The ACB Scheme - Department of Standards Malaysia

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DEPARTMENT OF STANDARDS MALAYSIA
SCHEME FOR THE ACCREDITATION OF CERTIFICATION BODIES
(The ACB Scheme)
ACB 1
Issue 2, 15 February 2007
(Amd. 5, 18 April 2012)
TERMS AND CONDITIONS GOVERNING THE SCHEME FOR THE
ACCREDITATION OF CERTIFICATION BODIES (ACB)
Authority To Issue
Director General
Department of Standards Malaysia
INDEX
TOPIC
PAGE
1.
Scope and Application
1
2.
References
1
3.
Definitions
2
4
General
3
5.
Prescription of Accreditation Criteria
5
6.
Eligibility
5
7.
Conditions for Accreditation
5
8
Significance of Accreditation
6
9.
Notification of Change
7
10.
Appeals
7
ACB 1: Terms and Conditions Governing
The Scheme for the Accreditation of Certification Bodies (ACB)
_____________________________________________________________________
1.
SCOPE AND APPLICATION
1.1
This document prescribes the terms and conditions governing the
accreditation of certification bodies by the Department of Standards Malaysia
(STANDARDS MALAYSIA). This document should be read in conjunction
with the relevant published policy and procedure documents governing the
ACB scheme, including the following documents: MS ISO/IEC 17021: Requirements for bodies providing audit and certification
of management systems
MS ISO/IEC Guide 65: General requirements for bodies operating product
certification systems
IAF GD 5:2006: IAF guidance on the Application of ISO/IEC Guide 65
MS ISO/IEC 17024: Conformity assessment – General requirements for
bodies operating certification of persons
MS ISO/IEC 27006: Information technology-Security techniquesRequirements for bodies providing audit and certification of information
security management systems
ISO/TS 22003:2007: Food safety management systems - Requirements for
bodies providing audit and certification of food safety management systems
ACB-HALAL PRODUCT: STANDARDS MALAYSIA Requirements for Bodies
Operating Halal Product Certification System
ACB-OSH: STANDARDS MALAYSIA Requirements for Bodies Operating
Assessment and Certification of Occupational Safety and Health
Management Systems
ACB-HACCP: STANDARDS MALAYSIA Requirements for The Accreditation
of Bodies Operating Certification of HACCP Based Food Safety Systems
ACB-FMC : Competency Requirements for Bodies Operating Forest
Management Certification
ACB-FMC : Audit Duration (Natural Forest) for Bodies Operating Forest
Management Certification
ACB-FMC : Peer Review Process Requirements for Bodies Operating Forest
Management Certification
ACB-FMC 2-1 : Competency Requirements for Bodies Operating Forest
Management Certification ( Forest Plantation) under the Malaysian Timber
Certification Scheme
ACB-FMC 2-2 : Audit Duration for Bodies Operating Forest Management
Certification ( Forest Plantation) under the Malaysian Timber Certification
Scheme
Issue 2, 15 February 2007
(Amd. 5, 18 April 2012)
Page 1 of 8
ACB 1: Terms and Conditions Governing
The Scheme for the Accreditation of Certification Bodies (ACB)
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ACB-FMC 2-3 : Peer Review Process Requirements for Bodies Operating
Forest Management Certification ( Forest Plantation) under the Malaysian
Timber Certification Scheme
ACB-FMC 2-4 : Requirements for Stakeholder Consultation for Forest Audit
for Bodies Operating Forest Management Certification ( Forest Plantation)
under the Malaysian Timber Certification Scheme
ACB-OPSC : Audit Duration for Bodies Operating Oil Palm Supply Cha
in Management Systems Certification
ACB-OPSC : Competency Requirements for Bodies Operating Oil Palm
Supply Chain Management Systems Certification
ACB-WEMS : STANDARDS MALAYSIA requirements for Bodies
Operating Work Environment Management Systems Certification
ACB 7: The conduct of accreditation assessments
IAF Mandatory documents
2.
REFERENCES
2.1
ISO/IEC 17000 – Conformity assessment – Vocabulary and general
principles
2.2
MS ISO/IEC 17011 – Conformity assessment – General requirements for
accreditation bodies accrediting conformity assessment bodies
3.
DEFINITIONS
3.1
For the purpose of this document, definitions in the relevant ISO standards
and the relevant ISO/IEC Guides shall apply. The following definitions and
abbreviations shall also apply.
(a)
Accreditation: Third-party attestation related to a conformity
assessment conveying formal demonstration of its competence to
carry out specific conformity assessment tasks.
(b)
Accreditation certificate: Formal document or a set of documents,
stating that accreditation has been granted for the defined scope.
[Note: The certificate of accreditation is valid for three (3) years.]
(c)
Accreditation criteria: Includes the appropriate accreditation
standard, and all STANDARDS MALAYSIA approved policies and
procedures at the time of application, and those approved from time
to time subsequent to accreditation, that are applicable to the
accreditation program under which accreditation is sought.
(d)
ACB Symbol: Symbol issued by STANDARDS MALAYSIA under the
Scheme for the Accreditation of Certification Bodies (the ACB
Scheme) to be used by accredited certification bodies to indicate their
accredited status.
Issue 2, 15 February 2007
(Amd. 5, 18 April 2012)
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ACB 1: Terms and Conditions Governing
The Scheme for the Accreditation of Certification Bodies (ACB)
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(e)
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.
(f)
Assessor: Person assigned by an accreditation body to perform,
alone or as part of an assessment team, an assessment of a CAB
(g)
Authorised management representative:
A person, with the
necessary authority, usually the senior executive officer, of the
certification body formally appointed or nominated by its top
management to represent it in all matters pertaining to accreditation.
(h)
Certification: Third-party attestation related to products, process,
system or persons
(i)
Conformity assessment body: Body that performs conformity
assessment services and that can be the object of accreditation e.g:
testing and calibration laboratories, certification bodies, inspection
bodies.
(j)
Malaysian Standards and Accreditation Council, MSAC
(hereinafter referred to as the Council): An Advisory Council
established under Section 13 of the Standards of Malaysia Act 1996
with delegated functions under the said Act in advising the Minister on
policies, criteria and procedures for the administration of a national
accreditation system.
(k)
Malaysian National Accreditation Committee (MyNAC):
A
Committee of the Council established under Section 14 of the
Standards of Malaysia Act 1996 and act on behalf of the Council for
discharging the duties and functions of the Council in connection with
accreditation matters.
4.
GENERAL
4.1
The Department of Standards Malaysia (STANDARDS MALAYSIA) is the
sole authority for processing application and undertaking, assessment of
certification bodies applying for accreditation.
4.2
The Director General is empowered under Section 16 of the Standards of
Malaysia Act 1996 to make accreditation decision such as granting,
maintaining, extending, reducing, suspending and withdrawing accreditation.
4.3
STANDARDS MALAYSIA will set the procedures and conditions by which
applications for accreditation will be made and the circumstances in which
accreditation may be granted, maintained, extended, reduced, refused,
suspended or withdrawn.
Under special circumstances, STANDARDS MALAYSIA may also consider
procedures and conditions under which accreditation may be transferred from
one legal entity to another legal entity such as in a situation resulting from
organisational restructure. Application for transfer will be considered on a
case to case basis.
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ACB 1: Terms and Conditions Governing
The Scheme for the Accreditation of Certification Bodies (ACB)
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4.4
STANDARDS MALAYSIA will prescribe how monitoring of compliance with
the Accreditation Criteria will be carried out.
4.5
The Director General of STANDARDS MALAYSIA will grant and maintain
accreditation to certification bodies which:
(a)
comply with the Accreditation Criteria;
(b)
has sufficient evidence to demonstrate that its arrangements for
management review and internal audit have been implemented, are
effective and will be maintained;
(c)
has sufficient evidence to demonstrate that adequate resources can
be deployed to conduct audits meeting the requirements of relevant
standard and the corresponding IAF Guidance;
(d)
pay such fees as are due to STANDARDS MALAYSIA in the manner
prescribed by STANDARDS MALAYSIA and,
(e)
give undertakings as STANDARDS MALAYSIA may require.
4.6
The frequency with which certification bodies are normally subject to
surveillance and re-assessment will be prescribed by STANDARDS
MALAYSIA. As a general rule, surveillance visits would normally be carried
out at intervals of around 6 months and re-assessment every 3 years.
4.7
However, after the first cycle of 3 years, the frequency of surveillance will be
reduced as follows:
i)
Surveillance I : 11 months after the renewal of its Certificate of
Accreditation
ii)
Surveillance II : 11 months from Surveillance I
iii)
Re-assessment : 10 months from Surveillance II
Over and above this, STANDARDS MALAYSIA reserves the right to carry out
unscheduled surveillance visits or re-assessment at intervals other than those
prescribed if circumstances indicate that continued confidence in the
accredited programme can not be sustained without such unscheduled action
taking place.
4.8
STANDARDS MALAYSIA may, at its discretion, suspend accreditation,
(a)
if a certification body is providing certification to any standard used as
a basis for accrediting laboratories (i.e ISO/IEC 17025 or ISO 15189);
(b)
if a certification body fails to submit the evidence of corrective action
within the agreed time frame;
(c)
if a certification body fails to complete the total number of witness
audits for one cycle of accreditation;
(d)
based on the outcome of any assessment;
(e)
results of investigation into a complaint;
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(Amd. 1, 27 August 2009)
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ACB 1: Terms and Conditions Governing
The Scheme for the Accreditation of Certification Bodies (ACB)
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4.9
STANDARDS MALAYSIA may, at its discretion, withdraw accreditation,
(a)
if a certification body, being a Company, enters into liquidation,
whether compulsory or voluntary (but not including liquidation for the
purposes of re-construction), or has a receiver of its business
appointed, or
(b)
if a certification body fails in any respects to comply with the law of the
country,
(c)
if, in the view of STANDARDS MALAYSIA, a certification body has
made unreasonable or irresponsible use of sub-contracting.
(d)
if suspension is not satisfactorily lifted;
(f)
if lapse of suspension period without any satisfactory action from
CABs
4.10
STANDARDS MALAYSIA may, at its discretion, reduce the scope of an
accreditation or require reassessment in the light of changes as stipulated in
clause 9.2 of this document.
4.11
All information gained by STANDARDS MALAYSIA, its Advisory Council,
Committees, Panels and its representatives and staff in the assessment of
certification bodies will be confidential between STANDARDS MALAYSIA and
the certification body and such information will be handled within
STANDARDS MALAYSIA on a strict ‘need to know’ basis and will not, subject
to the law of the land, be divulged without the prior written consent of the
certification body.
5.
PRESCRIPTION OF ACCREDITATION CRITERIA
5.1
STANDARDS MALAYSIA is responsible for formulating all policies, criteria,
accreditation and operational procedures, affecting the accreditation of
certification bodies.
5.2
STANDARDS MALAYSIA will set the relevant Accreditation Criteria based on
or adopted directly from ISO/IEC or other international harmonised
documents, against which an applicant certification body should be assessed.
The Council reserves the right, if necessary, to formulate its own guidelines
or to adopt / use the relevant international interpretative documents as
guidelines for assessment of compliance.
6.
ELIGIBILITY
6.1
Any certification body in Malaysia willing to demonstrate compliance with the
criteria and requirements for accreditation of STANDARDS MALAYSIA may
apply for accreditation. Whether a certification body operates on a “profit” or
“not for profit” basis shall not be a consideration for the purpose of
determining eligibility.
7.
CONDITIONS FOR ACCREDITATION
7.1
The certification body shall:
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ACB 1: Terms and Conditions Governing
The Scheme for the Accreditation of Certification Bodies (ACB)
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(a)
offer to all clients a standard of service consistent with the
Accreditation Criteria to which it has been accredited by STANDARDS
MALAYSIA.
(b)
offer STANDARDS MALAYSIA and its representatives such
reasonable accommodation and cooperation as necessary, to enable
STANDARDS MALAYSIA to monitor compliance with the
Accreditation Criteria. This shall apply to all premises where the
conformity assessment services take place.
(c)
at all times comply with the Accreditation Criteria. This includes the
commitment to adapt to changes in the requirements for accreditation
notified by STANDARDS MALAYSIA from time to time.
(d)
provide access to STANDARDS MALAYSIA to information,
documents and records as necessary for the assessment and
maintenance of accreditation, including those that provide insight into
the level of independence and impartiality of the CB from its related
bodies, where applicable. When requested, the records of all
complaints, appeals and disputes and subsequent actions shall also
be made available to STANDARDS MALAYSIA.
(e)
arrange for the witnessing of CB’s auditing or assessment of its client
when requested by STANDARDS MALAYSIA.
(f)
only claim that it is accredited in respect of those scopes / activities
which are the subject of the certificate of accreditation and which are
carried out in accordance with the Accreditation Criteria.
(g)
not use the accreditation report or certificate (nor any part thereof)
and the ACB Symbol in such a manner as to bring the arrangements
for accreditation into disrepute, and shall not make any statement,
and shall take such immediate steps as STANDARDS MALAYSIA
may require to correct any statement, which STANDARDS MALAYSIA
considers to be misleading.
(h)
pay such fees for application, assessment, surveillance other services
and if applicable, other additional costs incurred, as shall be from time
to time determined by STANDARDS MALAYSIA.
(i)
endeavour to ensure that the fact of accreditation shall not be used for
promotional or publicity purposes in any way that STANDARDS
MALAYSIA may consider to be misleading, and shall take such
immediate steps as STANDARDS MALAYSIA may require to correct
any such misleading use.
(j)
make it clear in all contacts with its clients that a certification
certificate issued by it in no way implies that the product or service
certified is approved by STANDARDS MALAYSIA.
(k)
upon the suspension of accreditation (however determined) forthwith
discontinue its use of a reference to accreditation and withdraw all
advertising matter which contains any reference thereto.
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(Amd.1, 25 November 2008)
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ACB 1: Terms and Conditions Governing
The Scheme for the Accreditation of Certification Bodies (ACB)
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(l)
fully conform to the requirements of STANDARDS MALAYSIA for
claiming accreditation status, when making reference to its
accreditation in communication media such as the Internet,
documents, brochures, billboards or advertisements.
7.2
The certification body may use in documents, brochures or advertising media,
with appropriate variation, the phrases ‘an accredited certification / body
listed under accreditation number.’ and ‘listed in STANDARDS MALAYSIA
Directory of accredited certification bodies under accreditation number..’.
The certification body shall, upon withdrawal of accreditation, take reasonable
steps to ensure the prompt withdrawal of all such documents, brochures and
advertising media.
7.3
The certification body where relevant shall carry adequate third party
indemnity insurance covering its certification / registration activities.
8.
SIGNIFICANCE OF ACCREDITATION
8.1
Accreditation should not be regarded as in any way diminishing the normal
contractual responsibilities between the certification body and its client.
While accreditation is an indication of the integrity and competence of the
certification body, it cannot be taken to constitute a guarantee by that the
certification body always maintains a particular level of performance.
8.2
Arrangements for charging of fees between a certification body and its client
are in no way the responsibility of, and are not subject to the control of
STANDARDS MALAYSIA.
9.
NOTIFICATION OF CHANGE
9.1
The certification body shall inform STANDARDS MALAYSIA immediately of
any changes bearing on the certification body’s compliance with these Terms
and Conditions and the accreditation criteria, or otherwise affecting the
certification body’s capability or scope of activity.
9.2
The certification body shall inform STANDARDS MALAYSIA immediately of
any intended changes to its:
i)
ii)
iii)
iv)
v)
legal, commercial, ownership or organisational status;
organisation, top management and key personnel;
policies or procedures, where appropriate;
premises;
equipment, facilities, working environment or other resources, where
significant
vi)
vii)
scope of accreditation; and
other such matters that may affect the ability of the CB to fulfill
requirements for accreditation.
9.3
The certification body shall have procedures to ensure that the information
supplied to STANDARDS MALAYSIA is kept up-to-date.
9.4
The certification body will be given due notice of any intended changes
relating to the Accreditation Criteria and will also be given such time, as in the
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(Amd.1, 25 November 2008)
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ACB 1: Terms and Conditions Governing
The Scheme for the Accreditation of Certification Bodies (ACB)
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opinion of STANDARDS MALAYSIA is reasonable, to carry out the necessary
adjustments to its procedures. Unless otherwise specified, a period of 6
months from the date of notification of change by STANDARDS MALAYSIA
will be given for certification body to carry out the necessary adjustments to
its procedures. The certification body shall notify STANDARDS MALAYSIA
when such adjustments have been completed. STANDARDS MALAYSIA
shall verify that each CAB carries out any necessary adjustment.
9.5
A certificate of accreditation may be relinquished by a certification body upon
giving one month’s notice in writing.
9.6
Any notice or other communication given or sent by STANDARDS
MALAYSIA to a certification body in connection with, or under, these Terms
and Conditions, shall be deemed to be duly given or sent if sent by recorded
delivery post to the address of the certification body last known to
STANDARDS
MALAYSIA
and
shall
be
deemed
to
be given at the time when the same would have been delivered in the
ordinary course of post.
10.
APPEAL
10.1
Appeals by a CB for reconsideration of any adverse decision made by
STANDARDS MALAYSIA related to its desired accreditation status, including
recommendation for refusal or withdrawal of accreditation will be considered
within the STANDARDS MALAYSIA Accreditation System. Appeals shall be
handled within the accreditation system always in an impartial and
independent manner.
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Page 7 of 7
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