DPUM 01 Rev.10 Terms and Conditions for accreditation of CAB 17 Nov 2016
DPUM 01 Rev. 10
TERMS AND CONDITIONS
FOR ACCREDITATION OF CONFORMITY
ASSESSMENT BODY (CAB)
Komite Akreditasi Nasional
National Accreditation Body of Indonesia
Gedung I BPPT, Lt. 14
Jl. M.H. Thamrin No. 8, Kebon Sirih, Jakarta 10340 – Indonesia
Tel.
: +62 21 3927422,
Fax.
: +62 21 3927527
Email
: akreditasi@bsn.go.id
Website : www.kan.or.id
DPUM 01
Revision : 10
Date: 17 November 2016
Terms and Conditions for
Accreditation of Conformity Assessment Body (CAB)
1. Introduction
The Government Regulation No. 102 Year 2000, on National Standardization and
Presidential Decree No. 78 Year 2001, on the National Accreditation Body of
Indonesia (KAN), stated that KAN is the authority body for the accreditation of
conformity assessment bodies in Indonesia. KAN ensures that their operation
including those activities the related body does not compromise the confidentiality,
objectivity and impartiality of its accreditation.
To operate the accreditation services, KAN issued Terms and Conditions for
Accreditation of Conformity Assessment Body (CAB) document providing the generic
information about the accreditation requirements, accreditation process, CAB rights
and obligations, KAN obligations, the use of KAN logo and PAC/IAF MLA Mark and
other conformity mark, accreditation certificate, confidentiality, complaints and
appeals, liability, accreditation fee, provision of legislation and KAN’s address.
The specific information about the specific accreditation scheme is provided in
Supporting Document for Accreditation of Certification Body (DPLS) and other
related documents.
2. Requirements for CAB
2.1
Accreditation of Conformity Assessment Bodies (CABs) which is operated
by KAN, aims to assess competence of the CAB is based on the requirements
that have been established in accordance with the scope/scheme. The
following is a list of the requirements that shall be fulfilled by:
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Management System CAB – ISO 17021
CAB Accreditation Requirements for scheme:
(√)
Requirements
SNI ISO/IEC 17021
and/or
SNI ISO/IEC 17021-1
SNI ISO/IEC TS 17021-2
SNI ISO/IEC TS 17021-3
SNI ISO/TS 22003:2013
ISO/IEC 27006:2011
ISO 50003:2014
DPLS 05 Rev. 4 Terms
and Conditions –
Accreditation of System
HACCP CBs and FSMS
CBs – Supplementary
DPLS 10 Rev. 0 Terms
and Conditions –
Accreditation of Security
Management Systems for
The Supply Chain
Certification Bodies –
Supplementary
DPLS 11 Rev. 0 Terms
and Conditions –
Accreditation of Medical
Devices Quality
Management Systems
Certification Bodies –
Supplementary
DPLS 12 Rev. 1 Terms
and Conditions –
Accreditation of Security
Management Systems for
Information Security
Management System
Certification Bodies–
Supplementary
DPLS 17 Rev. 1 Scope of
Accreditation QMS and
EMS
DPLS 18 Rev. 0 Terms
and Conditions –
Accreditation of Tourism
Business Certification
Bodies – Supplementary
QMS
EMS
FSMS
ISMS
MDQMS
Supply
Chain
HACCP
Tourism
EnMS
√
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CAB Accreditation Requirements for scheme:
(√)
Requirements
IAF MD 1:2007 IAF
Mandatory document for
Certification of Multiple
Sites Based on Sampling
IAF MD 2:2007 IAF
Mandatory Document for
Transfer of Accredited
Certification of
Management Systems
IAF MD 3:2008 IAF
Mandatory Document for
Transfer Advanced
Surveillance and
Recertification
Procedures (ASRP)
IAF MD 4:2008 IAF
Mandatory Document for
Use of Computer
Assisted Auditing
Techniques (CAAT) for
Accredited Certification of
Management Systems
IAF MD 5:2015
Determination of Time of
Quality and
Environmental
Management Systems
IAF MD 9:2015
Application of ISO/IEC
17021 in The Field of
Medical Devices Quality
Management Systems
(ISO 13485)
IAF MD11:2013 IAF
Mandatory Document for
Application of ISO/IEC
17021 for Audits of
Integrated Management
Systems (IMS)
IAF MD15:2014 IAF
Mandatory Document for
the Collection of Data to
Provide Indicators of
Management System
Certification Bodies'
Performance
Date: 17 November 2016
MDQMS
Supply
Chain
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QMS
EMS
FSMS
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ISMS
HACCP
Tourism
EnMS
√
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CAB Accreditation Requirements for scheme:
(√)
Requirements
QMS
IAF MD 16: 2015 IAF
Mandatory Document
Application of ISO/IEC
17011 for the
Accreditation of Food
Safety Management
System (FSMS)
Certification Bodies
IAF MD 17:2015
Witnessing Activities for
the Accreditation of
Management Systems
Certification Bodies
IAF MD 19:2016 IAF
Mandatory Document For
The Audit and
Certification of a
Management System
operated by a Multi-Site
Organization (where
application of site
sampling is not
appropriate)
DPLS 22 Terms and
Conditions –
Accreditation of Energy
Management System
Certification Bodies –
Supplementary
Ministry of Tourism of
Republic of Indonesia
regulation Number 1 year
2016 about Certification
on Tourism Business
Date: 17 November 2016
EMS
FSMS
ISMS
MDQMS
Supply
Chain
HACCP
√
Tourism
EnMS
√
√
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Products, processes and services CAB – ISO 17065
CAB Accreditation Requirements for scheme:
(√)
Requirements
SNI ISO/IEC 17065
SNI ISO/TS 22003:2013
Product
√
DPLS 04 Terms and Conditions –
Accreditation of Product
Certification Bodies–
Supplementary
DPLS 20 Terms and Conditions –
Accreditation of Organic Food
Certification Bodies–
Supplementary
DPLS 21 Requirements for Halal
Certification Bodies
DPLS 26 Requirements for
Ecolabel certification
DPLS 27 Competence criteria for
personnel of Ecolabel Certification
Body
KAN Guideline 403:2011
Conformity Assessment – General
Provision for the Use of Conformity
Marks based on SNI and/or
Technical Regulations
Regulation of Forestry Minister RI &
Regulation of Director General for
Sustainable Forest Management of
Forestry Minister RI
OIC/SMIIC 2:2011 Guidance For
Bodies Providing Halal Certification
Ecolabel
√
Organic
√
VLK
√
PHPL
√
Halal
√
√
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√
√
√
√
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Personnel CAB – ISO 17024
Requirements
SNI ISO/IEC 17024
DPLS 23 Terms and Conditions – Accreditation of
Personnel Certification Bodies – Supplementary
√
√
√
√
CAB Accreditation
Requirements for
scheme:
(√)
Personnel
√
√
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Green House Gases CAB – ISO 14065
Requirements
SNI ISO 14065
SNI ISO 14064-3:2009
ISO 14066:2011
DPLS 15 Terms and Conditions – Accreditation of
Green House Gasses Validation and/or Verification
Bodies – Supplementary
SNI ISO14064 series
IAF MD 6:2014 IAF Mandatory Document for the
Application of ISO 14065:2013
Date: 17 November 2016
CAB Accreditation
Requirements for
scheme:
(√)
GHG
√
√
√
√
√
√
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2.2
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CAB shall :
a.
b.
c.
d.
has documented quality system that implemented for at least 3 months.
has conducted at least one internal audit and management review.
has registered legal entity in Indonesia
has sufficient resources (such as human resources, laboratories, if
applicable, etc.)
e. meet all KAN requirements including accreditation fees
f. has issued at least 1 certificate of conformity (proven by copy of certificate)
g. has a list of certified clients or potential clients
3. Accreditation Procedure
3.1
3.1.1
3.1.2
3.1.3
3.1.4
3.1.5
Accreditation application
KAN proceeds the accreditation application submitted through online and
offline. The online application would proceed through www.akreditasi.bsn.go.id.
The offline application as follow:
CAB asks to KAN for information on accreditation procedures and
requirements
KAN sends an accreditation application form and other related documents or
CAB can visit the website of KAN and downloads the relevant documents.
CAB sends an application using such forms signed by top management CAB,
addressed to the Chairman of KAN c.q. Director for Accreditation of
Certification Body together with documents are as follows :
a. Application form
b. Applicant data form
c. Controlled and updated Quality System documentation
d. Certification scheme for each scope applied (for product, personnel CB,
and GHG VVB)
e. List of auditor/personel of validation/verify officer/technical experts/
evaluator/ competency examiner/ inspector/ certification decision using
forms and List of committee for safeguarding impartiality or governing
board, if applicable
f. List of certified clients (for initial accreditation, scope extension and reaccreditation)
g. Legal entity document (Notary deed, Kemenkumham Decree, SIUP, TDP
or decree for government institution)
h. List of supporting laboratory and Memorandum of Understanding (MoU)
documents between product certification body and supporting laboratory
if Product CB and laboratory are within different legal entities
i. Records of internal audit and management review
j. Statement of commitment from CAB’s clients to be audit by CAB (for new
accreditation application)
KAN reviews the completeness of the application submitted and reviews its
capability to provide an accreditation to CAB with taking into account:
a. Applicants location;
b. Language used in the assessment;
c. Scope of accreditation requested;
d. Availability of Assessor and/or technical expert;
e. Availability of accreditation scheme and related document;
KAN proceeds the application to the next step after all requirements fulfilled.
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3.2
Preliminary visit
3.2.1
3.2.2
3.2.3
Preliminary visit aims to identify the readiness of CAB against accreditation
requirements before the initial assessment carried out.
KAN may carry out the preliminary visit by request of the CABs.
The preliminary visit 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 nonconformity.
3.3
Assessment preparation
3.3.1
KAN proposes the assessment team and the assessment schedule to the
CAB based on complexity and accreditation scopes. The CAB has right to
refuse the assessment team by providing the reasonable objection. Where
the CAB did not approve the assessment team and the assessment schedule
by acceptable reason, KAN will replace the assessment team and rearranges
the assessment schedule.
KAN officially assigns the assessment team to conduct the adequacy audit
and the assessment based on related requirements. The technical experts
may be attached to the assessment team, if necessary. KAN ensures that
the team members have appropriate competencies and are free from any
potential conflict of interest with the CAB.
3.3.2
3.4
Adequacy audit
3.4.1
The assessment team conducts an adequacy audit to the CAB’s quality
system documentation and related documents against requirements.
If the assessment team concluded that the system is generally not comply
with the requirements, than the assessment team can make a
recommendation to Secretary-General through Director for discontinuing the
accreditation process.
If the CAB quality system documentation is adequate, the accreditation
process may be proceed to on-site assessment.
3.4.2
3.4.3
3.5
3.5.1
3.5.2
3.5.3
3.5.4
On-site assessment
KAN assesses the conformity assessment services at the premises of the
CAB from which one or more key activities performed.
The assessment team carries out the on-site assessment in 4 stages as
follow: opening meeting, assessment, team meeting, and closing meeting.
The assessment team should deliver to the CAB during closing meeting
summary report and/or any nonconformities/observations found. The CAB
shall be followed up any major non-conformity within 1 month after the onsite assessment, while any minor non-conformities shall be followed up within
2 months after. Observation should be followed up with action plan.
For initial assessment, if such non-conformities cannot be closed out until
specified time, KAN will give 1-month extension period to the CAB for
carrying out followed up action for any major non-conformity.
3.6
Surveillance
3.6.1
KAN establishes an annual surveillance program. The program should
ensure that all accreditation scope assessed during surveillance within
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3.6.2
3.6.3
3.6.4
3.7
3.7.1
3.7.2
3.7.3
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accreditation period. The regular surveillance visit is conducted at least twice
during accreditation period. However, if KAN Council decided that the first
surveillance conducted no later than 6 months after accreditation, than
surveillance shall conducted three times during accreditation period. In some
certain cases, KAN can decide to conduct additional surveillance. Additional
surveillance visit at any time if there is any:
- Complaints/disputes from related parties concerning the performance of
accredited CAB.
- Changes as mentioned DPUM 01 that have significant affect to capability of
accredited CAB.
- The assessment team of previous assessment recommends for additional
audit based on assessment result.
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.
First surveillance is carried out 12 (twelve) months after date of accreditation
status was granted, at the latest. If the first surveillance can not be conducted
in 12 months, the accreditation status for CAB can be suspended until the
first surveillance is conducted.
The second surveillance is carried out 24 (twenty-four) months after the date
of accreditation status was granted. KAN can give dispensation on the
postponement for 3 (three) months of the program. The reason of
postponement must be agreed by Director for Accreditation. If the first
surveillance conducted no later than 6 months after accreditation as decided
by KAN Council, the second surveillance should be conducted 18 (eighteen)
months after accreditation, and the third surveillance is carried out 30 (thirty)
months after accreditation.
Re-accreditation
Before the accreditation status is expired, at least 12 (twelve) months before
the expired date of accreditation certificate, Director for Accreditation informs
the CAB that its accreditation status will be expired, and suggests the CAB to
send an application for re-accreditation 9 (nine) months before the expired
date on the accreditation certificate.
If the CAB is willing to extend its accreditation status, the CAB shall send an
application for re-accreditation and other supporting documents which are
required. The CAB shall submit the application form and the applicant data
form, and other documents required in clause 3.1.3 unless there are no
changes with document submitted previously.
On site assessment for re-accreditation should be conducted at least 6
months before the expired date on the accreditation certificate.
3.8
Extension accreditation scope
3.8.1
CAB may request an extension of accreditation scopes to KAN by submitting:
Application form
Applicant data form
List of auditor / technical experts / evaluator /competency examiner/
inspector / certification decision related to scope extension
List of certified clients related to scope extension
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Controlled and updated Quality system documentation and related
documents to scope extension
3.8.2 The assessment for extension of accreditation scopes can be carried out
together with surveillance activity.
3.8.3 If the assessment is conducted not in the same time with the surveillance
visit, than the assessment can be conducted minimally 3 (three) months after
the last assessment visit.
3.9
Witness Assessment
3.9.1
KAN performs witness assessment at selected audit performed by the CAB to
ensure that the CAB is competent in carrying out their certification services
for the applicable scopes applied and conforms to the relevant standard(s)
and other requirements for accreditation.
Determination of scopes to be witnessed
a. Some aspects which are considered in determining of scopes to be
witnessed are:
- potential risk having for any scopes
- number and performance of auditor/evaluator/examiner/
expert/sampling officer for each scopes
- most scope of certification issued
- availability of audit/examination program
- feedback from interested parties
b. Within one accreditation cycle, witnesses should cover all potential risks
having for accreditation scope (high, medium, and low) for an
accreditation scheme which have such levels of potential risks such as
management systems and HACCP, if applicable.
c. Composition of witnesses number for Management System CABs consist
of 60 % high risk scope, 30 % for medium risk of scope, and 10% for low
risk of scope. Since the CBs have accreditation scope with two risk
categories such as high risk and medium risk, high risk and low risk, or
medium risk and low risk, even the calculation of the witness number
composition using comparative grade 60 : 40. Since the CBs have
accreditation scope with one risk categories scope, there is no
composition.
3.9.2
3.9.3
Determination of witness number for initial accreditation and scope extension
For processing of initial accreditation, and extension of accreditation scope,
witnesses number will be determined by refer to table 1 below. Type of audit
which might be witnessed is initial certification/re-certification or surveillance
audit which covers all certification requirements.
Tabel 1. Number of Witnesses for initial accreditation and scope extension
Number of accreditation scopes
1-4
5-16
> 16
Number of witness
1
2
3
NOTE: 1. Accreditation scope for product certification refers to DPLS 04
2. Accreditation scope for FSMS certification body refers to DPLS 19
3.9.4
Determination of witnesses within accreditation cycle
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a. Determination of witnesses number to be performed should be conducted
after an accreditation granted and should evaluate each year within an
accreditation cycle refers to table 2 (for all accreditation schemes except
personnel), while determination of witnesses number for personnel CB
refers to table 3.
b. If CAB can maintain the satisfactory performance continuously within two
(2) accreditation cycles, the number of witness can be reduced at
maximum 2 witnesses, however the lowest witnesses number to be
performed to the CAB are 2.
c. If there is negative feedback from interested parties on the performance
of the CAB, the number of witnesses can be added at minimum one
witness.
EXAMPLE:
- After an accreditation granted found that CAB have issued 100 certificates which mean the
witnesses should be performed during accreditation cycle are 4 witnesses, than during the
first year of accreditation the witnesses conducted was 1.
- After one year of accreditation the certificates issued by CAB are 203 certificates, which
mean the witnesses should be performed during accreditation cycle are 6 witnesses, than
during the second year of accreditation the witnesses conducted was 2.
- After two years of accreditation the certificates issued by CAB are 405 certificates, which
mean the witnesses should be performed during accreditation cycle are 8 witnesses, than
during the third year of accreditation the witnesses conducted was 3.
- After three years of accreditation the certificates issued by CAB are 580 certificates, which
mean the witnesses should be performed during accreditation cycle are 10 witnesses, than
during the last year of accreditation the witnesses shall conducted are 4 witnesses.
Tabel 2. Number of witnesses within an accreditation cycle (except Personnel CB)
Number of certification issued
1-50
51-200
201-400
401-600
> 600
Number of witness
2
4
6
10
11
Tabel 3. Number of witnesses within one accreditation cycle for Personnel CB
Number of certification issued
1-500
501-1000
1001-5000
> 5000
3.9.5
Number of witness
2
4
6
7
Determination of witness number for re-accreditation
a. There’s no need any additional witnesses for re-accreditation program
other than witnesses audit programmed within an accreditation cycle,
unless the CAB apply for an extension on accreditation scopes.
d. If CAB failed provided an audit programs to be witnessed as required
within previous accreditation cycle, than KAN shall conduct the witnesses
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3.9.6
3.9.7
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as required on the scope(s) that failed to be witnessed during previous
accreditation cycle.
Implementation of witness
a. Director for Accreditation informs the CAB on the assessment team that
will conduct the witness as well as the witness fees; KAN should consider
the following aspect when assigning the assessment team:
- an appropriate knowledge of CAB’s client type of business, process
and product,
- a general understanding of the kinds of regulations the client’s
products have to comply with, and
- the ability to witness an audit and to collect any necessary
information.
b. Witness assessment should be conducted in conjunction with an
assessment program.
c. KAN requests CAB to provide information :
- CAB’s audit plan
- Latest audit report of particular client or stage 1 audit report when the
audit being witness is initial certification
- Background information on the CAB’s audit team
- CAB’s audit or surveillance procedure
- Logistical information for the audit (date and location)
- Client’s permission before the witness is conduct.
d. During the witness, KAN’s assessment team evaluates the audit process
according to the audit plan and procedures of certification having by the
CAB, while also evaluates qualification of the audit team assigned
according to CAB’s audit team (auditor/examiner/expert/sampling officer)
criteria and competencies of CAB’s audit team covering audit technique,
knowledge
on
certification
criteria
and
other
relevant
documents/regulations, and knowledge on technical area being audited.
Follow up of witness
a. KAN’s assessment team should inform to the CAB’s audit team where
observation or nonconformity found during the witness process at the
post audit feedback session, and should be recorded in the witness
report.
b. Where the witness report includes nonconformity(es) and observation(s),
it should require that action is taken by the CAB management to address
the issues raised.
c. The assessment team should produce the witness report only after
received and reviewed of the CAB’ audit report which was witnessed.
d. The assessment team verifies the evidences of corrections and corrective
actions taken by CAB during the next surveillance if needed.
3.10
Assessment report
The assessment team analyzes all relevant information and evidence gathered
during the document and record review and the on-site assessment. The team’s
observations on areas for possible improvement may also present to the CAB.
3.11
Decision making on accreditation
3.11.1 Accreditation decision made by KAN Council.
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3.11.2 KAN will not delegate its responsibility in granting, maintaining, extending,
reducing, suspending and withdrawing an accreditation
3.11.3 Persons involves in decision making shall not involve in assessment
3.11.4 Before making an accreditation decision, the assessment report should be
reviewed by Technical Committee
3.12
Application Validity
The accreditation application submitted by CAB is valid for one-year after application
and the required documents submitted (completed). The accreditation process
(application to accreditation decision) shall be completed within one-year period. The
accreditation period would be terminated once the CAB failed to follow this period.
3.13
Sanctions
3.13.1 KAN may initiate to apply sanctions to the applicant CAB or the accredited
CAB when it found that an applicant/accredited CAB has persistently failed or
has lack of consistency to meet the requirements of accreditation or to abide
by the rules for accreditation. The sanctions could be, but are not limited to:
- Intensification of surveillance (office, witness or document review);
- Reduction of accreditation scope (including geographical scope);
- Suspension;
- Withdrawal;
- Public notice of scope reduction/suspension/withdrawal/misrepresentation
of accreditation;
- Legal actions
3.13.2 Intensification of surveillance (office, witness or document review)
KAN may carry out an additional or early surveillance to the CAB, when it
found that an applicant/accredited CAB lack of consistency in implementation
of CA procedures to abide by the rules for accreditation.
3.13.3 Reducing an accreditation
KAN may reduce an accreditation scope of the CAB if:
a. The CAB failed to maintain the availability of competence personnel
and/or facilities and/or equipments needed to support its accredited
activity;
b. Requested by CAB.
3.13.4 Suspension an accreditation
a. During the accreditation period, KAN may suspend the accreditation
status of the CAB, if the CAB failed to maintain its compliance to the
requirements,.
b. Suspension a part or all of CAB accreditation scopes are based on the
following:
- The CAB failed to resolve any non-conformities issued as results of
assessment, surveillance or re-assessment in the specified time
frame;
- There is negative outcome of complaint investigation.
- The CAB misuses/misrepresentation of KAN accreditation logo and
PAC/IAF MLA marks;
- The assessment result shows that the implementation of management
system is not effective;
- The CAB cannot facilitate KAN surveillance and/or witnessing within
period.
- Non-payment of fees.
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- Requested by CAB.
- There is no client certified when KAN conduct the survaillence
c. The CAB that its accreditation status is suspended may carry out
surveillance to its certified clients, however does not entitle to carry out
initial certification or re-certification audit by using KAN logo or statement
that accredited by KAN.
3.13.5 Withdrawal an accreditation
a. KAN may withdraw an accreditation status of the accredited CAB based
on the following:
- The CAB owned by individual and the owner that is bankrupt or to be
a part of its creditor;
- There is ”force majeure” that causes of the CAB could not be operate;
- The CAB is a part of a corporate that is liquidated.
- The CAB has persistently failed to meet the requirements of
accreditation or to abide by the rules for accreditation.
- The CAB failed to follow up recommendation for corrective action
within suspension period (3 months).
- There is proven evidence of fraudulent behavior.
- The CAB intentionally provides false information
b. Withdrawal can also be done on a part of scope that has no client for 1
(one) cycle of accreditation plus 1 (one) year
3.13.6 The CAB with accreditation status withdrawn, should not be doing
surveillance to their clients or to audit the initial certification or re-certification
audit by using KAN logo, or statement that is accredited by KAN. All clients
will be transferred to the other accredited certification bodies.
3.13.7 The CAB that its accreditation status is suspended or withdrawn is not
entitled to use KAN symbol and PAC/APLAC/IAF/ILAC logos for all of its
activities until the accreditation status is restored by KAN.
3.13.8 KAN will notify the CAB on the reason of suspension/withdrawal, within 14
days before the suspension/withdrawal.
3.13.9 Public notice of scope reduction/suspension/withdrawal/misrepresentation of
accreditation would be informed in KAN website.
3.13.10 KAN may restore the accreditation from the suspension once the CAB taken
appropriate followed up action.
3.13.11 Legal actions shall be taken if the CAB breaches The Act Number 20 Year
2014, on Standardization and Conformity Assessment.
4. CAB Rights and Obligations
4.1
4.1.1
4.1.2
4.1.3
4.1.4
4.1.5
4.1.6
4.2
CAB has the rights to
Make appeals and complaints to KAN.
Get information on any accreditation requirements changes.
Require explanation when the applied scope of accreditation is related to a
specific program and additional information related to accreditation
application.
Get information on names of an assessment team members who will carry
out assessment / surveillance/ re-assessment
Use the KAN accreditation logo and if applicable IAF MLA mark with
concerning related Guide stipulated by KAN
Apply for extending and reducing of accreditation scope.
CAB has obligations to
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4.2.1
4.2.2
4.2.3
4.2.4
4.2.5
4.2.6
4.2.7
4.2.8
4.2.9
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Commit to fulfill continually the requirements as mention in clause 1.1, and
this terms and conditions and adapt the changes of accreditation
requirements.
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
a. To permit KAN and auditors to conduct assessment, surveillance,
verification, witness and other activities related to accreditation for all
premises where CAB services operate
b. 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
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 for assessment, surveillance, re-assessment ,complaints handling
purposes) and document related to independence and impartiality from its
related bodies
CABs shall provide audit programs that will be witnessed by KAN before the
accreditation status is granted and during accreditation cycle as required. The
witness is to ensure that CABs have competent auditor to support their
services. CAB shall require their clients to allow KAN’s witnessing
assessment team
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
Pay such fees for application, assessment, surveillance, re-assessment,
extending scope and other fees as determined by KAN before on-site
assessment conducted
Inform KAN immediately, in case there are changes on:
a. Organization, top management and key personnel’s;
b. Address, ownership, legal status, and organization commercial status;
c. Main policy;
d. Equipments, premises, facilities and/or other resources that may affect
CAB performance;
e. Accreditation scopes;
f. Other such matters that may affect the ability of the CAB to fulfill
requirements for accreditation
Facilitate PAC/IAF peer evaluation in order to maintain MLA PAC/IAF.
CAB shall provide updated data at least once a year on January, but is not
limited to:
a. certified clients,
b. number of auditors,
c. number of transfers accepted (if applicable),
d. number of overdue audits, and
e. number of auditor-days delivered.
5. KAN has obligation to
5.1
Make publicly available information the current status of accredited CAB
regularly
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5.2
5.3
5.4
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Date: 17 November 2016
Provide the CAB with information related to the accreditation scopes, terms
and conditions, international arrangement, where applicable.
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.
Verify that each accredited body carries out any necessary adjustment against
the changes requirements.
6. Use of KAN logo and PAC/IAF MLA Mark and other conformity mark
6.1
6.2
6.3
6.4
6.5
KAN Guide 12: 2004 governs the use of KAN accreditation logo. CABs shall
use KAN logo only for its accredited scope and premises.
The use of PAC/IAF/APLAC/ILAC mark based on KAN Guide 13, where
applicable.
The use of other conformity marks based on Pedoman KAN 403:2012
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 one
months period.
If 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.
7. 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 or providing the evidence of shattered certificate
upon withdrawal or expire of the accreditation.
8. Confidentiality
8.1 KAN will keep confidentiality of any information collecting from accreditation
process.
8.2 All KAN personnel in all level including internal and external personnel shall
keep confidentiality of any information about CAB and sign Commitment letter to
keep confidentiality and free conflict of interest and other pressure.
8.3 Information about CAB shall not inform to other parties without any written
consent from CAB. If requires by law, KAN shall inform CAB.
8.4 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 CAB’s management.
9. Complaints and Appeals
9.1
KAN will respond and take an appropriate action of any complaints concerning
accredited CAB, KAN’s personnel or personnel who acts on behalf of KAN.
KAN will assess the effectiveness of such action taken.
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9.2
9.3
9.4
9.5
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KAN will respond an appeal from CAB by establishing the independent
committee.
KAN would respond any appeal submitted by CAB within one month after
decision issued.
KAN would proceed any appeal issued by CAB which related to decision not
proceed an accreditation because of technical matters, and decision to not
granted, suspended or withdraw the CAB accreditation because of CAB
performance, However, the appeal would not be proceed when decision
appealed according to not proceed or not granted, suspended or withdraw the
CAB accreditation because of the CAB failed to comply with an accreditation
pre-requirements and failed to follow the accreditation process (ex: The CAB
failed to provide the audit(s) to be witnessed, The CAB failed to response the
NC issued within period, The CAB may not be surveillance within period, The
accreditation process exceeded 1 year period)
KAN keeps the records of all appeals, complaints and corrective actions related
to accreditation.
10. Liability
KAN is responsible to the liability matters that might be arrises from its accreditation
activities. The guideline is governed on Government Regulation No. 43 Year 1991
concerning Indemnity and Its Procedure in Public Administration Court.
11. Accreditation Fee
11.1 KAN has stable finances from government budget and accreditation fee.
11.2 KAN establishes and publishes the accreditation fee structure (DPUM 02).
12. Provisions of Legislation
This terms and conditions is stipulated under the laws and regulation of Republic of
Indonesia.
13. KAN's ADDRESS
Gedung I BPPT, Lt. 14
Jl. M.H. Thamrin No. 8, Kebon Sirih, Jakarta 10340 – Indonesia
Tel.
: +62 21 3927422,
Fax. : +62 21 3927527
Email : akreditasi@bsn.go.id
Website : www.kan.or.id
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TERMS AND CONDITIONS
FOR ACCREDITATION OF CONFORMITY
ASSESSMENT BODY (CAB)
Komite Akreditasi Nasional
National Accreditation Body of Indonesia
Gedung I BPPT, Lt. 14
Jl. M.H. Thamrin No. 8, Kebon Sirih, Jakarta 10340 – Indonesia
Tel.
: +62 21 3927422,
Fax.
: +62 21 3927527
: akreditasi@bsn.go.id
Website : www.kan.or.id
DPUM 01
Revision : 10
Date: 17 November 2016
Terms and Conditions for
Accreditation of Conformity Assessment Body (CAB)
1. Introduction
The Government Regulation No. 102 Year 2000, on National Standardization and
Presidential Decree No. 78 Year 2001, on the National Accreditation Body of
Indonesia (KAN), stated that KAN is the authority body for the accreditation of
conformity assessment bodies in Indonesia. KAN ensures that their operation
including those activities the related body does not compromise the confidentiality,
objectivity and impartiality of its accreditation.
To operate the accreditation services, KAN issued Terms and Conditions for
Accreditation of Conformity Assessment Body (CAB) document providing the generic
information about the accreditation requirements, accreditation process, CAB rights
and obligations, KAN obligations, the use of KAN logo and PAC/IAF MLA Mark and
other conformity mark, accreditation certificate, confidentiality, complaints and
appeals, liability, accreditation fee, provision of legislation and KAN’s address.
The specific information about the specific accreditation scheme is provided in
Supporting Document for Accreditation of Certification Body (DPLS) and other
related documents.
2. Requirements for CAB
2.1
Accreditation of Conformity Assessment Bodies (CABs) which is operated
by KAN, aims to assess competence of the CAB is based on the requirements
that have been established in accordance with the scope/scheme. The
following is a list of the requirements that shall be fulfilled by:
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Management System CAB – ISO 17021
CAB Accreditation Requirements for scheme:
(√)
Requirements
SNI ISO/IEC 17021
and/or
SNI ISO/IEC 17021-1
SNI ISO/IEC TS 17021-2
SNI ISO/IEC TS 17021-3
SNI ISO/TS 22003:2013
ISO/IEC 27006:2011
ISO 50003:2014
DPLS 05 Rev. 4 Terms
and Conditions –
Accreditation of System
HACCP CBs and FSMS
CBs – Supplementary
DPLS 10 Rev. 0 Terms
and Conditions –
Accreditation of Security
Management Systems for
The Supply Chain
Certification Bodies –
Supplementary
DPLS 11 Rev. 0 Terms
and Conditions –
Accreditation of Medical
Devices Quality
Management Systems
Certification Bodies –
Supplementary
DPLS 12 Rev. 1 Terms
and Conditions –
Accreditation of Security
Management Systems for
Information Security
Management System
Certification Bodies–
Supplementary
DPLS 17 Rev. 1 Scope of
Accreditation QMS and
EMS
DPLS 18 Rev. 0 Terms
and Conditions –
Accreditation of Tourism
Business Certification
Bodies – Supplementary
QMS
EMS
FSMS
ISMS
MDQMS
Supply
Chain
HACCP
Tourism
EnMS
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
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CAB Accreditation Requirements for scheme:
(√)
Requirements
IAF MD 1:2007 IAF
Mandatory document for
Certification of Multiple
Sites Based on Sampling
IAF MD 2:2007 IAF
Mandatory Document for
Transfer of Accredited
Certification of
Management Systems
IAF MD 3:2008 IAF
Mandatory Document for
Transfer Advanced
Surveillance and
Recertification
Procedures (ASRP)
IAF MD 4:2008 IAF
Mandatory Document for
Use of Computer
Assisted Auditing
Techniques (CAAT) for
Accredited Certification of
Management Systems
IAF MD 5:2015
Determination of Time of
Quality and
Environmental
Management Systems
IAF MD 9:2015
Application of ISO/IEC
17021 in The Field of
Medical Devices Quality
Management Systems
(ISO 13485)
IAF MD11:2013 IAF
Mandatory Document for
Application of ISO/IEC
17021 for Audits of
Integrated Management
Systems (IMS)
IAF MD15:2014 IAF
Mandatory Document for
the Collection of Data to
Provide Indicators of
Management System
Certification Bodies'
Performance
Date: 17 November 2016
MDQMS
Supply
Chain
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
QMS
EMS
FSMS
√
√
√
√
√
√
√
√
√
√
√
ISMS
HACCP
Tourism
EnMS
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
√
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Revision : 10
CAB Accreditation Requirements for scheme:
(√)
Requirements
QMS
IAF MD 16: 2015 IAF
Mandatory Document
Application of ISO/IEC
17011 for the
Accreditation of Food
Safety Management
System (FSMS)
Certification Bodies
IAF MD 17:2015
Witnessing Activities for
the Accreditation of
Management Systems
Certification Bodies
IAF MD 19:2016 IAF
Mandatory Document For
The Audit and
Certification of a
Management System
operated by a Multi-Site
Organization (where
application of site
sampling is not
appropriate)
DPLS 22 Terms and
Conditions –
Accreditation of Energy
Management System
Certification Bodies –
Supplementary
Ministry of Tourism of
Republic of Indonesia
regulation Number 1 year
2016 about Certification
on Tourism Business
Date: 17 November 2016
EMS
FSMS
ISMS
MDQMS
Supply
Chain
HACCP
√
Tourism
EnMS
√
√
√
√
√
√
√
√
√
√
√
√
√
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Products, processes and services CAB – ISO 17065
CAB Accreditation Requirements for scheme:
(√)
Requirements
SNI ISO/IEC 17065
SNI ISO/TS 22003:2013
Product
√
DPLS 04 Terms and Conditions –
Accreditation of Product
Certification Bodies–
Supplementary
DPLS 20 Terms and Conditions –
Accreditation of Organic Food
Certification Bodies–
Supplementary
DPLS 21 Requirements for Halal
Certification Bodies
DPLS 26 Requirements for
Ecolabel certification
DPLS 27 Competence criteria for
personnel of Ecolabel Certification
Body
KAN Guideline 403:2011
Conformity Assessment – General
Provision for the Use of Conformity
Marks based on SNI and/or
Technical Regulations
Regulation of Forestry Minister RI &
Regulation of Director General for
Sustainable Forest Management of
Forestry Minister RI
OIC/SMIIC 2:2011 Guidance For
Bodies Providing Halal Certification
Ecolabel
√
Organic
√
VLK
√
PHPL
√
Halal
√
√
√
√
√
√
√
√
Personnel CAB – ISO 17024
Requirements
SNI ISO/IEC 17024
DPLS 23 Terms and Conditions – Accreditation of
Personnel Certification Bodies – Supplementary
√
√
√
√
CAB Accreditation
Requirements for
scheme:
(√)
Personnel
√
√
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Green House Gases CAB – ISO 14065
Requirements
SNI ISO 14065
SNI ISO 14064-3:2009
ISO 14066:2011
DPLS 15 Terms and Conditions – Accreditation of
Green House Gasses Validation and/or Verification
Bodies – Supplementary
SNI ISO14064 series
IAF MD 6:2014 IAF Mandatory Document for the
Application of ISO 14065:2013
Date: 17 November 2016
CAB Accreditation
Requirements for
scheme:
(√)
GHG
√
√
√
√
√
√
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2.2
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Date: 17 November 2016
CAB shall :
a.
b.
c.
d.
has documented quality system that implemented for at least 3 months.
has conducted at least one internal audit and management review.
has registered legal entity in Indonesia
has sufficient resources (such as human resources, laboratories, if
applicable, etc.)
e. meet all KAN requirements including accreditation fees
f. has issued at least 1 certificate of conformity (proven by copy of certificate)
g. has a list of certified clients or potential clients
3. Accreditation Procedure
3.1
3.1.1
3.1.2
3.1.3
3.1.4
3.1.5
Accreditation application
KAN proceeds the accreditation application submitted through online and
offline. The online application would proceed through www.akreditasi.bsn.go.id.
The offline application as follow:
CAB asks to KAN for information on accreditation procedures and
requirements
KAN sends an accreditation application form and other related documents or
CAB can visit the website of KAN and downloads the relevant documents.
CAB sends an application using such forms signed by top management CAB,
addressed to the Chairman of KAN c.q. Director for Accreditation of
Certification Body together with documents are as follows :
a. Application form
b. Applicant data form
c. Controlled and updated Quality System documentation
d. Certification scheme for each scope applied (for product, personnel CB,
and GHG VVB)
e. List of auditor/personel of validation/verify officer/technical experts/
evaluator/ competency examiner/ inspector/ certification decision using
forms and List of committee for safeguarding impartiality or governing
board, if applicable
f. List of certified clients (for initial accreditation, scope extension and reaccreditation)
g. Legal entity document (Notary deed, Kemenkumham Decree, SIUP, TDP
or decree for government institution)
h. List of supporting laboratory and Memorandum of Understanding (MoU)
documents between product certification body and supporting laboratory
if Product CB and laboratory are within different legal entities
i. Records of internal audit and management review
j. Statement of commitment from CAB’s clients to be audit by CAB (for new
accreditation application)
KAN reviews the completeness of the application submitted and reviews its
capability to provide an accreditation to CAB with taking into account:
a. Applicants location;
b. Language used in the assessment;
c. Scope of accreditation requested;
d. Availability of Assessor and/or technical expert;
e. Availability of accreditation scheme and related document;
KAN proceeds the application to the next step after all requirements fulfilled.
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3.2
Preliminary visit
3.2.1
3.2.2
3.2.3
Preliminary visit aims to identify the readiness of CAB against accreditation
requirements before the initial assessment carried out.
KAN may carry out the preliminary visit by request of the CABs.
The preliminary visit 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 nonconformity.
3.3
Assessment preparation
3.3.1
KAN proposes the assessment team and the assessment schedule to the
CAB based on complexity and accreditation scopes. The CAB has right to
refuse the assessment team by providing the reasonable objection. Where
the CAB did not approve the assessment team and the assessment schedule
by acceptable reason, KAN will replace the assessment team and rearranges
the assessment schedule.
KAN officially assigns the assessment team to conduct the adequacy audit
and the assessment based on related requirements. The technical experts
may be attached to the assessment team, if necessary. KAN ensures that
the team members have appropriate competencies and are free from any
potential conflict of interest with the CAB.
3.3.2
3.4
Adequacy audit
3.4.1
The assessment team conducts an adequacy audit to the CAB’s quality
system documentation and related documents against requirements.
If the assessment team concluded that the system is generally not comply
with the requirements, than the assessment team can make a
recommendation to Secretary-General through Director for discontinuing the
accreditation process.
If the CAB quality system documentation is adequate, the accreditation
process may be proceed to on-site assessment.
3.4.2
3.4.3
3.5
3.5.1
3.5.2
3.5.3
3.5.4
On-site assessment
KAN assesses the conformity assessment services at the premises of the
CAB from which one or more key activities performed.
The assessment team carries out the on-site assessment in 4 stages as
follow: opening meeting, assessment, team meeting, and closing meeting.
The assessment team should deliver to the CAB during closing meeting
summary report and/or any nonconformities/observations found. The CAB
shall be followed up any major non-conformity within 1 month after the onsite assessment, while any minor non-conformities shall be followed up within
2 months after. Observation should be followed up with action plan.
For initial assessment, if such non-conformities cannot be closed out until
specified time, KAN will give 1-month extension period to the CAB for
carrying out followed up action for any major non-conformity.
3.6
Surveillance
3.6.1
KAN establishes an annual surveillance program. The program should
ensure that all accreditation scope assessed during surveillance within
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3.6.2
3.6.3
3.6.4
3.7
3.7.1
3.7.2
3.7.3
Revision : 10
Date: 17 November 2016
accreditation period. The regular surveillance visit is conducted at least twice
during accreditation period. However, if KAN Council decided that the first
surveillance conducted no later than 6 months after accreditation, than
surveillance shall conducted three times during accreditation period. In some
certain cases, KAN can decide to conduct additional surveillance. Additional
surveillance visit at any time if there is any:
- Complaints/disputes from related parties concerning the performance of
accredited CAB.
- Changes as mentioned DPUM 01 that have significant affect to capability of
accredited CAB.
- The assessment team of previous assessment recommends for additional
audit based on assessment result.
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.
First surveillance is carried out 12 (twelve) months after date of accreditation
status was granted, at the latest. If the first surveillance can not be conducted
in 12 months, the accreditation status for CAB can be suspended until the
first surveillance is conducted.
The second surveillance is carried out 24 (twenty-four) months after the date
of accreditation status was granted. KAN can give dispensation on the
postponement for 3 (three) months of the program. The reason of
postponement must be agreed by Director for Accreditation. If the first
surveillance conducted no later than 6 months after accreditation as decided
by KAN Council, the second surveillance should be conducted 18 (eighteen)
months after accreditation, and the third surveillance is carried out 30 (thirty)
months after accreditation.
Re-accreditation
Before the accreditation status is expired, at least 12 (twelve) months before
the expired date of accreditation certificate, Director for Accreditation informs
the CAB that its accreditation status will be expired, and suggests the CAB to
send an application for re-accreditation 9 (nine) months before the expired
date on the accreditation certificate.
If the CAB is willing to extend its accreditation status, the CAB shall send an
application for re-accreditation and other supporting documents which are
required. The CAB shall submit the application form and the applicant data
form, and other documents required in clause 3.1.3 unless there are no
changes with document submitted previously.
On site assessment for re-accreditation should be conducted at least 6
months before the expired date on the accreditation certificate.
3.8
Extension accreditation scope
3.8.1
CAB may request an extension of accreditation scopes to KAN by submitting:
Application form
Applicant data form
List of auditor / technical experts / evaluator /competency examiner/
inspector / certification decision related to scope extension
List of certified clients related to scope extension
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Controlled and updated Quality system documentation and related
documents to scope extension
3.8.2 The assessment for extension of accreditation scopes can be carried out
together with surveillance activity.
3.8.3 If the assessment is conducted not in the same time with the surveillance
visit, than the assessment can be conducted minimally 3 (three) months after
the last assessment visit.
3.9
Witness Assessment
3.9.1
KAN performs witness assessment at selected audit performed by the CAB to
ensure that the CAB is competent in carrying out their certification services
for the applicable scopes applied and conforms to the relevant standard(s)
and other requirements for accreditation.
Determination of scopes to be witnessed
a. Some aspects which are considered in determining of scopes to be
witnessed are:
- potential risk having for any scopes
- number and performance of auditor/evaluator/examiner/
expert/sampling officer for each scopes
- most scope of certification issued
- availability of audit/examination program
- feedback from interested parties
b. Within one accreditation cycle, witnesses should cover all potential risks
having for accreditation scope (high, medium, and low) for an
accreditation scheme which have such levels of potential risks such as
management systems and HACCP, if applicable.
c. Composition of witnesses number for Management System CABs consist
of 60 % high risk scope, 30 % for medium risk of scope, and 10% for low
risk of scope. Since the CBs have accreditation scope with two risk
categories such as high risk and medium risk, high risk and low risk, or
medium risk and low risk, even the calculation of the witness number
composition using comparative grade 60 : 40. Since the CBs have
accreditation scope with one risk categories scope, there is no
composition.
3.9.2
3.9.3
Determination of witness number for initial accreditation and scope extension
For processing of initial accreditation, and extension of accreditation scope,
witnesses number will be determined by refer to table 1 below. Type of audit
which might be witnessed is initial certification/re-certification or surveillance
audit which covers all certification requirements.
Tabel 1. Number of Witnesses for initial accreditation and scope extension
Number of accreditation scopes
1-4
5-16
> 16
Number of witness
1
2
3
NOTE: 1. Accreditation scope for product certification refers to DPLS 04
2. Accreditation scope for FSMS certification body refers to DPLS 19
3.9.4
Determination of witnesses within accreditation cycle
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a. Determination of witnesses number to be performed should be conducted
after an accreditation granted and should evaluate each year within an
accreditation cycle refers to table 2 (for all accreditation schemes except
personnel), while determination of witnesses number for personnel CB
refers to table 3.
b. If CAB can maintain the satisfactory performance continuously within two
(2) accreditation cycles, the number of witness can be reduced at
maximum 2 witnesses, however the lowest witnesses number to be
performed to the CAB are 2.
c. If there is negative feedback from interested parties on the performance
of the CAB, the number of witnesses can be added at minimum one
witness.
EXAMPLE:
- After an accreditation granted found that CAB have issued 100 certificates which mean the
witnesses should be performed during accreditation cycle are 4 witnesses, than during the
first year of accreditation the witnesses conducted was 1.
- After one year of accreditation the certificates issued by CAB are 203 certificates, which
mean the witnesses should be performed during accreditation cycle are 6 witnesses, than
during the second year of accreditation the witnesses conducted was 2.
- After two years of accreditation the certificates issued by CAB are 405 certificates, which
mean the witnesses should be performed during accreditation cycle are 8 witnesses, than
during the third year of accreditation the witnesses conducted was 3.
- After three years of accreditation the certificates issued by CAB are 580 certificates, which
mean the witnesses should be performed during accreditation cycle are 10 witnesses, than
during the last year of accreditation the witnesses shall conducted are 4 witnesses.
Tabel 2. Number of witnesses within an accreditation cycle (except Personnel CB)
Number of certification issued
1-50
51-200
201-400
401-600
> 600
Number of witness
2
4
6
10
11
Tabel 3. Number of witnesses within one accreditation cycle for Personnel CB
Number of certification issued
1-500
501-1000
1001-5000
> 5000
3.9.5
Number of witness
2
4
6
7
Determination of witness number for re-accreditation
a. There’s no need any additional witnesses for re-accreditation program
other than witnesses audit programmed within an accreditation cycle,
unless the CAB apply for an extension on accreditation scopes.
d. If CAB failed provided an audit programs to be witnessed as required
within previous accreditation cycle, than KAN shall conduct the witnesses
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3.9.6
3.9.7
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as required on the scope(s) that failed to be witnessed during previous
accreditation cycle.
Implementation of witness
a. Director for Accreditation informs the CAB on the assessment team that
will conduct the witness as well as the witness fees; KAN should consider
the following aspect when assigning the assessment team:
- an appropriate knowledge of CAB’s client type of business, process
and product,
- a general understanding of the kinds of regulations the client’s
products have to comply with, and
- the ability to witness an audit and to collect any necessary
information.
b. Witness assessment should be conducted in conjunction with an
assessment program.
c. KAN requests CAB to provide information :
- CAB’s audit plan
- Latest audit report of particular client or stage 1 audit report when the
audit being witness is initial certification
- Background information on the CAB’s audit team
- CAB’s audit or surveillance procedure
- Logistical information for the audit (date and location)
- Client’s permission before the witness is conduct.
d. During the witness, KAN’s assessment team evaluates the audit process
according to the audit plan and procedures of certification having by the
CAB, while also evaluates qualification of the audit team assigned
according to CAB’s audit team (auditor/examiner/expert/sampling officer)
criteria and competencies of CAB’s audit team covering audit technique,
knowledge
on
certification
criteria
and
other
relevant
documents/regulations, and knowledge on technical area being audited.
Follow up of witness
a. KAN’s assessment team should inform to the CAB’s audit team where
observation or nonconformity found during the witness process at the
post audit feedback session, and should be recorded in the witness
report.
b. Where the witness report includes nonconformity(es) and observation(s),
it should require that action is taken by the CAB management to address
the issues raised.
c. The assessment team should produce the witness report only after
received and reviewed of the CAB’ audit report which was witnessed.
d. The assessment team verifies the evidences of corrections and corrective
actions taken by CAB during the next surveillance if needed.
3.10
Assessment report
The assessment team analyzes all relevant information and evidence gathered
during the document and record review and the on-site assessment. The team’s
observations on areas for possible improvement may also present to the CAB.
3.11
Decision making on accreditation
3.11.1 Accreditation decision made by KAN Council.
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3.11.2 KAN will not delegate its responsibility in granting, maintaining, extending,
reducing, suspending and withdrawing an accreditation
3.11.3 Persons involves in decision making shall not involve in assessment
3.11.4 Before making an accreditation decision, the assessment report should be
reviewed by Technical Committee
3.12
Application Validity
The accreditation application submitted by CAB is valid for one-year after application
and the required documents submitted (completed). The accreditation process
(application to accreditation decision) shall be completed within one-year period. The
accreditation period would be terminated once the CAB failed to follow this period.
3.13
Sanctions
3.13.1 KAN may initiate to apply sanctions to the applicant CAB or the accredited
CAB when it found that an applicant/accredited CAB has persistently failed or
has lack of consistency to meet the requirements of accreditation or to abide
by the rules for accreditation. The sanctions could be, but are not limited to:
- Intensification of surveillance (office, witness or document review);
- Reduction of accreditation scope (including geographical scope);
- Suspension;
- Withdrawal;
- Public notice of scope reduction/suspension/withdrawal/misrepresentation
of accreditation;
- Legal actions
3.13.2 Intensification of surveillance (office, witness or document review)
KAN may carry out an additional or early surveillance to the CAB, when it
found that an applicant/accredited CAB lack of consistency in implementation
of CA procedures to abide by the rules for accreditation.
3.13.3 Reducing an accreditation
KAN may reduce an accreditation scope of the CAB if:
a. The CAB failed to maintain the availability of competence personnel
and/or facilities and/or equipments needed to support its accredited
activity;
b. Requested by CAB.
3.13.4 Suspension an accreditation
a. During the accreditation period, KAN may suspend the accreditation
status of the CAB, if the CAB failed to maintain its compliance to the
requirements,.
b. Suspension a part or all of CAB accreditation scopes are based on the
following:
- The CAB failed to resolve any non-conformities issued as results of
assessment, surveillance or re-assessment in the specified time
frame;
- There is negative outcome of complaint investigation.
- The CAB misuses/misrepresentation of KAN accreditation logo and
PAC/IAF MLA marks;
- The assessment result shows that the implementation of management
system is not effective;
- The CAB cannot facilitate KAN surveillance and/or witnessing within
period.
- Non-payment of fees.
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- Requested by CAB.
- There is no client certified when KAN conduct the survaillence
c. The CAB that its accreditation status is suspended may carry out
surveillance to its certified clients, however does not entitle to carry out
initial certification or re-certification audit by using KAN logo or statement
that accredited by KAN.
3.13.5 Withdrawal an accreditation
a. KAN may withdraw an accreditation status of the accredited CAB based
on the following:
- The CAB owned by individual and the owner that is bankrupt or to be
a part of its creditor;
- There is ”force majeure” that causes of the CAB could not be operate;
- The CAB is a part of a corporate that is liquidated.
- The CAB has persistently failed to meet the requirements of
accreditation or to abide by the rules for accreditation.
- The CAB failed to follow up recommendation for corrective action
within suspension period (3 months).
- There is proven evidence of fraudulent behavior.
- The CAB intentionally provides false information
b. Withdrawal can also be done on a part of scope that has no client for 1
(one) cycle of accreditation plus 1 (one) year
3.13.6 The CAB with accreditation status withdrawn, should not be doing
surveillance to their clients or to audit the initial certification or re-certification
audit by using KAN logo, or statement that is accredited by KAN. All clients
will be transferred to the other accredited certification bodies.
3.13.7 The CAB that its accreditation status is suspended or withdrawn is not
entitled to use KAN symbol and PAC/APLAC/IAF/ILAC logos for all of its
activities until the accreditation status is restored by KAN.
3.13.8 KAN will notify the CAB on the reason of suspension/withdrawal, within 14
days before the suspension/withdrawal.
3.13.9 Public notice of scope reduction/suspension/withdrawal/misrepresentation of
accreditation would be informed in KAN website.
3.13.10 KAN may restore the accreditation from the suspension once the CAB taken
appropriate followed up action.
3.13.11 Legal actions shall be taken if the CAB breaches The Act Number 20 Year
2014, on Standardization and Conformity Assessment.
4. CAB Rights and Obligations
4.1
4.1.1
4.1.2
4.1.3
4.1.4
4.1.5
4.1.6
4.2
CAB has the rights to
Make appeals and complaints to KAN.
Get information on any accreditation requirements changes.
Require explanation when the applied scope of accreditation is related to a
specific program and additional information related to accreditation
application.
Get information on names of an assessment team members who will carry
out assessment / surveillance/ re-assessment
Use the KAN accreditation logo and if applicable IAF MLA mark with
concerning related Guide stipulated by KAN
Apply for extending and reducing of accreditation scope.
CAB has obligations to
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4.2.1
4.2.2
4.2.3
4.2.4
4.2.5
4.2.6
4.2.7
4.2.8
4.2.9
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Commit to fulfill continually the requirements as mention in clause 1.1, and
this terms and conditions and adapt the changes of accreditation
requirements.
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
a. To permit KAN and auditors to conduct assessment, surveillance,
verification, witness and other activities related to accreditation for all
premises where CAB services operate
b. 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
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 for assessment, surveillance, re-assessment ,complaints handling
purposes) and document related to independence and impartiality from its
related bodies
CABs shall provide audit programs that will be witnessed by KAN before the
accreditation status is granted and during accreditation cycle as required. The
witness is to ensure that CABs have competent auditor to support their
services. CAB shall require their clients to allow KAN’s witnessing
assessment team
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
Pay such fees for application, assessment, surveillance, re-assessment,
extending scope and other fees as determined by KAN before on-site
assessment conducted
Inform KAN immediately, in case there are changes on:
a. Organization, top management and key personnel’s;
b. Address, ownership, legal status, and organization commercial status;
c. Main policy;
d. Equipments, premises, facilities and/or other resources that may affect
CAB performance;
e. Accreditation scopes;
f. Other such matters that may affect the ability of the CAB to fulfill
requirements for accreditation
Facilitate PAC/IAF peer evaluation in order to maintain MLA PAC/IAF.
CAB shall provide updated data at least once a year on January, but is not
limited to:
a. certified clients,
b. number of auditors,
c. number of transfers accepted (if applicable),
d. number of overdue audits, and
e. number of auditor-days delivered.
5. KAN has obligation to
5.1
Make publicly available information the current status of accredited CAB
regularly
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5.2
5.3
5.4
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Provide the CAB with information related to the accreditation scopes, terms
and conditions, international arrangement, where applicable.
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.
Verify that each accredited body carries out any necessary adjustment against
the changes requirements.
6. Use of KAN logo and PAC/IAF MLA Mark and other conformity mark
6.1
6.2
6.3
6.4
6.5
KAN Guide 12: 2004 governs the use of KAN accreditation logo. CABs shall
use KAN logo only for its accredited scope and premises.
The use of PAC/IAF/APLAC/ILAC mark based on KAN Guide 13, where
applicable.
The use of other conformity marks based on Pedoman KAN 403:2012
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 one
months period.
If 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.
7. 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 or providing the evidence of shattered certificate
upon withdrawal or expire of the accreditation.
8. Confidentiality
8.1 KAN will keep confidentiality of any information collecting from accreditation
process.
8.2 All KAN personnel in all level including internal and external personnel shall
keep confidentiality of any information about CAB and sign Commitment letter to
keep confidentiality and free conflict of interest and other pressure.
8.3 Information about CAB shall not inform to other parties without any written
consent from CAB. If requires by law, KAN shall inform CAB.
8.4 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 CAB’s management.
9. Complaints and Appeals
9.1
KAN will respond and take an appropriate action of any complaints concerning
accredited CAB, KAN’s personnel or personnel who acts on behalf of KAN.
KAN will assess the effectiveness of such action taken.
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9.2
9.3
9.4
9.5
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KAN will respond an appeal from CAB by establishing the independent
committee.
KAN would respond any appeal submitted by CAB within one month after
decision issued.
KAN would proceed any appeal issued by CAB which related to decision not
proceed an accreditation because of technical matters, and decision to not
granted, suspended or withdraw the CAB accreditation because of CAB
performance, However, the appeal would not be proceed when decision
appealed according to not proceed or not granted, suspended or withdraw the
CAB accreditation because of the CAB failed to comply with an accreditation
pre-requirements and failed to follow the accreditation process (ex: The CAB
failed to provide the audit(s) to be witnessed, The CAB failed to response the
NC issued within period, The CAB may not be surveillance within period, The
accreditation process exceeded 1 year period)
KAN keeps the records of all appeals, complaints and corrective actions related
to accreditation.
10. Liability
KAN is responsible to the liability matters that might be arrises from its accreditation
activities. The guideline is governed on Government Regulation No. 43 Year 1991
concerning Indemnity and Its Procedure in Public Administration Court.
11. Accreditation Fee
11.1 KAN has stable finances from government budget and accreditation fee.
11.2 KAN establishes and publishes the accreditation fee structure (DPUM 02).
12. Provisions of Legislation
This terms and conditions is stipulated under the laws and regulation of Republic of
Indonesia.
13. KAN's ADDRESS
Gedung I BPPT, Lt. 14
Jl. M.H. Thamrin No. 8, Kebon Sirih, Jakarta 10340 – Indonesia
Tel.
: +62 21 3927422,
Fax. : +62 21 3927527
Email : akreditasi@bsn.go.id
Website : www.kan.or.id
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