Disagreement concerning 4.10.6.5 - National Recognized vs 'Home Grown' Procedures

R

Ron Dooley

#1
Discussion and some disagreement concerning 4.10.6.5 about recgonized laboratories.

We currently have an home grown procedures. All equipment and gages are sent to recgonized NIST labs for accreditation. The data returned with the gages is to NIST and references various Mil-Std.

Does this meet the requirement as spelled out in Laboratory Testing and Calibration Methods 4.10.6.5 or do we need the Mil-Standards referenced from our suppliers?

Thank for any help you might give.
 
Elsmar Forum Sponsor

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
Two questions:

1. What do you mean by 'NIST Recognized'?
2. 4.10.6.5 is about methods and sampling, not recognition.

Will you rephrase your question, please?

If you are talking about 'Recognition', I assume you mean 4.11.2.b.1 'Accredited Lab' requirement, in which case: The big 3 has waived the calibration laboratory requirements in the QS9000 Third Editon, 4.11.2.b.1 until January 2001.
 
R

Ron Dooley

#3
Clarification of question.

We are currently having all outside calibrations done by ISO Certified labs who calibrate to NIST traceable.

The statement of methods within 4.10.6.5 has been interpreted by my boss to think we need to know what method used to calibrate the equipment tested.

Again I am heading down the wrong road. As you know a lot of calibration houses refer to Mil-Std-46552A which is obsolete but still may be used for reference.

My boss wants all recommended methods for testing of equipment going outside to be documented.

I am currently going to a military database for all the methods recommended for testing of gages and equipment.

QS9000 Third edition is so much fun. If I seem confused it may because I really am.

Thanks again Mark.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
We are currently having all outside calibrations done by ISO Certified labs who calibrate to NIST traceable.
I would think the ISO registration would be sufficient. It remains to be seen in the QS9000 arena what will really happen with the A2LA and Guide 25 (and related) issues.
The statement of methods within 4.10.6.5 has been interpreted by my boss to think we need to know what method used to calibrate the equipment tested.
You can ask for or require a copy of the first page of the procedure used to calibrate the device / instrument if you want to take it to the extreme.
Again I am heading down the wrong road. As you know a lot of calibration houses refer to Mil-Std-46552A which is obsolete but still may be used for reference.
The only problem is 45662A 'the minimum' and it isn't recognized (well known or understood) by a lot of folks. A matrix would provide proof.
My boss wants all recommended methods for testing of equipment going outside to be documented.
If the labs you are dealing with are ISO9002 registered, they are required to have documented procedures - but ask for a copy of their quality manual.
I am currently going to a military database for all the methods recommended for testing of gages and equipment.
That will do most of the basics of QS cal requirements, but you should matrix the requirements to identify any extra QS issues and as a map. You do, as a minimum, have a written procedure for calibrating each device / instrument / system / gage. There is no requirement specific enought to proscribe content of calibration procedures.

[This message has been edited by Marc Smith (edited 21-03-99).]
 
Thread starter Similar threads Forum Replies Date
M AS9100 7.5.1 Control of Production disagreement of intentions AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
A Canada Importer Record Retention Requirements - Disagreement with NB auditor Canada Medical Device Regulations 5
E Customer - Disagreement on who the customer is... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
Mr Roo ISO 9001 - 7.1.3 Infrastructure - questions concerning evidence ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
L Special Processes - Technical reason concerning torque - Anaerobic compounds Manufacturing and Related Processes 10
M Informational EU – Application of transitional provisions concerning validity of certificates issued in accordance to Directives 90/385/EEC and 93/42/EEC Medical Device and FDA Regulations and Standards News 2
R Endless doubts and questions concerning procedure vs process. Process Maps, Process Mapping and Turtle Diagrams 22
I Concerning procedures within Quality Manual ISO 17025 related Discussions 10
P Study concerning adoption of and migration to ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T PPAP - Complaint from a Tier One customer concerning Product Dimension IATF 16949 - Automotive Quality Systems Standard 26
V Concerning CQI-15 Welding System Assessment Form Document Control Systems, Procedures, Forms and Templates 1
L New Website from the FDA concerning UDI Exceptions, Alternatives and Time Extensions Other US Medical Device Regulations 0
somashekar Business Process Plan concerning MOH Malaysia Other Medical Device Regulations World-Wide 9
B Very interesting article concerning MSA (Measurement System Analysis) Book, Video, Blog and Web Site Reviews and Recommendations 8
B Is the ISO 13485 auditor being too picky concerning CMDCAS? ISO 13485:2016 - Medical Device Quality Management Systems 5
R Risk Analysis and Hazard Identification concerning Clinical Decision Support Systems ISO 14971 - Medical Device Risk Management 1
A General Controls - GMP interpretation? General Requirements Concerning Records 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 15
8 Looking for opinions concerning the re-start up of a 5s Program Lean in Manufacturing and Service Industries 22
M Requesting Information From FDA concerning Archived 510K 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
D Standards concerning Medical Device Battery Charging DURING Use Other Medical Device Related Standards 3
Q Brief overview of Standards and Regulations concerning Breast Implants Other Medical Device and Orthopedic Related Topics 2
Q Notification to Registrar Concerning Continuous Dynamics including Restructuring ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P Regulations concerning Calibration of Stop Watches used for Testing Medical Devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Question concerning Medical Devices and Low Voltage Directive EU Medical Device Regulations 5
G Question concerning process troubleshooting and process FMEA usage in job shops FMEA and Control Plans 5
R For ISO/TS 16949 Auditors concerning the Auditor Development Process recertification General Auditing Discussions 4
P Complaints to CB concerning certified organization Registrars and Notified Bodies 17
C XR-charts question concerning R Statistical Analysis Tools, Techniques and SPC 18
C Who are these guys? E-mail from ASQ concerning a contested election for President ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 22
Q Concerning Special Characteristics Interpretation - Semiconductor commodity standard IATF 16949 - Automotive Quality Systems Standard 3
H Seeking Power Point Presentation Concerning Iso 17025 ISO 17025 related Discussions 4
L Concerning "allowable" supplier line accums before starting a corrective action Supplier Quality Assurance and other Supplier Issues 4
S Control chart limit calculation confusion concerning SPC control limit calculation Statistical Analysis Tools, Techniques and SPC 27
D Do User Manuals (Not Device Labeling) HAVE to be in their national languages for these countries? Will English Hardcopy not do? EU Medical Device Regulations 11
M Informational US – National Evaluation System for Health Technology Coordinating Center (NESTcc) Solicits Public Comments for Data Quality and Methods Frameworks Medical Device and FDA Regulations and Standards News 0
Marc China - CFDA is now National Medical Products Administration or NMPA China Medical Device Regulations 7
K IoT, AI, Big Data and National Strategies of Other Countries (in your country, do you have any?) IEC 27001 - Information Security Management Systems (ISMS) 12
M Medical Device News EU - List of national market surveillance authorities by sector and country EU Medical Device Regulations 0
SK13485 What are Regional or National Device Registries for Medical Devices? EU Medical Device Regulations 10
K Offshoring Data of NHS (National Health Service) England Medical Information Technology, Medical Software and Health Informatics 2
M Calibration Procedure Traceable to National/International Standards (API Q1 9th Ed) Oil and Gas Industry Standards and Regulations 3
Marc Elaine Stritch, National Treasure, Is Dead At 89 World News 0
Marc IAQG Listed AS9100 National Accreditation Bodies as of 29 June 2014 ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 7
Wes Bucey Hospital Turns Down Malcolm Baldrige National Quality Award World News 0
D National Highways Sector Schemes Checklists wanted Quality Manager and Management Related Issues 4
Hershal Happy National Teddy Bear Day! Coffee Break and Water Cooler Discussions 5
Ajit Basrur US FDA - National Medical Device Postmarket Surveillance Plan US Food and Drug Administration (FDA) 0
M Measurement Standards Traceable to International or National Measurement Standards AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
R EU-countries which don't accept English user manuals and require national translation CE Marking (Conformité Européene) / CB Scheme 9
E National Requirements for Resale of Medical Devices in EU EU Medical Device Regulations 9
Similar threads


















































Top Bottom