Standards - myASQ

Does the implementation of an ISO 9001: 2015 Quality ...

1 8

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

Bruno Luya 11d

4h

Bruno,

A QMS is only as good as the culture of the company and leadership involvement to ensure its survivability. ...

ISO 14001 SDS update requirements

1 5

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 Hyman 5d

11h

Meghan;
There is no quantified requirement per the standard. I suggest referencing the manufacturer or standard ...

"Special" Processes exemption taken incorrectly.

1 7

I am curious if anyone has run into the following situation- During review of an ISO 9001-2015 related Quality ...

Paul Ipolito 12d

10d

Hi
As per industry practice the following are special process
Welding, painting, PWHT, NDE, GRE bonding, ...

Minimum Acceptable Compliance % (Technical ...

6

I was browsing through the AQL for the Medical device industry regulation guidelines (EU & Japanese) and found the ...

Imran Rana 19d

ISO 13485 and 21CFR820 Interview Questions

4 31

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

May '21

Hi Dana Schultz ‍ - thanks for joining us here & posting a question. I'm going to bring in some members from the ...

May '21

Dana
I'd start with the sample exam questions from the Medical Device Auditor certification. You should be able to ...

May '21

Hi Dana!

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

28d

Hello Dana,

Agree with the comments from David and Lisa, I would also look to understand if the applicant has ...

Standard gap assessments

1 25

Can anyone provide the name of a software, database or process that your company utilizes to prepare, route and ...

Patricia Pope May '21

May '21

My company uses Enablon as a database for health and safety investigations, inspections, and audits, and is ...

Audit Finding Terminology

4 39

Hi everyone, I was going through my old documentation on auditing related topics and came across the types of ...

Jeff Christiansen Jan '21

Mar '21

There are not exact or common classification of non-conformities. Only ISO 19011-6.4.8: "Nonconformities can ...

Apr '21

Hi Jeff, I would like to throw this into the fray. I was trying to determine if 'concern' is a defined audit term or ...

Apr '21

This isn't quite what you were asking, but my source for the distinction between "major" and "minor" ...

Apr '21

Types of finding in an audit:

1. Conformance.

Fulfillment of a requeriment ( expectation estabilished, ...

IQ/OQ/PQ

1 8

I'm looking for a good IQ/OQ/PQ (Installation Qualification, Operational Qualification, and Performance ...

Rebecca Armstrong Apr '21

Apr '21

Hi Rebecca,

Thanks for your message.

Basically these are the Manufacturing related process documenttemplates ...

What are the qualifications for ISO certification.

3 17

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

Jan '21

Are you talking about ISO 9001?

Jan '21

As long as your organization has the funds to pay for the certification service it would be OK. You could look at it as ...

Mar '21

There is not such requirement in the standard. (threr are many nonprofit organizaitons which were certfied by ...

Documentation of Planning Actions for Objectives

1 7

My question is related to a Clarification of Intent regarding clause 6.2 of ISO 9001:2015. In the Standard, ...

Rafael De La Puente Mar '21

Mar '21

Hi,
No standard does not require any documented information for action plans(6.2.2), however as an 5-year lead ...