QCI – AIMED Voluntary Initiative on

Medical Devices

Indian Certification of Medical Devices

ICMED (Scheme)

Provisional Approval System for

Certification Bodies

Copyright © 2016 by Quality Council of India. All rights reserved. No part of this
publication shall be reproduced or distributed in any form or by any means, or stored in
a data base or retrieval system, without the prior permission of the publisher. Issued on
behalf of the QCI – AIMED Voluntary Initiative on Medical Devices Steering Committee.

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 TABLE OF CONTENTS

Sl No. Description Page No.

0 Introduction............................................................................................... 3
1 Scope ....................................................................................................... 3
2 Criteria for approval .................................................................................. 4
3 Procedure ................................................................................................. 6
4 Fee ........................................................................................................... 7

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 0. Introduction

0.1 The Certification Bodies (CBs), desirous of operating under the Indian
Certification For Medical Devices (ICMED) Scheme, hereinafter referred to as the
Scheme, shall need to primarily comply with the requirements specified in ISO 17021
and/or ISO17065, as applicable, and the additional requirements prescribed by QCI
and AIMED, as the j o i n t Scheme Owners.

0.2 In order to be formally accredited by the National Accreditation Board for

Certification Bodies (NABCB) as above, the CBs, even if already accredited to ISO
17021 for scope sector 19 a n d / o r ISO 17065, would need to undergo a limited
Office Assessment and a Witness Assessment of an actual audit under the Scheme.

0.3 The CBs would not get a client unless they are approved under the Scheme and
would not be able to offer an audit for witnessing and get the relevant scope
added in their accreditation.

0.4 Further, in order to launch the Scheme, it is necessary that some certification bodies
are available right at the beginning.

0.5 Therefore, it is necessary to establish a procedure for provisional approval of CBs

under the Scheme, till such time they can get the scope added in their
accreditation or get formally accredited from NABCB.

0.6 This document sets out the requirements to be fulfilled by t h e CBs desirous of
operating under the Scheme pending formal accreditation.

0.7 Since initially only management systems based certification is being launched, this
document covers requirements only for such certification bodies and requirements for
product certification bodies shall be added when the relevant certification is launched.

1. Scope

1.1 This document defines the process for Certification Bodies (CBs) to obtain
provisional approval to operate under the Scheme for ICMED 9000 and ICMED
13485 pending formal accreditation for the Scheme by NABCB as per the
prescribed international standard(s).

1.2 This approval shall be valid for a period of one year within which the approved CBs
would have to obtain formal NABCB accreditation.

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 2. Criteria for Approval
2.1 The CB shall be a legal entity in its economy, or shall be a defined part of a legal
entity, such that it can be held legally responsible for all its certification
activities. A governmental certification body is deemed to be a legal entity on the basis
of its governmental status.

2.2 Accreditation

2.2.1 For ICMED 9000 certification scope, the CB shall hold NABCB accreditation for
QMS certification as per ISO 17021-1:2015 for IAF Scope 19 covering the scope of
medical devices, NACE (Rev 1.1) DL33.1 and shall have undergone a witness for the
scope in the last 3 years;

2.2.2 For ICMED 13485 scope, the CB shall be accredited for ISO 13485 certification by
NABCB or be accredited for scope DL 33.1 for QMS as per ISO 17021 and in case of
latter, offer the first audit for ISO 13485 for witnessing to NABCB.

2.3 Competence

2.3.1 The CBs auditors for the Scheme shall have the following qualifications and
experience.

(i) A graduate in Bio Technology or degree in Electrical Engineering or Electronics

Engineering or Chemical Engineering or Bio Medical Engineering or Mechanical
Engineering from a University recognized by the Central Government for such
purposes, followed by 2 years’ experience of manufacturing or research or quality
assurance in medical device field.

or

a Graduate in Science, from a University recognized by the Central Government

for such purposes followed by a minimum of 3 years experience in the manufacturing
or quality assurance in medical device field;

or

a Diploma in Engineering or Pharmacy from a Board or Institute recognized by

the Central Government or the State Government, as the case may be, for such
purposes followed with a minimum of four years experience in the manufacturing
or quality assurance of medical device fields;

(ii) Auditor experience - For a first authorization, the auditor shall comply with the

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 following criteria, which shall be demonstrated in audits under guidance and
supervision:

a) For ICMED 9000 – The auditor shall have gained experience in the entire
process of auditing medical device quality management systems, including
review of documentation and risk management of medical devices,
implementation audit and audit reporting. This experience shall have been
gained by participation as a trainee in a minimum of two audits for a total of at
least 10 mandays under an accredited QMS programme,

b) Additionally for ICMED 13485 - This experience shall have been gained by
participation as a trainee in a minimum of two audits for a total of at least 10
mandays in an accredited ISO 13485 programme,

c) In addition to criteria a) and b) above, the audit team leaders shall have
performed as an audit team leader under the supervision of a qualified team
leader in at least three ISO 9001 audits for ICMED 9000 and ISO 13485 audits
for ICMED 13485.

d) The knowledge and skills for personnel involved with the ICMED 13485
certification as defined in Annexure B of IAF MD 9 shall be applicable.

NOTE: Kindly refer to IAF MD 9 for further guidance for ICMED 13485 auditor
competence and experience requirements.

2.3.2 The CBs may use ISO 9001 auditors who do not have the requisite qualifications as
prescribed above provided they are supported by technical experts (TEs) who meet the
qualifications at 2.3.1 ( i ) . The time spent by the TE on an audit shall not be counted
in determining the audit time as prescribed under the ‘Certification Process’ which the
CB is expected to spend.

2.4 Publicly available information

2.4.1 The certification body shall maintain a website for providing information about the
Scheme.

2.4.2 The certification body shall maintain and make publicly available information describing
its certification processes for granting, maintaining, extending, renewing, reducing,
suspending or withdrawing certification, and about the certification activities and
geographical areas in which it operates.

2.4.3 The certification body shall make publicly available information about applications
registered and certifications granted, suspended or withdrawn.
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 2.4.4 On request from any party, the certification body shall confirm the validity of a given
certification.

3. Procedure

3.1 The CB desirous of approval shall apply to QCI in the prescribed format for
approval.

3.2 It shall submit the documents related to auditor competence system and
certification process for the ICMED Schemes along with its application.

3.3 QCI shall designate an assessment team (AT) comprising an assessor for ISO 17021
and a technical expert to assess the competence of the CB for undertaking certification
under the Scheme. The AT shall review the application and the documents
specifically related to the Scheme and undertake an onsite office assessment of 2
mandays (including time of the TE) to verify competence and review certifications done
and submit a report containing both review of documents as well as onsite
findings. Any non-conformities/concerns observed shall be communicated to the CB at
the end of the assessment for necessary action.

3.4 Based on the report, and the action taken by the CB on the non-
conformities/concerns, if any, QCI shall take a decision on granting provisional approval
to the CB.

3.5 The approval shall be for a period of one year within which the CB shall obtain NABCB
accreditation as needed under the Scheme.

3.6 During the validity of approval, QCI shall undertake at least one witness
assessment to confirm the CB’s competence until it obtains NABCB accreditation.

3.7 The approval shall be subject to suspension/withdrawal with due notice of 15 days in
the event of any non- compliance to the requirements of the Scheme or if the NABCB
accreditation for ISO 17021 is suspended/withdrawn.

3.8 The approved CB shall inform QCI without delay about any significant changes
relevant to its approval, in any aspect of its status or operation relating to;

a) Its legal, commercial, ownership or organizational status,

b) The organization, top management and key personnel

c) Main policies
d) Resources and premises

e) S c o p e of approval, and

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 f) Other such matters that may affect the ability of the CB to fulfil requirements for
approval.

QCI shall examine such information and decide on the issue on merits with or without
an on-site verification.

4. Fee

4.1 The following fee structure shall apply:

Application fee Rs. 10,000/-

Man-day charges Rs. 20,000/- per man day

Travel / stay On actuals

Corrective actions review Charges – shall be charged after one round of review based
on extent of review required

4.2 QCI at its discretion may revise/levy any other fee necessary with due notice to the
CBs