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Bruno Luya
Hello passionate about quality! My name is Bruno and I am currently conducting research to see in what way, in what ...
Bruno,

A QMS is only as good as the culture of the company and leadership involvement to ensure its survivability. ...
Meghan Hyman
Hello! How often do SDS’s need to be updated for ISO 14001? I have heard its either yearly or as necessary, but some ...
Meghan;
There is no quantified requirement per the standard. I suggest referencing the manufacturer or standard ...
Paul Ipolito
I am curious if anyone has run into the following situation- During review of an ISO 9001-2015 related Quality ...
Hi
As per industry practice the following are special process
Welding, painting, PWHT, NDE, GRE bonding, ...
Imran Rana
I was browsing through the AQL for the Medical device industry regulation guidelines (EU & Japanese) and found the ...
Dana Schultz
Hi All, I am a quality engineer at a very small medical device company. We are in the process of hiring a new quality ...
Dana Schultz May '21
Hi Dana Schultz ‍ - thanks for joining us here & posting a question. I'm going to bring in some members from the ...
Dana
I'd start with the sample exam questions from the Medical Device Auditor certification. You should be able to ...
Hi Dana!

Thank you for reaching out--you are connecting with people who have a wealth of knowledge on this topic. ...
Hello Dana,

Agree with the comments from David and Lisa, I would also look to understand if the applicant has ...
Patricia Pope
Can anyone provide the name of a software, database or process that your company utilizes to prepare, route and ...
Patricia Pope May '21
My company uses Enablon as a database for health and safety investigations, inspections, and audits, and is ...
Jeff Christiansen
Hi everyone, I was going through my old documentation on auditing related topics and came across the types of ...
There are not exact or common classification of non-conformities. Only ISO 19011-6.4.8: "Nonconformities can ...
Hi Jeff, I would like to throw this into the fray. I was trying to determine if 'concern' is a defined audit term or ...
This isn't quite what you were asking, but my source for the distinction between "major" and "minor" ...
Types of finding in an audit:

1. Conformance.


Fulfillment of a requeriment ( expectation estabilished, ...
Rebecca Armstrong
I'm looking for a good IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance ...
Hi Rebecca,

Thanks for your message.
Basically these are the Manufacturing related process documenttemplates ...
Charles Nigro
A question from a senior member of my company was can you become ISO certified when you’re not a profitable company. ...
Charles Nigro Jan '21
Are you talking about ISO 9001? 
As long as your organization has the funds to pay for the certification service it would be OK. You could look at it as ...
There is not such requirement in the standard. (threr are many nonprofit organizaitons which were certfied by ...
Rafael De La Puente
My question is related to a Clarification of Intent regarding clause 6.2 of ISO 9001:2015. In the Standard, ...
Hi,
No standard does not require any documented information for action plans(6.2.2), however as an 5-year lead ...