A2LA Expalnations for ISO 17025 Requirements

A2LA Explanations for the ISO/IEC 17025 Requirements

A2LA Specific Applications of Additions to the Standard

ISO/IEC 17025 often uses the words “calibration andtesting” in describing requirements. How do laboratoriesthat only perform one or the other interpret thoserequirements?

04/30/20051.22005

ISO/IEC 17025 covers both calibration and testing laboratories, so the pairing of “calibration and test”is frequently repeated. In this context, test laboratories should ignore the word “calibration” (with theexception of Sections 5.4.6.1 and 5.6.2.2) and calibration laboratories should ignore the word “test”.

Do laboratories accredited to ISO/IEC 17025 also meetISO 9000?

04/30/20051.62005

According to the 2005 version of the Standard (within the Introduction), “Care has been taken…toincorporate all those requirements of ISO 9001 that are relevant to the scope of testing and calibrationservices that are covered by the laboratory’s management system.” In addition, “Testing and calibrationlaboratories that comply with this International Standard will therefore also operate in accordance withISO 9001.”

However, laboratories may not claim ISO 9000 registration based solely on their ISO/IEC 17025accreditation, though additional evaluation against ISO 9001/9002 should not be necessary forlaboratories accredited to ISO/IEC 17025.

It is also noted in the Introduction to ISO/IEC 17025 that conformity of a laboratory’s qualitymanagement system to the requirements of ISO 9001 does not of itself demonstrate the competence of thelab to produce technically valid data and results.

What is meant by the term “legally responsible?” 04/30/20054.1.12005

The laboratory may be a public or private entity, an established business or corporation, or anidentifiable division or in-house activity of a business or corporation, which meets the applicable legalrequirements of the governmental jurisdiction in which it conducts business. Legal responsibility aids inaddressing issues of liability/accountability, uniqueness, and independence of operation.

Untitled Document http://www.a2la.org/faq/printable17025explain.cfm

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Does this clause require the specified responsibilities tobe documented?

04/30/20054.1.42005

Yes. By using the word “defined”, this section requires documentation from the laboratory (e.g., in theform of job descriptions) outlining responsibilities of those people in the parent organization who have aninfluence over laboratory activities. It is important to note, however, that this requirement is predicatedon the lab’s being part of a larger organization involved in other activities (e.g., production, consulting,etc.).

What is meant by “key personnel”? Is this different fromA2LA’s term “essential personnel”? Who should Iconsider “key” vs. “essential”?

06/14/20074.1.4, 4.1.52005

The term “essential personnel” is one developed by A2LA to allow us to identify specific individuals whohave a unique, technical capability within the laboratory. A2LA defines “essential personnel” as:

…anyone whose absence or departure would remove the laboratory's competence to carry out one ormore specific tests or calibrations and results in a reduction in the Scope(s) of Accreditation.

The term “key personnel” is used in various places throughout ISO/IEC 17025. The current versions ofISO 17000 and the VIM do not contain a definition for this term. For practical purposes, A2LA defines a“key person” as:

…someone whose absence would jeopardize the integrity of the laboratory. Key personnel also playfundamental roles in the implementation of the management system.

Granted, this is very subjective and open to interpretation by the laboratory and the assessor. At aminimum and in most cases, it would be safe to assume that the laboratory quality manager, technicalmanager and any essential personnel are to be considered key for the purposes of compliance withISO/IEC 17025. Any other personnel who have a unique role in the laboratory that has an involvementwith or influence on the testing or calibration activities could also be considered key. For example, thelaboratory’s internal auditor might be considered key if s/he is the only staff member deemed qualified toconduct an internal audit.

This clause added the phrase "..including theimplementation, maintenance and improvement of themanagement system..." How would this be documented?

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It is expected that these individual responsibilities and authorities would be outlined and specified withinthe documentation required by Section 4.1.5 (f) for the appropriate managerial and technical personnel.


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What is considered “undue internal and externalpressures?”

06/10/20054.1.5 b2005

Both in-house and commercial laboratory personnel must be insulated from work-related undue pressuresthat could compromise the quality of work. The source of undue pressure may be internal (e.g.,management pressure, deadlines) or external (e.g., customer complaints, priority request). Managementshould decide which types of undue pressure the staff might encounter and implement clear policies andinstructions for countering them. Precautions should be taken to ensure that there are no conflicts ofinterest between staff and clients. If relevant, the laboratory should have a written policy againstacceptance of gifts and gratuities by employees from clients in order to avoid perception of conflict ofinterest. Also, a policy for handling internal complaints or concerns from employees should be included.Communications (priority request, complaints, status inquiries, etc.) could be directed throughsupervision or administrative personnel. Ethics programs, skip-level management interviews, arbitratorprograms, etc. may also provide avenues of coordination that preclude adverse effects resulting fromcommercial pressures. All these efforts may be included in the quality manual or issued as a policystatement to employees.

It is also important to note that, though the requirement is for the lab to have “arrangements” in place,this is understood to mean documented arrangements within the lab’s quality system (e.g., a policy orprocedure).

Do the clauses 4.1.5 (b) and (d) require our laboratory tohave a Code of Ethics in place?

08/06/20094.1.5 b2005

ISO/IEC 17025 does not explicitly require that a laboratory have a Code of Conduct or Code of Ethics inplace as part of its management system. That said, however, each accredited organization is stronglyencouraged to have such measures in place to aid in fully complying with these sections of the Standardand to aid in substantiating the ethical grounds upon which an organization operates if their actions areever called into question.

A helpful tool to assist any organization in developing and maintaining a Code of Conduct or Code ofEthics is an ethics self-assessment. Such a self-assessment can help an organization identify those areaswhere they are on strong ethical ground as well as areas that they may wish to examine further as anopportunity to enhance or further define their ethical and leadership practices. Some points to considerin an ethics self-assessment might include:

• Do you strive to be a role model for ethical behavior?

• Are your statements and actions consistent with professional ethical standards?

• Are your statements and actions honest even when circumstances would allow you to confuse the issues?

• Do you advocate ethical decision making by your organization’s Board, management team and staff?

• Do you use an ethical approach to conflict resolution?

• Do you initiate and encourage discussion on the ethical aspects of your organization’s managementissues?


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• Do you use your authority solely to fulfill your responsibilities and not for self-interest or to further theinterests of family, friends or associates?

• When an ethical conflict confronts you or your organization, are you successful in finding an effectiveresolution and ensuring it is followed?

• Do you demonstrate your organization’s vision, mission and value statements in your actions?

• Do you have a routine system in place for members of your organization to make full disclosure andreveal potential conflicts of interest?

• Do you maintain confidences entrusted to you?

• Do you demonstrate through personal action and organizational policies zero tolerance for any form ofstaff harassment?

• Do you expect and hold staff accountable for adherence to your organization’s ethical standards (forexample, through periodic performance reviews)?

• Do you hold all staff and business partners accountable for compliance with professional standards,including ethical behavior?

• Are you mindful of the importance of avoiding even the appearance of wrongdoing, conflict of interestor interference with free competition?

• Do your organization’s structure and processes ensure the integrity of its activities?

• Does your organization present itself accurately and honestly to the public?

• Do you understand and abide by local, state and federal laws and regulations applicable to you?

(Information drawn from The Joint Commission on Accreditation of Healthcare Organizations, TheAmerican College of Healthcare Executives and the Higher Learning Commission.)

How does this clause differ from 4.1.5 b)? 04/30/20054.1.5 d2005

This clause refers to activities undertaken by the laboratory or its staff outside of normal operations thatcould cast doubt upon the laboratory’s integrity.

Does an organization chart fulfill this requirement? 04/30/20054.1.5 e2005

An organization chart or charts with the reporting relationship to any parent organization or ownershipshould normally be a sufficient presentation of the organization and management structure of thelaboratory. However, the organizational structure may also be described in other fashions that may be


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equally acceptable.

What is meant by “direct access” 04/30/20054.1.5i2005

This section of ISO/IEC 17025 requires that a single member of the laboratory staff be givenresponsibility for acting as “quality manager”. A common misinterpretation in attempting to meet thisrequirement is that it is sufficient only to have an organizational chart that shows a direct line from thequality manager to the highest level of management. In order to determine whether a lab’s qualitymanager does indeed have direct access to the highest level of management, the following questions maybe asked: Can the quality manager call members of the “highest level of management”? Can the qualitymanager walk into their office? Can the quality manager email them or contact them by other means?These are all modes of “direct access” that an assessor may verify on site.

What position(s) require deputies? 06/10/20054.1.5j2005

Arrangements for designating the person(s) acting in the absence of the technical and qualitymanagement should be documented to ensure continuity of operation in case of absence(s). If the integrityof the laboratory is jeopardized by the lack of other key staff, deputies for those positions should also beprovided. Designated deputies must have the required knowledge and expertise to assume the position orthe activities should be appropriately curtailed where knowledge and expertise do not exist with thedeputy. A deputy A2LA Authorized Representative, knowledgeable about A2LA accreditation policy andprocedures, must also be identified.

What evidence is required to verify that personnel areaware of the relevance and importance of theiractivities?

07/18/20054.1.5k2005

This new clause within the standard requires that laboratory personnel be aware of their particular placeand function within the overall organization. Interviews with laboratory personnel would be expected toreveal that they are performing their functions correctly and that they are aware of the quality objectivesof the organization. This clause is closely related to several others within the standard as this awarenessby laboratory personnel can and should be directly tied to the effectiveness of communications throughlaboratory management, performance evaluations of laboratory personnel and management reviewswithin the organization.


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Must communication always be in a written form? 07/19/20054.1.62005

Effective communication may occur by a variety of means – e.g, through the use of written memos,telephone, email or oral discussions. Interviews with laboratory personnel would be expected to revealthat these processes are in place and that personnel are aware of issues that relate to the managementsystem and its overall effectiveness. For example, communication of results of periodic managementreviews could be one means of making laboratory personnel aware of the management system’seffectiveness. It would also be expected that no evidence would be found of system breakdowns resultingfrom a lack of effective communication amongst laboratory personnel.

How can a laboratory demonstrate that the managementsystem documentation has been communicated to andimplemented by the appropriate personnel?

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The laboratory may communicate the system’s documentation through the use of (for example) acontrolled distribution list of individuals having numbered copies of the quality documentation (orequivalent electronic means of distribution) or a documented laboratory training program.

For laboratories that are part of a larger organizationwith its own quality system, is a separate ISO/IEC 17025quality system required?

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Laboratory activities may already be incorporated in a quality manual covering a parent organization’stotal range of operations. If so, it may be necessary to extract that information and expand on it toestablish quality policy and objectives (and perhaps create a separate manual) specifically relating to thelaboratory’s functions. The alternative may be to expand the corporate quality documentation, wherenecessary, to satisfy the requirements of ISO/IEC 17025.

How detailed does the laboratory quality system have tobe?

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This section states that the laboratory shall document its policies, systems, programs, procedures andinstructions to the extent necessary, meaning that the laboratory is to determine the level of detail foundin its documentation. The laboratory must also be able to demonstrate, though, through objectiveevidence that the level of detail presented in its quality system documentation is producing the desiredand required outcome.

When a clause in ISO/IEC 17025 requires the laboratory to have one of the items listed above, some formof documentation must be presented in a form that is repeatable. In developing a quality systemappropriate to the scope of a laboratory’s activities, documentation may take many forms, including


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written documents, electronic systems, video or other media. Verbal representation of documentationwould normally be variable from person to person and so would not satisfy this requirement.

Any documentation that forms part of the quality system is subject to the document control requirementsof Section 4.3 and (per Section 4.2.1) must be communicated to, understood by, available to, andimplemented by the appropriate laboratory personnel. In essence, each person who requires a piece ofdocumentation to perform his job correctly must have access to that piece of documentation.

Must the quality manual include all of the laboratory’sprocedures?

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In many clauses, the standard will require a policy and procedure. The policies related to quality must bedefined in the quality manual (see 2011 explanation of Section 4.2.2 regarding this). However, theprocedure may be found in other documents as long as it is referenced from the quality manual (perSection 4.2.5). If the procedure is included in the quality manual, it is considered sufficient to satisfy boththe policy and procedure elements.

Is the laboratory now required to review its performanceagainst objectives?

07/19/20054.2.22005

Specific attention should be paid to this new second sentence of this section of the standard, as it outlinesan additional element to be taken “into account” during the management reviews required by Section4.15.

Must the quality manual include all of the laboratory’spolicies?

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Section 4.2.2 states that the laboratory’s management system policies must be defined in the qualitymanual and A2LA views the word “define” to mean describe, specify distinctly or delineate the outline orform; therefore, the policies themselves must either be contained within the manual or the manual mustclearly describe or delineate the outline or form of a policy with a reference or link to the more extensivepolicy itself. It is important to keep in mind, however, that Section 4.2.2 also qualifies the term “qualitymanual” with the parenthetical phrase “however named”. So, for example, a laboratory may choose todesign their quality manual as a single, physical document, or they may choose to design it as a directorywithin their electronic management system. (NOTE: These examples are not meant to be an inclusive listof all possible options.)

In the case of the former, all of the elements that ISO/IEC 17025 requires to be defined, within the qualitymanual must be defined within the physical “document” itself.


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In the case of the latter, the directory may include a series of electronic documents that, together,comprise the “quality manual”. One such electronic document may be a general document that describesthe overall structure & outline of the management system and that provides links to other documentswithin the electronic directory that are required by ISO/IEC 17025 to be defined within the “qualitymanual”.

Does section 4.2.2 require that all of the quality policystatement elements (4.2.2 a - e) be contained in onecontiguous statement? Or can the elements be addressedin different areas of the quality manual?

06/05/20084.2.22005

In most cases, a laboratory is required to address all of the quality policy statement elements in onecontiguous statement. According to the standard, the quality policy statement "shall include at least thefollowing:

• the laboratory's management commitment to good professional practice and to the quality of its testingand calibration in servicing its customers;

• the management's statement of the laboratory's standard of service;

• the purpose of the management system related to quality;

• a requirement that all personnel concerned with testing and calibration activities within the laboratoryfamiliarize themselves with the quality documentation and implement the policies and procedures in theirwork; and

• the laboratory's management's commitment to comply with this International Standard and tocontinually improve the effectiveness of the management system. "

It is important to consider the content of the “Note” that follows this section of the Standard. This notestates: “…When the test and/or calibration laboratory is part of a larger organization, some qualitypolicy elements may be in other documents.”

Therefore, the above elements may not appear in a single, contiguous statement but instead may appearelsewhere in corporate-level documents (i.e., in documents accessible and applicable to all accreditedlabs within the corporation) only when the laboratory is part of a larger organization.

What constitutes an "evidence of committment" by topmanagement?

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For either independent or in-house laboratories of larger organizations (e.g., production facilities), topmanagement is considered to be those individuals who have the authority and can provide the resourcesnecessary to make changes to any aspect within the laboratory. It is, therefore, important that theseindividuals participate in the laboratory’s management review, stress the importance of meeting customerrequirements and ensure integrity of the management system (reference Sections 4.2.4, 4.2.7, 4.15).Section 4.2.2 (e) of the standard already requires a statement of commitment to be issued by the


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laboratory’s management, which could be considered part of the evidence an assessor would look for todetermine compliance with this clause. In addition, evidence that proper resources are allocated to theperformance of appropriate and effective internal audits, management reviews, quality control analysis,proficiency testing, etc. could also be considered evidence of top management’s commitment to itsmanagement system. As a result, records demonstrating top management’s participation in these functionscould be considered evidence of compliance with this particular section of the standard.

In what ways may management communicate theimportance of meeting customer, statutory andregulatory requirements?

07/19/20054.2.42005

This communication may be accomplished by a variety of means. Although use of memos, videos, postersand other reproducible methods are most common, other forms of oral communication may also suffice.Again, interviews with laboratory personnel would be expected to reveal that no breakdowns areoccurring within the management system as a result of inappropriate or insufficient communication. Thisclause is closely related to Section 4.2.2 (a), which requires a written policy of the laboratory’scommitment to good professional practice and the quality of the services it offers.

My laboratory’s quality manual contains clearstatements of the roles and responsibilities for ourquality manager and technical management. However,none of these explicitly state that they are responsible forthe laboratory’s compliance with ISO/IEC 17025. Doesthis warrant a deficiency?

09/06/20074.2.62005

Yes. Section 4.2.6 of ISO/IEC 17025 requires that the quality manual define “the roles andresponsibilities…including…responsibility for ensuring compliance with this International Standard.” Assuch, ensuring compliance with ISO/IEC 17025 must be explicitly included in the responsibilities definedand listed within the lab’s quality manual for either or both the quality manager and technicalmanagement.

What is meant by the phrase "maintaining the integrityof the management system"?

07/19/20054.2.72005

This clause relates not only to maintaining integrity of the management system when major changes aremade to the organizational structure, reporting structure or management staff of a laboratory, but also tomore subtle changes that are frequently made to a management system. For example, has the integrity ofthe laboratory’s document control system remained intact when certain areas have been changed orupdated? When a change is made to one laboratory policy or protocol, have corresponding changes beenmade to other areas of the document control system that are affected such that contradictions andconflicts do not exist within the system? Are laboratory personnel appropriately informed of changes thataffect them? All of these issues speak to the overall integrity of a laboratory’s management system.


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Are forms in use by my laboratory governed under therequirements for document control?

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When forms are used as simple data collection devices, they need not be controlled. However, if a formcontains instructions for performance of a task or even instructions for filling out the form itself, then theform is subject to document control.

What is expected by way of document control forsoftware as required in Section 4.3.1?

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The term "software" as used in section 4.3 includes those pieces of software and firmware required forproper operation of equipment, as well as those used for other purposes necessary for the correctperformance of testing or analysis of data. The laboratory must control this software to ensure thatpersonnel and equipment are using the correct versions. In many cases, this control may be included inthe procedures by which the laboratory maintains and controls its equipment under Section 5.5 (e.g., whenthe software is integral to the equipment). All requirements of 4.3.1, 4.3.2 and 4.3.2.2 (a-d) as well as thepertinent requirements in section 5.5 must be met.

(NOTE: Word processing software does not have to be controlled unless it is used for calculation ofderived data.)

What does A2LA consider to be “normative documents”that my laboratory must control under our documentcontrol system?

03/20/20124.3.12005

Normative documents are those that provide rules, guidelines or characteristics for activities or theirresults. It is a generic term that covers such documents as standards, technical specifications, codes ofpractice and regulations.

For the purposes of A2LA accreditation, accredited laboratories are required to own (or have directaccess to) and have under their document control system current versions of the normative documentsthat are vital to maintaining their accreditation. These documents include (in addition to relevantregulations, standards and/or technical methods, etc.) ISO/IEC 17025, general A2LA policy documents,and the specific A2LA program requirement documents relating directly to their field of accreditation.A2LA does not consider “terminology documents”, such as ISO/IEC 17000 and the VIM, to be normativedocuments that a laboratory must control within their system.

For example, a calibration laboratory that performs calibrations at client sites would be expected topossess (or have direct access to) and have under its document control system current versions of thefollowing A2LA documents:

• ISO/IEC 17025;


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• R101 - General Requirements: Accreditation of ISO/IEC 17025 Laboratories

• R102 - Conditions for Accreditation;

• R103 - General Requirements: Proficiency Testing for ISO/IEC 17025 Accredited Laboratories;

• R103a - Annex: Proficiency Testing for ISO/IEC 17025 Laboratories;

• P102 - A2LA Policy on Measurement Traceability;

• P101 - Reference to A2LA Accredited Status-A2LA Advertising Policy;

• R205 - Specific Requirements: Calibration Laboratory Accreditation Program;

• P104 - Policy for Claims of Measurement Uncertainties for On-Site Calibrations on Scopes ofAccreditation; and

• P109 - Technical Consensus Decisions from the Measurement Advisory Committee;

• P110 - A2LA Policy on Measurement Uncertainty in Calibration;

• R104 - General Requirements: Accreditation of Field Testing and Field Calibration Laboratories.

Having these documents included in the laboratory’s document control system requires that they also beincluded on the lab’s “master list” (or equivalent) of controlled documents, identifying their currentrevision status and distribution, per Section 4.3.2.1 of ISO/IEC 17025.

Is the master list my lab created to meet Section 4.3.2.1 ofthe Standard considered a record or is it considered adocument that would be subject to document controlrequirements?

08/06/20094.3.2.12005

A2LA considers a laboratory’s “master list” to be a record and not a document that is subject to documentcontrol requirements. Section 4.3.2.1 of ISO/IEC 17025 indicates that the clause can be met by use ofeither a master list (subject to requirements associated with record management) OR an equivalentdocument control procedure (subject to document control requirements).

Our lab only maintains one controlled & centrally-located copy of every document in the managementsystem. Is a master list outlining distribution reallyrequired in this case?

03/14/20114.3.2.12005

Section 4.3.2.1 requires a “master list or an equivalent document control procedure identifying thecurrent revision status and distribution of documents in the management system…” In the situationdescribed above, a formal master list may not be warranted as long as the lab’s document controlprocedure outlines the documents contained within the management system, specifies their currentrevision status and indicates where they may be found. If the document control procedure does not containthis information, then a master list containing it is required.


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Does our master list have to explicitly contain eachrequired A2LA normative document and its revisionstatus or may we simply refer to the A2LA website? Also,how long does our lab have to implement changes madeto A2LA normative documents?

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A2LA’s explanation of Section 4.3.1 of ISO/IEC 17025 states:

Having these [normative] documents included in the laboratory’s document control system requires thatthey also be included on the lab’s “master list” (or equivalent) of controlled documents, identifying theircurrent revision status and distribution…

Section 4.3.2.1 of ISO/IEC 17025 is also clear in requiring that the master list (or equivalent) specificallyinclude the “revision status…of documents in the management system”. A reference to the A2LA websitealone does not meet this requirement and, therefore, A2LA normative documents must be specificallyincluded on the lab’s master list (or equivalent) and must be accompanied by a clear indication of theirrevision status (e.g., date issued, date revised).

Implementation timeframes for revisions or updates to A2LA documents vary, depending on the nature ofthe update or revision. In some cases, an implementation deadline is contained within the document itself(e.g., for Advertising Policy changes) or a separate Transition Memorandum is published along with theupdated document (e.g., for specific or general requirements revisions). In other cases, implementation isexpected immediately upon receipt of notice of the update when the revision is considered minor andlaboratories are reminded of their responsibility to obtain these updates through the RSS feed availableon the A2LA website. If a laboratory is ever in doubt as to the implementation timeframe for an updatedA2LA document, they are encouraged to contact their Accreditation Services representative forclarification.

How should we identify new or altered text in a reviseddocument and when would it be consideredimpracticable to do so?

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ISO/IEC 17025 is not explicit in dictating how a laboratory is to identify new or altered text in a reviseddocument and the language that is used in Section 4.3.3.2 allows for considerable variation inapplication. New or altered text shall be identified, for example, by the following means:

• using highlight and strikethrough features;

• using a “revision history” at the end of a document that outlines the changes made to specific sections,paragraphs, sentences, etc;

• using “track changes” to revise the document and maintaining a single, controlled version with thetracked changes in place while issuing “clean”, unmarked and controlled versions to the users of thedocument. (NOTE: This is only an option when the laboratory’s document control procedure clearlydescribes this system and all relevant personnel have been informed of the exact changes made or haveaccess to the fully-marked, revised version in order to understand the changes made.)

It is important to note that the Standard requires an identification of new/altered text wheneverpracticable. A2LA interprets this to mean whenever “practice-able” and so it is expected that thisrequirement would be met in the vast majority of cases. There are some scenarios, however, where A2LAdoes acknowledge the impracticability of identifying new/altered text. For example, if a document has


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been completely revised so that it bears little or no resemblance to the previous version, it can be issuedas a complete rewrite since, in this case, it could be considered impracticable to include references toevery change made (such as with highlights and strikethroughs) that would render the document difficultor impossible to use.

What is the difference between a request, a tender and acontract?

04/30/20054.42005

Requests, tenders and contracts are three different activities. Initially, a request is received from theclient for a scope of work. The lab, in response, makes a tender (proposal) to the client. The tender mayinclude clarifications to the scope of work, scheduling information, monetary compensation, etc. Acontract is the agreement between the client and the lab. The standard requires a review and record (perSection 4.4.2) of all three phases of the process.

If a client does not make any specific request formeasurement uncertainty data, does a calibrationlaboratory need to address the issue in contract review?

04/30/20054.4.1 c)2005

During contract review, calibration laboratories should specifically discuss their measurementuncertainty with their clients to ensure that they can meet the clients’ specifications. Likewise, accreditedlaboratories requesting calibration services should ask their calibration providers about measurementuncertainty before procuring those services to ensure that they receive the service and information theyrequire.

My laboratory is part of a multi-laboratory organization.All laboratories within my organization are A2LAaccredited and fall under the classification of a “branchsystem” as defined by A2LA. If my laboratory receiveswork from a client but sends the work to another of ouraccredited branch laboratories (with the final reportbeing issued by my laboratory), is this consideredsub-contracting?

08/06/20094.52005

As stated in Part C, Section I of R101 – General Requirements: Accreditation of ISO/IEC 17025Laboratories, A2LA accreditation is “site specific”, meaning that each discrete location is considered tobe its own entity – whether or not it is part of a larger, accredited, multi-laboratory organization. As such,transfer of work among accredited locations within such a “branch system” is considered to besub-contracting and is subject to all requirements related to sub-contracting in ISO/IEC 17025 andrelated A2LA requirements documents.


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If a laboratory subcontracts for tests or calibrations itcannot perform, is that covered by its A2LAaccreditation?

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The Scope of Accreditation defines the tests or calibrations for which a laboratory is accredited. If atest/calibration is not on a laboratory’s Scope, it is not covered by the laboratory’s accreditation – even ifthe test/calibration is ultimately subcontracted to another laboratory that is accredited for it. A2LA willonly include on a laboratory’s Scope those tests or calibrations that the laboratory has been assessed asbeing competent and capable to perform, meaning that it has the appropriate equipment, method(s) andtrained personnel. A2LA will not accredit a laboratory for any test or calibration if it does not maintainpermanent ability to perform that test or calibration.

It is important to note that using an outside supplier for calibration of equipment is not consideredsubcontracting. Calibration providers are considered outside services, which are addressed in Section4.6.

Does A2LA have any criteria for defining a “competentsubcontractor?”

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Section 4.5.1 of ISO/IEC 17025 gives one example of a competent subcontractor as being a laboratorythat complies with 17025 for the work in question. However, Section 4.5.4 of the standard states that thelab must have a record of evidence of the subcontractor’s compliance with 17025 for the work inquestion. Although these two sections appear inconsistent with each other, it is important to understandthat the standard is allowing a laboratory to use whatever means it deems appropriate to evaluate itssubcontractors. However, the record produced from this evaluation must detail the subcontractor’s levelof compliance with ISO/IEC 17025 for the work in question. Accredited laboratories using the services ofa subcontracted laboratory are responsible for the subcontractor’s work (per Section 4.5.3) and mustnotify the client of the proposed subcontracting in writing (per Section 4.5.2). So, in most cases,acceptability of the subcontractor is a matter of laboratory-customer agreement. In the absence of anyspecific customer requirements, the laboratory is responsible for assuring their client that thesubcontractor has a satisfactory quality system and is competent to perform the required calibrations ortests. Ideally, laboratory should document their policy and procedure for hiring subcontractors. Relianceon the A2LA-accredited status of a subcontractor for the pertinent calibrations or tests is sufficient.However, when a subcontractor is not accredited by A2LA (or other organization recognized asequivalent) the laboratory should record its assessment of that subcontractor’s capability to meet 17025for the subcontracted work in question. As an example, the laboratory should require the followingrecords of their subcontractor to demonstrate their compliance with ISO/IEC 17025 (again, only asrelated to the subcontracted work in question):

A copy of the subcontractor’s quality manual demonstrating compliance with ISO/IEC 17025;A copy of the subcontractor’s procedure(s) for the work in question and demonstration of adequateperformance through proficiency testing;A copy of the training records for the personnel responsible for performing the subcontractedwork; andAn example report or certificate for the work intended to be subcontracted.


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Does this requirement apply when subcontracting testsor calibrations outside of a laboratory’s Scope ofAccreditation?

04/30/20054.5.12005

The subcontracting requirement of ISO/IEC 17025 applies only to subcontracting of any part of the testsor calibrations included on a laboratory’s Scope of Accreditation.

My laboratory utilizes commercial calibration servicesfor our equipment. However, we use no other supplies orconsumable materials for the tests/calibrations on ourScope. Is Section 4.6 applicable to us?

05/03/20074.62005

Yes. Section 4.6 of ISO/IEC 17025 relates not only to supplies, reagents and consumable materials butalso to services used by a laboratory. If you utilize the services of an outside calibration provider, thenSection 4.6 is applicable to you and the outside calibration services you use – even if no otherconsumable materials are used by your lab.

Should I consider the commercial proficiency testingproviders that my laboratory uses to be suppliers ofcritical services?

02/08/20064.6.1 and 4.6.42005

Yes. Commercial proficiency testing providers are considered suppliers of critical services and so therequirements of Sections 4.6.1 & 4.6.4 are applicable to the PT providers used by a laboratory. It isimportant to point out that Section 4.6 of the standard applies to purchased services and supplies.Therefore, a laboratory utilizing internal proficiency programs is not considered to be "purchasing" theseservices and so Section 4.6 is not applicable

What types of services and supplies are covered by thisrequirement?

04/30/20054.6.12005

The most common service covered by this requirement is equipment calibration. The A2LA TraceabilityPolicy requires that calibration services be obtained from recognized National Metrology Institutes(NMIs) or laboratories accredited to ISO/IEC 17025 by A2LA (or another accrediting body recognized byA2LA through its mutual recognition arrangements) when such laboratories are available for thecalibrations required. This ensures that traceability to the relevant national or international metrologystandards as required by Section 5.6 is authenticated. Laboratories should evaluate the measurementuncertainties claimed by their calibration provider to ensure any application specifications orrequirements are met.

The laboratory should also identify any other inputs to its processes in terms of equipment, materials andservices that affect the integrity of its calibrations or tests and develop appropriate specifications andquality control measures.


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Reference material suppliers should be accredited if possible and all suppliers of other outside supportservices and products should have a registered quality system to one of the ISO 9000 standards.

Must the records of actions taken to check compliance ofreceived supplies, services and/or consumable materialsbe tied to the specific shipment/box/lot of materialreceived?

06/14/20074.6.22005

Section 4.6.2 of ISO/IEC 17025:2005 requires that records of actions taken be maintained to confirmcompliance of such materials/services with standard specifications or requirements defined in themethods for the tests and/or calibrations concerned. While the standard does not require that specificmaterial identifications (e.g., lot numbers) be recorded on every compliance check record, a laboratorymust maintain sufficient traceability throughout their record system of the actions that were taken, suchthat this information could be determined and retrieved should an audit trail ever be required per Section4.13.2.1 of ISO/IEC 17025 in the case of a malfunctioning or substandard supply or material. Thistraceability of records must allow the laboratory to determine through their audit trail what materials areaffected and what test results may be or may have been affected.

What specific items does A2LA look for in my purchasingdocuments in order to meet the requirements in Section4.6.3?

09/10/20094.6.32005

Section 4.6.3 of ISO/IEC 17025:2005 does not indicate what specific items must be included in a lab’spurchasing documentation nor does it specify what form this documentation must take. It simply requiresthat the documentation produced during purchasing (e.g., purchase order, credit card or other receipt,packing slip, etc.) include data describing the services and supplies ordered and that it be reviewed andapproved in some manner for technical content prior to release. This “data” and “technical content”could be any parameters that the lab associates with a quality purchase. The Note to this section listssome specific details that a laboratory may include in their purchasing documents, but these are by nomeans requirements.

When the service/supply is ultimately received, it is incumbent upon the laboratory to ensure that it meetstheir needs and requirements. If their needs are fully met, then their purchasing procedure is assumed tobe adequate since there is no evidence to the contrary. If there are shortcomings or omissions in theservice/supply received, then the laboratory must determine what actions must be taken to address theunacceptable service/supply and to ensure this does not happen in the future. This may result in a changeto their process such that additional or specific detail, information or instructions are captured inpurchasing documentation for their vendor/supplier.

In what ways may a laboratory seek feedback, and howmust this feedback be analyzed?

07/10/20084.7.22005


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As the note to this clause suggests, there are many ways in which a laboratory may solicit feedback fromits customers - as long as this feedback is solicited in a general way so as to apply not only to the contentand presentation of the final certificate or report, but also to the entire range of a client's interactionwith the laboratory (including, for example, customer service, turn-around-time, contract review, etc.).Surveys may be utilized, as may general solicitations for feedback on a laboratory's website, a generalstatement on a laboratory's certificate or report soliciting feedback, etc., as long as the client is directedto or informed of the mechanism they may use to provide feedback. In-house or captive laboratoriescould seek feedback in much the same manner that commercial laboratories do. Perhaps by sending asurvey to the organization's engineers or product development personnel or perhaps by solicitingcomments during meetings with other departments. It is important to remember, however, that in order tobe fully compliant with this section of the standard, laboratories are required to maintain records of theanalysis of any feedback received as well as records of the manner in which this feedback is used toimprove the management system, testing/calibration activities and customer service. The latter maygenerally be accomplished through the examination of customer feedback during periodic managementreviews and so may be tied to the requirements of Section 4.15 and the records maintained in accordancewith those requirements.

What constitutes a complaint? 06/10/20054.82005

Complaints need not be received in writing, as they may arrive via telephone or other oral means. Arecord must be made of the complaint and it should be promptly assigned to someone for resolution.Guidance should be supplied in the quality manual as to when a conversation becomes recorded as acomplaint and all complaints should be documented in a file including the substance of the complaint andits resolution. Complaints may be generated by external customers or from within the laboratory’sorganization.

Complaints referred to in this section should not be confused with complaints against qualitycharacteristics of the actual product or item being tested or calibrated. ISO 10002: 2004 providesdetailed guidance on handling complaints.

Must my laboratory have records to demonstrate thateach of the requirements in a-e of this clause isspecifically identified for each instance ofnon-conforming work?

05/03/20074.9.12005

Yes. Section 4.9.1 of ISO/IEC 17025 requires that a laboratory’s procedure for controllingnon-conforming work ensures each of the items listed in a-e is accomplished, if applicable. In order toconfirm that a laboratory’s procedure does indeed ensure these things, an assessor would expect each,individual record of non-conforming work to specifically identify each of the items in a-e of this clause.

This section seems to encompass areas found in othersections of the standard (quality policy and objectives,management review, etc.). What additional information

07/19/20054.10


17 of 27 06/29/2012 9:22 AM

must the laboratory provide? 2005

Requirements for the quality policy, quality objectives, internal audits, data analysis, corrective andpreventive actions and management reviews are all addressed in other sections of the standard. Recordsof appropriate completion and use of these activities for the improvement of the management system areconsidered sufficient evidence of compliance to this clause.

What is the difference between corrective action andpreventive action?

04/30/20054.11 and 4.122005

Corrective action is the systematic investigation of nonconformity events. Even when steps are taken toensure that a nonconformity event does not occur again, this is considered part of the corrective action -not a preventive action. Preventive action is the proactive identification of potential problems or areasfor improvement. In essence, no nonconformity event takes place in order to stimulate a preventiveaction.

Is a laboratory’s cause analysis procedure deficient if itlacks the words “root cause”?

04/16/20074.11.22005

ISO/IEC 17025:2005 4.11.2 requires that the laboratory develop a corrective action procedure that startswith an investigation to determine root cause; however, a deficiency against 4.11.2 cannot be cited solelyupon the absence of “root cause” from the procedure when other objective evidence suggests thatappropriate cause analysis took place.

What is meant by a “root cause” investigation and howdo I go about this?

11/06/20094.11.22005

Root cause analysis is the most challenging aspect of the corrective action process and should be used asa tool for continuous improvement, which may reduce or eliminate the likelihood of future deficiencies.Understanding why an event occurred is the key to developing effective corrective actions. In some cases,the root cause is singular and easily discerned; in most cases it is not, and there may be multiple rootcauses. Because of this, there is no single ‘recipe’ that can be followed. While it is impossible to create aprocedure that would apply to all scenarios, there are some guiding principles which can be employed,the most important of which is that the root cause should address the question: “Why did this deficiencyoccur?” Other points to consider:

• Statements of root cause which are essentially a restatement of the deficiency provide no newinformation beyond the deficiency and are of little benefit to you and are not considered to be anacceptable response by A2LA. In these instances, the root cause is a result of the laboratory asking “whywas this deficiency cited?” instead of “why did this deficiency occur?”


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• Each deficiency must be evaluated independently.

• While each deficiency and its associated root cause must be approached individually, trends in theidentified root causes for a group of deficiencies is a strong indicator that further investigation is needed.For example, upon conclusion of an assessment during which 8 deficiencies were cited, it is determinedthat the root cause of 6 of the 8 deficiencies pertains to employee training. In this example, additionalinvestigation into the employee training program would be prudent and should be evident in the responsesupplied to A2LA.

The investigation which begins by asking “why did this deficiency occur?” will uncover a reason why thedeficiency occurred. A proper root cause investigation will continue to ask ‘why did this occur’ until youcan no longer identify a reason. At this point you can be reasonably assured that you have isolated thecrux of the issue.

Additional resources that may be of help are found at:

"Presentation on Root Cause Analysis", found under "A2LA Guidance Documents" in the DocumentFinder on the A2LA website.

The February 2007 Issue of the A2LA Newsletter, found under the "Publications" tab, and "NewsletterArchive" menu item on the A2LA website.

Does my laboratory have to maintain records to showthat we have monitored the results of corrective actionstaken?

05/03/20074.11.42005

es. Section 4.11.4 of ISO/IEC 17025 requires that the results of corrective actions be monitored. A2LAinterprets verbs in ISO/IEC 17025 such as “monitor” as something that necessarily results in a record. Assuch, in order to confirm compliance with this clause, an A2LA assessor would expect to see records of thelaboratory’s monitoring activities to confirm the effectiveness of corrective actions taken.

Are the “action plans” specified required to bedocumented?(section 4.12.1 of ISO 17025:2005)

04/30/20054.122005

These “action plans” (developed once possible preventive actions have been identified) are to be in adocumented form.

Does a laboratory have to retain all originalobservations?(section 4.13.2.1 of ISO 17025:2005)

04/30/20054.13.2.12005


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A record of original observations may include data that has been transferred from one media to another(e.g., written on paper, then entered into a computer). The form of original recording need not bemaintained in the record system after transfer (e.g., the original paper may be destroyed). However it isimportant to note that other specific A2LA accreditation programs or regulatory requirements mayoverride this interpretation. The laboratory should meet all applicable customer and regulatoryrequirements for retention of original observations.

How much detail is required to be kept in the requiredrecords? For example, must lot numbers for everyreagent (or other consumable material) used be recordedon every test record?

09/07/20064.13.2.12005

Section 4.13.2.1 of ISO/IEC 17025 requires that the records for every test or calibration “containsufficient information to facilitate, if possible, identification of factors affecting the uncertainty and toenable the test or calibration to be repeated under conditions as close as possible to the original.” Whilethe standard does not specifically require that lot numbers for reagents (or other consumable materials)be recorded on every individual test record, a laboratory should maintain sufficient traceabilitythroughout their record system such that this information could be determined and retrieved if necessary(e.g., if it is determined that a lot of reagents was contaminated such that certain test results could bepotentially affected). Please keep in mind, however, that individual A2LA Specific Program Requirements(e.g., for NELAP in the environmental field, etc.) may contain additional, more stringent requirementsrelated to this question that laboratories applying for accreditation within those fields would have tomeet.

How does Note 1 from Section 4.13.2.1 apply to mylaboratory? My lab runs a significant number of thesame tests each day. It seems impractical for me torecord and retain so much original data when mycustomers do not wish to receive this additionalinformation with their final test reports.

09/06/20074.13.2.1 (Note 1)2005

Note 1 only applies to certain situations. For example, it would be applicable to laboratories thataccumulate significant amounts of ancillary data (such as control data or pass/fail data) where thereading is qualitative or dial-read, or to laboratories that run copious samples through automated testingmachines that output only an average or another type of derived data. However, if the original test datagenerated by a laboratory is fundamental to the test result reported, then Note 1 does not apply -regardless of the amount of tests run per day. If the original data supports an end result and is notqualitative in nature, a laboratory must record the original observations. This original data establishes anaudit trail and allows for the test/calibration to be repeated under as close to the original conditions aspossible.

What is considered an “equivalent measure” for avoidingloss or change of original data that is storedelectronically?

09/10/20094.13.2.32005


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“Electronic records” are considered to be records that exist in electronic form such as data stored on acomputer hard drive, network, or other storage media. Appropriate measures are to be implemented bythe laboratory that safeguard against loss or change of the originally recorded data. Such measures mayinclude:

• Preventing the overwriting of an existing record, but saving a revision of the original record whichincludes the corrected or altered data;

• Retaining a register of changes/revisions in electronic records that detail the changes made;

• Limiting write access to electronic records to only authorized individuals;

• Using revision control features of the application that is used to generate the electronic record (e.g.,“track changes” in MS Word).

My internal audit consists of completing only the A2LAISO/IEC 17025 checklist. Is this sufficient?

06/09/20114.14.12005

No. Section 4.14.1 of ISO/IEC 17025 states that the internal audit must “verify that [the laboratory’s]operations continue to comply with the requirements of the management system and this InternationalStandard” (i.e., ISO/IEC 17025) and that the audit “shall address all elements of the management system,including the testing and/or calibration activities.” Section 4.1.2 of ISO/IEC 17025 also states that thelaboratory must “carry out its testing and calibration activities in such a way as to meet the requirementsof…organizations providing recognition.” (i.e., A2LA) As such, your complete internal audit program (inaccordance with your pre-determined schedule) must consist of at least the following:

• Determination of compliance with ISO/IEC 17025;

• Determination of compliance with all laboratory policies, procedures, instructions, etc. that form yourmanagement system;

• Determination of compliance within all testing and/or calibration activities;

• Determination of compliance with all relevant A2LA policies and requirements (NOTE: This may beaccomplished via an audit against the actual A2LA policy and requirement documents; however, if allrequired elements of the relevant A2LA policies and requirements have been enveloped within thelaboratory’s management system, then an audit of the management system itself will necessarily includean examination of compliance with relevant A2LA policies and requirements.)

My laboratory performs an internal audit annually perour predetermined schedule and procedure. Since wehave over 100 test methods on our Scope ofAccreditation, we do not address all elements of ourmanagement system and its compliance to ISO 17025during each audit, nor do we address every test methoddefined on our Scope of Accreditation. Instead, we audita sampling of the management system and methods at

10/04/20074.14.12005


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each interval. Are we required to perform an audit on allelements of our management system and its complianceto ISO 17025 and an audit of all testing methods definedon our Scope of Accreditation at each audit interval?

Section 4.14.1 of ISO/IEC 17025 states:

“The laboratory shall…..conduct internal audits of its activities to verify that its operations continue tocomply with the requirements of the management system and this International Standard. The internalaudit program shall address all elements of the management system, including the testing and/orcalibration activities.”

It is acceptable for a laboratory to audit a sampling of their management system at each audit interval, aslong as their overall audit program specifies how this sampling is to be done such that all elements of themanagement system and the accredited testing/calibration activities are audited within a given timeframe.It is also important to note that the standard requires auditing all “testing and/or calibration activities”,not necessarily all testing and/or calibration methods. For some laboratories, auditing all accreditedtechnologies and/or parameters may constitute a sufficiently thorough and comprehensive audit of theiraccredited activities, such that auditing all methods (which may be redundant and overlap) may not benecessary - as long as there is no evidence or indication that the depth and expanse of the technicalportion of their audit is inadequate.

Also, since the standard does not require that a full internal audit be done annually, it is acceptable for alaboratory’s audit program to cover the entire management system (including testing/calibrationactivities) over a span of a number of years, as long as there is no evidence or indication that thetimeframe of this cycle is inadequate. Although R102 – Conditions for Accreditation requires that eachorganization retain records at least for the period of time between full A2LA assessments, it also requiresthat:

“…adequate records…must be available to demonstrate full compliance with the requirements foraccreditation.”

Therefore, if a laboratory’s full audit cycle spans a period of time that is greater than the period of timebetween full A2LA assessments, they must maintain adequate records for their full audit cycle todemonstrate compliance with the requirements for conducting internal audits. For example, a laboratorymay specify a record retention period of two years, but their complete audit cycle may span 5 years. Inthis case, they must retain full records of each 5-year audit cycle even though it exceeds their normalrecord-retention period.

I am a new laboratory getting ready to apply foraccreditation. Do I have to perform a complete internalaudit of my management system and testing activitiesbefore I can become accredited?

06/05/20084.14.12005

In order to confirm full compliance with this section of the Standard, A2LA assessors will look forevidence during the on-site assessment that a complete internal audit has been conducted by thelaboratory in accordance with their documented procedure and pre-determined schedule. If only aportion of the internal audit has been conducted by the time of the on-site assessment, a deficiency will becited and the internal audit must be completed before initial accreditation is granted.

NOTE: This must be implemented and will be enforced for all applications received as of January 1,2009.


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Can the results of an external audit be accepted as partof or entirely in place of a laboratory’s internal audit?

03/25/20074.14.12005

ISO/IEC 17025, Section 4.14.1 requires that the laboratory conduct internal audits. With theunderstanding that it is the laboratory’s responsibility to conduct their own internal audit, third partyaudits of the laboratory are not acceptable for meeting any portion of this requirement of the standard.Only internal audits completed by the laboratory’s staff or contracted consultants of the laboratory areacceptable. Please note that his application represents a change in policy from an application that waspreviously posted to this website in 2005. As such, it will be implemented as of renewal and initialapplications for accreditation submitted to A2LA June 30, 2007 and later.

Does this section require that an internal auditor havespecific training on ISO/IEC 17025?

01/26/20064.14.12005

The standard requires that a laboratory's internal auditor be "trained and qualified" but does not specifythe training and qualifications. Therefore, A2LA does not require an internal auditor to have specifictraining to ISO/IEC 17025. As long as there is no evidence that an inadequate internal audit wasperformed due to insufficient training and qualification by the internal auditor, A2LA will consideracceptable whatever training a particular laboratory stipulates. (See also a related discussion underSection 5.2.)

Are “audit findings” considered to be nonconformitiesonly?(section 4.14.3 of ISO 17025:2005)

04/30/20054.14.32005

“Audit findings” include areas of conformance as well as areas of nonconformity. An internal auditrecord must therefore include (at a minimum) the area of activity audited, the resultant “findings” –related to areas of both conformance and nonconformity – and corrective actions taken for areas ofnonconformity.

What is meant by a “predetermined schedule” forconducting internal audits and management reviews?(sections 4.14.1 and 4.15.1 of ISO 17025:2005)

04/30/20054.14.1 and 4.15.12005

The predetermined schedule for each, individual activity must be either part of the internal audit andmanagement review procedures or referenced from the quality manual. The predetermined schedule mayspecify dates and/or times (e.g., “audits will be performed in June of every odd-numbered year”) or may


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indicate an interval of performance (e.g., “management reviews will be performed on an annual basis”).

I am a new laboratory getting ready to apply foraccreditation. Do I have to perform my managementreview before I can become accredited?

06/05/20084.152005

In order to confirm full compliance with this section of the Standard, A2LA assessors will look forevidence during the on-site assessment that a complete management review has been conducted by thelaboratory in accordance with their documented procedure and pre-determined schedule. If only aportion of the management review has been conducted by the time of the on-site assessment, a deficiencywill be cited and the management review must be completed before initial accreditation is granted.

NOTE: This must be implemented and will be enforced for all applications received as of January 1,2009.

Who is considered to be a laboratory’s “topmanagement”?

06/05/20084.15.12005

For either independent laboratories or in-house laboratories of production facilities, executive or topmanagement is considered to be those individuals who have the authority and can provide the resourcesnecessary to make changes to any aspect within the laboratory. Although it is up to the individuallaboratory to identify who these individuals are (e.g., President, Quality Manager, Technical Manager,etc.) for their specific organization, it is important that these individuals lead the laboratory’smanagement review and that it be clear from the laboratory’s records of the management review that thiswas indeed the case.

It is also important to understand that “top management” as referenced in Section 4.15.1 is considered tobe the same as the “highest level of management” referenced in Section 4.1.5 (i).

Is this section applicable to a laboratory's internalauditor?

01/26/20065.22005

Since a laboratory's internal auditor is responsible for examining various aspects associated withequipment, the performance of tests/calibrations and the issuing of results, it is required that the trainingand qualifications of the internal auditor be identified, documented and evaluated. As a result, all ofSection 5.2 of ISO/IEC 17025 (e.g., formulation of goals, policy and procedure for identifying trainingneeds, evaluation of the effectiveness of training administered, etc.) is applicable to the persondesignated as a laboratory's internal auditor and laboratories are expected to maintain records todemonstrate compliance with Sections 5.2.1 - 5.2.5 as related to their internal auditor. (See also a relateddiscussion under Section 4.14.1 (17025:2005) or 4.13.1 (17025:1999).)


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For one particular test/measurement on our laboratory’sScope of Accreditation, we only have one person in ourlaboratory that is competent to perform the test. Duringthe assessment, must that person be available fordemonstration for each test/measurement on our Scopethat only they are capable of performing?

05/06/20085.2.12005

Section 5.2.1 of ISO/IEC 17025 requires that there be personnel at the laboratory who are competent tooperate specific equipment and perform tests and/or calibrations. In order to confirm this, the assessor isrequired to verify that at least one person is available who can demonstrate each test/measurement onyour Scope of Accreditation. If there is only one person qualified and competent to perform a specifictest/measurement on your Scope, this person is defined as “essential” by A2LA and must be availableduring the assessment – even if this person is a contracted “employee”.

Some flexibility may be allowed on a case-by-case basis, however, for laboratories undergoing a renewalassessment for a particular test or calibration for which there is only one competent technician, as it isunderstood that brief illness and unexpected personal emergencies do occur. As long as the training,qualification and competence of the essential person can be verified through review of records and aslong as the person in question was interviewed by the previous assessor, then a deficiency may not becited. In cases of extended absence of an essential person, however, the laboratory must be able todemonstrate competence via other means or else the tests/calibrations affected must be temporarilyremoved from the Scope of Accreditation.

For new assessments and for assessments of newly added tests/calibrations for which there exist essentialpersonnel, this flexibility cannot be allowed as it would prevent the assessor from making a critical,initial determination of whether or not the laboratory does indeed have at least one person (even if thisperson is a contracted employee) who is competent to perform each of the tests/calibrations for whichthey are seeking accreditation.

Must my laboratory maintain records of actualcompetency data for all technical personnel?

06/14/20075.2.1, 5.2.52005

ISO/IEC 17025, Section 5.2.1 requires that “personnel performing specific tasks be qualified on the basisof appropriate education, training, experience and/or demonstrated skills, as required.” Section 5.2.5requires that the laboratory authorize personnel to perform certain duties and that “records of therelevant authorization(s), competence, educational and professional qualifications, training, skills andexperience of all technical personnel” be maintained. The standard sets no requirements for how alaboratory must judge this authorization and/or competence and sets no requirement for the actualcontent of competency records beyond requiring the date on which authorization and/or competence isconfirmed. While recording actual competency data for all technical personnel may be preferred, it is notrequired by the standard. ISO/IEC 17025 simply requires that a record of the competence be maintained –this is not the same as requiring a record of the competency data. For example, for technical personnelthat have been with a laboratory for many years, a simple statement of competence for certain tasksbased upon years of service may be sufficient. However, once statements of competence/qualification aremade by the laboratory, an A2LA assessor has the right and duty to ask for demonstration of the task fromthe person deemed competent in order to confirm this in practice.


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What does A2LA look for regarding competency ofpersonnel?

06/10/20055.2.12005

The appraisal of personnel is a major part of laboratory assessments. This criterion is evaluated based onthe range, complexity and frequency of performance of calibrations or tests for which accreditation issought. Some programs (e.g., environmental) include specific personnel qualification requirements.

Technical personnel must have demonstrable knowledge and skills to perform calibrations or tests andcompute results. They may be asked to demonstrate tests or specific techniques during an assessment.

The qualifications and experience required for senior staff are reviewed during the assessment. Factorsto be considered include:

The number of calibrations or tests for which accreditation is sought;The technical complexity of the calibrations or tests;Measurement uncertainty claimed;The frequency at which specific calibrations or tests are conducted, particularly those calibrationsor tests that are judged to be highly experience-dependent;The involvement that the senior staff member has with the development and adoption of newmethodologies within the laboratory.

In assessing qualifications, the balance between relevant academic qualifications and practicalcalibration or test experience is considered in light of the range, complexity and accuracy required. In allcases, senior staff must demonstrate appropriate understanding of the calibration or test areas overwhich they exercise supervision.

For a laboratory seeking accreditation for a wide range of complex calibrations or tests, senior staffwould be expected to have attained a high level of education in the relevant discipline together withsufficient experience in the relevant calibrations or tests. The senior staff engaged in a limited range ofrelatively simple calibrations or tests (while holding lesser qualifications) may demonstrate appropriatecompetence by having relevant calibration or test experience and demonstrable laboratory managementexpertise.

In many cases, more than one staff person may be involved to assure technical competence. For example,a supervisor exercising technical control may be relatively inexperienced with respect to one facet of thelaboratory’s work, but another person or persons working in close collaboration with the supervisor maycompensate for this inexperience. The accreditation in such a case would be reviewed if there were amajor change in either person’s duties. The loss of key personnel may also affect continuingaccreditation. For example, A2LA assessors identify key (or indispensable) staff whose absence wouldreduce the laboratory’s technical competence and may prompt a reassessment before it would normally bescheduled or removal of the affected tests from the Scope of Accreditation.

Do the required “goals” have to be documented? 04/30/20055.2.22005


26 of 27 06/29/2012 9:22 AM

Goals with respect to education, training and skills must form part of the laboratory’s documented recordsystem (e.g., within records of regular staff performance reviews, etc.).

The last sentence of this clause requires an evaluation ofthe effectiveness of training actions. How can this beaccomplished?

07/19/20055.2.22005

Only this last sentence of Section 5.2.2 is new to ISO/IEC 17025: 2005. It is important to understand thatthis evaluation is not to be done for the laboratory’s training program as a whole, but rather is to be doneto determine the effectiveness of individual training actions that are taken for laboratory personnel inrelation to the goals that were to have been established for them per the first sentence of this clause.Records of this evaluation are required and may be tied to Section 4.15, as “staff training” is one of theitems to be taken into account during a laboratory’s periodic management reviews. In addition,laboratories may also maintain records of evaluation of proficiency testing results, internal audits andexternal assessments, and actual performance evaluations of staff relating to their definedresponsibilities and as approved by the evaluator (e.g., the Technical and/or Quality Manager) consistentwith Section 5.2.5, as a means of attesting to the effectiveness of the training that was given to laboratorypersonnel.

What is the difference between the words “method” and“procedure” as contained in the standard?

04/30/20055.42005

Although normative references such as the VIM contain separate definitions for “method” and“procedure”, the ISO/IEC 17025 working group intended these words to be functionally equivalent forthe purposes of technical validation related to the requirements of this section.

Can a laboratory be accredited for non-standardmethods (i.e. developed in-house)?

06/10/20055.4.22005

A2LA considers accreditation of in-house methods where existing standard methods are not suitable.These methods must be documented and appropriately validated in accordance with Section 5.4.5. Thedocumentation should normally follow the format as described in the Note following Section 5.4.4.Documentation of the validation of the method as established by the laboratory is the primary basis fordetermining if the method can be included on the Scope of Accreditation.

If a laboratory uses non-standard methods, but they arespecified/required directly by the client during contractreview, must the laboratory validate these methods perISO/IEC 17025, Section 5.4.5?

02/06/20075.4.52005


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