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New Post
27th April 2017 11:34 PM
Should Forms printed for daily use in the shop floor be controlled documents?
This is an old thread, but can anyone comment on the post above this one? (Marc is "crusin' some of the old threads" tonight... ) (3,411 views, 14 replies)
New Post
27th April 2017 11:20 PM
Do all Controlled Document copies require a Stamp?
Happy to help. To start you out, you might want to read a few discussions here. Many are old, as this is a topic which has been discussed for many years. Document and Data Control Stamps ... (51 views, 3 replies)
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27th April 2017 10:57 PM
New Folks - Please Take a Minute & Introduce Yourself/Say Hello! (8/2010 to TBD)
Welcome to Elsmar, Emily! (334,285 views, 1,498 replies)
New Post
Big Jim
27th April 2017 10:19 PM
Identifying AS9100 for a Legacy Product
I have seen situations where companies adhere to the requirements of AS9100 when required by customers, and ISO 9001 for everything else. Their scope documentation clearly shows this. One of... (91 views, 6 replies)
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Big Jim
27th April 2017 10:10 PM
Charged for an AS9102 FAI Report when requested as part of a Purchase Order?
Are you asking about the first article requirement for AS9100 or for an AS9102 first article? (5,443 views, 19 replies)
New Post
Big Jim
27th April 2017 09:05 PM
Nonconformance Found Outside the Audit Scope - Supplier Audit
Please note that I started off with "in my opinion". You are all welcome to your own opinions, but anything other than a robust audit flies in the face of "outcomes matter". It weakens the... (270 views, 12 replies)
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Ronen E
27th April 2017 08:34 PM
Regarding Essential Requirements Checklist
It's also not an Australian requirement, just a format preferred by TGA auditors. The TGA template is provided as a courtesy. (124 views, 4 replies)
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Ronen E
27th April 2017 08:27 PM
Meeting ISO 10993-1 2009 Material Risk Assessment Requirements
Hi, As there seems to be only indirect (gas) patient contact, this standard is probably applicable. Do you have it? Cheers, Ronen. (2,058 views, 4 replies)
New Post
Ronen E
27th April 2017 08:06 PM
How to document Corrections made to a Medical Device History File
There are, in the regulations, no special document control requirements related to the DHF. General document control requirements, and the contents of your own document control SOP, apply. (67 views, 1 replies)
New Post
Ronen E
27th April 2017 08:01 PM
"Quality Management System" Certificate vs. "Quality" Certificate?
Quality management system certificate is quite clear. What they mean by "Qualiy certificate" is a little more vague, but it seems that they're looking for some esteemed regulatory domain clearance... (47 views, 1 replies)
New Post
27th April 2017 07:45 PM
Specific Actions where Timely and/or Effective Actions are not Achieved
Josephjoet Do you think that does it deserve to raise the nc for that?if you resolve CAs in timely manner? Why it should be written down in procedure if is not addressed?if it were like that, you'd... (204 views, 4 replies)
New Thread
27th April 2017 07:23 PM
Lack of Awareness in ISO 9001 - Share a Presentation for Employees
Hi everybody Does someone can share a presentation which is to be used for People who is not interested in following an ISO system? The system runs with difficulty,even when CEO is insisting ... (41 views, 0 replies)
New Post
Marcelo Antunes
27th April 2017 06:29 PM
What is the difference between "Overall Risk" and "Risk"? (ISO 14971)
As I mentioned before, you can use some techniques, such as risk summing, if you want to perform overall risk evaluation focused on quantitatively risk management, but there's no risk summing method... (61 views, 4 replies)
New Post
Coury Ferguson
27th April 2017 05:10 PM
Who can make a Correction of Entry on GMP Records
I believe you need to define that responsibility. If you want the leads or Supervisors to have that authority, then state so. It is really up to how the Organization want to define authorities. ... (53 views, 1 replies)
New Post
27th April 2017 04:46 PM
Drowning in ECR/ECO/ECN Document Changes
Hi Heather312, I don't have much experience in MD QMS (have just started couple of months ago), but I think one general CR is sufficient for everything you do. Just develop a form in a way that you... (65 views, 1 replies)
New Post
27th April 2017 04:24 PM
Help with 8.5.1 regarding Welding Procedure Specifications (WPS's)
It's not a valid NC for ISO 9001. And although I only know enough about API to be dangerous I don't think it's even a valid NC for API. Now API has specific product standard requirements like 11D1,... (295 views, 9 replies)
New Post
27th April 2017 04:12 PM
Special Characteristic - IATF Definition
I wonder why they added "requirements". It's not in the TS16949 definition or the AIAG PPAP Fourth Edition definition. (368 views, 2 replies)
New Post
27th April 2017 03:19 PM
Attribute Gage R&R Form - Long Version - AIAG's MSA Manual
:thanx:Can someone please tell me what the AIAG "long method" and "Short method" are referring to? We have Mini-tab and it gives us the choices of the two AIAG methods or ANOVA. (35,536 views, 31 replies)
New Post
27th April 2017 02:11 PM
FDA Inspection (Audit) Readiness Procedure
We do have a procedure. It covers everything from who to contact first, who clears out conference rooms, What we need in the front and back rooms (we keep logs and records, communicate through lync... (392 views, 12 replies)
New Post
27th April 2017 12:45 PM
New position and AS9100 audit is 1 month away- need advice
When I started with ESM Aerospace, there was a MR there who was on contract and was being transitioned out of the company. Our audit was in two weeks. I printed the quality manual and every... (168 views, 8 replies)

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