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21st February 2018 12:45 AM
IATF 16949 - Manufacturing and Product Audit Approach
Thanks for your reply Golfman. But I am not completely agree with the approach of doing dock audit only to comply with the requirement of Product audit. Product audit asks to audit product at... (1,192 views, 10 replies)
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20th February 2018 09:56 PM
NC if word "development" stated in Policy?
I think you might be better off rethinking your policy. Why include "development"? Surely, a policy has to be pretty simple. Smoking policy is simple, Dress code policy is simple. So should Quality... (266 views, 11 replies)
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20th February 2018 09:27 PM
FDA Medical Device Accessory Packaging Requirements
QAengineer13 , To your point, If I have a medical device class I, non-sterile, that comes packed in a poly-bag (10 units per dispenser box)- does each unite need to carry the lot and expiry or... (1,557 views, 6 replies)
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Richard Regalado
20th February 2018 08:32 PM
Management representative transition checklist
Hello. First and foremost, a management representative is not a requirement for the ISO/IEC 27001. I am assuming here, that the ISMS you are referring to is based on ISO/IEC 27001 (there are other... (213 views, 6 replies)
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20th February 2018 06:26 PM
Web based tool for benchmarking audit findings
New posts have been split off for it's own thread. (46 views, 5 replies)
New Thread
Sidney Vianna
20th February 2018 05:24 PM
High number of certificate suspensions in the IAQG OASIS database
I ran a search in OASIS earlier today (see search options below) and was surprised with the high number of entries in the Deleted / Withdrawn / Suspended / CB Withdrawn / Cancelled category. In... (74 views, 0 replies)
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20th February 2018 03:31 PM
CER - Equivalent Medical Devices Criteria - MDR/MEDDEV REV 4
Thanks a lot for your clarification! (198 views, 4 replies)
New Thread
Jeff Putman
20th February 2018 02:52 PM
EQI Prelaunch Control Plan - Definition
In the Navistar Ramp-Up Assessment there is a question: “Has supplier implemented an EQI pre-launch control plan, to prevent quality/delivery issues during ramp up?” Can any of you fine people... (55 views, 0 replies)
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20th February 2018 02:38 PM
AIAG FMEA - Major customers of the FMEA process
Thx very much (145 views, 2 replies)
New Post
20th February 2018 01:04 PM
Certificate of calibration from Manufacturer allowed?
I always used the manufacturer's cert; I paid for calibration to NIST, and never had an issue with any auditor. One side note: I also found it cheaper to buy a new caliper, scale, dial indicator... (956 views, 10 replies)
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Sidney Vianna
20th February 2018 12:00 PM
Non-destructive testing methods are special processes?
If you do a Cove search for the words "special process" in the title of the thread, you will find numerous threads where this has been discussed. (155 views, 6 replies)
New Post
20th February 2018 08:27 AM
IMDS - Creating an MDS out of material and a made item?
Yes I've used it before but always simple entries. Just figured it out, I need to create a node which then allows a lower level to be used. For example, component with a component or... (79 views, 2 replies)

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