ac89 - The International Accreditation Service

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ACCREDITATION CRITERIA FOR TESTING LABORATORIES
AC89
February 2016
(Effective April 1, 2016)
PREFACE
The attached accreditation criteria has been issued to provide all interested parties with guidelines on
implementing performance features of the applicable standards referenced herein. The criteria was
developed and adopted following public hearings conducted by the International Accreditation Service,
Inc. (IAS), Accreditation Committee and is effective on the date shown above. All accreditations issued
or reissued on or after the effective date must comply with this criteria. If the criteria is an updated
version from a previous edition, solid vertical lines (|) in the outer margin within the criteria indicate a
technical change or addition from the previous edition. Deletion indicators (→) are provided in the outer
margins where a paragraph or item has been deleted if the deletion resulted from a technical change.
This criteria may be further revised as the need dictates.
IAS may consider alternate criteria provided the proponent submits substantiating data demonstrating
that the alternate criteria are at least equivalent to the attached criteria and otherwise meet applicable
accreditation requirements.
Copyright © 2016
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February 8, 2016
ACCREDITATION CRITERIA FOR TESTING LABORATORIES
1.0 INTRODUCTION
demonstration of its competence to carry out specific
conformity assessment tasks.
1.1
Scope: The purpose of this criteria is to set forth
requirements for obtaining and maintaining International
Accreditation Service, Inc. (IAS), testing laboratory
accreditation and for the qualifying data that must be
submitted relating to the scope of testing for which
accreditation is sought. This criteria supplements the IAS
Rules of Procedure for Laboratory Accreditation.
3.2
Accreditation Body (AB):
that performs accreditation.
3.3
Assessment:
Process undertaken by an
accreditation body to assess the competence of a CAB,
based on particular standard(s) and/or other normative
documents and for a defined scope of accreditation.
1.2
References and Normative Documents:
Publications listed below refer to current editions (unless
otherwise stated), current editions of related construction
codes published by the International Code Council or
codes duly adopted by the relevant jurisdiction.
3.4
Calibration: Operation that, under specified
conditions, in a first step, establishes a relation between
the quantity values with measurement uncertainties
provided by measurement standards and corresponding
indications with associated measurement uncertainties
and, in a second step, uses this information to establish a
relation for obtaining a measurement result from an
indication.
1.2.1 ISO/IEC
(International
Organization
for
Standardization/International
Electrotechnical
Commission) Standard 17025, General requirements for
the competence of testing and calibration laboratories.
1.2.2 IAS
Accreditation.
Rules
of
Procedure
for
3.5
Calibration and Measurement Capability
(CMC):
Calibration and measurement capabilities
provided by the laboratory, available to customers under
normal conditions, and as described in the laboratory’s
scope of accreditation granted by a signatory to the ILAC
Arrangement.
Laboratory
1.2.3 ISO/IEC
Standard
17011,
Conformity
assessment—General requirements for accreditation
bodies accrediting conformity assessment bodies.
1.2.4 IAS Calibration and
Accreditation Programs Definitions.
Testing
3.6
Certified Reference Material (CRM): Reference
material, accompanied by documentation issued by an
authoritative body and providing one or more specified
property values with associated uncertainties and
traceability, using valid procedures.
Laboratory
1.2.5 ILAC-P9, ILAC Policy for Participation in
Proficiency Testing Activities.
3.7
Conformity Assessment Body (CAB): Body
that performs conformity assessment services and that
can be the object of accreditation.
1.2.6 Information on Proficiency Testing Providers
for IAS Clients.
1.2.7 IAS Policy Guide on Calibration, Traceability,
and Measurement Uncertainty for Testing Laboratories.
NOTE: Whenever the word “CAB” is used in the text, it
applies to both the “applicant and accredited CABs” unless
otherwise specified.
1.2.8 Joint Committee for Guides in Metrology,
International vocabulary of metrology – Basic and general
concepts and associated terms (VIM).
3.8
Extending Accreditation: Process of enlarging
the scope of accreditation.
1.2.9 IAS Policy on the Expansion of the Scope of
Accreditation of Accredited Testing Laboratories and
Inspection Agencies.
3.9
ILAC:
Cooperation.
3.10
1.2.10 IAS Policy on Authorized Signatories.
1.2.11 IAS
Laboratories.
Policy
on
Proficiency
Testing
BASIC INFORMATION
3.13 Reference Material:
Material, sufficiently
homogeneous and stable with reference to specified
properties, which has been established to be fit for its
intended use in measurement or in examination of nominal
properties.
The following basic information is necessary:
2.1
Data showing compliance with the IAS Rules of
Procedure for Laboratory Accreditation.
3.0
a
with
Section
Laboratory: A body that calibrates and/or tests.
3.12 Proficiency Testing: A determination of the
laboratory calibration or testing performance by means of
interlaboratory comparisons.
1.2.13 IAS Policy on Accreditation Certificate Validity.
2.2
Data showing compliance
Required Data, of this criteria.
International Laboratory Accreditation
3.11 Metrological Traceability Chain: Sequence of
measurement standards and calibrations that is used to
relate a measurement result to a reference.
for
1.2.12 IAS Policy on Testing at Off-site Locations by
IAS-Accredited Laboratories.
2.0
Authoritative body
4,
3.14 Reference Standard: Measurement standard
designated for the calibration of other measurement
standards for quantities of a given kind in a given
organization or at a given location.
DEFINITIONS
3.1
Accreditation: Third-party attestation related to
conformity assessment body conveying formal
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3.15 Remote Surveillance Assessment: A remote
assessment tool used to evaluate compliance as part of
the IAS ongoing plan of surveillance. Remote surveillance
assessments are limited in scope, typically covering a
sampling of key requirements. Remote surveillance
assessments rely on computer-assisted auditing
techniques, including teleconferencing, interactive webbased communications or remote access to management
system documentation and records. Remote surveillance
assessments do not replace the requirement for initial
assessments or periodic on-site reassessments of an
accredited organization.
by compliance with the requirement for evaluation of a
nonaccredited calibration provider in accordance with the
document referenced in Section 1.2.7 of this criteria. In all
cases, bodies issuing accreditations to calibration
laboratories must operate under ISO/IEC Standard 17011.
4.3
Laboratories performing in-house calibrations are
required to maintain the reference standards and
equipment necessary to ensure traceability. The reference
standards/equipment must be calibrated by an accredited
calibration laboratory or by NIST. In cases in which
calibration services are not available from an accredited
laboratory as defined above, laboratories must be able to
demonstrate the steps they take to ensure the quality and
traceability of their calibration services. Laboratories
performing internal calibrations shall issue calibration
certificates or reports that are in compliance with
requirements detailed in Section 5.10 of ISO/IEC Standard
17025:2005.
NOTES: In cases where a laboratory forms part of an
organization that carries out other activities besides
calibration and testing, the term “laboratory” refers only to
those parts of that organization that are involved in the
calibration and testing process. As used herein, the term
“laboratory” refers to a body that carries out calibration or
testing at or from a permanent location.
4.4
Internal Calibration: Testing laboratories that
perform internal calibrations must meet all applicable
requirements of the IAS Policy Guide on Calibration,
Traceability and Measurement Uncertainty for Testing
Laboratories for the calibrations that are performed
internally. Additionally, the following information must be
provided or made available to IAS:
3.16 Scope of Accreditation: Specific conformity
assessment services for which accreditation is sought or
has been granted.
3.17 Surveillance:
Set of activities, except
reassessment, to monitor the continued fulfillment by
accredited CABs of requirements for accreditation.
4.4.1 A list of equipment that is calibrated internally
and the equipment used as the reference standard(s).
NOTE: Surveillance includes both surveillance on-site
assessments and other surveillance activities, such as the
following:
4.4.2 The specific procedures used for calibration of
equipment.
a) Enquiries from the accreditation body to the CAB on
aspects concerning the accreditation;
4.4.3 The training records of personnel qualified to
perform the internal calibration.
b) Reviewing the declarations of the CAB with respect to
what is covered by the accreditation;
4.4.4 A scope that lists the disciplines and
parameters of the internal calibration, including the
Calibration and Measurement Capability (CMC).
c) Requests to the CAB to provide documents and
records (e.g. audit reports, results of internal quality
control for verifying the validity of CAB services,
complaints records, management review records);
4.4.5 The calibration activity shall be audited as part
of the laboratory’s internal audit.
d) Monitoring the performance of the CAB (such as
results of participating in proficiency testing).
4.4.6 The laboratory shall participate in proficiency
testing, where available, for its calibration activity. The
laboratory may also choose other options as indicated in
Clause 5.9 of ISO/IEC Standard 17025:2005, Assuring the
quality of test and calibration results.
3.18 Verification: Provision of objective evidence
that a given item fulfills specified requirements.
3.19 Witnessing: Observation of the CAB carrying
out conformity assessment services within its scope of
accreditation.
4.0
4.5
Internal Audit: The testing laboratory shall, in
accordance with a predetermined schedule and
procedure, conduct internal audits annually of its activities
to verify that its operations continue to comply with the
requirements of the management system and ISO/IEC
Standard 17025. (The internal audit program shall address
all elements of the management system, including the
testing and/or calibration activities. It is the responsibility of
the quality manager to plan and organize audits as
required by the schedule and requested by management.)
Such audits shall be carried out by trained and qualified
personnel who are, wherever resources permit,
independent of the activity to be audited.
REQUIRED DATA
4.1
The laboratory seeking accreditation must submit
data showing compliance with ISO/IEC Standard 17025,
General requirements for the competence of testing and
calibration laboratories.
4.2
The following policy on measurement traceability
and calibration is supplemental to the requirements noted
in ISO/IEC Standard 17025: Accredited testing
laboratories are required to ensure traceability of their
measurements (whenever such traceability is achievable)
by obtaining calibration services either directly from a
national laboratory, such as the National Institute of
Standards and Technology (NIST), or from a calibration
laboratory accredited under ISO/IEC Standard 17025 or
4.6
Management Review: In accordance with a
predetermined schedule and procedure, the laboratory's
top management shall annually conduct a review of the
laboratory's management system and testing and/or
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calibration activities to ensure their continuing suitability
and effectiveness and to introduce necessary changes or
improvements. The review shall take account of:
•
determine compliance with this criteria (AC89), and IAS
policies, and to evaluate expertise and equipment in the
area(s) of testing where accreditation is sought.
5.2
After the initial year of accreditation, laboratories
are subject to a remote surveillance assessment as part of
the ongoing plan of assessment. Upon request from IAS,
laboratories shall provide the following information: the
laboratory’s internal audit and management review
reports/minutes; any complaints; actions resulting from
any Concerns noted in the previous IAS assessment
report; results of proficiency testing, if any; any major
changes in key personnel, facilities, equipment or in the
laboratory’s management system and actual test reports
for test methods that are within the laboratory’s scope with
IAS.
Suitability of policies and procedures,
•
Reports from managerial and supervisory
personnel,
•
Outcome of recent internal audits,
•
Corrective and preventive actions,
•
Assessments by external bodies,
•
Results of interlaboratory comparisons or
proficiency tests,
•
Changes in the volume and type of the work,
•
Customer feedback,
•
Complaints,
•
Recommendations for improvement,
5.3
IAS will conduct an on-site reassessment of
accredited laboratories at a minimum of once every two
years, commencing from the date of the initial
accreditation, for verification of continued compliance with
IAS accreditation requirements.
6.0
•
Other relevant factors, such as quality control
activities, resources and staff training.
5.0
PROFICIENCY TESTING ACTIVITY
Proficiency testing activity shall be completed in
accordance with ILAC-P9. 
ASSESSMENTS
5.1
Prior to accreditation, laboratories are subject to
an on-site assessment by IAS. This assessment is to
(Previously issued:
February 2015)
September 2002, June 2003, May 2004, May 2005, August 2006, April 2008, May 2010 and
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