I suppose it was too good to last.

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G How I am suppose to chose the clean room class for my product? ISO 13485:2016 - Medical Device Quality Management Systems 9
E Are we suppose to include sub-component PPAP's to our customer? APQP and PPAP 2
J Can I issue a NCR if the auditee did not comply what he is suppose to do? General Auditing Discussions 6
K OEM specific requirements - PPAP was rejected by STA Customer and Company Specific Requirements 5
K %GRR was between 10-30% so we have to have a "backup plan" per auditor IATF 16949 - Automotive Quality Systems Standard 15
I When exactly was "competence" added to the ISO-9001 standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
I "On the job training" as a response to how someone was trained? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 75
T Was Just told we could ONLY buy material for AS9100 customers if the DISTRIBUTION house is AS9100 / AS9120 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
U Own Procedure was not effectively implemented Problem Solving, Root Cause Fault and Failure Analysis 3
B How to reply NCR on ineffectiveness of corrective action during IATF external audit? This is repeated issue whereby some mistake was done. IATF 16949 - Automotive Quality Systems Standard 7
R Major nonformance finding was given during a closing meeting of a ISO9001 certification audit General Auditing Discussions 76
M Case study - If the restaurant (ISO 9001:2015 certified) was run by 2 persons covering cooking and purchasing processes (Mother and Father) supported ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Ed Panek ISOTECH TTI-10 found out of calibration - Calibration house was wrong? General Measurement Device and Calibration Topics 7
E Audited to ISO 13485 standard although customer was aware we're not and have no plans to be ISO 13485:2016 - Medical Device Quality Management Systems 23
H Claiming equivalence with the product that was sold earlier in the market but not now EU Medical Device Regulations 1
E Interesting Discussion Was this the fastest ever stage 2 ISO9001:2015 audit? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 76
M Products Manufactured while CE was valid CE Marking (Conformité Européene) / CB Scheme 1
S Corrections and Removals - Fiber Content in our textile products was incorrect Other US Medical Device Regulations 1
Q Risk closeout , mitigation was not effective, next? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
J AS9100D Clause Brain Fade - Tool was past due for Calibration AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 11
P Retired equipment that was never validated Qualification and Validation (including 21 CFR Part 11) 2
Jane's What steps do you take to terminate a product which was licensed for sale in Canada Canada Medical Device Regulations 14
Q Change revision number in document when only codification was changed Document Control Systems, Procedures, Forms and Templates 8
Marc Before the 760mph Hyperloop dream, there was the atmospheric railway Coffee Break and Water Cooler Discussions 1
Ninja Getting eaten by Big Business - My company was bought by a huge multinational Coffee Break and Water Cooler Discussions 54
M When was ISO started and Where? Other ISO and International Standards and European Regulations 3
R Why was Drip-Rate Infusion Pump removed from IEC 60601-2-24:2012? IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J Dinged on Internal Audits for supervising an auditor I was training Internal Auditing 10
Q 21CFR820 as it was in 1993 or 1997? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
R 5.4.1 Quality Objectives - Nonconformity: The process was not fully effective ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
C CB Accreditaton - CB that was accredited by IAS Registrars and Notified Bodies 5
GStough Rx-360 - Has Anyone Used This and What Was Your Experience? Supplier Quality Assurance and other Supplier Issues 3
R IEC 62304 was brought up during an FDA Inspection/Audit IEC 62304 - Medical Device Software Life Cycle Processes 6
M I was wondering what happened to them (Joke) Funny Stuff - Jokes and Humour 5
U-DOG Major Nonconformance - We had a control in place that was not on the control plan IATF 16949 - Automotive Quality Systems Standard 14
J What are the changes in CMDR that was revised in Dec 2013? Canada Medical Device Regulations 2
W The 2nd printing of the AWS D17.1 2010 which was 2011 - Page missing? Various Other Specifications, Standards, and related Requirements 3
P ISO 15197:2013 (Blood glucose monitoring system) was released in May Other US Medical Device Regulations 10
B Was EN 980:2008 superseded by EN 15223-1:2012 on January 31, 2013 CE Marking (Conformité Européene) / CB Scheme 2
Q Reduced Device License Fee was rejected for being sent in too early Canada Medical Device Regulations 2
M AS9100A (old revision) - Required C=0 sampling plans if sampling was used? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
S The days before International Standards - Has ISO done what it was supposed to? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
R Internal Auditing Checklist - Major NCR because the Checklist was not Completed Internal Auditing 17
Richard Regalado ISO 22301 was published 2012 May 15 - New Standard for BCM - Published! Business Continuity & Resiliency Planning (BCRP) 2
Q I was assigned as Kaizen Leader for our MRB Area - Your advice appreciated Quality Tools, Improvement and Analysis 5
R New to MSA - I was told to use ANOVA for the GRR's Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
S Multiple Prints Sent by Customer Over Time as Design was Developed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
V Can't PPAP to Customer because a Supplier was Re-Sourced APQP and PPAP 2
B Which type of DOE was likely used for this transfer function? Six Sigma 4
Wes Bucey One of his habits was to call the World Series the "World Serious" Coffee Break and Water Cooler Discussions 24
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