A2LA Explanations for the ISOIEC 17025 Requirements

5/26/2018 A2LA Explanations for the ISOIEC 17025 Requirements

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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 calibrationand testing in describing requirements. How do

laboratories that only perform one or the other

interpret those requirements?

04/30/20051.2

2005

ISO/IEC 17025 covers both calibration and testing laboratories, so the pairing of calibra

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 laborato

should ignore the word test.

Do laboratories accredited to ISO/IEC 17025 also

meet ISO 9000?

04/30/2005

1.6

2005

ccording 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.

addition, Testing and calibration laboratories that comply with this International Standa

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 qua

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, o

identifiable division or in-house activity of a business or corporation, which meets the


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applicable legal requirements of the governmental jurisdiction in which it conducts busine

Legal responsibility aids in addressing issues of liability/accountability, uniqueness, and

independence of operation.

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 paren

organization who have an influence over laboratory activities. It is important to note, how

that this requirement is predicated on the labs being part of a larger organization involve

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

one or more specific tests or calibrations and results in a reduction in the Scope(s) of

ccreditation.

The term key personnel is used in various places throughout ISO/IEC 17025. The curre

versions of ISO 17000 and the VIM do not contain a definition for this term. For practical

urposes, A2LA defines a key person as:

someone whose absence would jeopardize the integrity of the laboratory. Key personnellay fundamental roles in the implementation of the management system.

Granted, this is very subjective and open to interpretation by the laboratory and the assess

t 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

urposes of compliance with ISO/IEC 17025. Any other personnel who have a unique role

the laboratory that has an involvement with or influence on the testing or calibration activ


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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 aud

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 manag

and technical personnel.

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

be internal (e.g., management pressure, deadlines) or external (e.g., customer complaints,

riority request). Management should decide which types of undue pressure the staff migh

encounter and implement clear policies and instructions for countering them. Precautionsshould 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 gratu

by employees from clients in order to avoid perception of conflict of interest. Also, a policy

handling internal complaints or concerns from employees should be included. Communica

(priority request, complaints, status inquiries, etc.) could be directed through supervision

administrative personnel. Ethics programs, skip-level management interviews, arbitrator

rograms, etc. may also provide avenues of coordination that preclude adverse effects

resulting from commercial pressures. All these efforts may be included in the quality manu

issued as a policy statement to employees.

It is also important to note that, though the requirement is for the lab to have arrangeme

in place, this is understood to mean documented arrangements within the labs quality sys

(e.g., a policy or procedure).


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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 Co

of Ethics in place as part of its management system. That said, however, each accreditedorganization is strongly encouraged to have such measures in place to aid in fully complyi

with these sections of the Standard and to aid in substantiating the ethical grounds upon w

an organization operates if their actions are ever called into question.

helpful tool to assist any organization in developing and maintaining a Code of Conduct

Code of Ethics is an ethics self-assessment. Such a self-assessment can help an organizatio

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 con

the issues?

Do you advocate ethical decision making by your organizations Board, management tea

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?

Do you use your authority solely to fulfill your responsibilities and not for self-interest or

urther the interests of family, friends or associates?

When an ethical conflict confronts you or your organization, are you successful in finding

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?


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Do you maintain confidences entrusted to you?

Do you demonstrate through personal action and organizational policies zero tolerance f

any form of staff harassment?

Do you expect and hold staff accountable for adherence to your organizations ethicalstandards (for example, through periodic performance reviews)?

Do you hold all staff and business partners accountable for compliance with professiona

standards, including ethical behavior?

Are you mindful of the importance of avoiding even the appearance of wrongdoing, confl

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

ou?

(Information drawn from The Joint Commission on Accreditation of Healthcare Organizat

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

n organization chart or charts with the reporting relationship to any parent organization

ownership should normally be a sufficient presentation of the organization and manageme

structure of the laboratory. However, the organizational structure may also be described i


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other fashions that may be equally acceptable.

What is meant by direct access 04/30/20054.1.5i

2005

This section of ISO/IEC 17025 requires that a single member of the laboratory staff be giv

responsibility for acting as quality manager. A common misinterpretation in attempting

meet this requirement is that it is sufficient only to have an organizational chart that shows

direct line from the quality manager to the highest level of management. In order to determ

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 member

the highest level of management? Can the quality manager walk into their office? Can tquality manager email them or contact them by other means? These are all modes of dire

access that an assessor may verify on site.

What position(s) require deputies? 06/10/2005

4.1.5j

2005

rrangements for designating the person(s) acting in the absence of the technical and quamanagement should be documented to ensure continuity of operation in case of absence(s)

the integrity of the laboratory is jeopardized by the lack of other key staff, deputies for tho

ositions should also be provided. Designated deputies must have the required knowledge

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 als

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

articular place and function within the overall organization. Interviews with laboratory


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ersonnel would be expected to reveal that they are performing their functions correctly an

that they are aware of the quality objectives of the organization. This clause is closely rela

to several others within the standard as this awareness by laboratory personnel can and sh

be directly tied to the effectiveness of communications through laboratory management,

erformance evaluations of laboratory personnel and management reviews within the

organization.

Must communication always be in a written form? 07/19/2005

4.1.6

2005

Effective communication may occur by a variety of meanse.g, through the use of written

memos, telephone, email or oral discussions. Interviews with laboratory personnel would bexpected to reveal that these processes are in place and that personnel are aware of issues

relate to the management system and its overall effectiveness. For example, communicatio

results of periodic management reviews could be one means of making laboratory personn

aware of the management systems effectiveness. It would also be expected that no evidenc

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 exam

a controlled distribution list of individuals having numbered copies of the quality

documentation (or equivalent electronic means of distribution) or a documented laborator

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


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organizations total range of operations. If so, it may be necessary to extract that informat

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 expa

the corporate quality documentation, where necessary, to satisfy the requirements of ISO/I

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,

rocedures 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 demonstrate, though, through objective evidence that the level of detail presented in its qu

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 ab

some form of documentation must be presented in a form that is repeatable. In developing

quality system appropriate to the scope of a laboratorys activities, documentation may tak

many forms, including written documents, electronic systems, video or other media. Verba

representation of documentation would normally be variable from person to person and so

would not satisfy this requirement.

ny 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

available to, and implemented by the appropriate laboratory personnel. In essence, each

erson who requires a piece of documentation to perform his job correctly must have acce

that piece of documentation.

Must the quality manual include all of thelaboratorys procedures? 04/30/20054.2.2

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 regar

this). However, the procedure may be found in other documents as long as it is referenced

the quality manual (per Section 4.2.5). If the procedure is included in the quality manual, i


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considered sufficient to satisfy both the policy and procedure elements.

Is the laboratory now required to review itsperformance against objectives?

07/19/20054.2.2

2005

Specific attention should be paid to this new second sentence of this section of the standard

it outlines an additional element to be taken into account during the management review

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 th

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 w

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 parenthetica

hrase however named. So, for example, a laboratory may choose to design their qualitmanual as a single, physical document, or they may choose to design it as a directory with

their electronic management system. (NOTE: These examples are not meant to be an inclu

list of all possible options.)

In the case of the former, all of the elements that ISO/IEC 17025 requires to be defined, w

the quality manual must be defined within the physical document itself.

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 tharovides links to other documents within the electronic directory that are required by ISO/

17025 to be defined within the quality manual.

Does section 4.2.2 require that all of the quality 06/05/2008


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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?

4.2.2

2005

In most cases, a laboratory is required to address all of the quality policy statement eleme

one contiguous statement. According to the standard, the quality policy statement "shallinclude at least the following:

the laboratory's management commitment to good professional practice and to the quali

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

laboratory familiarize themselves with the quality documentation and implement the polici

and procedures in their work; and

the laboratory's management's commitment to comply with this International Standard a

continually improve the effectiveness of the management system. "

It is important to consider the content of the Note that follows this section of the Standa

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 insteamay 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 o

larger organization.

What constitutes an "evidence of commitment" by

top management?

07/19/2005

4.2.3

2005

For either independent or in-house laboratories of larger organizations (e.g., production

acilities), top management is considered to be those individuals who have the authority an

can provide the resources necessary to make changes to any aspect within the laboratory.

therefore, important that these individuals participate in the laboratorys management rev

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 standar


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already requires a statement of commitment to be issued by the 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 th

erformance of appropriate and effective internal audits, management reviews, quality con

analysis, proficiency testing, etc. could also be considered evidence of top managements

commitment to its management system. As a result, records demonstrating top managemen

articipation in these functions could be considered evidence of compliance with this

articular 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 r

of inappropriate or insufficient communication. This clause is closely related to Section 4.

(a), which requires a written policy of the laboratorys commitment to good professional

ractice and the quality of the services it offers.

My laboratorys quality manual contains clear

statements of the roles and responsibilities for our

quality manager and technical management.

However, none of these explicitly state that they are

responsible for the laboratorys compliance with

ISO/IEC 17025. Does this warrant a deficiency?

09/06/2007

4.2.6

2005

Yes. Section 4.2.6 ofISO/IEC 17025 requires that the quality manual define the roles and

responsibilitiesincludingresponsibility for ensuring compliance with this Internationa

Standard. As such, ensuring compliance with ISO/IEC 17025 must be explicitly included the responsibilities defined and listed within the labs quality manual for either or both the

quality manager and technical management.


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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 majo

changes are made to the organizational structure, reporting structure or management stafflaboratory, but also to more subtle changes that are frequently made to a management sys

For example, has the integrity of the laboratorys document control system remained intac

when certain areas have been changed or updated? When a change is made to one labora

olicy 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 th

system? Are laboratory personnel appropriately informed of changes that affect them? All

these issues speak to the overall integrity of a laboratorys management system.

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. Howe

if a form contains instructions for performance of a task or even instructions for filling out

orm 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 neces

or 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 c

this control may be included in the procedures by which the laboratory maintains and con

its equipment under Section 5.5 (e.g., when the software is integral to the equipment). Allrequirements of 4.3.1, 4.3.2 and 4.3.2.2 (a-d) as well as the pertinent requirements in secti

5.5 must be met.

(NOTE: Word processing software does not have to be controlled unless it is used for

calculation of derived data.)


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What does A2LA consider to be normative

documents that my laboratory must control under

our document control system?

03/20/2012

4.3.1

2005Normative documents are those that provide rules, guidelines or characteristics for activit

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 h

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

17025, general A2LA policy documents, and the specific A2LA program requirement

documents relating directly to their field of accreditation. A2LA does not considerterminology documents, such as ISO/IEC 17000 and the VIM, to be normative documen

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;

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 Scop

of Accreditation; and


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P109 - Technical Consensus Decisions from the Measurement Advisory Committee;

R104 - General Requirements: Accreditation of Field Testing and Field Calibration

Laboratories.

Having these documents included in the laboratorys document control system requires ththey 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 17

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?

09/06/2012

4.3.2.1

2005

2LA considers a laboratorys master list to be a record and not a document that is sub

to document control requirements. Section 4.3.2.1 of ISO/IEC 17025 indicates that the cla

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). If the master list is an online file directory or a screen from an intranet Con

Management System (CMS), it is considered to be an electronic record that is a living list

reflecting the online status of each document.

Our lab only maintains one controlled & centrally-

located copy of every document in the management

system. Is a master list outlining distribution really

required in this case?

09/06/2012

4.3.2.1

2005

No, a master list is not necessary. 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 Many laboratories now maintain their managem

system through a lab file server or from within a content management system (CMS). In bothese cases, the user accessible file directory or CMS cabinet provides adequate metadata

satisfy this clause of ISO/IEC 17025. If a laboratory maintains a controlled paper copy of

documents within their management system, it is assumed that each is also maintained as a

word-processed object in a server file directory. The directory itself may then serve as the

master list required by this clause of the Standard, as long as the document control proced

also specifies the location/distribution of the controlled hardcopy.


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Does our master list have to explicitly contain each

required 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 made to A2LA normative documents?

03/14/2011

4.3.2.12005

2LAs explanation of Section 4.3.1 of ISO/IEC 17025 states:

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 equivalespecifically include the revision statusof documents in the management system. A gen

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

rocedure) and must be accompanied by a clear indication of their revision status (e.g., da

issued, date revised). A direct link within the master list (or equivalent procedure) to the a

document on the A2LA website is considered sufficient indication of the document and its

revision status.

Implementation timeframes for revisions or updates to A2LA documents vary, depending o

nature of the update or revision. In some cases, an implementation deadline is contained wthe 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 rece

of notice of the update when the revision is considered minor and laboratories are reminde

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

2LA document, they are encouraged to contact their Accreditation Services representativ

clarification.

Are older versions of test methods to be considered

obsolete when they are in use by my laboratory

and appear on my Scope of Accreditation?

07/11/2013

4.3.2.2 (c) and (d)

2005

Obsolete documents in this context are those that are no longer in use by the laboratory an


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that are no longer part of their controlled management system. Obsolete documents may b

those that have been retired completely from the management system or may be documents

have simply been superseded by an updated version. Either way, the term obsolete in th

section of the Standard relates to the laboratorys actual use of the document. It is underst

that some laboratories implement standard methods and procedures other than the most

current published version. In these cases, this is clearly documented on their Scopes of

ccreditation and on their final test/calibration reports and the older version of the standa

method/procedure is part of the laboratorys controlled management system. In these case

older version of a standard method/procedure is not considered obsolete in the context

the laboratorys use and so A2LA would not expect it to be marked obsolete per this sec

of the Standard.

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 te

a revised document and the language that is used in Section 4.3.3.2 allows for considerabl

variation in application. New or altered text shall be identified, for example, by the followi

means:

using highlight and strikethrough features;

using a revision history at the end of a document that outlines the changes made to spe

sections, paragraphs, sentences, etc;

using track changes to revise the document and maintaining a single, controlled versio

with the tracked changes in place while issuing clean, unmarked and controlled version

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 infor

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 when

racticable. A2LA interprets this to mean whenever practice-able and so it is expected t

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 tex

For example, if a document has 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 ca


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it could be considered impracticable to include references to every change made (such as

highlights and strikethroughs) that would render the document difficult or impossible to us

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 receive

rom 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. T

standard requires a review and record (per Section 4.4.2) of all three phases of the proces

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 measure

uncertainty with their clients to ensure that they can meet the clients specifications. Likew

accredited laboratories requesting calibration services should ask their calibration providabout measurement uncertainty before procuring those services to ensure that they receive

service and information they require.

My laboratory is part of a multi-laboratory

organization. All laboratories within my

organization are A2LA accredited and fall under the

classification of a branch system as defined byA2LA. 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?

08/06/2009

4.5

2005

s stated in Part C, Section I of R101General Requirements: Accreditation of ISO/IEC


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17025 Laboratories, A2LA accreditation is site specific, meaning that each discrete loc

is considered to be its own entitywhether or not it is part of a larger, accredited, multi-

laboratory organization. As such, transfer of work among accredited locations within such

branch system is considered to be sub-contracting and is subject to all requirements rel

to sub-contracting in ISO/IEC 17025 and related A2LA requirements documents.

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 anotlaboratory that is accredited for it. A2LA will only include on a laboratorys Scope those t

or calibrations that the laboratory has been assessed as being competent and capable to

erform, meaning that it has the appropriate equipment, method(s) and trained personnel.

2LA will not accredit a laboratory for any test or calibration if it does not maintain

ermanent 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 a

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

laboratory that complies with 17025 for the work in question. However, Section 4.5.4 of th

standard states that the lab must have a record of evidence of the subcontractors complia

with 17025 for the work in question. Although these two sections appear inconsistent with other, it is important to understand that the standard is allowing a laboratory to use whate

means it deems appropriate to evaluate its subcontractors. However, the record produced

this evaluation must detail the subcontractors level of compliance with ISO/IEC 17025 fo

work in question. Accredited laboratories using the services of a subcontracted laboratory

responsible for thesubcontractors work (per Section 4.5.3) and must notify the client of th

roposed subcontracting in writing (per Section 4.5.2). So, in most cases, acceptability of


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subcontractor is a matter of laboratory-customer agreement. In the absence of any specifi

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 h

subcontractors. Reliance on the A2LA-accredited status of a subcontractor for the pertinen

calibrations or tests is sufficient. However, when a subcontractor is not accredited by A2L

other organization recognized as equivalent) the laboratory should record its assessment o

that subcontractors capability to meet 17025 for the subcontracted work in question. As a

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 subcontra

work in question):

A copy of the subcontractors quality manual demonstrating compliance with ISO/IE17025;

A copy of the subcontractors procedure(s) for the work in question and demonstratof adequate performance through proficiency testing;

A copy of the training records for the personnel responsible for performing thesubcontracted work; and

An example report or certificate for the work intended to be subcontracted.

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 p

of the tests or calibrations included on a laboratorys Scope of Accreditation.

My laboratory utilizes commercial calibration

services for our equipment. However, we use noother supplies or consumable materials for the

tests/calibrations on our Scope. Is Section 4.6

applicable to us?

05/03/2007

4.62005

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 serv


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ou useeven if no other consumable materials are used by your lab.

Should I consider the commercial proficiency testingproviders that my laboratory uses to be suppliers of

critical services?

02/07/20134.6.1 and 4.6.4

2005

Yes. Commercial proficiency testing providers are considered suppliers of critical services

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 purchase

services and supplies. Therefore, a laboratory utilizing internal proficiency programs is no

considered to be "purchasing" these services and so Section 4.6 is not applicable. It is also

important to remember that ISO/IEC 17025 does not require the laboratory to maintain a

single approved vendors list and so commercial proficiency testing providers approved use by the laboratory (particularly those mandated by specifiers or users of the laboratory

services) may be listed in a number of places, such as the laboratorys quality manual, wit

contract records for particular customers or within the proficiency testing plan required by

PT4 of A2LAs R103 General Requirements: Proficiency Testing for ISO/IEC 17025

Laboratories.

What types of services and supplies are covered bythis requirement? 04/30/20054.6.1

2005

The most common service covered by this requirement is equipment calibration. The A2LA

Traceability Policy requires that calibration services be obtained from recognized Nationa

Metrology Institutes (NMIs) or laboratories accredited to ISO/IEC 17025 by A2LA (or ano

accrediting body recognized by A2LA through its mutual recognition arrangements) when

laboratories are available for the calibrations required. This ensures that traceability to th

relevant national or international metrology standards as required by Section 5.6 is

authenticated. Laboratories should evaluate the measurement uncertainties claimed by the

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.

Reference material suppliers should be accredited if possible and all suppliers of other ou


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support services and products should have a registered quality system to one of the ISO 90

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

confirm compliance of such materials/services with standard specifications or requiremen

defined in the methods for the tests and/or calibrations concerned. While the standard doe

require that specific material identifications (e.g., lot numbers) be recorded on every

compliance check record, a laboratory must maintain sufficient traceability throughout therecord system of the actions that were taken, such that this information could be determine

and retrieved should an audit trail ever be required per Section 4.13.2.1 of ISO/IEC 17025

the case of a malfunctioning or substandard supply or material. This traceability of record

must allow the laboratory to determine through their audit trail what materials are affecte

and what test results may be or may have been affected.

What specific items does A2LA look for in mypurchasing documents in order to meet the

requirements in Section 4.6.3?

09/10/20094.6.3

2005

Section 4.6.3 of ISO/IEC 17025:2005 does not indicate what specific items must be include

a labs purchasing documentation nor does it specify what form this documentation must t

It simply requires that the documentation produced during purchasing (e.g., purchase ord

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 conte

rior 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

laboratory may include in their purchasing documents, but these are by no meansrequirements.

When the service/supply is ultimately received, it is incumbent upon the laboratory to ensu

that it meets their needs and requirements. If their needs are fully met, then their purchasin

rocedure is assumed to be adequate since there is no evidence to the contrary. If there ar

shortcomings or omissions in the service/supply received, then the laboratory must determ


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what actions must be taken to address the unacceptable service/supply and to ensure this d

not happen in the future. This may result in a change to their process such that additional

specific detail, information or instructions are captured in purchasing documentation for t

vendor/supplier.

In what ways may a laboratory seek feedback, and

how must this feedback be analyzed?

07/10/2008

4.7.2

2005

s the note to this clause suggests, there are many ways in which a laboratory may solicit

eedback 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

entire range of a client's interaction with the laboratory (including, for example, customerservice, 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 informe

the mechanism they may use to provide feedback. In-house or captive laboratories could s

eedback 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

required to maintain records of the analysis of any feedback received as well as records of

manner in which this feedback is used to improve the management system, testing/calibratactivities and customer service. The latter may generally be accomplished through the

examination of customer feedback during periodic management reviews and so may be tie

the requirements of Section 4.15 and the records maintained in accordance with those

requirements.

What constitutes a complaint? 06/10/2005

4.82005

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 som

or resolution. Guidance should be supplied in the quality manual as to when a conversati

becomes recorded as a complaint and all complaints should be documented in a file includ

the substance of the complaint and its resolution. Complaints may be generated by externa


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customers or from within the laboratorys organization.

Complaints referred to in this section should not be confused with complaints against qual

characteristics of the actual product or item being tested or calibrated. ISO 10002: 2004

rovides 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 laboratorysprocedure for controlling

non-conforming work ensures each of the items listed in a-e is accomplished, if applicable

order to confirm that a laboratorys procedure does indeed ensure these things, an assesso

would expect each, individual record of non-conforming work to specifically identify each

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 must the laboratory provide?

07/19/2005

4.10

2005

Requirements for the quality policy, quality objectives, internal audits, data analysis,

corrective and preventive actions and management reviews are all addressed in other sect

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 t

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

taken to ensure that a nonconformity event does not occur again, this is considered part of

corrective action - not a preventive action. Preventive action is the proactive identification


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otential problems or areas for improvement. In essence, no nonconformity event takes pla

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 proce

that starts with an investigation to determine root cause; however, a deficiency against 4.1

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 sh

be used as a tool for continuous improvement, which may reduce or eliminate the likelihoo

uture 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

it is not, and there may be multiple root causes. Because of this, there is no single recipecan be followed. While it is impossible to create a procedure that would apply to all scena

there are some guiding principles which can be employed, the most important of which is t

the root cause should address the question: Why did this deficiency occur? Other points

consider:

Statements of root cause which are essentially a restatement of the deficiency provide no

information beyond the deficiency and are of little benefit to you and are not considered to

an acceptable response by A2LA. In these instances, the root cause is a result of the labora

asking why was this deficiency cited? instead of why did this deficiency occur?

Each deficiency must be evaluated independently.

While each deficiency and its associated root cause must be approached individually, tre

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 pertai


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employee training. In this example, additional investigation into the employee training

rogram 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.

dditional 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, a

2LA assessor would expect to see records of the laboratorys monitoring activities to con

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) ar

be in a documented form.

Does a laboratory have to retain all original

observations?

04/30/2005

4.13.2.1


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(section 4.13.2.1 of ISO 17025:2005) 2005

record of original observations may include data that has been transferred from one me

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 pap

may be destroyed). However it is important to note that other specific A2LA accreditationrograms or regulatory requirements may override this interpretation. The laboratory sho

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 th

uncertainty and to enable the test or calibration to be repeated under conditions as close a

ossible to the original. While the standard does not specifically require that lot numbers

reagents (or other consumable materials) be recorded on every individual test record, a

laboratory should maintain sufficient traceability throughout their record system such tha

information could be determined and retrieved if necessary (e.g., if it is determined that a

reagents was contaminated such that certain test results could be potentially affected). Ple

keep in mind, however, that individual A2LA Specific Program Requirements (e.g., for NEin the environmental field, etc.) may contain additional, more stringent requirements relat

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

laboratory? My lab runs a significant number of the

same tests each day. It seems impractical for me torecord and retain so much original data when my

customers do not wish to receive this additional

information with their final test reports.

09/06/2007

4.13.2.1 (Note 1)

2005

Note 1 only applies to certain situations. For example, it would be applicable to laborator

that accumulate significant amounts of ancillary data (such as control data or pass/fail da

where the reading is qualitative or dial-read, or to laboratories that run copious samples


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through automated testing machines that output only an average or another type of derive

data. However, if the original test data generated by a laboratory is fundamental to the tes

result reported, then Note 1 does not apply - regardless of the amount of tests run per day.

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 fo

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?

09/06/2012

4.13.2.3

2005

Electronic records are records whoseoriginal (or source) data is entered electronically

either automatically by test equipment or by hand. Appropriate measures are to beimplemented by the laboratory to safeguard against loss or change of the originally record

data. The equivalent measure pertains to the initial/date/cross-out concept. To ensur

against the loss or change of original data that is stored electronically, audit trails are

so as not to obscure the original observation(s). Audit trails provide an indelible history of

data from original observation to the final value. The metadata required for each change a

timestamp and record the identity of the person capturing or changing the data, thus allow

the records to show when and by whom each original entry was made and when and by wh

each subsequent change was made. Electronic datasets generated automatically by test

equipment are typically not a concern, since any revisions would be automatically regener

by the test equipment with the assumption that the dataset is not subject to datapointmanipulation.

This equivalent measure to the initial/date/cross-out concept also requires the additi

concept of session time. This is the time allowed for the user to maintain the data in an

editable state prior to committing or checking-in the data. This time should be reason

short to ensure that the history of changes is captured but not so short as to capture every

backspace. Suggested timeframes are end of shift, end of logical portions of tests, or end of

day.

There are mature software tools and techniques that may be used to avoid loss or change oelectronic source data, such as:

The use of Document Management, Content Management, or Code Management applica

that require named users to check-in and check-out documents, spreadsheets, etc. Th

tools retain all versions in history and identify when and by whom the new versions were


28/53

saved.

The use of a database that expires data rather than deleting it. This is a standard featu

SQL databases that also manage the who and when via user IDs.

The removal of the modify permission in the file directory containing the data files. Thwill require the user to save-as the data file, thereby creating unique filenames of each

instance of revision or change.

Printing out the data and saving the paper copy as the original observation.

Use of less mature software tools and techniques is not encouraged but certainly is not

rohibited by the Standard. This may include:

Retaining a register of changes/revisions in electronic records that detail the changes ma

and by whom.

Using revision control features of the application that is used to generate the electronic

record (e.g., track changes in MS Word) but only in combination with removal of the

modify permission in the file directory so that the track changes are not inadvertently

incorporated and turned off, thereby obliterating the original information.

My internal audit consists of completing only theA2LA ISO/IEC 17025 checklist. Is this sufficient?

06/09/20114.14.1

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 sys

and thisInternational Standard (i.e., ISO/IEC 17025) and that the audit shall address a

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 a

calibration activities in such a way as to meet the requirements oforganizations providin

recognition. (i.e., A2LA) As such, your complete internal audit program (in accordance w

our 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. t

orm your management system;


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

Determination of compliance with all relevant A2LA policies and requirements (NOTE:

may be accomplished via an audit against the actual A2LA policy and requirement docum

however, if all required elements of the relevant A2LA policies and requirements have bee

enveloped within the laboratorys management system, then an audit of the management

system itself will necessarily include an examination of compliance with relevant A2LA po

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 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?

10/04/2007

4.14.1

2005

Section 4.14.1 of ISO/IEC 17025 states:

The laboratory shall..conduct internal audits of its activities to verify thatits operation

continue to comply with the requirements of the management system and this Internationa

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 a

interval, as long as their overall audit program specifies how this sampling is to be done s

that all elements of the management system and the accredited testing/calibration activitieaudited 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

arameters may constitute a sufficiently thorough and comprehensive audit of their accred

activities, such that auditing all methods (which may be redundant and overlap) may not b

necessary - as long as there is no evidence or indication that the depth and expanse of the


30/53

technical portion of their audit is inadequate.

lso, 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 (inclu

testing/calibration activities) over a span of a number of years, as long as there is no evide

or indication that the timeframe of this cycle is inadequate. Although R102Conditions fo

ccreditation 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 requirem

or accreditation.

Therefore, if a laboratorysfull audit cycle spans a period of time that is greater than the

eriod of time between full A2LA assessments, they must maintain adequate records for th

ull 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

complete audit cycle may span 5 years. In this case, they must retain full records of each 5

ear 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

or evidence during the on-site assessment that a complete internal audit has been conduc

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-si

assessment, a deficiency will be cited and the internal audit must be completed before initi

accreditation is granted.

NOTE: This must be implemented and will be enforced for all applications received as of

January 1, 2009.

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


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ISO/IEC 17025, Section 4.14.1 requires that the laboratory conduct internal audits. With t

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 websi

2005. As such, it will be implemented as of renewal and initial applications for accreditati

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 d

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 t

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 inte

audit record must therefore include (at a minimum) the area of activity audited, the resulta

findings related to areas of both conformance and nonconformityand corrective act

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 interna


32/53

audit and management review procedures or referenced from the quality manual. The

redetermined schedule may specify dates and/or times (e.g., audits will be performed in

of every odd-numbered year) or may indicate an interval of performance (e.g., managem

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

or 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 thtime of the on-site assessment, a deficiency will be cited and the management review must

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, exec

or top management is considered to be those individuals who have the authority and can

rovide the resources necessary to make changes to any aspect within the laboratory. Alth

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

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

considered to be the same as the highest level of management referenced in Section 4.1.

Is this section applicable to a laboratory's internal 01/26/2006


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auditor? 5.2

2005

Since a laboratory's internal auditor is responsible for examining various aspects associat

with equipment, the performance of tests/calibrations and the issuing of results, it is requir

that the training and qualifications of the internal auditor be identified, documented andevaluated. As a result, all of Section 5.2 of ISO/IEC 17025 (e.g., formulation of goals, poli

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 audito

laboratories are expected to maintain records to demonstrate compliance with Sections 5.2

5.2.5 as related to their internal auditor. (See also a related discussion under Section 4.14

(17025:2005) or 4.13.1 (17025:1999).)

For one particular test/measurement on our

laboratorys Scope of Accreditation, we only have

one person in our laboratory that is competent to

perform the test. During the assessment, must that

person be available for demonstration for each

test/measurement on our Scope that only they are

capable of performing?

05/06/2008

5.2.1

2005

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 candemonstrate each test/measurement on your Scope of Accreditation. If there is only one pe

qualified and competent to perform a specific test/measurement on your Scope, this person

defined as essential by A2LA and must be available during the assessment even if this

erson is a contracted employee.

Some flexibility may be allowed on a case-by-case basis, however, for laboratories underg

a renewal assessment for a particular test or calibration for which there is only one compe

technician, as it is understood that brief illness and unexpected personal emergencies do o

s long as the training, qualification and competence of the essential person can be verifie

through review of records and as long as the person in question was interviewed by therevious 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 oth

means or else the tests/calibrations affected must be temporarily removed from the Scope o

ccreditation.

For new assessments and for assessments of newly added tests/calibrations for which ther


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exist essential personnel, this flexibility cannot be allowed as it would prevent the assessor

rom making a critical, initial determination of whether or not the laboratory does indeed

at least one person (even if this person is a contracted employee) who is competent to perf

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 qualif

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 certa

duties and that records of the relevant authorization(s), competence, educational androfessional 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 compet

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

required by the standard. ISO/IEC 17025 simply requires that a record of the competence

maintainedthis is not the same as requiring a record of the competency data. For examp

or technical personnel that have been with a laboratory for many years, a simple statemen

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 hasright and duty to ask for demonstration of the task from the person deemed competent in o

to confirm this in practice.

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 isevaluated based on the range, complexity and frequency of performance of calibrations or

or which accreditation is sought. Some programs (e.g., environmental) include specific

ersonnel qualification requirements.

Technical personnel must have demonstrable knowledge and skills to perform calibrations

tests and compute results. They may be asked to demonstrate tests or specific techniques d


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an assessment.

The qualifications and experience required for senior staff are reviewed during the assessm

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 tho

calibrations or tests that are judged to be highly experience-dependent;

The involvement that the senior staff member has with the development and adoptionew methodologies within the laboratory.

In assessing qualifications, the balance between relevant academic qualifications and prac

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 senio

staff engaged in a limited range of relatively simple calibrations or tests (while holding les

qualifications) may demonstrate appropriate competence by having relevant calibration o

experience and demonstrable laboratory management expertise.

In many cases, more than one staff person may be involved to assure technical competenceFor example, a supervisor exercising technical control may be relatively inexperienced wi

respect to one facet of the laboratorys work, but another person or persons working in clo

collaboration with the supervisor may compensate for this inexperience. The accreditation

such a case would be reviewed if there were a major change in either persons duties. The

of key personnel may also affect continuing accreditation. For example, A2LA assessors

identify key (or indispensable) staff whose absence would reduce the laboratorys technica

competence and may prompt a reassessment before it would normally be scheduled or rem

of the affected tests from the Scope of Accreditation.

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

5.2.2

2005

Goals with respect to education, training and skills must form part of the laboratorys


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documented record system (e.g., within records of regular staff performance reviews, etc.)

The last sentence of this clause requires anevaluation of the effectiveness of training actions.

How can this be accomplished?

07/19/20055.2.2

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

whole, but rather is to be done to determine the effectiveness of individual training actions

are taken for laboratory personnel in relation to the goals that were to have been establish

or them per the first sentence of this clause. Records of this evaluation are required and m

be tied to Section 4.15, as staff training is one of the items to be taken into account duri

laboratorys periodic management reviews. In addition, laboratories may also maintainrecords of evaluation of proficiency testing results, internal audits and external assessmen

and actual performance evaluations of staff relating to their defined responsibilities and a

approved by the evaluator (e.g., the Technical and/or Quality Manager) consistent with Se

5.2.5, as a means of attesting to the effectiveness of the training that was given to laborato

ersonnel.

What is the difference between the words methodand procedure as contained in the standard? 04/30/20055.4

2005

lthough normative references such as the VIM contain separate definitions for method

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 secti

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

06/10/20055.4.2

2005

2LA considers accreditation of in-house methods where existing standard methods are no

suitable. These methods must be documented and appropriately validated in accordance w

Section 5.4.5. The documentation should normally follow the format as described in the No

ollowing Section 5.4.4. Documentation of the validation of the method as established by th


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laboratory is the primary basis for determining if the method can be included on the Scope

ccreditation.

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

If the non-standard method is actually listed on the labs Scope of Accreditation (e.g., due

requent or repeat requests for the method by their client) or if the non-standard method is

modification of a standard method listed on the labs Scope, then the laboratory is respons

or validating that non-standard method per Section 5.4.5 of the standard if they wish the w

to be considered accredited. If the client specifies exactly which non-standard method thelaboratory must use but that method is not listed in any form on the labs Scope of

ccreditation, then the client is essentially taking responsibility for the validity of the meth

itself. In this case, the laboratory need not validate the non-standard method required by t

client. However, for the work to be considered accredited, the laboratorys Scope of

ccreditation must clearly indicate that the laboratory is accredited to perform client-prov

methods and the method required by the client must be within the stated ranges and/or

arameters listed on the labs Scope. Scopes of this nature are technology-" or "paramet

based and are the exception rather than the rule. In addition, the laboratorys contract re

documentation must clearly indicate that the method used was chosen and required by the

client. For those Scopes of Accreditation that do list specific methods (i.e., Scopes that aretechnology- or parameter-based) but also include a footnote conferring accreditation for o

similar types of methods, the laboratory is required to validate those similar methods

the same manner in which the A2LA assessor confirmed that they validated the specific

methods that are actually listed on their Scope of Accreditation.

If a testing laboratory only performs tests that do

not require measurement uncertainty, does thisrequirement still apply?

04/30/2005

5.4.6.12005

Even though the A2LA Policy on Measurement Uncertainty for Testing Laboratories

identifies some classifications of test methods for which additional uncertainty analysis is

required, that exemption does not extend to the calibration of equipment used for those tes

In the case of tests that fall under Section 5.4.6.2 - Note 2, uncertainty analysis for the test

5/26/2018 A2LA Explana