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法規名稱: ASIA PACIFIC LABORATORY ACCREDITATION COOPERATION MUTUAL RECOGNITION ARRANGEMENT
簽訂日期: 民國 94 年 11 月 16 日
生效日期: 民國 94 年 11 月 16 日
簽約國: 亞太地區 > 亞太實驗室認證聯盟
沿革:
1.Signed on Novenber 16, 2005; Entered into force on Novenber 16, 2005.

 
PREAMBLE
The Asia Pacific Laboratory Accreditation Cooperation (APLAC) is
an organisation of laboratory, reference material producer and
inspection body accreditation bodies in the Asia Pacific Region,
formalised with the signing of a Memorandum of Understanding
(MOU) in April 1995, among 20 accreditation bodies.

Signatories to the MOU committed to cooperate so as to generally
improve standards of testing, calibration, inspection in the
economies of the region, and to enhance the free trade
objectives of the region, and between the region, and economies
elsewhere.

APLAC is one of the Specialist Regional Bodies supporting the
trade facilitation activities of the APEC1 Subcommittee on
Standards and Conformance (SCSC).

This document describes the elements of a Mutual Recognition
Arrangement (MRA) as a means by which the signatories formally
recognise with mutual confidence one another's accreditations
within each signatory's scope of recognition under this MRA. The
scopes of recognition (testing; calibration; inspection) are
listed below for each signatory.

This MRA does not supersede other recognitions required by laws
and regulations in the economies of the signatory bodies.

PRINCIPAL ELEMENTS OF MUTUAL CONFIDENCE
The principal elements of the APLAC (MRA), listed below,
establish confidence among the signatory accreditation bodies.
These elements are designed to ensure conformity with the
requirements in order to establish and maintain mutual
confidence in the technical competence of APLAC signatories and
their accredited laboratories, inspection bodies. The elements
are:

1 Exchange of information on the development and operation of
APLAC member laboratory, and inspection body accreditation
bodies.

2 Participation in the work and decision making of the APLAC
General Assembly, including timely return of postal ballots.

3 Participation in international interlaboratory comparisons and
proficiency testing programs.

4 Participation in the technical and other work of APLAC related
to accreditation of testing, calibration and inspection in
various technical fields.

5 Evaluation of applicants to this Arrangement is in the form of
visits by teams of evaluators constituted and operating to the
provisions of the document, APLAC MR 001, Procedure for
Establishing and Maintaining Mutual Recognition Arrangements
Amongst Accreditation Bodies to determine if the applicant
meets the requirements of ISO/IEC Guide 58, Calibration and
testing laboratory accreditation systems- General requirements
for operation and recognition, and/or ISO/IEC TR 17010 General
requirements for bodies providing accreditation of inspection
bodies accreditation bodies.

6 Evaluation of signatories to the Arrangement takes place at
intervals of approximately four years for the purpose of
assuring that the signatory bodies continue to meet the
requirements of ISO/IEC Guide 58 (from 1 January 2006, ISO/IEC
17011) and/or ISO/IEC TR17010 (from 1 January 2006, ISO/IEC
17011).

7 Observation of applicant bodies' assessments of their
laboratories to determine if these laboratories meet the
requirements of ISO/IEC 17025, General requirements for the
competence of calibration and testing laboratories (previously
ISO/IEC Guide 25), or of ISO 15189, Medical laboratories -
Particular requirements for quality and competence (for
medical laboratories), and/or observation of applicant bodies'
assessments of their inspection bodies to determine if these
inspection bodies meet the requirements of ISO/IEC 17020
General criteria for the operation of various types of bodies
performing inspection.

8 Application, evaluation, decisions, and maintenance pertaining
to the MRA are conducted in accordance with the APLAC MR 001
Procedures for establishing and maintaining mutual recognition
arrangements amongst accreditation bodies or its equivalent.

9 Appropriate information developed during the evaluation of
applicants and periodic reevaluation of signatories is shared
among the signatories on a confidential basis.

10 Confidence in the national measurement institutes that
underpin the traceability claimed by accredited laboratories,
inspection bodies and support for the measurement comparison
activities of CIPM2 and regional metrology organisations.

ARRANGEMENT

Upon fulfilling the requirements described in the Principal
Elements of Mutual Confidence described above, each signatory to
the APLAC MRA enters into the following Arrangement:

1 Each APLAC MRA Signatory for Testing, Calibration, and/or
Inspection:
(i) uses equivalent procedures in the accreditation of
laboratories under ISO/IEC Guide 58 (from 1 January 2006,
ISO/IEC 17011)and ISO/IEC 17025 (previously ISO/IEC Guide
25), or ISO 15189 for medical laboratories, and/or uses
equivalent procedures in the accreditation of inspection
bodies under ISO/IEC TR 17010 (from 1 January 2006, ISO/IEC
17011);

(ii) recognises, within its scope of recognition of this MRA,
the accreditation of a laboratory, or inspection body by
other signatories as being equivalent to an accreditation
by its own organisation;

(iii) accepts, for its own purposes, endorsed calibration, test
or inspection reports, issued by laboratories or
inspection bodies, accredited by other signatories on the
same basis as it accepts endorsed calibration, test or
inspection reports issued by its own accredited
laboratories,and/or inspection bodies;

(iv) recommends and promotes the acceptance by users in its
economy of endorsed test, calibration, and inspection
reports issued by organisations accredited by other
signatories;

(v) investigates all complaints initiated by a signatory
resulting from test reports and calibration certificates
issued by their accredited testing and calibration
laboratories and/or inspection reports issued by their
accredited inspection bodies;

(vi) contributes to the work of the APLAC MRA Council;

(vii) participates in the work of APLAC including the return of
ballots;

(viii) provides evaluators for the evaluation and re-evaluation
of accreditation bodies appropriate to their size and to
the needs of the APLAC MRA Council as resolved
periodically by the MRA Council;

(ix) uses all information obtained from the peer evaluation
process in a confidential and professional manner;

(x) informs one another, as soon as possible, of any significant
changes that have occurred or will occur in the status
and/or operational practices of its accreditation body.

2 The scope of recognition of a signatory may be extended or
reduced following reevaluation.

3 The addition of new signatories to the APLAC Mutual
Recognition Arrangement or the withdrawal of an APLAC MRA
signatory will not change the terms of this Arrangement.

4 The conclusion of a further Arrangement between APLAC and a
recognised laboratory, reference material producer and/or
inspection body accreditation body not participating in APLAC,
or between APLAC and another regional association of
laboratory, inspection body and reference material producer
accreditation bodies, does not change the terms of this
Arrangement. The evaluation information may be shared with
these bodies only with the agreement of the evaluated
laboratory, and/or inspection body accreditation body.

5 This Arrangement will be null and void if the incorporation
and Constitution referred to in the preamble are terminated.

6 This Arrangement may be amended at any time by agreement in
writing among the signatories.

7 In the event of a dispute between signatories to this
Arrangement or with applicants concerning elements,
objectives, procedures, and requirements, the matter will be
referred to the APLAC General Assembly.

8 This Arrangement will come into effect for each participant
upon signature by the affected parties.

9 If a signatory wishes to withdraw from this MRA, it shall
notify the APLAC MRA Council in writing not later than three
months in advance of the withdrawal. The MRA Council will
notify the other signatories. Upon withdrawal of a signatory,
its signature sheet shall be deleted from this MRA.

10 It is recognised and accepted by each of the signatories that
this Arrangement does not create any rights, liabilities or
obligations that would have binding effect in domestic or
international law. This Arrangement by itself does not
provide any recognition or accreditation under any law or
regulation in the economy of any signatory.
However, the signatories commit to promote to their governments
the use of this Arrangement in support of recognition
arrangements in the regulated sector.

MEMBER, APLAC MUTUAL RECOGNITION ARRANGEMENT
SIGNATORIES
We, the undersigned, endorse the terms of the APLAC Mutual
Recognition Arrangement and undertake, to the best of our
ability, fulfilment of its objectives.
Testing, Calibration, Inspection

Organisation: NATA
Economy: Australia
Authorised Representative: Regina Robertson

Organisation: HKAS
Economy: Hong Kong, China
Authorised Representative: Terence SS Chan

Organisation: IANZ
Economy: New Zealand
Authorised Representative: Dr W L Richards

Organisation: SAC
Economy: Singapore
Authorised Representative: Chang Kwei Fern

Organisation: CNAL
Economy: People's Republic of China
Authorised Representative: Wei Hao

Organisation: BoA
Economy: Viet Nam
Authorised Representative: Dr Ho Tat Thang

Organisation: KAN
Economy: Indonesia
Authorised Representative: Dr Sunarya

Organisation: IAS
Economy: United States of America
Authorised Representative: Patrick McCullen

Organisation: TAF
Economy: Chinese Taipei
Authorised Representative: Neng-Jong Lin

Organisation: ema
Economy: Mexico
Authorised Representative: Maria Isabel L?pez Mart?nez

Testing and Calibration

Organisation: A2LA
Economy: United States of America
Authorised Representative: Peter S Unger

Organisation: NVLAP
Economy: United States of America
Authorised Representative: Warren Merkel

Organisation: Standards Council of Canada/Conseil canadien des
normes
Economy: Canada
Authorised Representative: Peter Clark

Organisation: NABL
Economy: India
Authorised Representative: Dr Sulbha Gupta

Organisation: KOLAS
Economy: Korea
Authorised Representative: Yang Whan Jeong

Organisation: TLAS
Economy: Thailand
Authorised Representative: Pairoj Sanyadechakul

Organisation: IAJapan
Economy: Japan
Authorised Representative: Dr Katuo Seta

Organisation: JAB
Economy: Japan
Authorised Representative: Yuichiro Isu

Organisation: DSM on behalf of the Government of Malaysia
Economy: Malaysia
Authorised Representative: Mariani Mohammed

Organisation: PAO (previously BPSLAS)
Economy: The Philippines
Authorised Representative: Cirila Botor

Testing

Organisation: BLQS, DMSc
Economy: Thailand
Authorised Representative: Panadda Silva

Organisation: VLAC
Economy: Japan
Authorised Representative: Seiichi Kawashima

Organisation: CAEAL/ACLAE
Economy: Canada
Authorised Representative: J E J Gravel


Chair, APLAC MRA Council: _____________________ _______________
Barry Ashcroft Date


Chair, APLAC: _____________________ _______________
Terence S S Chan Date