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Laurence George
2013 ANSI/AAMI ES60601-1:2005 & A1:2012 “Medical Electrical Equipment, Oxygen-Rich Environment,” ...
Joseph Manske
Hi all, I'm wondering if anyone can help me here.
If a company provides a Cert of RoHS Compliance that says "EU RoHS ...
Joseph Manske Jul '20
Based on  https://www.rohsguide.com/ , it seems that RoHS 2 and 3 would both be considered those subsequent ...
Robert Martin:
Based on  https://www.rohsguide.com/ , it seems that RoHS 2 and 3 would both be considered those ...
Ben Osburn
Hello all,

I have a question about 8.7.1. "The organization shall ensure that outputs that do not conform to their ...
I am not an expert but I can tell you that every company set their goal and if you don't have one then you need to take ...
Keith Boehler
Should job descriptions be controlled documents in ISO 9001:2015?
Hi Keith,
My opinion on this, and based on things I have seen when auditing QMSs. If the job description is used for ...
Hello Jodi,
I like and appreciate your response.  I was thinking along the lines you provided but I did not have your ...
Hi Keith Boehler,
As a Lead Audit about 6 years experience, my answer to your question is: Yes.
The JDs are the part of ...
Yes JOb description must have   a revision so when this change it et documented ,but their are not level 1 or 2 ...
Ellen Gragg
Can anyone point me to a definitive standard for defect severity levels in software testing? A search of ASQ turned ...
Ellen Gragg Aug '20
Hello Ellen Gragg ‍ 

If you are interested in searching through ASQ's published magazines and journals for ...
Duke Okes Duke Okes Aug '20
Here's a website that might be useful.

https://www.westfallteam.com/
IEEE 1044 Classification of Software Anomalies has definitions and related guidance.  The standard was ...
Zubin Khalfay
Any advice on designing a QMS for a small organization? where there is not a lot of hierarchy, can any one share their ...
Zubin Khalfay Aug '20
I'd say keep it simple.  This new standard allows for less documentation than the 2008 version did, but you should ...
Hi Zubin Khalfay ‍, 

Perhaps this Quality Press title could help you?

ISO 9001: 2015 Handbook for Small and ...
I'm tagging  Amanda Foster ‍ - I know she took her former company through ISO.  Any suggestions Amanda Foster ‍ ?
Hi Zubin Khalfay ‍!

The most important thing is you get leadership commitment and buy-in. Since there is little ...
Peng Yuan
 According to IATF 16949:2016 7.1.5.1.1 Measurement systems analysis
Statistical studies shall be conducted ...
Peng Yuan Jul '20
Hi Peng Yuan ‍ - I'm going to tag a couple of members who might have some insights into this.  Lou Ann Lathrop ‍ and Lisa ...
Duke Okes Duke Okes Jul '20
It's been a while since I worked with the auto industry, but it's my guess that MSA is not expected on validation test ...
Please review the AIAG MSA document.  Need to make sure equipment is doing it's job. 
Yosi Shiloni
Hi there,
I would like to know if there any guideline on what to do in case there is a chance that we sent defective ...
Yosi Shiloni Jul '20
Duke Okes Duke Okes Jul '20
It will depend on the industry you're in, the related product risks, and any applicable regulations.
Hi Duke,
Thank you for the prompt reply,
We are making flanges for oil, gas and water pipes do you have any ...
Duke Okes Duke Okes Jul '20
I've worked with natural gas distribution, but not at the level to know all the regs.  However, since the industry ...
Thank you, I appreciate that!
 
Tom Hudson
I work in medical device so 21 CFR Part 820 and ISO13485 are some of my governing regulations and I am curious how you ...
Tom Hudson Jul '20
That depends on how you track your changes, releases, and deployments in the Design History File and the Device ...
Ben Osburn
Hey guys,

I work in a factory where our products are measured on many different machines. Do we need to make work ...
Ben Osburn Jun '20
Not necessarily. If the instructions are something that can be trained effectively, or are intuitive, then you ...

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