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John C. Abnet
20th April 2018 02:26 PM
ISO 9001:2015 Clause - Is Measurement traceability applicable?
Good day @ren33 Based on the limited information shared, I will assume that your organization is a service provider (i.e. call center, polling center, customer service center, etc...) and not a... (85 views, 1 replies)
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20th April 2018 02:24 PM
ISO 14001:2015 transition from the 2004 standard
Everybody turns into a pumpkin (59 views, 3 replies)
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20th April 2018 02:07 PM
ISO 9001:2015 Cl. 4.1 Note 1 - External and Internal issues
I agree with the last post - a SWOT is a good tool to use to get at this requirement. Determine external and internal issues that are relevant to the strategic direction. May be a good idea to have... (243 views, 8 replies)
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20th April 2018 01:54 PM
Consultant for Risk Management File for a Class II Medical device
Hello, Staci, Can you please call me at 319 202 8798 so i can explain you my requirements. Thanks Bhim (140 views, 1 replies)
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Coury Ferguson
20th April 2018 12:56 PM
AS9100D - Good ways to document an internal audit plan / schedule
If you are talking about UTC/UTAS Requirements of ASQR-01, here is the paragraph that states the requirements: ASQR-01, Paragraph 8.2.2 Internal Audit "1. Supplier that receives a Member PO... (419 views, 15 replies)
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20th April 2018 11:38 AM
What is a Customer Complaint? (ISO 9001:2015)
One way to approach it is log it all and then ask your questions about the issue and categorize as appropriate. (148 views, 6 replies)
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20th April 2018 10:11 AM
Supplier Assessment for Hardware supporting SaMD
Well, supplier assessments need to be commensurate with the risk so what are the risks associated with equipment from those suppliers? My guess is that the risk is pretty low so the assessment can... (49 views, 1 replies)
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John Broomfield
20th April 2018 08:06 AM
What does a good business practice Process Audit look like for AS9100D?
Audit Coordinator, I feel your pain. But you must stay true to yourself instead of being blown around by asking for an auditor’s opinion. Never ask an auditor for their opinion; it may be... (204 views, 8 replies)
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20th April 2018 07:38 AM
ISO 17025 Guide and Ideas for a New Calibration Business
In my opinion you have to check again some basic force measurements. (3,050 views, 16 replies)
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Howard Atkins
20th April 2018 07:31 AM
IATF 16949 certification rules
from the rules (224 views, 5 replies)
New Post
20th April 2018 04:53 AM
EFA or F/C on the TAG
I assume your Tag is a EASA Form 1 in which case the only place you can put the information requested by the customer is in Block 12 Remarks. You can enter it directly or attach a Test report or... (93 views, 1 replies)
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20th April 2018 04:43 AM
Triple insulated wire for transformer isolation
Hi Peter Thank you that is very useful information. It ties in with my feeling that the stress test is a voltage far in excess of the working the insulation will see. The transformers are 100%... (153 views, 4 replies)
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20th April 2018 03:41 AM
China's CFDA - Medical Device Validation Requirements
Hi, According to me, Peterstechnology.com is one of the best options for you. They are providing quality material at an affordable price with CFDA approved. It’s a certified industry which... (2,205 views, 9 replies)
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20th April 2018 03:41 AM
Task analysis and ISO 14971
Sorry to here that my wording received condescending. It was not the purpose at all. More was on that all these risk analysis activities are in a universe of immense uncertainties. Reassurance... (186 views, 6 replies)
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19th April 2018 11:57 PM
Is a DHR enough to fulfill 13485:2016's Medical Device File requirement?
It need not be your own specification... Part of the File will be what your principle has shared with you as a controlled external document + your own set of procedures / work instructions. You as... (146 views, 3 replies)
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19th April 2018 11:26 PM
Do I have to register with the FDA and pay fee?
Articles to also keep in mind in your assessment: Walgreens Halts Sale of Genetic Test Kit After FDA Criticism FDA Regulation Defines Business Strategy in Direct-to-Consumer Genetic Testing (184 views, 5 replies)

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