SBS - The best value in QMS software

Replacing multimeters to comply with clause 7.6

A

Ashley Cardin

#11
Our Service Department does repair work on the Computers that we sell and the multimeters are being used to help identify what needs to be fixed.
 
Elsmar Forum Sponsor
A

Ashley Cardin

#12
Thanks for all the help everybody. I just talked to the Service Manager he said that he uses it to test contiuity and voltage to locate the problem but that he doesn't use it once the system is repaired. He checks whether or not it is still doing what the customer said it was doing when they brought it in.

What do you think, need for calibration or no? I'm leaning towards no right now since we use it to diagnose problems but not provide evidence of conformity.
 

Al Rosen

Staff member
Super Moderator
#13
Ashley Cardin said:
Thanks for all the help everybody. I just talked to the Service Manager he said that he uses it to test contiuity and voltage to locate the problem but that he doesn't use it once the system is repaired. He checks whether or not it is still doing what the customer said it was doing when they brought it in.

What do you think, need for calibration or no? I'm leaning towards no right now since we use it to diagnose problems but not provide evidence of conformity.
I don't think you need to calibrate, but be sure to identify the meters as not to be used for acceptance of product.
 
Last edited:
T

tomvehoski

#14
I second that you don't need to calibrate. Your quality check is functional, not a measurement. Spend the extra money on a good quality reliable meter and skip the calibration.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#16
Actually, you may need what is known as a limited cal.....that is, only certain functions/ranges are cal'd.....

To check continuity you typically seek less than an ohm or two and for voltage then check for some value. The short is not difficult, have a specific wire, say 6", 16 gauge and the meter should beep or otherwise show short, which for continuity is good. Voltage - if to see whether you are going to get bitten or fried, then have that cal'd. After all, even with a good meter, if it is not cal'd, I would not stick my hand into a circuit where that meter was used to read.....the meter could be wrong and if no cal, then there is no sufficient periodic check.

Just my thoughts.

Hershal
 
Thread starter Similar threads Forum Replies Date
S Final Medical Device Regulations replacing MDD 93/42/EEC, etc. EU Medical Device Regulations 15
J Replacing RoHS1 certs with RoHS2 certs required? RoHS, REACH, ELV, IMDS and Restricted Substances 2
M Replacing Components in an IVD Reagent Kit ISO 13485:2016 - Medical Device Quality Management Systems 2
F Replacing End of Life (EOL) Components - What triggers retesting to IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
W ISO 10993 - Replacing Sensitization Test with Systemic Toxicity Test? Other Medical Device Related Standards 4
J Lean "replacing" Quality/ISO - A System vs. A Tool Lean in Manufacturing and Service Industries 34
C ISO/ IEC 17021 Accreditation replacing Guide 62 & Guide 66 Registrars and Notified Bodies 33
C Labeling of Medical Devices - Distributor replacing device serial number label 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
R Device Labeling Standards: Is ISO 15223:2000 Replacing EN980? ISO 13485:2016 - Medical Device Quality Management Systems 3
F Is TS 16949 Replacing QS-9000? IATF 16949 - Automotive Quality Systems Standard 3
B Baldrige replacing ISO 9001? Misc. Quality Assurance and Business Systems Related Topics 11
L Tapes and Multimeters - Identification on Instrument General Measurement Device and Calibration Topics 4
C Best Method for Calibrating Multimeters General Measurement Device and Calibration Topics 8
T Non-Replicable MSA when using digital multimeters or oscilloscopes Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 9
M Is it possible to calibrate multimeters in house? General Measurement Device and Calibration Topics 5
A Including multimeters and network testers as monitoring and measurement devices ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Validating Multimeters (how to) General Measurement Device and Calibration Topics 8
M Less expensive way to calibrate multimeters such as a "Fluke"? General Measurement Device and Calibration Topics 2
J WAIVED ON Q1 - We Don't have to comply with FORDS customer specific requirements IATF 16949 - Automotive Quality Systems Standard 2
M FULFILMENT of compliance obligation versus COMPLY with compliance obligations ISO 14001:2015 Specific Discussions 2
L Proof of Concept Studies - Do we need to comply with SAE reporting? Medical Device and FDA Regulations and Standards News 3
M MDR, RED and LVD - Should our device comply with them? EU Medical Device Regulations 3
R MDR standards - which standards to comply with ? EU Medical Device Regulations 3
M Informational Some things the EU MDR 2017/745 does not tell you, but you may need to know to comply with it effectively – Part 1 Medical Device and FDA Regulations and Standards News 0
B How to comply with IATF 16949:2016 9.3.2.1k - Management review IATF 16949 - Automotive Quality Systems Standard 2
S How to make Single Sign On (SSO) Comply e-sig requirements? ISO 13485:2016 - Medical Device Quality Management Systems 4
Z Does a website needs to comply with Part 11? Qualification and Validation (including 21 CFR Part 11) 6
Q How to comply with ISO 9001:2015 Clause 7.4 Communication ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Quality Policy does not include a commitment to comply with legal requirements Quality Management System (QMS) Manuals 5
S A CE Marked Product that does not comply with the Standard EU Medical Device Regulations 7
H Job Descriptions to comply with ISO Standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Medical devices are CE mark but not sold in EU - Need to comply with REACH? RoHS, REACH, ELV, IMDS and Restricted Substances 9
M How do you comply with 7.2.3 Customer Comunication AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 9
M Do I need to comply with both the MDD and the PED for my Medical Device? EU Medical Device Regulations 8
S Selecting materials for implants to comply with ISO 10993 biocompatibility Other Medical Device Related Standards 4
A Type of Materials to comply with IEC 60601 (Dental Laser Case) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S Definition Comply - What does 'comply' mean to you? (Definition) Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 3
O Comply with 21 CFR 11, but no other FDA regulations? Qualification and Validation (including 21 CFR Part 11) 4
J ISO 9001 Clause 7.5.2 Validation of Processes - How to comply? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 32
A ISO/TS 16949 - Comply SPC requirements Statistical Analysis Tools, Techniques and SPC 22
K Identifying Required Testing to comply with IEC 60601 EU Medical Device Regulations 4
G What is meant by FAI (First Article Inspection) and how do we comply? AS9102 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 26
C Do all Class 1 Medical Devices (Electrical) have to comply with IEC60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
P Outsourced Manufacturing - Making Subcontractors comply with TL9000 TL 9000 Telecommunications Standard and QuEST 2
R Dielectric Strength of Triple Insulated Wire to comply with 2MOPP IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
Fender1 How to comply with ISO 9001 and provide quick/short lead-time orders? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
B Commitment to Comply - ISO 14001 Clause 4.2 - Environmental Policy ISO 14001:2015 Specific Discussions 6
G Are Component Manufacturers required to comply with ISO13485:2003 ISO 13485:2016 - Medical Device Quality Management Systems 4
G How to comply with 4.4.5 Contol of Documents - Documents of External Origion Miscellaneous Environmental Standards and EMS Related Discussions 6
J Which kind of medical equipment must comply with IEC60601-1-8? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2

Similar threads

Top Bottom