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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
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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
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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
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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
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