ISO 17025 and Business Changes

ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratoriesQuestion

My organization has just been recently accredited to ISO/IEC 17025:2005. Shortly thereafter, changes were made to the organization’s structure and business operations.  I would like to know:

1) When should these changes be reflected in the Quality Manual?

2) Do I need to advise the local registrar about the changes?

3) Are these changes time-sensitive that need to be reported to the certifying body to maintain certification or, should I just wait for the next surveillance audit coming in about six (6) months?

Answer

Thank you for your question.  Updates to your Quality Management System and Quality Manual should be made as soon as they are implemented.  I would suggest notifying your CB of the changes now and let them plan for auditing these changes.  They will likely want to roll that into your next surveillance and not make a special visit.  That decision, of course, would be up to them.

Denis.

Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
(519) 476-8951
www.DevosAssociates.com

ISO 17025 Certified Testing Lab Not Required to Provide Raw Testing Data?

ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories

Question

I have sent a sample for testing to a lab which is ISO certified, they have provided me with the test results, however, when I asked them for the Raw Data to support the testing performed as well as to keep it on record for the future investigational use, the testing lab refuses to provide the raw data, stating that we are not a GMP lab and as an ISO certified lab, we are not obliged to provide the raw data. They say the raw data could be shown to the regulatory authorities. Is this true?

The contract testing lab we mentioned is certified to ISO 17025.

Answer

Since the laboratory is “accredited” to ISO/IEC 17025, it will be useful to review a few relevant passages from that standard (note that the term “certified” or “registered” is usually used for organizations registered or certified to ISO 9001 quality management systems).

ISO/IEC 17025 Clause 4.13.2.1 states:

“The laboratory shall retain records of original observations, derived data and sufficient information to establish an audit trail, calibration records, staff records and a copy of each test report or calibration certificate issued, for a defined period. The records for each test or calibration shall contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original. The records shall include the identity of personnel responsible for the sampling, performance of each test and/or calibration and checking of results.”

ISO/IEC 17025 Clause 5.10.1 paragraph 3 states:

“In the case of tests or calibrations performed for internal customers, or in the case of a written agreement with the customer, the results may be reported in a simplified way. Any information listed in 5.10.2 to 5.10.4 which is not reported to the customer shall be readily available in the laboratory which carried out the tests and/or calibrations.”

Further, ISO/IEC 17025 Clause 5.10.4.2 paragraph 2 states:

“When a statement of compliance with a specification is made omitting the measurement results and associated uncertainties, the laboratory shall record those results and maintain them for possible future reference.”

The ISO/IEC 17025 accredited laboratories are required to retain test results when they do not report the results on the test certificate (or report) to the customer. A word of caution: The laboratory may have a record retention policy (it should be documented in their quality system per ISO/IEC 17025 Clause 4.13.1.2). Ensure that future record requests are made within the record retention policy period!

In the future, it would be best to specify in the purchase requisition what test data the customer requires from the test laboratory. This forms the basis for a contractual requirement and can be contested legally if the laboratory does not fulfill the customer’s requirements if it accepted the purchase requisition (This would apply to both ISO 9001 registered and ISO/IEC 17025 accredited laboratories).

The laboratory’s other argument about “GMP lab and as an ISO certified lab, they are not obliged to provide the raw data” is not consistent with the requirements of ISO/IEC 17025. The customer should file the refusal to provide data as a complaint to the laboratory under the clauses cited and ask the laboratory for corrective action under ISO/IEC 17025 Clause 4.8 (complaints) and 4.11 (corrective action).

If an ISO/IEC 17025 accredited laboratory refutes to provide corrective action under the requirements stated in this article, it is possible to escalate this complaint to their accrediting body.

Dilip A Shah
ASQ Fellow, ASQ CQE, CQA, CCT
President, E = mc3 Solutions,
Technical Director, Sapphire Proficiency Testing Services.
Past Chair, ASQ Measurement Quality Division (2012-2013)
Former Member of the A2LA Board of Directors (2006-2014)

Difference Between ISO/IEC 17025 and ISO 10012

ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratoriesQ: I am updating the instrumentation section of a product fabrication specification to replace a cancelled military specification (MIL-STD 45662) that specified calibration systems requirements.  I am looking for an industry standard that provides requirements/guidance for documentation of our established schedules and procedures for all of our measuring and test equipment and measurement standards.

I am looking into ANSI/ISO/ASQ Q10012-2003: Measurement management systems — Requirements for measurement processes and measuring equipment and ISO/IEC 17025-2005: General requirements for the competence of testing and calibration laboratories, and I would like guidance on usage and application of these standards.

A: The two standards in question, ISO 10012 and ISO 17025 have different scopes.

While the scope of both documents includes language that can perhaps cause confusion, what follows is the salient text from both that illuminates the difference between the two.

From the scope of ISO 10012:

“It specifies the quality management requirements of a measurement management system that can be used by an organization performing measurements as part of the overall management system, and to ensure metrological requirements are met.”

From scope of ISO 17025:

“This International Standard is for use by laboratories in developing their management system for quality, administrative and technical operations.”

ISO 10012 focuses on the requirements of the measurement management system. You can consider it a system within the quality management system. It defines requirements relevant to the measurement management system in language that may illustrate interrelations to other parts of an overall quality management system.

ISO 10012 is a guidance document and not intended for certification. An organization, for example, could have a quality management systems that is certified to ISO 9001:2008. Even if the organization chooses to adhere to the requirements of ISO 10012, the certification to ISO 9001 does not imply certification to the requirements of ISO 10012.

ISO 17025 describes the requirements for a quality management system that can be accredited (a process comparable but different from certification). It encompasses all aspects of the laboratory.

The competence referred to in the title of the standard relates to the competence of the entire system – not just training of personnel. It addresses such factors as contracts with customers, purchasing, internal auditing, and management review of the entire quality management system – ISO 10012 does not.

In summary, ISO 10012 is a guidance document that addresses one element (namely management of a measurement system) of a quality management system. ISO 17025 defines requirements for entire quality management system that can be accredited.

Denise Robitaille
Vice Chair, U.S. TAG to ISO/TC 176 on Quality Management and Assurance
SC3 Expert – Supporting Technologies

Related Content:

Expert Answers: Metrology Program 101, Quality Progress

Question and answer related to defining an organization’s metrology program. Read more. 

Measure for Measure: Managing the Measurement System, Quality Progress

Discussion related to the importance and timing of equipment calibration. Read more. 

10 Quality Basics, Quality Progress

Correctly applied measurement, wherever and however it occurs, is an essential element of a successful business QMS. Read more.

Standards Column: Using the Whole ISO 9000 Family of Quality Management System Standards, Quality Engineering

There is a great deal of richness in the ISO 9000 family of documents and it is a shame for users to not know about and take advantage of the full range of possibilities. Read more.

Ask A Librarian

ISO 9001 7.6a Calibration and Traceability

Gage R&R, Torque Wrence

Q: ANSI/ISO/ASQ Q9001-2008 Quality management systems — Requirements, clause 7.6a states, in part:

“Where necessary to ensure valid results, measuring equipment shall

a) be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international standards or national measurement standards…”

Does this sub clause require that the calibration process be performed in accordance with international or national calibration procedures? Or does it require that the measurement standards (hardware) used for calibration be traceable to international or national measurement standards (hardware)?

A: The standard is clear that it is the traceability of the calibration standards they are looking for.

Note: By definition, the traceability needs to eventually lead to an accredited lab who will be following procedures such as those set forth in ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories.

 Your internal calibration processes can best be guided by acquiring a copy of ANSI/NCSL Z540.3.

I hope this helped answer your questions.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Related Content:

Open access articles from ASQ

Measure for Measure: Improved Gage R&R Measurement Studies, Quality Progress

Back to Basics: Assessing Failure — The effect of faulty measurement on previously produced products, Quality Progress

The Prediction Properties of Classical and Inverse Regression for the Simple Linear Calibration Problem, Journal of Quality Technology

Explore more articles.

Accuracy of Measurement Equipment

Automotive inspection, TS 16949, IATF 16949

Q: I work for an incoming quality assurance department. In our recent audits, the auditor claimed that high precision machines such as the Coordinate Measuring Machines (CMM) and touchless measurement system should have higher Gage Repeatability and Reproducibility (GR&R) values compared to less precise equipment such as hand-held calipers and gages. If this is the case, does Measurement System Analysis (MSA) cater to this by providing a guidance on what are the recommended values for each measuring equipment by general? If not, should we still stick to the general MSA rules, regardless of the equipment’s precision value?

A: When you noted “higher GR&R values,” that in itself can be a bit confusing because the GR&R value is a percentage of errors caused by repeatability and reproducibility variation. The higher the number, the more variation present — and the worse the measurement method is.

As far as I know, MSA doesn’t give specific guidance for recommended values depending on the measuring equipment. Also, I’m not sure of the validity of saying that a CMM is consistently more accurate than other equipment, such as calipers. Although the equipment may theoretically be more accurate, how you stage the part to be measured will also affect the amount of variability, as will the feature being measured.  Consequently, even though the CMM is theoretically more accurate, there may be 20 percent GR&R, mainly due to the holding fixture or the feature being measured. I’m sure you get the point here.

As far as I know, MSA manuals do discuss what the major inputs should be when deciding the amount of acceptable variation. It strongly recommends to look at each application individually to verify what is required and how the measurement is going to be used.

Another thing to consider is whether you are looking at the GR&R based on total variation or on the specified tolerance. Tolerance-based is more commonly used than total variation, but that may depend on the type of industry.

One thing I would like to mention is that if you have three people take 10 measurements each, and then dump the information into one of the common software programs, it will not matter if they take the 10 measurements with a dial caliper or with a CMM. The instruments’ “accuracy” should not be the deciding factor, but the tolerance base should be.

Also, ISO standards do not dictate GR&R values. If you do what your quality management system says you do, most auditors will not push such an issue. While some auditors may offer “opinions” and suggestions, such items are rarely cause for nonconformance findings.

I hope this helps answer your question.

Bud Salsbury
ASQ Senior Member, CQT, CQI

Editor’s picks: Read open access content on measurement from the ASQ Knowledge Center:

Measure for Measure: Improved Gage R&R Measurement Studies, Quality Progress

Comparing Variability of Two Measurement Processes Using R&R Studies, Journal of Quality Technology

Confidence Intervals for Misclassification Rates in a Gauge R&R Study, Journal of Quality Technology

Quality Quandaries – A Gage R&R Study in a Hospital, Quality Engineering

ISO 17025 Clause 5.4.2 – Selection of Methods

ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratoriesQ: We are working with the Mexican Accreditation Entity (EMA) for certification to ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories. Clause 5.4.2 states: The laboratory shall confirm that it can properly operate standard methods before introducing the tests or calibrations.

We are a testing laboratory and work with Method 21 – Determination of Volatile Organic Compound, EPA 40 CFR Ch.1 ( 01/07/04 Edition ) Test: Monitoring of Fugitive Emissions.

The question is: What would be the best way or a way to confirm the method? Or, to put it another way, how can we satisfy the requirements in clause 5.4.2 ?

A: The questioner is referring to clause 5.4.2 from ISO/IEC 17025:2005. An excerpt of this clause is below. Please refer to ISO/IEC 17025:2005 for the full clause.

5.4.2 Selection of methods

“…Methods published in international, regional or national standards shall preferably be used….. Laboratory-developed methods or methods adopted by the laboratory may also be used if they are appropriate for the intended use and if they are validated…. The customer shall be informed as to the method chosen. The laboratory shall confirm that it can properly operate standard methods before introducing the tests or calibrations.…”

Since the questioner is using the published methods, there is no need for validation of the method unless the method is modified.

However, the proficiency of being able to apply the published method needs to be demonstrated. This can be demonstrated by a documented Gage R & R study, Analysis of Variance (ANOVA) or Design of Experiments (DOE) study as appropriate to show proficiency in being able to utilize the test method properly.

The results from these studies may also be used to estimate the uncertainty of measurement for the tests. Reporting uncertainty of measurement with both test and calibration results is a requirement in ISO/IEC 17025:2005. The ILAC P14 document is a good guidance document on reporting uncertainty.

Dilip A Shah
ASQ CQE, CQA, CCT
President, E = mc3 Solutions
Chair, ASQ Measurement Quality Division (2012-2013)
Secretary and Member of the A2LA Board of Directors (2006-2014)
Medina, Ohio
www.emc3solutions.com/

ISO 17025; Rounding Measurements

ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories

Q: At the lab I work for, certified to ISO 17025:2005 General requirements for the competence of testing and calibration laboratories, the documented quality assurance system does not allow the rounding of numbers. For example, the requirement for the weight of an adhesive material is 25 to 35 grams, and the actual weight is 24.6 grams.

The engineering member of the team feels this is acceptable because 25 grams is specified with two significant figures; 24.6 grams, expressed as two significant figures is 25 grams. If the intent was not to round off in the tenths place, the document would read “25.0” and rounding would be in the hundredths.

A: If the requirement (specification) is 25 to 35 grams, the need to specify accurately (24.6 grams) is not as critical and the number can be rounded to 25 grams. We would assume that the nominal desired value would be 30 grams. (Personal opinion: the 25 to 35 gram requirement is a fairly loose tolerance, but I do not know the application).

But, this raises more questions:

How was the weight measured? Was the reported value an average of repeated measurements? Was the measuring instrument capable of reading two or three significant digits? What was the measurement uncertainty of the measurement? Was the measurement uncertainty higher than the 25 to 35 grams requirement?

If the reported measurement was an average of n number of measurements made with a two significant digit measuring scale, the reported averaged is always carried to an extra significant digit. If it was three significant digits, then round to four significant digits.

If the measurement uncertainty was +/- 7 grams, the reported value could fall between 17.6 to 31.6 grams. This scenario would require a better measurement process with smaller measurement uncertainty.

For general number rounding conventions, NIST offers Publication SP811 (appendix B.7 on page 43) which provides a good reference. It can be downloaded as a free PDF.

Dilip A Shah
ASQ CQE, CQA, CCT
President, E = mc3 Solutions
Chair, ASQ Measurement Quality Division (2012-2013)
Secretary and Member of the A2LA Board of Directors (2006-2014)
Medina, Ohio
www.emc3solutions.com/

Using the 10:1 Ratio Rule and the 4:1 Ratio Rule

Q: Can you explain when I should be using  the 10:1 ratio rule and the 4:1 ratio rule within my calibration lab? We calibrate standards as well as manufacturing gages.

A: First, I will use the right nomenclature. What the user means is 10:1 and 4:1 Test Accuracy Ratio (TAR). That is, one uses standards 4 or 10 times as accurate as the Unit Under Test (UUT) to calibrate it with.

Unfortunately, the answer to the user’s question is NEVER if we were to use newer metrologically accepted practices.

The TAR is replaced by Test Uncertainty Ratio (TUR).  The ANSI/NCSLI Z540.3:2006 definition of TUR is:

“The ratio of the span of the tolerance of a measurement quantity subject to calibration, to twice the 95% expanded uncertainty of the measurement process used for calibration.”

*NOTE: This applies to two-sided tolerances.

The TUR is represented as a mathematical equation below:

Test Uncertainty Ratio (TUR) represented as an equation

 

Because of advances in technology, one can purchase highly precise and accurate instrumentation at the end user level, it gets challenging to find standards 4 or 10 times as precise with which to calibrate it and maintain metrological traceability at the same time (definition per ISO Guide 99:2007, Property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty).

Proper measurement uncertainty analysis of the UUT (including standards used with its uncertainty) identifies all the errors associated with the measurement process and ensures confidence that calibration is within the specification desired by the end user.

ISO/IEC 17025-2005: General requirements for the competence of testing and calibration laboratories, clause 5.10.4.2, third paragraph, also states that “When statements of compliance are made, the uncertainty of measurement shall be taken into account.”

This would also ensure confidence in the calibration employing the metrological and statistical practices recommended.

The other rule of thumb not to be confused in this discussion is to measure/calibrate with the right resolution. In the ASQ Quality Progress March 2011 Measure for Measure column, I wrote more on resolution with respect to specification and measurement uncertainty. The general rule of the thumb is if you want to measure/calibrate a 2-decimal place resolution device, you need at least 3-decimal place or higher resolution device.

This is a very good question posed and it is also unfortunately the most misunderstood practice among a lot of folks performing calibration.

Dilip A Shah
ASQ CQE, CQA, CCT
President, E = mc3 Solutions
Chair, ASQ Measurement Quality Division (2012-2013)
Secretary and Member of the A2LA Board of Directors (2006-2014)
Medina, Ohio
www.emc3solutions.com/

Related Content: 

Measure for Measure: Avoiding Calibration Overkill, Quality Progress

History and overview of calibration science. Read more.

Evolution of Measurement Acceptance Risk Decisions, World Conference on Quality and Improvement

TAR, TUR, and GUM are examined. Read more. 

Measure for Measure: Calculating Uncertainty, Quality Progress

Understanding test accuracy and uncertainty ratios. Read more. 

Ask A Librarian

Measurement tolerances and techniques

Q: I am looking for some information regarding blueprint tolerances and measurement tools used to measure certain features.

For example, can the same type of tolerance be applied over the length of 450 mm as it could be for a distance of 3 mm?  Is there additional measurement error or gage error that needs to be applied for longer distances?  If one uses a 1” micrometer for measuring a feature, does it make a difference in the measurement error by using the top end of the instrument versus using it to measure just very small features?

A: Thank you for your questions about measurement tolerances. First of all, since your questions were multi-layered, my answers will be as well. Nonetheless, I think I should be able to help you.

As for using the same type of tolerance for a dimension of 450 mm and a dimension of 3 mm, there is more than one answer. We’re talking about 17.7165 inches vs. .118 inches. The 3 F’s must first be considered.  That is Form, Fit, and Function.  In other words, where will this product be used?  If this will be for a medical product or for anything whatsoever where safety is a factor, the design engineer will most likely use a tighter tolerance. So both dimensions could be ± .001 or a more liberal ± .010.  The difference between the two sizes would just change the way they are manufactured.  For example: a 17.717 inch product with a tolerance of ± .030 could probably be rough machined or even made on a burn table.  If the size or location of the smaller dimension is critical, you would machine it with appropriate equipment and hold a tighter tolerance.  OK, enough Manufacturing 101 lingo.

With regard to measurement error, larger/longer dimensions can introduce the possibility of increased measurement error. However, if a “qualified” and experienced individual is doing the measurement, that should not be a major factor.  The same basic skills and standards would apply. The type of measurement equipment can make a difference.  In other words; if you use a Dial Caliper, you can probably rely on it to be accurate within .001-.002 inches.  If you use a 0-1 inch micrometer, you should be able to trust it’s accuracy within .0001 inch.

A qualified metrologist and/or a quality technician would know to check a micrometer at numerous points over its measuring range.  Measurement error should not increase significantly from one end to the other.  If it does, there is something wrong with the calibration or with the tool itself.

I know the above can be perceived as general answers, but I am confident you will see the specifics there as well.

Bud Salsbury
ASQ Senior Member, CQT, CQI

ISO 17025 Certified Facility

ISO/IEC 17025:2017 General requirements for the competence of testing and calibration laboratories

Q: We have a specification that states test reports shall be from an facility certified to ISO 9001:2008 Quality management systems–Requirements. Our test reports are from a facility certified to ISO/IEC 17025-2005: General requirements for the competence of testing and calibration laboratories.

Isn’t ISO 17025:2005 under the ISO 9001:2008 umbrella?

A: Your interpretation is, indeed, correct. Actually, for a testing lab, accreditation to ISO/IEC 17025 is superior to registration to ISO 9001! As you know, your accreditation agency actually observed your personnel performing tests. They had to demonstrate competency. This was in addition to the verification that you had a working management system in place (that’s why they call it accreditation and not registration. We won’t even get into the misuse of the word certification).

To make sure your customer gets the assurance they want, I recommend you contact your accreditation agency. Ask them for a letter that states this equivalency. That will probably blow your customer away – or at least amaze them! Unless you can show the text you provided to ASQ was from one of the ISO or ANSI standards-writing committees, as an official interpretation, it probably holds little weight.

Your customer is right to monitor your performance this way. Recent food safety issues, prominent in the news, have a common element to them — insufficient attention to supplier performance. Expect to see more of this as the manufacturers and distributors pay more attention to their supply chain. I expect you are or will be doing the same for your critical sub-suppliers. Remember too, there are many ways to monitor supplier performance. Registration/accreditation is one of the ways.

Dennis Arter
ASQ Fellow
The Audit Guy
Columbia Audit Resources
Kennewick, WA
http://auditguy.net