New Trend of not seeking Official ISO 9001 Registration

Randy

Super Moderator
Yeah the tide is changing and certification is and always has been something where a business case has to be made for or against. I've had a couple client locations cease the certification process in the last year mainly because they couldn't build a true and accurate business case to maintain it.

It's about money, always has been and always will be.
 

Edward Reesor

Trusted Information Resource
The irony is that companies are being asked for a higher and higher standard of post clinical evaluations using a high degree of statistical proof by a system that cannot prove that these data do, in fact, improve safety. A lot of what I see and hear are the result of the PIP Scandal a few years back, however without absolute statistical proof that the world is a safer place through these mechanisms.

It may intuitive, but I have received NC's because our intuition isn't as good as their intuition.
 

Sidney Vianna

Post Responsibly
Leader
Admin
The irony is that companies are being asked for a higher and higher standard of post clinical evaluations using a high degree of statistical proof by a system that cannot prove that these data do, in fact, improve safety. SNIP .
I think your feedback is meant at Notified Bodies, who are a component of the regulatory oversight for medical devices, while this thread is primarily aimed at ISO 9001 certification, a voluntary standard.
 

SpinDr99

Involved In Discussions
Yes, Randy. For the companies, the consultants, the registrars, those making software for gaining certification and more. Let's not forget anyone who has their hand out.
 

Terry Cook

Registered
G'day all,

as a relative newbie to the process I have found that all our clients both old, present and future(as in Tender applications) all ask for certification, as in actual up to date certificates.....Is anyone else noting this in 2021
 

dwperron

Trusted Information Resource
What you have out there are a bunch of lazy organizations who pretend that having a valid ISO 9001 certificate on file for a company means that they meet their quality requirements as a supplier. There is a grain of truth in that philosophy, which makes it even worse.
 

Mike S.

Happy to be Alive
Trusted Information Resource
G'day all,

as a relative newbie to the process I have found that all our clients both old, present and future(as in Tender applications) all ask for certification, as in actual up to date certificates.....Is anyone else noting this in 2021

In the A&D world many, maybe most, customers expect us to be either ISO9001 or AS9100 certified in order to be their supplier, but some say if you aren't you can be a supplier if you pass their audit (sometimes paper, sometimes on-site, sometimes both).
 

Big Jim

Admin
G'day all,

as a relative newbie to the process I have found that all our clients both old, present and future(as in Tender applications) all ask for certification, as in actual up to date certificates.....Is anyone else noting this in 2021

This is more likely in some countires or regions or industries. It is far from universal.
 

OnQue

Registered
G'day all,

as a relative newbie to the process I have found that all our clients both old, present and future(as in Tender applications) all ask for certification, as in actual up to date certificates.....Is anyone else noting this in 2021

Only companies doing business with ISO (or QS) certified companies find it useful to be certified themselves. And then, they only certify the segments (facilities) of their organization that serves the registered companies. If there is no demand to achieve it then the certification would only serve as a tool in the arsenal to gain new business. Therefore, as almost everyone above noted, it is strictly a financial decision which answers the question, "Will doing this make us more money in the short run?"
 
Top Bottom