Komite Akreditasi Nasional

Part : DPUM 01

Revision : 5

Date: 6 August 2009

TERMS AND CONDITIONS

FOR ACCREDITATION OF CONFORMITY ASSESSMENT BODY (CAB)

Based on Government Regulation No. 102 Year 2000, on National Standardization and
Presidential Decree No. 78 Year 2001, on the National Accreditation Body of Indonesia
(KAN), KAN is the authority body for the accreditation of conformity assessment activities
in Indonesia. KAN ensure that their operation including that activities the related body do
not comprise the confidentiality, objectivity and impartiality of its accreditation

1.

Requirements for CAB

1.1. Accreditation of Conformity Assessment Bodies (CABs) are operated by KAN to

assess competency of CAB based on the defined requirements. The following is a list of
the requirements that shall be fulfilled by :
a.

b.

Quality Management System (QMS) Certification Bodies (CBs) :

-

ISO/IEC 17021:2006: Conformity assessment Requirements for bodies providing

audit and certification of management systems

IAF Mandatory Documents

Environmental Management System (EMS) CBs :
- ISO/IEC 17021:2006: Conformity assessment Requirements for bodies providing
audit and certification of management systems
- IAF Mandatory Documents

c.

Hazard Analysis Critical Control Point System (SHACCP) CBs :

- ISO/IEC 17021:2006: Conformity assessment Requirements for bodies providing
audit and certification of management systems
- BSN Guide 1003 : 1999 : Kriteria Auditor Sertifikasi Sistem HACCP (Criteria for
Certification Auditor of HACCP System)
- DPLS 05 : Persyaratan Tambahan bagi Lembaga Sertifikasi Sistem HACCP dan
Lembaga

Sertifikasi

Sistem

Manajemen

Keamanan

Requirements for SHACCP CBs and FSMS CBs)

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Food Safety Management System (FSMS) CBs :

- ISO/IEC 17021:2006 : Conformity assessment Requirements for bodies providing
audit and certification of management systems
- ISO/TS 22003:2007 Food safety management systems Requirements for bodies
providing audit and certification of food safety management systems
- DPLS 05 : Persyaratan Tambahan bagi Lembaga Sertifikasi Sistem HACCP dan
Lembaga

Sertifikasi

Sistem

Manajemen

Keamanan

Pangan

(Supplement

Requirements for SHACCP CBs and FSMS CBs)

e.

Information Security Management System (ISMS) CBs :

- ISO/IEC 17021:2006 : Conformity assessment Requirements for bodies providing
audit and certification of management systems
- ISO/IEC

27006:2007

Information

technology

Security

techniques

Requirements for bodies providing audit and certification of information security

management systems
f.

Personnel CBs :
- KAN Guide 5012003 : Persyaratan Umum Lembaga Sertifikasi Personel (ISO/IEC
Guide 17024-2003, General Requirements for Bodies Operating Personnel
Certification)
- KAN Guide 506-2009 : Panduan Penerapan Butir-butir Pedoman KAN 501-2003)
(IAF Guidance on the application of ISO/IEC 17024)

g.

Product CBs :
- BSN Guide 4012000: Persyaratan Umum Lembaga Sertifikasi Produk (ISO/IEC
Guide 65: 1996, General Requirements for Bodies Operating Product Certification)
- KAN Guide 402 2007: Panduan Penerapan Butir-butir Pedoman BSN 401-2000
(IAF Guidance on the application of ISO/IEC Guide 65, issue 2)
- DPLS 04 Rev 1: Syarat dan Aturan Akreditasi Lembaga Sertifikasi Produk (Terms
and Condition for Accreditation of Product Certification Bodies)

h.

Ecolabelling CBs :
- KAN Guide 800-2004 : Pedoman Umum Akreditasi dan Sertifikasi Ekolabel

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- KAN Guide 801-2004: Persyaratan Umum Lembaga Sertifikasi Ekolabel (General

Requirements for Bodies Operating Ecolabel Certification)
i.

Organic Food CBs :

- KAN Guide 901-2006 as as requirement that shall be fulfilled by Organic Food
Certification Body

j.

Sustainable Forest Management CBs:

- ISO/IEC 17021:2006: Conformity assessment Requirements for bodies providing
audit and certification of management systems
- DPLS 13; Syarat dan aturan tambahan akreditasi Lembaga Sertifikasi Pengelolaan
Hutan Produksi Lestari

k.

Timber Legallity CBs:

- ISO/IEC Guide 65:1996, General Requirements for Bodies Operating Product
Certification
- DPLS 14; Syarat dan aturan tambahan akreditasi Lembaga Verifikasi Legalitas
Kayu

l.

Testing and calibration laboratories:

- ISO/IEC 17025:2005, General requirements for the competence of testing and
calibration laboratories
- DPLP 05: Persyaratan tambahan untuk akreditasi laboratorium pengujian mekanik
(Supplement requirements for accreditation of mechanical testing laboratories)
- DPLP 06: Persyaratan tambahan untuk akreditasi laboratorium uji kimia dan biologi
(Supplement requirements for accreditation of chemical and biological testing
laboratories)
- DPLP 07: Persyaratan tambahan untuk akreditasi laboratorium pengujian kimia dan
biologi Jaminan mutu peralatan yang digunakan dalam laboratorium pengujian
kimia dan biologi (Supplement requirements for accreditation of chemical and
biological testing laboratories Quality assurance of equipments using in chemical
and biological testing laboratories
- DPLP 08: Persyaratan tambahan untuk akreditasi laboratorium pengujian
kelistrikan (Supplement requirements for accreditation of electrical testing
laboratories)
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- DPLP 09: Persyaratan tambahan untuk laboratorium kalibrasi (Supplement

requirements for calibration laboratories)
m. Inspection Bodies:
- SNI 19-17020-1999: Persyaratan umum pengoperasian berbagai tipe lembaga
inspeksi (General requirement for operating numerous types of inspection bodies)
n.

Medical Laboratories:
- ISO 15189:2007: Medical laboratories particular requirement for quality and
competence
- SR 01: Specific requirement for accreditation of medical laboratory in the field of
clinical chemistry
- SR 02: Specific requirement for accreditation of medical laboratory in the field of
clinical microbiology
- SR 03: Specific requirement for accreditation of medical laboratory in the field of
clinical immunology
- SR 04: Specific requirement for accreditation of medical laboratory in the field of
hematology

1.2 CAB shall have:

a. documented quality manual of related requirements. It has to be implemented
for at least 3 months and at least one internal audit has to be conducted.
b. registered legal entity
c. sufficient resources including human and technical resources
d. fulfilled all KAN requirements including accreditation fees
e. issued at least 1 certificate
f. for testing laboratory and calibration, has followed proficiency test and/or inter
laboratory comparation arrange by KAN and/or other institution with good
reputation in arranging of proficiency test and/or inter laboratory comparation.

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Accreditation Procedure

2.1 Accreditation flow chart (Annex 1)

2.2 Accreditation application
2.2.1 CAB asks for information on accreditation procedures and requirements to KAN
2.2.2 KAN sends an accreditation application form and other related documents.
2.2.3 Application shall be made on such form, signed by top management of CAB and
supported by:
a.

Legal entity of CAB,

b.

Updated copy of quality manual and associated documents needed for

assessment,

c.

List of CAB certified clients,

d.

CAB Personnel record,

e.

Record of last internal audit and management review,

f.

Receipt of payment application fee

g.

Complete descriptions on accreditation scope applied.

2.2.4. Laboratory shall use up to date testing method and calibration method for its
activity, unless required in contractual agreement signed. CAB shall get written
permission from KAN, in case of laboratory need to use non up to date testing
method or calibration method. Inspection body shall use inspection methods as
stated in last edition standard/publications with clients permission and/or stated in
agreement.
2.3.

Preliminary visit

2.3.1. Preliminary visit is aimed to identify the readiness of certification body against
accreditation requirements before the initial assessment is carried out.
2.3.2. CABs may ask to KAN to carry out a preliminary visit. This visit is not mandatory.
2.3.3. The preliminary visit is carried out to observe gaps of compliances to the
requirements including technical requirements. it is not a form of consultation.
KAN will issue the preliminary visit report without any non-conformities.
2.3.4. The preliminary visit team is appointed by Director for Accreditation.

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2.4.

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Assessment preparation

2.4.1. Contract review

2.4.1.1.

KAN carries out contract review against the substantial application of CABs.
This review considers several points as follows:
-

requirements of standard for accreditation as mentioned on clause 1.1.

requested scope of accreditation

used methods and equipments

uncertainty sources to evaluate best measurement capability for

calibration laboratories

2.4.1.2.

measurement traceability

If the result of document and record review is not adequate, KAN will inform
CABs for completing required documents/records.

2.4.1.3.

According to the result of review as stated in clause 2.4.1.2, KAN reviews its
capability to provide accreditation application of CAB taking into account as
follow:

2.4.1.4.

Location and languages;

Scopes and complexity;

Availability of assessor and/or technical experts;

Availability of accreditation scheme and related documents;

Time to conduct initial assessment.

Should the review is complete KAN will ask CABs to sign contract agreement
between KAN and CABs.

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2.4.2. Assessment planning

2.4.2.1.

KAN informs officially to CABs concerning assessment plan and date of

assessment as well as assessment team member's name. CABs have the
right to refuse the assessment team by providing the rationale of objection.

2.4.2.2.

To ensure that assessment is carried out correctly and completely, each

assessor is provided with the appropriate documents.

2.4.3. Document and record review

2.4.3.1.

The applicant CABs shall provide to KAN, as follows:

a. general features of the CAB, including corporate entity, name, addresses,
legal status and human and technical resources;
b. general information concerning the CAB such as its activities, its
relationship in a larger corporate entity if any, and addresses of all its
physical location(s) to be covered by the scope of accreditation;
c. a clearly defined, requested, scope of accreditation;
d. an agreement to fulfill the requirements for accreditation;
e. a description of the conformity assessment services that the CAB
undertakes, and a list of standards,
f. methods or procedures for which the CAB seeks accreditation, including
limits of capability where applicable;
g. a copy (on paper or in electronic form) of the quality manual of the CAB,
and relevant associated documents and records, such as information on
participation in proficiency testing where applicable;

2.4.3.2.

KAN proposes assessment team and assessment plan to CABs based on

complexity and accreditation scopes.

2.4.3.3.

KAN appoints assessment team officially to conduct document and record

review and an assessment on be half of KAN based on related requirements.
The technical experts will be added to the team as an adviser, if necessary.
On the appointment of assessment team, KAN ensures that the team
members have appropriate competencies and free for any potential conflict of
interest with CABs in the last 2 years.

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KAN establishes sampling method where the scope of the CAB covers a
variety of specific conformity assessment services and all of multi-site
locations of CAB to ensure that the assessment conduct properly.

2.5.

On site assessment

2.5.1. KAN assesses the conformity assessment services at the premises of the CAB
from which one or more key activities are performed.
2.5.2. Make any corrective and preventive actions based on root cause analysis of any
non-conformities found during the assessment as specified time agreed.
2.5.3. For initial assessment, if such non-conformities cannot be closed out until
specified time, KAN will give 2-month extension period to CAB for carrying out
corrective action. KAN will give the letter for reminding CAB to complete it. If such
letter is waived, KAN will discontinue the accreditation process.
2.6.

Surveillance

2.6.1. KAN conducts surveillance of each accredited CAB so that representative

samples of the scope of accreditation are assessed on a regular basis.
2.6.2. It is recommended that the first surveillance on-site assessment is carried out no
later than 12 months from the date of initial accreditation.
2.6.3. KAN establishes sampling method to ensure proper assessment. All premises
from which one or more key activities are performed will be assessed within a
defined timeframe.
2.6.4. Other than periodic surveillance, KAN could carry out unscheduled visit in case of:
-

Written complaints concerning accredited CABs performance from interested

parties

Unsatisfied results of proficiency testing or inter-laboratory comparison and the

corrective actions taken are not effective.

2.6.5. Surveillance is conducted by covering the following aspects:

a. Confirmation on the change of ownership, name, contact person, address,
telephone, facsimile, e-mail, certificate signatories
b. Brief review on quality management system documentation
c.

Internal audit and management review

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d. Evaluation on the effectiveness of document control

e. Review on testing result data and/or calibration results including proficiency
testing result and/or inter-laboratory comparison (for testing and calibration
laboratories)
f.

Customer complaint and its handling

g. The effectiveness of corrective actions

h. Evaluation on the consistency of the implementation of accreditation
requirements

2.7.

i.

The use of accreditation mark

j.

Planned activity progress to achieve continual performance improvement

k.

Other matters which are highlighted from previous assessment

Re-assessment

2.7.1. KAN will carry out re-assessment to CAB, if:

a. The accreditation period was end
b. The assessment (initial) result shows that CAB not complies with most clauses
in the requirements.
2.7.2. In case of re-accreditation, CAB shall apply at least 9 months before the end of
accreditation. Where the application is submitted after the accreditation period is
finished, KAN will withdraw CABs accreditation and CABs shall follow up all
consequences raised due to that case.
2.7.3. KAN will conduct on-site re-assessment at least 6 months before the end of
accreditation.
2.8.

Witness Assessment

2.8.1. KAN perform witness at selected locations where the CAB operates to gather
objective evidence that the applicable scope of the CAB is competent and
conforms to the relevant standard(s) and other requirements for accreditation.
2.8.2. The assessment team witnesses the performance of auditor of the CAB to ensure
the competence of the CAB in carrying out their certification services.

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Extraordinary Assessment

KAN will conduct extraordinary assessment as a result of complains or significant

changes of accredited CAB relevant to its accreditation and any aspect of its status or
operation.
2.10.

Assessment report

The assessment team analyzes all relevant information and evidence gathered during the
document and record review and the on-site assessment. The teams observations on
areas for possible improvement may also be presented to the CAB.
2.11.

Decision making and granting accreditation

2.11.1. In order to make decision, KAN will evaluate any information collects during
accreditation process, including:
a.

unique identification of the CAB;

b.

date(s) of the on-site assessment;

c.

name(s) of the assessor(s) and/or experts involved in the assessment;

d.

unique identification of all premises assessed;

e.

proposed scope of accreditation that was assessed;

f.

the assessment report;

g.

a statement on the adequacy of the internal organization and procedures

adopted by the CAB to give confidence in its competence, as determined
through its fulfillment of the requirements for accreditation;

h.

information on the resolution of all nonconformities;

i.

any further information that may assist in determining fulfillment of

requirements and the competence of the CAB;

j.

where applicable, a summary of the results of proficiency testing or other

comparisons conducted by the CAB and any actions taken as a
consequence of the results;

k.

where appropriate, a recommendation as to granting, reducing or

extending accreditation for the proposed scope

2.10.2. Persons involves in decision making shall not involve in assessment

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2.10.3 KAN will not delegate its responsibility in granting, maintaining, extending,
reducing, suspending and withdrawing an accreditation.
2.12.

Suspension

2.12.1. KAN may suspend an accreditation status of CAB where:

-

witness audit has not been conducted related to accreditation or reaccreditation application

any nonconformities found during assessment has not been closed out

2.12.2.Within the suspension period, KAN may withdraw an accreditation, if CABs

make other nonconformities against requirements.
2.12.3. Under suspension period, CABs shall not process new clients and issue certificate
under KAN accreditation.
2.12.4. KAN will notify CAB on the reason of suspension/withdrawal, within 14 days
before the suspension/withdrawal.
2.13.

Withdrawal

2.13.1. KAN may withdraw the accreditation if the accredited CAB:

a. Bankrupts
b. Be part of an enterprise that enters into liquidation.
c. CAB failed to comply the terms and conditions.
2.13.2. Under withdrawal period, CABs shall terminate its related certification activity
including

maintaining

certification

(surveillance

and

issuing

certificate),

processing new clients, issuing and publishing any information such as certified
company under KAN accreditation.
2.14.

Reducing and extending of scope of accreditation

2.14.1. KAN will proceed any application for reducing or extending scope of accreditation
from CABs, after concluded that application fulfill the requirements.
2.14.2. KAN may reduce CABs accreditation scopes if there are changes of CABs key
personnel (assessor and/or technical expert) that may cause related scopes do
not have supporting assessor and/or technical experts.

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3.

CAB Rights and Obligations

3.1

The rights

Date: 6 August 2009

CAB has the rights to:

a. Make appeals and complaints to KAN.
b. Get information on any accreditation requirements changes.
c. Require explanation when the applied scope of accreditation is related to a
specific programme and additional information related to accreditation
application.
d. Get information on names of an assessment team members who will carry out
assessment / surveillance/ re-assessment
e. Use the KAN accreditation logo with concerning related Guide stipulated by
KAN.
f. Apply for extending and reducing of accreditation scope.
3.2

The obligations
CAB has obligations to:
a. Sign contractual agreement between KAN and CAB;
b. Commit to fullfil continually the requirements as mention in clause 1.1, and this
terms and conditions and adapt the changes of accreditation requirements.
c. CAB shall provide proper assistance and required cooperation to KAN and its
staffs to enable

KAN to monitor the fulfillment of the related accreditation

requirements and criteria, that include :

- To permit KAN and auditors to conduct assessment, surveillance,
verification, witness and other activities related to accreditation for all
premisies where CAB services operate
- To assist KAN or its personnel conducting the investigation and solving
any complaints submitting by a third party concerning the CAB activities
that are included in the accredited scope. Ensure any information given to
KAN is up to date.
d. Prepare any necessary arrangements conducting assessment or evaluation
including accommodation and arrangements for assessment of documents, and
access in any fields, the records (including internal audit report and personnel

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for assessment, surveillance, re-assessment ,complaints handling purposes)

and document related to independence and impartility from its related bodies.
e. CABs shall provide at least one client to be witnessed by KAN before the
accreditation status is granted. The witness is to ensure that CABs have
competent auditor to support their services. CAB shall require their clients to
permit KANs witnessing assessment team.
f. Use its accreditation in appropriate way and shall not make any misleading
statement on its accreditation in accordance to the accredited scopes including
their certified clients and other parties.
g. Pay such fees for application, assessment, surveillance, re-assessment,
extending scope and other fees as determined by KAN before on-site
assessment conducted.
h. Inform KAN immediately, in case there are changes on:
- Organization, top management and key personnels,;
- Address, ownership, legal status, and organization commercial status;
- Main policy;
- Equipments, premises, facilities and/or other resources that may affect
CAB performance;
- Accreditation scopes;
- Other such matters that may affect the ability of the CAB to fulfill
requirements for accreditation
i. Provide data of number of certified clients to KAN at least once a year
j. Facilitate PAC peer evaluation in order to maintain MLA PAC.

4.

KAN obligation to CAB

KAN has obligation to:
a. Make publicly available information the current status of accredited CAB
regularly

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b. Provide the CAB with information related to the accreditation scopes, terms and
conditions, international arrangement, where applicable, by website or INFO
KAN bulletin.
c. Give the notice of any changes to its requirement for accreditation in a
reasonable time. Any changes made shall take into account of views expressed
by interest third parties.
d. Verify that each accredited body carries out any necessary adjustment against
the changes requirements.

5.

Use of KAN and PAC/IAF/APLAC/ILAC Mark

5.1. The use of KAN accreditation logo is governed by KAN Guide No. 12 - 2004. CABs
shall use KAN logo only for its accredited scope and premises.
5.2. The use of PAC/IAF/APLAC/ILAC mark based on KAN Guide 13 2005 , where
applicable
5.3. For Testing Laboratory and Calibration Laboratory that use of KAN logo on
certificates or reports for non-accredited scope shall follow conditions as follow:
a. Parameters accredited at least 60% of all parameters write in
certificate/report.
b. Any non-accredited parameters shall mark clearly, to show that
parameters is not accredited by KAN such as use of mark *) with an
explanation about mark.
5.4. If there is evidence related to improper use of KAN accreditation logo, KAN shall
warns and instructs CAB to carry out the corrective action within two months period
5.5. Shall CAB cannot complete the corrective action, its accreditation status will be
suspended or withdrawn. If such cases breach the law, KAN will report to the
relevant authority.

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6. The Certificate
KAN Accreditation certificate:
a. Be valid for a four years period.
b. Can be withdrawn when KAN concludes that CAB failed to comply with the
requirements and this terms and conditions determined by KAN.
c. Must be returned to KAN upon withdrawal or expire of the accreditation.

7.

Confidentiality

7.1.

KAN will keep confidentiality of any information collecting from accreditation

process.

7.2.

All KAN personnel in all level including internal and external personnel shall keep
confidentiality of any information about CAB and sign Commitment to keep
confidentiality and free conflict of interest and other pressure.

7.3.

Information about CAB shall not inform to other parties without any written
consent from CAB. If requires by law, KAN shall inform CAB.

7.4.

All information gained by KAN during the process for granting, maintaining,
extending and reducing of accreditation are confidential. All KAN personnel at all
level including any committees and external personnel or institution, which acts on
behalf of KAN, shall commit to obey these confidentiality requirements. All such
information will only be handed over to other interested parties in accordance with
the existing laws or with a written permission from the respective CABs
management.

8.
8.1.

Complaints and Appeals

KAN will respond and take an appropriate action of any complaints concerning
accredited CAB, KANs personnel or personnel who acts on behalf of KAN. KAN
will assess the effectiveness of such action taken.

8.2.

KAN will respond an appeal from CAB by establishing the independent committee.

8.3.

KAN keep the records of all appeals, complaints and corrective actions related to
accreditation.

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Liability

KAN is responsible to the liability matters that could be caused from accreditation
activities. The guideline is governed on Government Regulation No. 43 Year 1991
concerning Indemnity and Its Procedure in Public Administration Court.

10.

Accreditation Fee

10.1.

KAN has stable finances from government budget and accreditation fee.

10.2.

KAN establishes and publishes the accreditation fee structure.

11.

Provisions of Legislation

This terms and conditions are stipulated under the laws and regulation of Republic of
Indonesia.

12.

KAN's ADDRESS

Gedung Manggala Wanabakti block IV 4th floor

Jln. Jend. Gatot Subroto, Senayan, Jakarta 10270
Telp : 5747043-4, Fax : 5747045, 57902948
E-mail : sertifikasi@bsn.or.id

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