New Post

JaneB
9th January 2009 02:15 AM

Documentation of training and retraining procedures, specifically how training should
I'm not sure if this is a direct quote from a finding, but do remember that ISO 9001 focusses on competence and how that is ascertained and maintained. That's why it says the organisation "where... (64 views, 5 replies)

New Post

Debbie Kerr
9th January 2009 02:02 AM

ISO 9001 in Plain English by Craig Cochran - NEW BOOK
As a newcomer to the world of Quality, I have found "ISO 9001 Made Simple" to be a godsend at a time when I was just about to pull out my hair. Thanks, Craig. Debbie PS: I may know you... (5,998 views, 84 replies)

New Post

Howard Atkins
9th January 2009 01:55 AM

Problem defining MSA (Measurement System Analysis) to Ford
The Ford requirement for MSA is per type of gauge/equipment. Download these Ford Motor Company Customer Specifics for ISO/TS 16949 Ford Motor Company Customer Specifics for PPAP 4th Edition ... (28 views, 1 replies)

New Post

Wes Bucey
9th January 2009 01:32 AM

Registrar Registration Certification Fees
After reading through this thread, it appears there are only TWO possible interpretations for the reason behind this incredible delay: An incredible back-office SNAFU on the part of the CB... (411 views, 25 replies)

New Post

Varadarajan
9th January 2009 01:29 AM

Registration to ISO 9001:2000 in 2009?
Also Cost implications on certification process again in Nov 2009? Varada (70 views, 6 replies)

New Post

Varadarajan
9th January 2009 01:08 AM

Internal Audit for Management Representative
1.Yes:yes: 2.Need not be.The person performing Internal audits can be a trained auditor by ANY CERTIFIED LEAD AUDITORS 3.Frequency decided by management team and specified in the Internal... (193 views, 12 replies)

New Post

Ron Rompen
9th January 2009 12:52 AM

Longevity at work - How long have you been working for your present employer?
I just started with my present employer; got caught up in all the cutbacks in automotive last summer. It's a difficult time to find a job right now, I'm just glad that I was able to find one that I... (1,031 views, 41 replies)

New Post

Marc
9th January 2009 12:13 AM

Validating the AOI process (Automated Optical Inspection)
Has anyone here validated an AOI process (Automated Optical Inspection)? (38 views, 2 replies)

New Post

neelu
8th January 2009 11:51 PM

BSI changes accreditation - ANAB will provide accreditation services to BSI
In the development period of QMS certification(nineti es), it was a practice among importing countries, to insist on the supplier to get certified/registered with a CB that has accreditation from AB... (780 views, 22 replies)

New Thread

Ron Rompen
8th January 2009 11:46 PM

Alternatives to welding two pieces of aluminum extrusion together at a miter joint
Yet another plea for help from the rest of the team here. Another challenge that we face in our assembly process is the quality of welds which result from joining two pieces of aluminum extrusion... (15 views, 0 replies)

New Post

Ron Rompen
8th January 2009 11:39 PM

Measurement of long pieces of Aluminum extrusions
I am just starting to do some analysis on what the REAL amount of failure is, however the last few weeks out in the field dealing with customer feedback, and my own visual observations of fixtures... (106 views, 9 replies)

New Post

reynald
8th January 2009 11:30 PM

Another binomial use/misuse question
Ok now i think i understand what you are thinking. 2 things to point out. 1. You forgot to account for x=0 2. The sum of all P(x) should be 100% I have attached an excel file that hope helps. (85 views, 3 replies)

New Post

Miner
8th January 2009 11:27 PM

CP CPk from Min Max Data?
It depends. Are the Min/Max from the same part or from a subgroup? If from a subgroup, and you are sure that the process is in control, you can calculate Cp from the Ranges. This is exactly what... (32 views, 2 replies)

New Post

celia4237
8th January 2009 11:16 PM

510(k) submission - Questions about page 2 of form 3654
Here is the response i received from FDA. "You could group the sections. For example if sections 12, 13, and 14 are all N/A then you could state it that way. Please let me know if you need... (194 views, 5 replies)

New Post

JaneB
8th January 2009 09:39 PM

Va pensiero
All I can say is: Eee-yerrrk. An acquired taste, methinks. Kinda like this one (grubs & honey ants) from our local indigenous population: ... (151 views, 11 replies)

New Post

littlejackwang
8th January 2009 09:36 PM

Have ISO 9001 and ISO 14001 requirements reached Russia?
Sorry for that I can't be helpful on the ISO matter, but I do know if you want to export any goods to Russia, you have to get a GOST certificate which probably costs you UR 3000. (920 views, 14 replies)

New Post

trainerbob
8th January 2009 08:45 PM

R&D and Design Process. Where the borders are?
I think there is enough leeway in ISO to allow the organization to determine where 7.3 starts. I usually think of terms of interaction with a customer. As far as calibration of your hi-tech... (198 views, 10 replies)

New Post

blewispunk
8th January 2009 07:19 PM

Italian Ministry of Health Medical Device Databank regulation
I work at a medical device company in the United States. To determine how to obtain a smart card I contacted a number of companies listed on the europa esignatures website. I found out that CNIPA... (2,053 views, 18 replies)

New Post

Al Rosen
8th January 2009 06:53 PM

Leakage current from battery - IEC 60601-1 Medical Device
Let's be real here. The standard, is concerned with leakage current to earth ground. I suggest the OP find a qualified engineer. (54 views, 3 replies)

New Post

MIREGMGR
8th January 2009 06:41 PM

Update Service for Legal & Regulatory Requirements
Heh. You know when something new comes out because you regularly participate at Elsmar Cove, and everything new is discussed here. :D (32 views, 1 replies)