Is ISO 10012-2 equivalent to Z540-1 section II

M

Michelle

#1
Iso10012-2

still looking for a copy of this standard....really hate to purchase if it's not necessary. Can anyone tell me if it's the same as the Z540-1 section II????

Please help:bigwave:
 
Elsmar Forum Sponsor
G

Graeme

#2
Michelle,

I am not sure what you mean by "Z540-1 section II". Here is what I am aware of:
  • ANSI/NCSL Z540-1, "American National Standard for Calibration: Calibration Laboratories and Measuring and Test Equipment - General Requirements"; which sort of combines ISO Guide 25 (obsolete), ISO 9002:1994 (obsolete) and MIL-STD-45662A (obsolete) into a standard that comes close to meeting about 2/3 of the requirements of ISO 17025:1999.
  • ANSI/NCSL Z540-2, "U. S. Guide to the Expression of Uncertainty in Measurement", which is the US "legal equivalent" of the ISO Guide to Uncertainty in Measurement (GUM). Dry, boring, confusing, laden with math, and absolutely necessary for a calibration lab.
  • ISO 10012-1-1992, "Quality Assurance Requirements for Measuring Equipment - Part 1: Metrological Confirmation System for Measuring Equipment", which defines genreral calibration reqiurements for the cal lab itself.
  • ISO 10012-2-1997, "Quality Assurance Requirements for Measuring Equipment - Part 2: Guidelines for Control of Measurement Processes", which can apply to control of any measurement process but is intended mostly for calibration labs.

None of these are "equivalent". Both 10012-1 and 10012-2 can be used for additional guidance to aid in meeting the requirements of Z540-1, but in no way can they replace it. And none of those three cover anything that is in Z540-2! Does that answer your question?

Both of the NCSL standards can be purchased from NCSL ( www.ncsli.org ). Both of the ISO standards can be purchased from ASQ ( www.asq.org ) or ANSI ( www.ansi.org ). As with ALL standards documents, these are copyrighted publications that are the intellectual property of international or national organizations, and must be purchased in exactly the same way as any other book or magazine.

Also of interest to some is ANSI/ASQC M1-1996, "American National Standard for Calibration Systems", which describes the two prioncipal methods og managing a calibration system and the requirements for each.
 
Last edited by a moderator:
R

Ryan Wilde

#3
Re: Iso10012-2

Michelle said:

still looking for a copy of this standard....really hate to purchase if it's not necessary. Can anyone tell me if it's the same as the Z540-1 section II????

Please help:bigwave:
Actually, Z540-1 section II is based on MIL-STD-45662A, and includes the items that the government requires for contracts that are not addressed by ISO Guide 25.

From what I understand from a few people I've met on the commitee that wrote 10012-2, it was written mainly for use by internal laboratories. It is not nearly as stringent as 17025 or Z540-1, but does have some elements not addressed by either of the other standards. The elements that it adds really make little to no sense for an external laboratory, but great sense for internal laboratories. It has no requirements for competency, however, and in my opinion, is a weak document.

Ryan
 
G

Graeme

#4
memory defect corrected

to whoever may have noticed before I fixed it - I got the descriptions two standards confused in the reply I posted yesterday. It has now been fixed, after checking the documents at the office instead of relying on brain lapses at home ... late at night.

gcp
 
Thread starter Similar threads Forum Replies Date
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
A ISO 10012:2003 question (Confirmation ID) Other ISO and International Standards and European Regulations 1
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
L ISO 10012:2003 question (Confirmation ID) General Measurement Device and Calibration Topics 2
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
F ISO 10012 and ISO 17025 - Doing research about metrology systems confirmation ISO 17025 related Discussions 7
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 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
C ISO 10012-1 4.10 Confirmation Labeling General Measurement Device and Calibration Topics 2
S Need ISO 15189:2012 Documentation toolkit. Document Control Systems, Procedures, Forms and Templates 0
chris1price Archiving of paper records - ISO 9001 7.5.3.1b Records and Data - Quality, Legal and Other Evidence 4
M Transferring ISO 17025 from one company to another ISO 17025 related Discussions 1
D Common practices in ISO 9001 deployment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Q ISO 9001-2015 Internal audit finding Internal Auditing 12
B ISO 17025:2017 risk management Risk Management Principles and Generic Guidelines 0
P Audit check for IT company (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
Sidney Vianna Interesting Discussion Should ISO 9004 be changed from a guidance standard to a requirements standard? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Ed Panek ISO 13485:2016 Section 5.5.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Do these certificates of calibration meet ISO 9001 requirements for traceability to NIST? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO 2768-mk print call out Other ISO and International Standards and European Regulations 11
T ISO 17024, clauses 4.3.8. and 5.1.1. Other ISO and International Standards and European Regulations 4
C ISO 14001:2015 6.1.3 Compliance Obligations - Legal requirements monitoring ISO 14001:2015 Specific Discussions 0
C Requirement to link Quality Manual to ISO 9001 clause numbers? ISO 13485:2016 - Medical Device Quality Management Systems 13
D ISO 13485 scope (implantable) - Polymers for dental application EU Medical Device Regulations 9
W First time being audited (ISO 9001), asking for advice ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
John C. Abnet ISO 26262 ISO 26262 - Road vehicles – Functional safety 3
Marc ISO 26262- Road vehicles – Functional safety ISO 26262 - Road vehicles – Functional safety 0
John C. Abnet ISO 26262 IATF 16949 - Automotive Quality Systems Standard 0
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
P ISO 14644 Class 8 Cleanroom Air Filter Requirements Other Medical Device Related Standards 4
K PDCA cycle and ISO processes alternative model Quality Management System (QMS) Manuals 14
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
D ISO 13485 & CE Certification for Surgical Gloves CE Marking (Conformité Européene) / CB Scheme 0
S ISO 11137- Simulated product vs SIP Other Medical Device Related Standards 2
D Which ISO Standard to purchase? ISO 13485:2016 - Medical Device Quality Management Systems 7

Similar threads

Top Bottom