholders.

So, no matter the marketing benefits of accredited certification, develop your organization as a management system so it provides confidence that stakeholder requirements will be fulfilled while it conforms to the standards that are applicable to your business.
 
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