SBS - The Best Value in QMS software

Register of the monitoring and measuring equipment

J

jpickett

Registered
#1
#1
Recent AS9100D certificate suspension and need guidance.
2 Questions regarding AS9100D 7.1.5.2 Measurement Traceability

1.
"The organization shall maintain a register of the monitoring and measuring equipment."
Would "for reference only" monitoring and measuring equipment be required to be included in such a list?

2.
Also, does monitoring and measuring equipment for which "traceability is NOT a requirement" and that is not deemed to be "an essential part of providing confidence in the validity of measurement results" have to be identified at all?
 
Standard Work Instruction Software by Dozuki
Elsmar Forum Sponsor
R

Randall Beck

Starting to get Involved
#2
#2
7.1.5.2 When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results....

The items we have tagged " for reference only" or "device not calibrated" are not in our Calibration control list. BUT every item has some kind of tag on it.

If the item you are questioning is used in any way in the process of final verification or non final intermittent verification activities then it must be calibrated, and should be. If there is a decision made during the process using a device of any kind in order to verify the process parameters for the next operation then it really becomes a traceable item. We have a hardness tester in the shop that we use for an intermittent hardness test but not the final hardness test. All are calibrated and documented.

I have taken this approach for 15 years and never had a problem. I just make sure EVERYTHING has a tag of some sort on it and I can thoroughly explain the need to not have it calibrated or validated.

Could you give us a couple examples of the items you are questioning perhaps?
 
J

jpickett

Registered
#3
#3
Hi Randall, thanks for the quick reply.

An example would be a pressure transducer uses in a piece of equipment that measures a reference parameter that is not considered key or critical to the output of the process.

In most instance like this the measured values are not formally reacted to. Note these processes are many decade old and do not have control plans.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
3 Non-conformance Register vs Corrective Action Register ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
A Medical Device Contract Manufacturer - Does the CM need to register with FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B New Facility register with FDA Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 4
D Equipment Register and PM question ISO 13485:2016 - Medical Device Quality Management Systems 2
S How long does it take to register a product with MHRA? UK Medical Device Regulations 8
D Equipment Register related question ISO 13485:2016 - Medical Device Quality Management Systems 1
F How to register class I device to all European Competent Autorities(CA) when we are European manufacturer EU Medical Device Regulations 4
S How to register class IIA medical device accessories EU Medical Device Regulations 1
Tagin Is SARS-CoV-2/COVID-19 on your risk register? Misc. Quality Assurance and Business Systems Related Topics 11
G ISO 9001 Legal Compliance and Legal Register Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
JoshuaFroud The withdrawal of Lloyd’s Register MDD & IVDD Notified Body Status CE Marking (Conformité Européene) / CB Scheme 1
L A Taiwan company want to sell Class I medical device (510(k) exempt) on Amazon, should we register with FDA? US Food and Drug Administration (FDA) 4
K Capturing local government development/planning activities in aspect register ISO 14001:2015 Specific Discussions 2
S Necessity of Legal Register to conform to ISO 9001, ISO 14001, IATF 16949 ISO 14001:2015 Specific Discussions 6
L Need to register Medical Devices in Canada (FDA, HC, CMDCAS...) Canada Medical Device Regulations 3
D Design developer - 21 CFR 807 - do we need to register? Other US Medical Device Regulations 0
MrTetris Informational Risk Register - Same hazardous situation, different severity of harms ISO 14971 - Medical Device Risk Management 7
C Do Distributors need to register with competent authorities in the EU? EU Medical Device Regulations 2
A Do I have to register with the FDA and pay fee? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
K EU MDR - PMS (Post Market Surveillance) SOP - definition of "register(s)" EU Medical Device Regulations 2
D Risk Register - have we considered enough and is the format acceptable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H REACH Registration Requirements - Who is required to Register REACH and RoHS Conversations 1
Z Do we need a Risk Register for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P Content of an IVD Technical Dossier to Register a Device to Japan Japan Medical Device Regulations 0
P Approved Supplier Register and Calibration Suppliers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
T Register of TS 16949 Certified Companies IATF 16949 - Automotive Quality Systems Standard 2
B List of Legislation - Legal Register for ISO14001 ISO 14001:2015 Specific Discussions 3
T ISO 9001:2015 vs AS9100D - Register to one or both Standards? Manufacturing and Related Processes 10
L In Venezuela, do I have to register Molecular diagnostics kits or IVD kits? Other Medical Device Regulations World-Wide 1
B Before new supplier register into ASL ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B Get information into English about medical devices register in Serbia Other Medical Device Regulations World-Wide 2
B Register's Ownership in Iran, India, Jordan, Arab Saudi, Egypt Other Medical Device Regulations World-Wide 8
R Legal Register - Does anyone have an example of a legal register? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Risk Register template as per ISO 27001:2013 wanted IEC 27001 - Information Security Management Systems (ISMS) 9
C Should we register to ISO 9001:2008 or ISO 9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P Do I need to Register with FDA? How shall my structure of processes look like? US Food and Drug Administration (FDA) 4
N How to register a non notified Medical Device in India Other Medical Device Regulations World-Wide 5
A Legislation Register in Dubai (Free Zone) ISO 14001:2015 Specific Discussions 1
I Feedback on an Environmental Aspects and Impacts Register Miscellaneous Environmental Standards and EMS Related Discussions 5
V What is the importance of a Risk Register? FMEA and Control Plans 3
L Examples of a Legal Register - Environmental ISO 14001 ISO 14001:2015 Specific Discussions 2
H Source for Compiling and Maintaining an EHS Legal Register Miscellaneous Environmental Standards and EMS Related Discussions 4
S MDR (Master Document Register) for Planning of Documents in Process Engineering Document Control Systems, Procedures, Forms and Templates 2
S Basic Environmental Aspects Register template wanted Document Control Systems, Procedures, Forms and Templates 1
G Combining Aspect Impact and Hazard Risk Register Miscellaneous Environmental Standards and EMS Related Discussions 8
I What information do you place in a "register"? Quality Manager and Management Related Issues 2
I Is a Register of Signatures Required by ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
R Risk Register, Risk Analysis and Risk Response/Treatment IEC 27001 - Information Security Management Systems (ISMS) 5
T What to include in our Legal Register? Miscellaneous Environmental Standards and EMS Related Discussions 8

Similar threads

Top Bottom