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Sidney Vianna
16th August 2018 04:54 PM
ISO 45001:2018 - Occupational Health and Safety Management Standard
Just like in this post, you insist in denying the obvious. The IAF document that I hyperlinked is freely available for people to read and reach their own conclusions. Au revoir...:bigwave: (28,925 views, 79 replies)
New Thread
16th August 2018 04:36 PM
Facility Expansion and ISO 14001
Hello, Our site will be undergoing an expansion lasting a little over 12 months. I was wondering if there would be any specific requirements that I would need to follow for ISO 14001 (we are already... (45 views, 0 replies)
New Post
16th August 2018 04:05 PM
What is the general time line to prepare for IATF Letter of Conformance?
Typically, yes, since the CB won't want to write up (major) non-conformities for parts of the QMS which you could have audited before they arrive. Depends on the contractual need for the letter... (67 views, 1 replies)
New Post
16th August 2018 03:55 PM
Electrical contact resistance testing in MIL-DTL-5541
The problem is that the test is so damn sensitive. Coating the 6061 panel to Class 3 is no problem to pass salt spray but the electrical probe on our test fixture usually damages the coating and... (58 views, 2 replies)
New Post
16th August 2018 03:11 PM
ISO 9001:2015 for a Small Machine Shop need Resources
Yes, that was the one I was referring to. (100 views, 5 replies)
New Post
16th August 2018 03:07 PM
MedAccred Program - article
Exactly, Scott. Instead of using the term "Special" (since for the suppliers who do them, they aren't "special") they are referred to as "critical". (67 views, 2 replies)
New Post
Marcelo Antunes
16th August 2018 02:54 PM
IEC 60601-1-11 - Home Care Device Minimal requirements
Please note that the title of the standard is "home healthcare environment" as Basically, it's any place that is not a professional healthcare facility environment. So it's not really... (78 views, 3 replies)
New Post
Mark Meer
16th August 2018 01:28 PM
Questions about the Risk-based approach to QMS processes
:topic: Yup. Agreed. Though I have to admit, I also feel a (perverse? conflicted?) exciting anticipation of what is to come... Could discuss at length...topic for another thread, another... (1,080 views, 14 replies)
New Post
16th August 2018 12:31 PM
DOE - 11 Factors (2^2, 3^7 , 4^2)
It is not quite as bad as it sounds. The only resolution III aliasing is between the infill pattern and the interaction of print velocity * print thickness. All other aliasing is resolution IV. ... (68 views, 3 replies)
New Post
16th August 2018 12:28 PM
US Made class I CE Mark product for export only to EU
Thank you for your help! (48 views, 4 replies)
New Thread
16th August 2018 12:24 PM
Gear Profile & Lead report
Help needed. Got a gear report from a customer showing profile and lead(report attached). Its AGMA 2000, on the result sheet its showing Vphi(profile & Vpsi)Lead. Is this Total profile(Fa) &... (34 views, 0 replies)
New Post
16th August 2018 12:10 PM
VW Supplier Product Safety Representative (PSB) Responsibilities and Requirements
Hello The company where I work is contract manufacturer which is a Tier 2 or in some cases Tier 3. I just received an e-mail from one of my customer to delivers directly to VW to: 1.-... (14,583 views, 4 replies)
New Post
Marcelo Antunes
16th August 2018 11:30 AM
Software validation (4.1.6 ISO 13485:2016)
ISO 13485:2016 was modified to require validation for the application of all software (but using a risk-based approach to both the validation and validation activities). There's no option to... (93 views, 3 replies)
New Post
16th August 2018 11:02 AM
AIAG's IATF 16949 section - Torque MSA Requirement
What is your current torque process? In most cases, I consider the use of a torque wrench as the process, not as a gauge. I would use a torque analyzer as the gauge. Therefore, I would perform a... (1,141 views, 10 replies)
New Thread
16th August 2018 10:35 AM
Purified Potable Water Testing Parameters during Qualification
Hi to all Im going to validate a purified water system, what parameters must i report from the potable water analysis?, im going to analyze all, but what should i review or inlcude in a format to... (36 views, 0 replies)
New Thread
16th August 2018 08:23 AM
Welcome to the MedAccred Forum!
Welcome! This forum is intended to provide details of the MedAccred Critical Process Accreditation Program: MedAccred is an industry-managed supply chain oversight program for critical... (64 views, 0 replies)
New Post
16th August 2018 07:52 AM
Control of outsourced processes - drop shipped products
Control does not require inspection. It may also include how a supplier is qualified, might include audits of the supplier's QMS or many other options. Inspection is just one of many possibilities. (120 views, 3 replies)
New Post
16th August 2018 07:33 AM
Is something happening with Linkedin "Groups"? July 2018
It seems a pretty useless platform to me. Some content is useful, but overall it's an unfulfilling experience... (1,152 views, 8 replies)
New Post
16th August 2018 05:41 AM
Importing Medical devices class I in EU
Hi, Have they given you a procedure for applying the labels? The label or device must have a CE Mark on it somewhere. A EU Authorised Representative is compulsory for manufacturers outside of... (57 views, 3 replies)
New Post
16th August 2018 05:20 AM
DFMEA / PFMEA linkage - Where in the standards do I find it?
Dears, we are trying to use the special characteristics Matrix as a way to link the DFMEA to the PFMEA. Anyone has the experience how to create such a matrix using the IQ RM software from APIS? ... (924 views, 2 replies)

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