ISO 17025 - Testing and Calibration Laboratories Archives -

Approved Supplier List 17025 or 9001?

Question

Every once and while our company will need to find a rare or hard to find item on the web. Due to the rarity of the item we sometimes need to look at sites that are not a typical supplier. So how would you go about approving a supplier such as Amazon or EBay since they are more like a distributor then a supplier and utilize a large pool of other retailers/sellers?

Answer

I think ISO 17025 is not the correct citing; ISO 9001: 2015 Section 8.4. would be a better fit.

Approving a distributor is meaningless whether the distributor is Amazon or EBay. The requirement is under Section 8.4.1 of ISO 9001: 2015. Consider that the supplier is the manufacturer of the item (product) being bought on the web. The user needs to approve the use of that item – not the supplier.

The last paragraph under Section 8.4.1 reads, in part: The organization shall determine and apply criteria of the evaluation, selection, and monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in according with requirements. This means that the organization determines the requirements, documents those requirements, and follows the establish requirements. The requirements here, I suggest, are to approve the supplier based on the supplied item meeting the organization’s needs – specifications.

For example, Home Depot or Lowes is a distributor (source) of a hex-nut that is infrequently used. The hex-nut has a specification, thread size, length, etc. The requirement then would be that an inspection of the hex-nut confirms it meets the predetermined requirements. This is all documented.

James Werner

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Charging Lab Fees

Calipers, Measuring, Measurement, Accreditation, ISO 17025

Question

We are in the process of getting our new laboratory ISO 17025 certified. At this moment, our lab is a part of a parent organization. However, it has been requested that the lab should have its own name and with the ability to charge fees, etc. My question is would that be possible without establishing the lab as its own company (LLC, division, etc.)? If we charge fees, would we be considered a third party lab in relation to our parent company with our own, HR, admins, IT, etc separate from the parent company?

Answer

The ISO/IEC 17025 accreditation (not certification) process allows for captive laboratory under a parent organization to become accredited. ISO/IEC 17025:2005 Clause 4.1.4 states:

“If the laboratory is part of an organization performing activities other than testing and/or calibration, the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest.

NOTE 1 Where a laboratory is part of a larger organization, the organizational arrangements should be such that departments having conflicting interests, such as production, commercial marketing or financing do not adversely influence the laboratory’s compliance with the requirements of this International Standard.

NOTE 2 If the laboratory wishes to be recognized as a third-party laboratory, it should be able to demonstrate that it is impartial and that it and its personnel are free from any undue commercial, financial and other pressures which might influence their technical judgement. The third-party testing or calibration laboratory should not engage in any activities that may endanger the trust in its independence of judgement and integrity in relation to its testing or calibration activities.”

There is no requirement that the “laboratory should have its own name and have ability to charge fees”. It is up to the laboratory to organize in a manner that it sees fit as long potential conflicts with the parent organization are identified. Notes 1 and 2 provide more guidance for this Clause. Nor is there a requirement that it have its own IT, HR and other departments as long as those arrangements are identified and any potential conflict of interest resolved to the Accrediting Body’s interest.

Dilip A. Shah
ASQ Fellow, ASQ-CQE, CQA, CCT,
President, E = mc3 Solutions,
Technical Director, Sapphire Proficiency Testing Services
Chair, ASQ Measurement Quality Division (2016, 2012-2013, 2007, 2004-2005)
Past Member of the A2LA Board of Directors (2006-2014)
Tel: 330-328-4400
Fax: 1-888-226-9533
E-mail: emc3solu@aol.com

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ISO 17025 and Business Changes

Question

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

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ISO 17025 Calibration Requirements

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

Question:

I was recently in a discussion with someone about ISO 17025 calibration requirements. It was my understanding that all equipment associated with the tests within our ISO 17025 scope needed to have an uncertainty value reported with each calibration. However, my coworker said only tests that actually use the uncertainty value as a part of their test results calculations require an uncertainty value. Meaning, we have may have tests performed within our ISO 17025 scope but the equipment doesn’t need an uncertainty value?

Could you please provide some clarity on this?

Response:

First let us understand why the measurement uncertainty is required. This is to support the metrological traceability requirement for any measurement made.

The definition of metrological traceability per ISO Guide 99:2007 is:
“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”.

Therefore, if you require your measurements to be traceable, then measurement uncertainty is required. Since this definition of Metrological Traceability was defined per ISO Guide 99 in 2007, there has been confusion on the requirement for reporting measurement uncertainty. The current version of ISO/IEC 17025:2005 does not help by stating “and/or” requirement in Section 5.6.2.1.1 when reporting measurement results with measurement uncertainty.

Whenever such ambiguity exists in the standards, International Laboratory Accreditation Cooperation provides guides and policy documents for clarification for accrediting bodies and accredited laboratories. The ILAC P14:2013 is one such document which provides policy guidance in reporting measurement uncertainties for the laboratories and for accrediting bodies to enforce.

In short, if any equipment (and its associated measurements) requires metrological traceability, then measurement uncertainty must be estimated for that equipment regardless of if it is within the ISO/IEC 17025 scope of accreditation or not.

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

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“As Found” Calibration Data – Available for a Fee?

Automotive inspection, TS 16949, IATF 16949

Q: I have been an auditor of ISO/ANSI/ASQ 9001:2008 Quality management systems–Requirements since 1992 and recently began consulting hospitals who seek ISO 9001 certification.

My experience with auditing to ISO 9001 is mostly in the manufacturing sector. When I audited against ISO 9001 clause 7.6 control of monitoring and measuring equipment, I routinely included questions regarding the process for assessing the validity of previous measurement results when equipment did not conform to established limits. I found no real issues with this until lately.

Now, clients say that calibration service providers do not routinely provide “as found” data in the report that’s sent to clients/customers. I have been told that “as found” data only becomes available to the client/customer for an additional charge (and it’s not cheap).

Obviously, organizations cannot comply with the ISO 9001 requirement to perform the aforementioned assessment without this data. Since this has only come to my attention recently, I am wondering about the ethics and legality of withholding specific information in the calibration report – unless an additional fee is paid.

Could you please provide some insight or justification for this business practice?

A: It is always a good idea to evaluate one’s suppliers. This requirement is in ISO 9001 clause 7.4 purchasing. The May 2010 Quality Progress Measure for Measure column, “Supplier Demand,” provides guidance on evaluating and selecting calibration providers accredited to ISO/IEC 17025-2005: General requirements for the competence of testing and calibration laboratories. In addition, the ILAC-P14:12/2010 policy document requires ISO/IEC 17025 accredited laboratories to provide measurement uncertainty data with the measurement results as of December 1, 2011.

The customer should specify their requirements in their purchasing documents for calibration. ISO/IEC 17025 has contract review requirements that accredited laboratories must meet in order to to comply with clause 4.4 of ISO/IEC 17025.

In order for the laboratory to make an out of tolerance decision, it has to measure “as found” data. Even if the laboratory does not report it, it is required to retain it per ISO/IEC 17025 clause 5.10.4.2, second paragraph:

“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.”

So, for a start, it is a good idea to use ISO/IEC 17025 accredited calibration providers and specify the customer’s requirements. Some provide “as found – as left” data routinely. Others may charge because they may claim that it takes extra time. But, if a competing laboratory provides it as part of the service, the other laboratories will follow suit or lose market share.

If the ISO/IEC 17025 accredited providers have to make a compliance decision on an item being calibrated, why would they not record the data? Even if it’s not provided, they are required to retain it for future reference in case of an inquiry. Calibration providers (whether accredited or not) that do not provide “as found – as left” data should probably be avoided. One does not know if they provided a legitimate calibration or they “stickered” the calibrated item and produced a generic certificate.

Other laboratories complying with ANSI Z540-1 or ANSI Z540.3 requirements are also required to provide “as found – as left” data. Otherwise, they are not fully complying with Z540 requirements.

The September 2010 Quality Progress Measure for Measure column, “Calibration Evaluation,” discusses evaluating non-accredited calibration providers and what to look for when assessing them.

For more on this topic, please visit ASQ’s website.

Difference Between ISO/IEC 17025 and ISO 10012

Q: 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

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Expert Answers: Metrology Program 101, Quality Progress

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ISO 17025 Clause 5.4.2 – Selection of Methods

Q: 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.

For more on this topic, please visit ASQ’s website.

Calibration of AutoCAD Software

About ASQ's Ask the Standards Expert program and blog

Q: To what extent must an engineering firm, specializing in railway infrastructure and transportation, have its AutoCAD software “calibrated” or verified?

Also, what about software designed to calculate earthwork quantities for railway alignments laid out on topographic mapping for all levels of studies – pre-feasibility through preliminary engineering (not for final design, operation simulation and design dynamic system models)? This type of software is utilized by competent draft persons and engineers, but it is not verified prior to use or periodically calibrated.

We don’t confirm “the ability of computer software to satisfy the intended application…”

Your assistance or reference is appreciated

A: AutoCAD is considered “Commercial -Off-The-Shelf” (COTS) software. It is purchased without modification and cannot be modified by the end-user. A similar example would be Excel spreadsheet software. The COTS software by itself should be considered validated and used as is provided it is configured per the software manufacturer’s instructions.

The functionality of the software (distance, volume, formulae and other functions) is fit to be used as intended. If an application is created using COTS software (Excel Templates, AutoCAD applications), then it must be validated and records of validation must be kept.

It should also be noted that definitions of verification and validation are not clearly understood. So, I am repeating them here:

ISO/IEC Guide 99:2007—International vocabulary of metrology—Basic and general concepts and associated terms, defines these terms as:

Verification: provision of objective evidence that a given item fulfills specified requirements

Validation: verification, where the specified requirements are adequate for an intended use

Further explanation:

Validation is a quality assurance process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance of fitness for purpose with end users and other product stakeholders.

It is sometimes said that validation can be expressed by the query “Are you building the right product?” and verification by “Are you building it right?”

“Building the right thing” refers back to the user’s needs, while “Are we building the product right?” checks that the specifications are correctly implemented by the system. In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.

For more on this topic, please visit ASQ’s website.

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.

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.