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KAN U-02 Rev.

LIST OF AMENDMENT

No Date Clause Brief description of changes


number
revised
1 01 Dec 2019 2.1 Adding clause 2.1.7 and 2.1.8
Renumbering the others clauses
2 01 Dec 2019 2.3 Adding examples of observation finding
3 01 Dec 2019 3 Delete “nonconformity” in paragraph 1
4 01 Dec 2019 3 Adding “CAB would like to continue the
accreditation process for that related scope“ in
paragraph 2
5 01 Dec 2019 3 Delete “analysis” in paragraph 4

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KAN U-02 Rev.1

Table of Content

1. Introduction..................................................................................................... 1
2. Findings Category ......................................................................................... 1
2.1 Nonconformities Category 1 ........................................................................... 1
2.2 Nonconformities Category 2 ........................................................................... 2
2.3 Opportunity for Improvement .......................................................................... 2
3 Response to Findings according to Conformity Assessment Report .............. 3

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Findings Category

1. Introduction

This document contains categorizing of findings in assessement activities, time


frame and actions needed to response to findings.

This document applies to all types of assessment conducted by Komite Akreditasi


Nasional (KAN), except pre-assessment activities.

2. Findings Category

Findings in assessment activities to conformity assessment body (CAB) are divided


into three categories, namely:

2.1 Nonconformities Category 1

Nonconformities Category 1 is inability or failure to implement one or more


accreditation requirements which results in doubts about credibility of
conformity assessment results issued by conformity assessment body.

Assessment team may recommend to stop the accreditation process for whole
or some part of the proposed scope, or to suspend some part or whole scope
or recommending carry out ons site verification assessment.

Nonconformities Category 1 can not be responded only through submission of


documents as corrective actions evidence.

Examples of Nonconformities Category 1 :

2.1.1 All CAB personnel are not competent to carry out conformity
assessment activities in accordance with requirements in their scope;

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2.1.2 Conformity assessment activities (certification, testing, etc.) as a whole


are done not in compliance with the relevant requirements or their own
system;
2.1.3 Laboratory does not have analysts / technicians who are competent to
operate equipment to conduct testing / calibration in accordance with
their scope;
2.1.4 Certification body does not have adequate schemes, personnel, or
resources to carry out certification activities in accordance with their
scope;
2.1.5 Laboratory does not have equipment needed for testing / calibration
according to their scope;
2.1.6 There is no record of their conformity assessment activities of its scope
at the time of assessment;
2.1.7 CAB issues certificates using KAN accreditation symbols for scopes
that are not accreditated.
2.1.8 There are repeated findings related to misuse of accreditation symbol
which was found as nonconformity category 2 in previous on site
assessment.
2.1.9 CAB still issues certificates using KAN accreditation symbols for scopes
that are not accredited after receiving notification on the misuse of
accreditation symbol from KAN for 2 (two) times or there have been
found 2 (two) nonconformities related to misuse of accreditation
symbol;
2.1.10 Conformity assessment activities are not carried out in accordance with
impartiality principle.
2.1.11 CAB still continue the conformities assessment activities although CAB
does not received the decision for granting re-accreditation yet.

2.2 Nonconformities Category 2

Nonconformities Category 2 is nonconformities arising from conformity


assessment activities that is not in accordance with the relevant requirements.

2.3 Opportunity for Improvement (OFI)

Opportunity for improvement is a documented statement to identify areas that


have the potential to be improved or have the potential to arise
nonconformities. OFI shall not contain specific recommendations. OFI should
be followed up by CAB so that they can provide solutions in order to improve

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performance and provide added value to the CAB operational / management


systems.

Examples of Opportunity for Improvement (OFI) :


2.3.1 CAB has many clients for a scope of conformity assessment activities,
but has limited resources for that scope, hence some personnel have
high workload. This case could risk the performance and possible to be
as a nonconformity in the future.
2.3.2 CAB has resources to do the conformity assessment activities but
doesn’t have a plan/procedure for using the others resources, in case
there is a problem with current resources.
2.3.3 CAB doesn’t conduct the management review in particularly,
management review is conducted at the same time with monthly
management routine meeting, which the agenda is according to the
case in that meeting.

3 Response to Findings

CAB shall respond on any findings according to which accreditation process is being
undertaken, for initial accreditation, corrective actions and verification of corrective
actions shall be completed within 3 (three) months. For surveillance, renewal and
extending scope, corrective actions and verification of corrective actions shall be
completed within 2 (two) months.

In the event that assessment team issues a nonconformities category 1 and CAB
would like to continue the accreditation process for that related scope, a follow-up on
site assessment (if needed) must be carried out within the deadline for corrective
action.

Follow-up on-site assessment to verify the corrective actions submitted by CAB can
only be done once, and there is no more correction after follow-up on site
assessment being conducted.

For OFI findings, CAB respond with action plan if needed.

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