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Ronen E
22nd February 2017 06:43 PM
Medical Device Reporting In US/ EU/ Canada
In my opinion this is a little too expansive of an interpretation, considering the following text from 21 CFR 803: I read it to mean that even if nothing of that sort happened but could likely... (603 views, 3 replies)
New Post
joekirk
22nd February 2017 06:30 PM
IATF 16949 Clause 8.5.6.1.1 - Temporary Change of Process Controls
I had an interested discussion with an IATF auditor yesterday regarding this clause. My interpretation is that you would develop and document back-up or alternate methods for inspection... (436 views, 2 replies)
New Post
Ronen E
22nd February 2017 06:28 PM
Israel Demonstration Medical Device Requirements
Hello Bender and welcome to (posting on) the Cove :bigwave: There are provisions in the Israeli regulations for usage of devices pending registration. However, the details in your post are not... (39 views, 1 replies)
New Post
Sarah Stec
22nd February 2017 05:34 PM
Getting Married - How Will It Affect My Taxes?
Congrats on getting married next weekend! It's T-17 days for me! Also, thank you for reminding me to talk to my fiancee about getting in front of that financial planner... I also agree to... (91 views, 8 replies)
New Thread
Molson S
22nd February 2017 05:25 PM
API Monogram License for a Small Machine Shop
We are a small machine shop that machine wellhead components per API 6A for large oil companies, such as FMC & Cameron. We are currently AS9100 certified and would like to Monogram components to 6A.... (27 views, 0 replies)
New Post
jga444
22nd February 2017 04:46 PM
ISO 9001:2015 - Clause for Correction of a QMS Nonconformity
howste Thanks for the reply. That is the way I have always don it in the past. (90 views, 3 replies)
New Post
Buckyb
22nd February 2017 02:57 PM
AS9100 Rev. D - When and what?
A former President once said, "I feel your pain"...... As for us, we are peeling off the AS9100 and finally seeking ISO9001. We were shackled to AS9100 due to Boeing D6-82479 but have made the... (8,917 views, 56 replies)
New Post
Kwilson
22nd February 2017 02:05 PM
Solar Energy is now close to Half the Price of Coal - 2016
My system is 22 panels, 6Kw at peak production. When we sized my system, we looked at the previous 12 electric bills. Total system cost was $24k, but well worth it, especially after federal, state,... (627 views, 11 replies)
New Post
DannyK
22nd February 2017 01:21 PM
Has anyone taken the AS9100 Delta course / exam?
Has anyone taken the AS9120B exam? Any comments on the exam? Thank you, Danny (926 views, 29 replies)
New Thread
jelly1921
22nd February 2017 12:23 PM
How to understand the word "include" in IATF 16949
In some clauses the word "shall include but is not limited to the following, as applicable" used, such as 8.3.5.1. --- this makes sense, because not all of the items listed must be included, if they... (42 views, 0 replies)
New Post
zac2944
22nd February 2017 12:20 PM
Is the next revision of ISO 15378 following the High Level Structure?
Looks like the new version of this standard with the new high level structure is still in draft. Anyone know when this new version is expected to be released? (435 views, 5 replies)
New Post
RCH2016
22nd February 2017 11:45 AM
Should customers influence a supplier's registrar selection?
Two things strike me in this discussion. First, if a customer can dictate a registrar, it seems to me that it leaves the system open to some major abuse. In other words, the possibility that... (14,733 views, 87 replies)
New Post
bpillar
22nd February 2017 10:27 AM
IATF 16949 - TS vs IATF side by side
:bigwave: Hello! Marc you're right, but I think the following document can be shared, due to the fact it's a pubblic document coming from AIAG website, and can help a little bit to understand... (88 views, 2 replies)
New Post
RunningMommaCT
22nd February 2017 10:10 AM
Retention Requirements of Complaint Medical Devices
Hi! I started my medical device career investigating complaints for a large medical device manufacturer. Implant related complaints were held onto indefinitely. Due to potential product... (478 views, 2 replies)
New Post
dsantos24
22nd February 2017 09:54 AM
Is anyone changing their ISO 14001:2004 EMS Policy?
My bad I was obviously looking at the 2004 standard (196 views, 7 replies)
New Post
Marc
22nd February 2017 08:44 AM
Setup Verification in IATF 16949 Clause 8.5.1.3
A quick "Bump". Thanks in advance to anyone who can help with this one. (147 views, 1 replies)
New Post
Dumitru Ivanov
22nd February 2017 05:58 AM
Implementing ISO 9001 in the Services Industry
Neither in Romania. It impacts other services, though. (7,841 views, 11 replies)
New Post
somashekar
22nd February 2017 05:47 AM
"On An Annual Basis" - Definition
The term is always in context with the first occurance of the event, and an annum is 12 months period. Even in respect of premium for insurance with term Yearly (Yly) OR annually OR per annum, its... (306 views, 10 replies)
New Post
Howard Atkins
22nd February 2017 12:35 AM
PPAP Rejection for "MSA-GR&R are not using the latest AIAG format"
BUT the customers shall overrides this (220 views, 7 replies)
New Post
John Martinez
21st February 2017 09:07 PM
4.1 & 4.2 - Context of the Organization and Interested Parties, ISO 9001:2015
Has anyone obtained a copy of ISO 9000:2015 Quality management systems — Fundamentals and vocabulary? While some may be vague, some are quite definitive. Keep in mind. From the third party... (5,070 views, 19 replies)

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