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A2LA Explanations for the ISO/IEC 17025 Requirements

A2LA Specific Applications of Additions to the Standard
ISO/IEC 17025 often uses the words calibration and testing in describing requirements. How do laboratories that only perform one or the other interpret those requirements? 04/30/2005 1.2 2005

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 the exception 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 meet ISO 9000?

04/30/2005 1.6 2005

According to the 2005 version of the Standard (within the Introduction), Care has been takento incorporate all those requirements of ISO 9001 that are relevant to the scope of testing and calibration services that are covered by the laboratorys management system. In addition, Testing and calibration laboratories that comply with this International Standard will therefore also operate in accordance with ISO 9001. However, laboratories may not claim ISO 9000 registration based solely on their ISO/IEC 17025 accreditation, though additional evaluation against ISO 9001/9002 should not be necessary for laboratories accredited to ISO/IEC 17025. It is also noted in the Introduction to ISO/IEC 17025 that conformity of a laboratorys quality management system to the requirements of ISO 9001 does not of itself demonstrate the competence of the lab to produce technically valid data and results.

What is meant by the term legally responsible? 04/30/2005 4.1.1 2005 The laboratory may be a public or private entity, an established business or corporation, or an identifiable division or in-house activity of a business or corporation, which meets the applicable legal requirements of the governmental jurisdiction in which it conducts business. Legal responsibility aids in addressing issues of liability/accountability, uniqueness, and independence of operation.

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Does this clause require the specified responsibilities to be documented?

04/30/2005 4.1.4 2005

Yes. By using the word defined, this section requires documentation from the laboratory (e.g., in the form of job descriptions) outlining responsibilities of those people in the parent organization who have an influence over laboratory activities. It is important to note, however, that this requirement is predicated on the labs being part of a larger organization involved in other activities (e.g., production, consulting, etc.).

What is meant by key personnel? Is this different from A2LAs term essential personnel? Who should I consider key vs. essential?

06/14/2007 4.1.4, 4.1.5 2005

The term essential personnel is one developed by A2LA to allow us to identify specific individuals who have 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 or more 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 of ISO 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 play fundamental roles in the implementation of the management system. Granted, this is very subjective and open to interpretation by the laboratory and the assessor. At a minimum and in most cases, it would be safe to assume that the laboratory quality manager, technical manager and any essential personnel are to be considered key for the purposes of compliance with ISO/IEC 17025. Any other personnel who have a unique role in the laboratory that has an involvement with or influence on the testing or calibration activities could also be considered key. For example, the laboratorys internal auditor might be considered key if s/he is the only staff member deemed qualified to conduct an internal audit.

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

07/19/2005 4.1.5a 2005

It is expected that these individual responsibilities and authorities would be outlined and specified within the 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 external pressures?

06/10/2005 4.1.5 b 2005

Both in-house and commercial laboratory personnel must be insulated from work-related undue pressures that 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). Management should decide which types of undue pressure the staff might encounter and implement clear policies and instructions for countering them. Precautions should be taken to ensure that there are no conflicts of interest between staff and clients. If relevant, the laboratory should have a written policy against acceptance of gifts and gratuities by employees from clients in order to avoid perception of conflict of interest. Also, a policy for handling internal complaints or concerns from employees should be included. Communications (priority request, complaints, status inquiries, etc.) could be directed through supervision or administrative personnel. Ethics programs, skip-level management interviews, arbitrator programs, etc. may also provide avenues of coordination that preclude adverse effects resulting from commercial pressures. All these efforts may be included in the quality manual or issued as a policy statement 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 labs quality system (e.g., a policy or procedure).

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

08/06/2009 4.1.5 b 2005

ISO/IEC 17025 does not explicitly require that a laboratory have a Code of Conduct or Code of Ethics in place as part of its management system. That said, however, each accredited organization is strongly encouraged to have such measures in place to aid in fully complying with these sections of the Standard and to aid in substantiating the ethical grounds upon which an organization operates if their actions are ever called into question. A helpful tool to assist any organization in developing and maintaining a Code of Conduct or Code of Ethics is an ethics self-assessment. Such a self-assessment can help an organization identify those areas where they are on strong ethical ground as well as areas that they may wish to examine further as an opportunity to enhance or further define their ethical and leadership practices. Some points to consider in 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 organizations 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 organizations management issues?

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Do you use your authority solely to fulfill your responsibilities and not for self-interest or to further the interests of family, friends or associates? When an ethical conflict confronts you or your organization, are you successful in finding an effective resolution and ensuring it is followed? Do you demonstrate your organizations 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 and reveal 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 of staff harassment? Do you expect and hold staff accountable for adherence to your organizations ethical standards (for example, 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 interest or interference with free competition? Do your organizations 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, The American College of Healthcare Executives and the Higher Learning Commission.)

How does this clause differ from 4.1.5 b)? 04/30/2005 4.1.5 d 2005 This clause refers to activities undertaken by the laboratory or its staff outside of normal operations that could cast doubt upon the laboratorys integrity.

Does an organization chart fulfill this requirement? 04/30/2005 4.1.5 e 2005 An organization chart or charts with the reporting relationship to any parent organization or ownership should normally be a sufficient presentation of the organization and management structure of the laboratory. 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 04/30/2005 4.1.5i 2005 This section of ISO/IEC 17025 requires that a single member of the laboratory staff be given responsibility for acting as quality manager. A common misinterpretation in attempting to meet this requirement is that it is sufficient only to have an organizational chart that shows a direct line from the quality manager to the highest level of management. In order to determine whether a labs quality manager does indeed have direct access to the highest level of management, the following questions may be asked: Can the quality manager call members of the highest level of management? Can the quality manager 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? 06/10/2005 4.1.5j 2005 Arrangements for designating the person(s) acting in the absence of the technical and quality management should be documented to ensure continuity of operation in case of absence(s). If the integrity of the laboratory is jeopardized by the lack of other key staff, deputies for those positions should also be provided. Designated deputies must have the required knowledge and expertise to assume the position or the activities should be appropriately curtailed where knowledge and expertise do not exist with the deputy. A deputy A2LA Authorized Representative, knowledgeable about A2LA accreditation policy and procedures, must also be identified.

What evidence is required to verify that personnel are aware of the relevance and importance of their activities?

07/18/2005 4.1.5k 2005

This new clause within the standard requires that laboratory personnel be aware of their particular place and function within the overall organization. Interviews with laboratory personnel would be expected to reveal that they are performing their functions correctly and that they are aware of the quality objectives of the organization. This clause is closely related to several others within the standard as this awareness by laboratory personnel can and should be directly tied to the effectiveness of communications through laboratory management, performance evaluations of laboratory personnel and management reviews within the organization.

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Must communication always be in a written form? 07/19/2005 4.1.6 2005 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 reveal that these processes are in place and that personnel are aware of issues that relate to the management system and its overall effectiveness. For example, communication of results of periodic management reviews could be one means of making laboratory personnel aware of the management systems effectiveness. It would also be expected that no evidence would be found of system breakdowns resulting from a lack of effective communication amongst laboratory personnel.

How can a laboratory demonstrate that the management system documentation has been communicated to and implemented by the appropriate personnel?

04/30/2005 4.2.1 2005

The laboratory may communicate the systems documentation through the use of (for example) a controlled distribution list of individuals having numbered copies of the quality documentation (or equivalent electronic means of distribution) or a documented laboratory training program.

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

04/30/2005 4.2.1 2005

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

How detailed does the laboratory quality system have to be?

04/30/2005 4.2.1 2005

This section states that the laboratory shall document its policies, systems, programs, procedures and instructions to the extent necessary, meaning that the laboratory is to determine the level of detail found in its documentation. The laboratory must also be able to demonstrate, though, through objective evidence that the level of detail presented in its quality system documentation is producing the desired and required outcome. When a clause in ISO/IEC 17025 requires the laboratory to have one of the items listed above, some form of documentation must be presented in a form that is repeatable. In developing a quality system appropriate to the scope of a laboratorys activities, documentation may take many forms, including

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written documents, electronic systems, video or other media. Verbal representation of documentation would 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 requirements of Section 4.3 and (per Section 4.2.1) must be communicated to, understood by, available to, and implemented by the appropriate laboratory personnel. In essence, each person who requires a piece of documentation to perform his job correctly must have access to that piece of documentation.

Must the quality manual include all of the laboratorys procedures?

04/30/2005 4.2.2 2005

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

Is the laboratory now required to review its performance against objectives?

07/19/2005 4.2.2 2005

Specific attention should be paid to this new second sentence of this section of the standard, as it outlines an additional element to be taken into account during the management reviews required by Section 4.15.

Must the quality manual include all of the laboratorys policies?

10/13/2011 4.2.2 2005

Section 4.2.2 states that the laboratorys management system policies must be defined in the quality manual and A2LA views the word define to mean describe, specify distinctly or delineate the outline or form; therefore, the policies themselves must either be contained within the manual or the manual must clearly describe or delineate the outline or form of a policy with a reference or link to the more extensive policy itself. It is important to keep in mind, however, that Section 4.2.2 also qualifies the term quality manual with the parenthetical phrase however named. So, for example, a laboratory may choose to design their quality manual as a single, physical document, or they may choose to design it as a directory within their electronic management system. (NOTE: These examples are not meant to be an inclusive list of all possible options.) In the case of the former, all of the elements that ISO/IEC 17025 requires to be defined, within the quality manual 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 describes the overall structure & outline of the management system and that provides links to other documents within the electronic directory that are required by ISO/IEC 17025 to be defined within the quality manual.

Does section 4.2.2 require that all of the quality policy statement elements (4.2.2 a - e) be contained in one contiguous statement? Or can the elements be addressed in different areas of the quality manual?

06/05/2008 4.2.2 2005

In most cases, a laboratory is required to address all of the quality policy statement elements in one contiguous statement. According to the standard, the quality policy statement "shall include at least the following: the laboratory's management commitment to good professional practice and to the quality of its testing and 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 laboratory familiarize themselves with the quality documentation and implement the policies and procedures in their work; and the laboratory's management's commitment to comply with this International Standard and to continually 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 note states: When the test and/or calibration laboratory is part of a larger organization, some quality policy elements may be in other documents. Therefore, the above elements may not appear in a single, contiguous statement but instead may appear elsewhere in corporate-level documents (i.e., in documents accessible and applicable to all accredited labs within the corporation) only when the laboratory is part of a larger organization.

What constitutes an "evidence of committment" by top management?

07/19/2005 4.2.3 2005

For either independent or in-house laboratories of larger organizations (e.g., production facilities), top management is considered to be those individuals who have the authority and can provide the resources necessary to make changes to any aspect within the laboratory. It is, therefore, important that these individuals participate in the laboratorys management review, stress the importance of meeting customer requirements 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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laboratorys management, which could be considered part of the evidence an assessor would look for to determine compliance with this clause. In addition, evidence that proper resources are allocated to the performance of appropriate and effective internal audits, management reviews, quality control analysis, proficiency testing, etc. could also be considered evidence of top managements commitment to its management system. As a result, records demonstrating top managements participation in these functions could be considered evidence of compliance with this particular section of the standard.

In what ways may management communicate the importance of meeting customer, statutory and regulatory requirements?

07/19/2005 4.2.4 2005

This communication may be accomplished by a variety of means. Although use of memos, videos, posters and 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 are occurring within the management system as a result of inappropriate or insufficient communication. This clause is closely related to Section 4.2.2 (a), which requires a written policy of the laboratorys commitment to good professional practice and the quality of the services it offers.

My laboratorys quality manual contains clear 09/06/2007 statements of the roles and responsibilities for our 4.2.6 quality manager and technical management. However, 2005 none of these explicitly state that they are responsible for the laboratorys compliance with ISO/IEC 17025. Does this warrant a deficiency? Yes. Section 4.2.6 of ISO/IEC 17025 requires that the quality manual define the roles and responsibilitiesincludingresponsibility for ensuring compliance with this International Standard. As such, ensuring compliance with ISO/IEC 17025 must be explicitly included in the responsibilities defined and listed within the labs quality manual for either or both the quality manager and technical management.

What is meant by the phrase "maintaining the integrity of the management system"?

07/19/2005 4.2.7 2005

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

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

05/03/2007 4.3.1 2005

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

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

06/05/2008 4.3.1 2005

The term "software" as used in section 4.3 includes those pieces of software and firmware required for proper operation of equipment, as well as those used for other purposes necessary for the correct performance of testing or analysis of data. The laboratory must control this software to ensure that personnel and equipment are using the correct versions. In many cases, this control may be included in the procedures by which the laboratory maintains and controls its equipment under Section 5.5 (e.g., when the 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 the pertinent requirements in section 5.5 must be met. (NOTE: Word processing software does not have to be controlled unless it is used for calculation of derived data.)

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

03/20/2012 4.3.1 2005

Normative documents are those that provide rules, guidelines or characteristics for activities or their results. It is a generic term that covers such documents as standards, technical specifications, codes of practice and regulations. For the purposes of A2LA accreditation, accredited laboratories are required to own (or have direct access to) and have under their document control system current versions of the normative documents that are vital to maintaining their accreditation. These documents include (in addition to relevant regulations, 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 normative documents that a laboratory must control within their system. For example, a calibration laboratory that performs calibrations at client sites would be expected to possess (or have direct access to) and have under its document control system current versions of the following 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 of Accreditation; 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 laboratorys document control system requires that they also be included on the labs master list (or equivalent) of controlled documents, identifying their current revision 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 of the Standard considered a record or is it considered a document that would be subject to document control requirements?

08/06/2009 4.3.2.1 2005

A2LA considers a laboratorys master list to be a record and not a document that is subject to document control requirements. Section 4.3.2.1 of ISO/IEC 17025 indicates that the clause can be met by use of either a master list (subject to requirements associated with record management) OR an equivalent document control procedure (subject to document control requirements).

Our lab only maintains one controlled & centrallylocated copy of every document in the management system. Is a master list outlining distribution really required in this case?

03/14/2011 4.3.2.1 2005

Section 4.3.2.1 requires a master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the management system In the situation described above, a formal master list may not be warranted as long as the labs document control procedure outlines the documents contained within the management system, specifies their current revision status and indicates where they may be found. If the document control procedure does not contain this information, then a master list containing it is required.

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Does our master list have to explicitly contain each required A2LA normative document and its revision status or may we simply refer to the A2LA website? Also, how long does our lab have to implement changes made to A2LA normative documents? A2LAs explanation of Section 4.3.1 of ISO/IEC 17025 states:

03/14/2011 4.3.2.1 2005

Having these [normative] documents included in the laboratorys document control system requires that they also be included on the labs master list (or equivalent) of controlled documents, identifying their current revision status and distribution Section 4.3.2.1 of ISO/IEC 17025 is also clear in requiring that the master list (or equivalent) specifically include the revision statusof documents in the management system. A reference to the A2LA website alone does not meet this requirement and, therefore, A2LA normative documents must be specifically included on the labs master list (or equivalent) and must be accompanied by a clear indication of their revision status (e.g., date issued, date revised). Implementation timeframes for revisions or updates to A2LA documents vary, depending on the nature of the 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 the updated document (e.g., for specific or general requirements revisions). In other cases, implementation is expected immediately upon receipt of notice of the update when the revision is considered minor and laboratories are reminded of their responsibility to obtain these updates through the RSS feed available on the A2LA website. If a laboratory is ever in doubt as to the implementation timeframe for an updated A2LA document, they are encouraged to contact their Accreditation Services representative for clarification.

How should we identify new or altered text in a revised document and when would it be considered impracticable to do so?

03/14/2011 4.3.3.2 2005

ISO/IEC 17025 is not explicit in dictating how a laboratory is to identify new or altered text in a revised document and the language that is used in Section 4.3.3.2 allows for considerable variation in application. 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 the tracked changes in place while issuing clean, unmarked and controlled versions to the users of the document. (NOTE: This is only an option when the laboratorys document control procedure clearly describes this system and all relevant personnel have been informed of the exact changes made or have access 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 whenever practicable. A2LA interprets this to mean whenever practice-able and so it is expected that this requirement would be met in the vast majority of cases. There are some scenarios, however, where A2LA does 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 issued as a complete rewrite since, in this case, it could be considered impracticable to include references to every change made (such as with highlights and strikethroughs) that would render the document difficult or impossible to use.

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

04/30/2005 4.4 2005

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

If a client does not make any specific request for measurement uncertainty data, does a calibration laboratory need to address the issue in contract review?

04/30/2005 4.4.1 c) 2005

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

My laboratory is part of a multi-laboratory organization. 08/06/2009 All laboratories within my organization are A2LA 4.5 accredited and fall under the classification of a branch 2005 system as defined by A2LA. If my laboratory receives work from a client but sends the work to another of our accredited branch laboratories (with the final report being issued by my laboratory), is this considered sub-contracting? As stated in Part C, Section I of R101 General Requirements: Accreditation of ISO/IEC 17025 Laboratories, A2LA accreditation is site specific, meaning that each discrete location is considered to be 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 be sub-contracting and is subject to all requirements related to sub-contracting in ISO/IEC 17025 and related A2LA requirements documents.

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If a laboratory subcontracts for tests or calibrations it cannot perform, is that covered by its A2LA accreditation?

04/30/2005 4.5.1 2005

The Scope of Accreditation defines the tests or calibrations for which a laboratory is accredited. If a test/calibration is not on a laboratorys Scope, it is not covered by the laboratorys accreditation even if the test/calibration is ultimately subcontracted to another laboratory that is accredited for it. A2LA will only include on a laboratorys Scope those tests or calibrations that the laboratory has been assessed as being competent and capable to perform, meaning that it has the appropriate equipment, method(s) and trained personnel. A2LA will not accredit a laboratory for any test or calibration if it does not maintain permanent ability to perform that test or calibration. It is important to note that using an outside supplier for calibration of equipment is not considered subcontracting. Calibration providers are considered outside services, which are addressed in Section 4.6.

Does A2LA have any criteria for defining a competent subcontractor?

04/30/2005 4.5.1 2005

Section 4.5.1 of ISO/IEC 17025 gives one example of a competent subcontractor as being a laboratory that complies with 17025 for the work in question. However, Section 4.5.4 of the standard states that the lab must have a record of evidence of the subcontractors compliance with 17025 for the work in question. Although these two sections appear inconsistent with each other, it is important to understand that the standard is allowing a laboratory to use whatever means it deems appropriate to evaluate its subcontractors. However, the record produced from this evaluation must detail the subcontractors level of compliance with ISO/IEC 17025 for the work in question. Accredited laboratories using the services of a subcontracted laboratory are responsible for the subcontractors work (per Section 4.5.3) and must notify 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 any specific customer requirements, the laboratory is responsible for assuring their client that the subcontractor has a satisfactory quality system and is competent to perform the required calibrations or tests. Ideally, laboratory should document their policy and procedure for hiring subcontractors. Reliance on 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 as equivalent) the laboratory should record its assessment of that subcontractors capability to meet 17025 for the subcontracted work in question. As an example, the laboratory should require the following records of their subcontractor to demonstrate their compliance with ISO/IEC 17025 (again, only as related to the subcontracted work in question): A copy of the subcontractors quality manual demonstrating compliance with ISO/IEC 17025; A copy of the subcontractors procedure(s) for the work in question and demonstration of adequate performance through proficiency testing; A copy of the training records for the personnel responsible for performing the subcontracted work; and An example report or certificate for the work intended to be subcontracted.

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Does this requirement apply when subcontracting tests or calibrations outside of a laboratorys Scope of Accreditation?

04/30/2005 4.5.1 2005

The subcontracting requirement of ISO/IEC 17025 applies only to subcontracting of any part of the tests or calibrations included on a laboratorys Scope of Accreditation.

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

05/03/2007 4.6 2005

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

Should I consider the commercial proficiency testing providers that my laboratory uses to be suppliers of critical services?

02/08/2006 4.6.1 and 4.6.4 2005

Yes. Commercial proficiency testing providers are considered suppliers of critical services and so the requirements of Sections 4.6.1 & 4.6.4 are applicable to the PT providers used by a laboratory. It is important 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" these services and so Section 4.6 is not applicable

What types of services and supplies are covered by this requirement?

04/30/2005 4.6.1 2005

The most common service covered by this requirement is equipment calibration. The A2LA Traceability Policy 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 by A2LA through its mutual recognition arrangements) when such laboratories are available for the calibrations required. This ensures that traceability to the relevant national or international metrology standards as required by Section 5.6 is authenticated. Laboratories should evaluate the measurement uncertainties claimed by their calibration provider to ensure any application specifications or requirements are met. The laboratory should also identify any other inputs to its processes in terms of equipment, materials and services that affect the integrity of its calibrations or tests and develop appropriate specifications and quality control measures.

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

Must the records of actions taken to check compliance of received supplies, services and/or consumable materials be tied to the specific shipment/box/lot of material received?

06/14/2007 4.6.2 2005

Section 4.6.2 of ISO/IEC 17025:2005 requires that records of actions taken be maintained to confirm compliance of such materials/services with standard specifications or requirements defined in the methods for the tests and/or calibrations concerned. While the standard does not require that specific material identifications (e.g., lot numbers) be recorded on every compliance check record, a laboratory must maintain sufficient traceability throughout their record system of the actions that were taken, such that this information could be determined and retrieved should an audit trail ever be required per Section 4.13.2.1 of ISO/IEC 17025 in the case of a malfunctioning or substandard supply or material. This traceability of records must allow the laboratory to determine through their audit trail what materials are affected and what test results may be or may have been affected.

What specific items does A2LA look for in my purchasing documents in order to meet the requirements in Section 4.6.3?

09/10/2009 4.6.3 2005

Section 4.6.3 of ISO/IEC 17025:2005 does not indicate what specific items must be included in a labs purchasing documentation nor does it specify what form this documentation must take. It simply requires that 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 and approved 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 lists some specific details that a laboratory may include in their purchasing documents, but these are by no means requirements. When the service/supply is ultimately received, it is incumbent upon the laboratory to ensure that it meets their needs and requirements. If their needs are fully met, then their purchasing procedure is assumed to be adequate since there is no evidence to the contrary. If there are shortcomings or omissions in the service/supply received, then the laboratory must determine what actions must be taken to address the unacceptable service/supply and to ensure this does not happen in the future. This may result in a change to their process such that additional or specific detail, information or instructions are captured in purchasing documentation for their vendor/supplier.

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

07/10/2008 4.7.2 2005

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As the note to this clause suggests, there are many ways in which a laboratory may solicit feedback from its customers - as long as this feedback is solicited in a general way so as to apply not only to the content and presentation of the final certificate or report, but also to the entire range of a client's interaction with 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 general statement on a laboratory's certificate or report soliciting feedback, etc., as long as the client is directed to or informed of the mechanism they may use to provide feedback. In-house or captive laboratories could seek feedback in much the same manner that commercial laboratories do. Perhaps by sending a survey to the organization's engineers or product development personnel or perhaps by soliciting comments during meetings with other departments. It is important to remember, however, that in order to be fully compliant with this section of the standard, laboratories are required to maintain records of the analysis of any feedback received as well as records of the manner in which this feedback is used to improve the management system, testing/calibration activities and customer service. The latter may generally be accomplished through the examination of customer feedback during periodic management reviews and so may be tied to the requirements of Section 4.15 and the records maintained in accordance with those requirements.

What constitutes a complaint? 06/10/2005 4.8 2005 Complaints need not be received in writing, as they may arrive via telephone or other oral means. A record 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 a complaint and all complaints should be documented in a file including the substance of the complaint and its resolution. Complaints may be generated by external customers or from within the laboratorys organization. Complaints referred to in this section should not be confused with complaints against quality characteristics of the actual product or item being tested or calibrated. ISO 10002: 2004 provides detailed guidance on handling complaints.

Must my laboratory have records to demonstrate that each of the requirements in a-e of this clause is specifically identified for each instance of non-conforming work?

05/03/2007 4.9.1 2005

Yes. Section 4.9.1 of ISO/IEC 17025 requires that a laboratorys procedure for controlling non-conforming work ensures each of the items listed in a-e is accomplished, if applicable. In order to confirm that a laboratorys 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 other sections of the standard (quality policy and objectives, management review, etc.). What additional information

07/19/2005 4.10

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must the laboratory provide?

2005

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

What is the difference between corrective action and preventive action?

04/30/2005 4.11 and 4.12 2005

Corrective action is the systematic investigation of nonconformity events. Even when steps are taken to ensure 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 areas for improvement. In essence, no nonconformity event takes place in order to stimulate a preventive action.

Is a laboratorys cause analysis procedure deficient if it lacks the words root cause?

04/16/2007 4.11.2 2005

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

What is meant by a root cause investigation and how do I go about this?

11/06/2009 4.11.2 2005

Root cause analysis is the most challenging aspect of the corrective action process and should be used as a 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 root causes. Because of this, there is no single recipe that can be followed. While it is impossible to create a procedure 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 deficiency occur? Other points to consider: Statements of root cause which are essentially a restatement of the deficiency provide no new information beyond the deficiency and are of little benefit to you and are not considered to be an acceptable response by A2LA. In these instances, the root cause is a result of the laboratory asking why was 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 the identified 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 determined that the root cause of 6 of the 8 deficiencies pertains to employee training. In this example, additional investigation into the employee training program would be prudent and should be evident in the response supplied to A2LA. The investigation which begins by asking why did this deficiency occur? will uncover a reason why the deficiency occurred. A proper root cause investigation will continue to ask why did this occur until you can no longer identify a reason. At this point you can be reasonably assured that you have isolated the crux 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 Document Finder on the A2LA website. The February 2007 Issue of the A2LA Newsletter, found under the "Publications" tab, and "Newsletter Archive" menu item on the A2LA website.

Does my laboratory have to maintain records to show that we have monitored the results of corrective actions taken?

05/03/2007 4.11.4 2005

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

Are the action plans specified required to be documented? (section 4.12.1 of ISO 17025:2005)

04/30/2005 4.12 2005

These action plans (developed once possible preventive actions have been identified) are to be in a documented form.

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

04/30/2005 4.13.2.1 2005

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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 be maintained in the record system after transfer (e.g., the original paper may be destroyed). However it is important to note that other specific A2LA accreditation programs or regulatory requirements may override this interpretation. The laboratory should meet all applicable customer and regulatory requirements for retention of original observations.

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

09/07/2006 4.13.2.1 2005

Section 4.13.2.1 of ISO/IEC 17025 requires that the records for every test or calibration contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to enable the test or calibration to be repeated under conditions as close as possible to the original. While the 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 traceability throughout 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 be potentially 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 requirements related to this question that laboratories applying for accreditation within those fields would have to meet.

How does Note 1 from Section 4.13.2.1 apply to my 09/06/2007 laboratory? My lab runs a significant number of the 4.13.2.1 (Note 1) same tests each day. It seems impractical for me to 2005 record and retain so much original data when my customers do not wish to receive this additional information with their final test reports. Note 1 only applies to certain situations. For example, it would be applicable to laboratories that accumulate significant amounts of ancillary data (such as control data or pass/fail data) where the reading is qualitative or dial-read, or to laboratories that run copious samples through automated testing machines that output only an average or another type of derived data. However, if the original test data generated 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 not qualitative in nature, a laboratory must record the original observations. This original data establishes an audit trail and allows for the test/calibration to be repeated under as close to the original conditions as possible.

What is considered an equivalent measure for avoiding loss or change of original data that is stored electronically?

09/10/2009 4.13.2.3 2005

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Electronic records are considered to be records that exist in electronic form such as data stored on a computer hard drive, network, or other storage media. Appropriate measures are to be implemented by the laboratory that safeguard against loss or change of the originally recorded data. Such measures may include: Preventing the overwriting of an existing record, but saving a revision of the original record which includes 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 A2LA ISO/IEC 17025 checklist. Is this sufficient?

06/09/2011 4.14.1 2005

No. Section 4.14.1 of ISO/IEC 17025 states that the internal audit must verify that [the laboratorys] operations continue to comply with the requirements of the management system and this International Standard (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 the laboratory must carry out its testing and calibration activities in such a way as to meet the requirements oforganizations providing recognition. (i.e., A2LA) As such, your complete internal audit program (in accordance 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 your management system; Determination of compliance within all testing and/or calibration activities; Determination of compliance with all relevant A2LA policies and requirements (NOTE: This may be accomplished via an audit against the actual A2LA policy and requirement documents; however, if all required elements of the relevant A2LA policies and requirements have been enveloped within the laboratorys management system, then an audit of the management system itself will necessarily include an examination of compliance with relevant A2LA policies and requirements.)

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

10/04/2007 4.14.1 2005

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each interval. Are we required to perform an audit on all elements of our management system and its compliance to ISO 17025 and an audit of all testing methods defined on 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 to comply with the requirements of the management system and this International Standard. The internal audit program shall address all elements of the management system, including the testing and/or calibration activities. It is acceptable for a laboratory to audit a sampling of their management system at each audit interval, as long as their overall audit program specifies how this sampling is to be done such that all elements of the management 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 accredited technologies and/or parameters may constitute a sufficiently thorough and comprehensive audit of their accredited activities, such that auditing all methods (which may be redundant and overlap) may not be necessary - as long as there is no evidence or indication that the depth and expanse of the technical portion of their audit is inadequate. Also, since the standard does not require that a full internal audit be done annually, it is acceptable for a laboratorys audit program to cover the entire management system (including testing/calibration activities) over a span of a number of years, as long as there is no evidence or indication that the timeframe of this cycle is inadequate. Although R102 Conditions for Accreditation requires that each organization retain records at least for the period of time between full A2LA assessments, it also requires that: adequate recordsmust be available to demonstrate full compliance with the requirements for accreditation. Therefore, if a laboratorys full audit cycle spans a period of time that is greater than the period of time between full A2LA assessments, they must maintain adequate records for their full audit cycle to demonstrate compliance with the requirements for conducting internal audits. For example, a laboratory may specify a record retention period of two years, but their complete audit cycle may span 5 years. In this case, they must retain full records of each 5-year audit cycle even though it exceeds their normal record-retention period.

I am a new laboratory getting ready to apply for accreditation. Do I have to perform a complete internal audit of my management system and testing activities before I can become accredited?

06/05/2008 4.14.1 2005

In order to confirm full compliance with this section of the Standard, A2LA assessors will look for evidence during the on-site assessment that a complete internal audit has been conducted by the laboratory in accordance with their documented procedure and pre-determined schedule. If only a portion of the internal audit has been conducted by the time of the on-site assessment, a deficiency will be cited 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 part of or entirely in place of a laboratorys internal audit?

03/25/2007 4.14.1 2005

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

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

01/26/2006 4.14.1 2005

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

Are audit findings considered to be nonconformities only? (section 4.14.3 of ISO 17025:2005)

04/30/2005 4.14.3 2005

Audit findings include areas of conformance as well as areas of nonconformity. An internal audit record 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 of nonconformity.

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

04/30/2005 4.14.1 and 4.15.1 2005

The predetermined schedule for each, individual activity must be either part of the internal audit and management review procedures or referenced from the quality manual. The predetermined schedule may specify 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 for accreditation. Do I have to perform my management review before I can become accredited?

06/05/2008 4.15 2005

In order to confirm full compliance with this section of the Standard, A2LA assessors will look for evidence during the on-site assessment that a complete management review has been conducted by the laboratory in accordance with their documented procedure and pre-determined schedule. If only a portion of the management review has been conducted by the time of the on-site assessment, a deficiency will 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 laboratorys top management?

06/05/2008 4.15.1 2005

For either independent laboratories or in-house laboratories of production facilities, executive or top management is considered to be those individuals who have the authority and can provide the resources necessary to make changes to any aspect within the laboratory. Although it is up to the individual laboratory 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 laboratorys management review and that it be clear from the laboratorys records of the management review that this was indeed the case. It is also important to understand that top management as referenced in Section 4.15.1 is considered to be the same as the highest level of management referenced in Section 4.1.5 (i).

Is this section applicable to a laboratory's internal auditor?

01/26/2006 5.2 2005

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

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For one particular test/measurement on our laboratorys 05/06/2008 Scope of Accreditation, we only have one person in our 5.2.1 laboratory that is competent to perform the test. During 2005 the assessment, must that person be available for demonstration for each test/measurement on our Scope that only they are capable of performing? Section 5.2.1 of ISO/IEC 17025 requires that there be personnel at the laboratory who are competent to operate specific equipment and perform tests and/or calibrations. In order to confirm this, the assessor is required to verify that at least one person is available who can demonstrate each test/measurement on your Scope of Accreditation. If there is only one person qualified and competent to perform a specific test/measurement on your Scope, this person is defined as essential by A2LA and must be available during 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 renewal assessment for a particular test or calibration for which there is only one competent technician, as it is understood 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 as long as the person in question was interviewed by the previous assessor, then a deficiency may not be cited. In cases of extended absence of an essential person, however, the laboratory must be able to demonstrate competence via other means or else the tests/calibrations affected must be temporarily removed from the Scope of Accreditation. For new assessments and for assessments of newly added tests/calibrations for which there exist essential personnel, 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 this person is a contracted employee) who is competent to perform each of the tests/calibrations for which they are seeking accreditation.

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

06/14/2007 5.2.1, 5.2.5 2005

ISO/IEC 17025, Section 5.2.1 requires that personnel performing specific tasks be qualified on the basis of appropriate education, training, experience and/or demonstrated skills, as required. Section 5.2.5 requires that the laboratory authorize personnel to perform certain duties and that records of the relevant authorization(s), competence, educational and professional qualifications, training, skills and experience of all technical personnel be maintained. The standard sets no requirements for how a laboratory must judge this authorization and/or competence and sets no requirement for the actual content of competency records beyond requiring the date on which authorization and/or competence is confirmed. While recording actual competency data for all technical personnel may be preferred, it is not required 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 personnel that have been with a laboratory for many years, a simple statement of competence for certain tasks based upon years of service may be sufficient. However, once statements of competence/qualification are made by the laboratory, an A2LA assessor has the right and duty to ask for demonstration of the task from the person deemed competent in order to confirm this in practice.

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What does A2LA look for regarding competency of personnel?

06/10/2005 5.2.1 2005

The appraisal of personnel is a major part of laboratory assessments. This criterion is evaluated based on the range, complexity and frequency of performance of calibrations or tests for which accreditation is sought. Some programs (e.g., environmental) include specific personnel qualification requirements. Technical personnel must have demonstrable knowledge and skills to perform calibrations or tests and compute 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. Factors to 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 calibrations or tests that are judged to be highly experience-dependent; The involvement that the senior staff member has with the development and adoption of new methodologies within the laboratory. In assessing qualifications, the balance between relevant academic qualifications and practical calibration or test experience is considered in light of the range, complexity and accuracy required. In all cases, senior staff must demonstrate appropriate understanding of the calibration or test areas over which they exercise supervision. For a laboratory seeking accreditation for a wide range of complex calibrations or tests, senior staff would be expected to have attained a high level of education in the relevant discipline together with sufficient experience in the relevant calibrations or tests. The senior staff engaged in a limited range of relatively simple calibrations or tests (while holding lesser qualifications) may demonstrate appropriate competence by having relevant calibration or test experience and demonstrable laboratory management expertise. 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 the laboratorys work, but another person or persons working in close collaboration with the supervisor may compensate for this inexperience. The accreditation in such a case would be reviewed if there were a major change in either persons duties. The loss of key personnel may also affect continuing accreditation. For example, A2LA assessors identify key (or indispensable) staff whose absence would reduce the laboratorys technical competence and may prompt a reassessment before it would normally be scheduled or removal of the affected tests from the Scope of Accreditation.

Do the required goals have to be documented? 04/30/2005 5.2.2 2005

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Goals with respect to education, training and skills must form part of the laboratorys documented record system (e.g., within records of regular staff performance reviews, etc.).

The last sentence of this clause requires an evaluation of the effectiveness of training actions. How can this be accomplished?

07/19/2005 5.2.2 2005

Only this last sentence of Section 5.2.2 is new to ISO/IEC 17025: 2005. It is important to understand that this evaluation is not to be done for the laboratorys training program as a whole, but rather is to be done to determine the effectiveness of individual training actions that are taken for laboratory personnel in relation 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 the items to be taken into account during a laboratorys periodic management reviews. In addition, laboratories may also maintain records of evaluation of proficiency testing results, internal audits and external assessments, and actual performance evaluations of staff relating to their defined responsibilities and as approved by the evaluator (e.g., the Technical and/or Quality Manager) consistent with Section 5.2.5, as a means of attesting to the effectiveness of the training that was given to laboratory personnel.

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

04/30/2005 5.4 2005

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 for the purposes of technical validation related to the requirements of this section.

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

06/10/2005 5.4.2 2005

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. The documentation 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 for determining if the method can be included on the Scope of Accreditation.

If a laboratory uses non-standard methods, but they are specified/required directly by the client during contract review, must the laboratory validate these methods per ISO/IEC 17025, Section 5.4.5?

02/06/2007 5.4.5 2005

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