Standards - myASQ

Discussion Topic List

IEC/AAMI/ANSI 60601-1

2013 ANSI/AAMI ES60601-1:2005 & A1:2012 “Medical Electrical Equipment, Oxygen-Rich Environment,” ...

Laurence George 16d

Question about RoHS 1 vs. RoHS 3

2 17

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

Robert Martin Jul '20

Based on https://www.rohsguide.com/ , it seems that RoHS 2 and 3 would both be considered those subsequent ...

Han Fortner 18d

Robert Martin:
Based on https://www.rohsguide.com/ , it seems that RoHS 2 and 3 would both be considered those ...

ISO 8.7 Control of nonconforming outputs

1 7

Hello all,

I have a question about 8.7.1. "The organization shall ensure that outputs that do not conform to their ...

Ben Osburn 21d

Maria Isabel Butcher 19d

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 ...

Job Descriptions

4 21

Should job descriptions be controlled documents in ISO 9001:2015?

Keith Boehler 25d

Jodi Medley-McMahon 25d

Hi Keith,
My opinion on this, and based on things I have seen when auditing QMSs. If the job description is used for ...

Keith Boehler 24d

Hello Jodi,
I like and appreciate your response. I was thinking along the lines you provided but I did not have your ...

Seyid Aghayev 22d

Hi Keith Boehler,
As a Lead Audit about 6 years experience, my answer to your question is: Yes.
The JDs are the part of ...

Maria Isabel Butcher 22d

Yes JOb description must have a revision so when this change it et documented ,but their are not level 1 or 2 ...

Defect Severity in Software Testing

3 20

Can anyone point me to a definitive standard for defect severity levels in software testing? A search of ASQ turned ...

Ellen Gragg Aug '20

Gretchen Peterson Aug '20

Hello Ellen Gragg ‍

If you are interested in searching through ASQ's published magazines and journals for ...

Duke Okes Aug '20

Here's a website that might be useful.

https://www.westfallteam.com/

David Zubrow 26d

IEEE 1044 Classification of Software Anomalies has definitions and related guidance. The standard was ...

ISO 9001: 2015 for small organizations!

4 22

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

Melody Sands Aug '20

I'd say keep it simple. This new standard allows for less documentation than the 2008 version did, but you should ...

Gretchen Peterson Aug '20

Hi Zubin Khalfay ‍,

Perhaps this Quality Press title could help you?

ISO 9001: 2015 Handbook for Small and ...

Trish Borzon Aug '20

I'm tagging Amanda Foster ‍ - I know she took her former company through ISO. Any suggestions Amanda Foster ‍ ?

Amanda Foster Aug '20

Hi Zubin Khalfay ‍!

The most important thing is you get leadership commitment and buy-in. Since there is little ...

MSA question

3 44

According to IATF 16949:2016 7.1.5.1.1 Measurement systems analysis
Statistical studies shall be conducted ...

Peng Yuan Jul '20

Trish Borzon 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 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 ...

Lou Ann Lathrop Jul '20

Please review the AIAG MSA document. Need to make sure equipment is doing it's job.

liability

4 17

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 Jul '20

It will depend on the industry you're in, the related product risks, and any applicable regulations.

Yosi Shiloni Jul '20

Hi Duke,
Thank you for the prompt reply,
We are making flanges for oil, gas and water pipes do you have any ...

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 ...

Yosi Shiloni Jul '20

Thank you, I appreciate that!

Software Validation of Cloud Based Applications

1 6

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

Daniel Zrymiak Jul '20

That depends on how you track your changes, releases, and deployments in the Design History File and the Device ...

Work Instructions for ISO 9001:2015

1 19

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

Amanda Foster Jun '20

Not necessarily. If the instructions are something that can be trained effectively, or are intuitive, then you ...

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Discussion File Associations

The Empirical Rule uploaded by John Finley	Peel Testing MSA - Nested Gage R&R uploaded by Daniel Callahan
NYS DOH Clinical Laboratory Guidance LIMS S4 uploaded by Doan-Trinh Nguyen	Lean Six Sigma uploaded by Daniel Zrymiak