ISO 10012-1 4.10 Confirmation Labeling

C

cjkurtz

#1
ISO 10012-1 4.10 Confirmation Labeling


We really don't want to put labels on our gages. We are pursuing QS-9000 at one plant and ISO 9002 at another. We do precision machining of engine and gear parts, and have about 10,000 special gages, air gages, ring, thread, plug, mikes, etc.
Can you give us some advice about this?
 
Elsmar Forum Sponsor
B

Batman

#2
No doubt about it, your measurement / test equipment must be identified "...with a suitable indicator..." as to its calibration status. QS9000, 4.11.2.d

Note that the note in 4.11.2.d states a serial number traceable to a calibration record is acceptable.


I saw a system that had only serial numbers on all measurement devices. The gage person stated that ALL gages out on the floor were within their calibration cycle or they would not be there. Try as I could, every gage I sampled was up to date. This worked for them.

Our system is to put the due date on all gages. We have done this for years, and has worked. We have only about 1,000 total controlled gages. Prior to that we tried colored stickers and paint dots. Too complicated, though, so we found stickers that STUCK and just put the due date on it.

It would be difficult to not have some form of serialization in place, particularly when you must demonstrate bias, linearity, adjustment trends, etc., for each gage. If you have 10 similar pressure gages, for instance, is one more or less used than another? Is one wearing out more than another.
 
Thread starter Similar threads Forum Replies Date
A ISO 10012:2003 question (Confirmation ID) Other ISO and International Standards and European Regulations 1
L ISO 10012:2003 question (Confirmation ID) General Measurement Device and Calibration Topics 2
F ISO 10012 and ISO 17025 - Doing research about metrology systems confirmation ISO 17025 related Discussions 7
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
A Calibration system must meet ISO 10012, ISO 17025 or ANSI/NCSL Z540? ISO 17025 related Discussions 38
R ISO 10012, ANSI/NCSL Z540, ISO 17025 reference meet ISO 9001 7.4.2 (a) intent? ISO 17025 related Discussions 13
L ISO 10012:2003 - Interpretation of Managment Responsibility clause Other ISO and International Standards and European Regulations 1
M ISO 9001:2008 vs. ISO 10012:2003 - Can anyone expain the need for 10012:2003 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
G Question on Historical Background on ISO 10012 General Measurement Device and Calibration Topics 2
G Does ISO 17025 and Z540-3 cover all the elements of ISO 10012? ISO 17025 related Discussions 2
J MSA - Is ISO 10012 the standard we are looking for to ensure the FDA will be happy Other ISO and International Standards and European Regulations 3
M ISO 10012-1:1992 - Quality assurance requirements for measuring equipment General Measurement Device and Calibration Topics 17
Antonio Vieira ISO 9001:2000 vs. ISO 10012:2003 Procedure and Related Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Demystifying ISO 10012:2003 - Measurement Management Systems Other ISO and International Standards and European Regulations 4
D Comparing ISO 10012 and 17025 ISO 17025 related Discussions 2
G Relationships: ISO 17025 vs. Guide 25 vs. ISO 10012 ISO 17025 related Discussions 1
M Is ISO 10012-2 equivalent to Z540-1 section II General Measurement Device and Calibration Topics 3
M ISO 10012-2-1997: Quality Assurance Requirements for Measuring Equipment General Measurement Device and Calibration Topics 5
K ISO 10012 Part 1 (replaced by ISO 10012:2003) and Part 2 General Measurement Device and Calibration Topics 3
B MIL STD 45662 TO ISO 10012-1? General Measurement Device and Calibration Topics 2
T ISO 10012-1 vs ISO Guide 25/17025/Z540 ISO 17025 related Discussions 3
R ISO 13485 Certification for an Internal Warehouse? ISO 13485:2016 - Medical Device Quality Management Systems 1
S ISO 9001: 2015 MR Outputs - "any need for changes to the quality management system' Management Review Meetings and related Processes 3
Dirk S Contact duration (ISO 10993-1) vs. body contact days (ISO TS 21726) Other Medical Device Related Standards 2
O ISO 14971 for Biologics? ISO 14971 - Medical Device Risk Management 6
J Is ISO 13485 certification necessary for Class I (non-sterile) medical devices? ISO 13485:2016 - Medical Device Quality Management Systems 4
A ISO:13485 Strategy for a Startup ISO 13485:2016 - Medical Device Quality Management Systems 5
G ISO 13485 and CE certification strategy ISO 13485:2016 - Medical Device Quality Management Systems 7
A Small Company Implementing ISO 13485 Timeline/Process/Steps Advice ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Informational ISO 45002:2023 General guidelines for the implementation of ISO 45001:2018 Occupational Health & Safety Management Standards 1
K ISO 17025 Query Relating to Monitoring of Equipment ISO 17025 related Discussions 2
A ISO 27001_Audit IEC 27001 - Information Security Management Systems (ISMS) 4
R ISO 13485:2016 “Lifetime” of a product Manufacturing and Related Processes 4
A Help required in establishing Laboratory Information Management System as per ISO 17025, Cl.7.11.2 ISO 17025 related Discussions 0
R Do I need to get calibration certificate from ISO 17025 for IATF Audit IATF 16949 - Automotive Quality Systems Standard 8
kys123 Implications of failing an Anvisa Audit for ISO 13485 Certification ISO 13485:2016 - Medical Device Quality Management Systems 4
A Risk Assessment for ISO 13485:2016 section 7?? ISO 13485:2016 - Medical Device Quality Management Systems 11
L Annex of ISO 13485:2016 as harmonized standard (MDR/IVDR) ISO 13485:2016 - Medical Device Quality Management Systems 2
S Microdermabrasion device - classification according to the ISO 10993-1 Other Medical Device Related Standards 1
C ISO Certified Company ERP implementation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D Is ISO 10993-1:2020 a Harmonized Standard? Other Medical Device Related Standards 3
J Maintaining site specific ISO Compliance/Certification within a non-certified organization & centralized processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q External providers assessment - ISO 14001 ISO 14001:2015 Specific Discussions 4
LostLouie DHF linked to ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 7
L ISO 27001:2022 IEC 27001 - Information Security Management Systems (ISMS) 1
L ISO 9001, 14001, 45001 Audit Questions for a Security & Corporate Affairs Department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ISO 13485 Certificate Location / Scope ISO 13485:2016 - Medical Device Quality Management Systems 9
Moncia Full system pre certification audit ISO 50001 Other ISO and International Standards and European Regulations 8
C Test Method Validation - ISO Standards Qualification and Validation (including 21 CFR Part 11) 1
M ISO 13485 Supplier Question ISO 13485:2016 - Medical Device Quality Management Systems 13

Similar threads

Top Bottom