Professional Documents
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Copyright 2015 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.
ICMED 13485
Members
Dr. Ganesh K. Mani
Representing
Association of Healthcare Providers (India)
Mr. PK Sharma
Mr. R. Sachdeva
Mr. D K Agarwal
Mr. Sempal
Mr. R D Khatri
ICMED 13485
Table of Contents
Technical Committee for QCI AIMED Voluntary Initiative on Medical Devices ........ 1
1.
Scope .............................................................................................................. 4
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7.2.1 Customer communication .................................................................................... 14
7.3 Traceability, labelling, cleaning and/or sterilization for products shall be ensured ..... 15
7.3.1 Traceability .......................................................................................................... 15
7.3.2 Labelling ............................................................................................................ 15
7.3.3 Cleaning and/or sterilization ................................................................................ 15
7.4 Operational Life Cycle Management ........................................................................ 16
7.4.1 Organization shall ensure consistency in product characteristics ........................ 16
7.4.2 Installation procedures shall be determined by the organization ......................... 16
7.4.3 Organization shall maintain after sale documents ............................................... 17
7.4.4 Non-conformity after dispatch and maintenance procedures shall be determined
by the organization ............................................................................................ 17
7.4.5 The organization shall arrange for post-production requirements...................... 18
7.5 Purchase ................................................................................................................... 18
7.5.1 Organization shall have a procurement system that supports product quality ..... 18
8. Responsibility of Management Measurement, Analysis and Improvement ....... 19
8.1 Organization shall be led by a management which promotes quality in products and
consistency in processes ...................................................................................... 19
8.2 Organization shall have appropriate and adequate number of audits ........................ 19
8.3 Organization ensures product safety, reliability and credibility .................................. 19
8.4 Assessment and improvement in the Quality Management System .......................... 20
Bibliography ............................................................................................................. 21
Amendment Sheet.................................................................................................... 23
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1. Scope
1.1 This document specifies the requirements for a quality management systems for
medical device industry which
a) needs to demonstrate its ability to consistently provide medical devices that meet
customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the
system, including processes for continual improvement of the system and the
assurance of conformity to customer and applicable statutory and regulatory
requirements.
1.2 The requirements prescribed in this document shall be read with the
requirements prescribed in ISO 13485: 2003.
1.3 Application
All requirements of this ICMED Standard are generic to organizations providing
medical devices, regardless of the type or size of the organization.
If regulatory requirements permit exclusions of design and development controls
(see 7.1.4.d), this can be used as a justification for their exclusion from the quality
management system. These regulations can provide alternative arrangements that
are to be addressed in the quality management system. It is the responsibility of the
organization to ensure that claims of conformity with this ICMED Standard reflect
exclusion of design and development controls
If any requirement(s) of this iCMED Standard is(are) not applicable due to the nature
of the medical device(s) for which the quality management system is applied, the
organization does not need to include such a requirement(s) in its quality
management system and appropriate justification shall be recorded.
The processes required by this ICMED Standard, which are applicable to the
medical device(s), but which are not performed by the organization, are the
responsibility of the organization and are accounted for in the organization's quality
management system
2. Normative references
The following referenced documents are indispensable for the application of this
document.
a. ISO 9000 Quality management systems - Fundamentals and vocabulary
b. ISO 13485: 2003 Medical devices Quality management systems
requirements for regulatory purposes
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Corresponding
Clause of ISO
13485: 2003
d)
e)
f)
4.1
4.1
4.1
4.1
5.5.1
7.1
6
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installation, maintenance, repair and disposal shall be
documented for every product.
4.3 Documentation requirements
4.3.1 The organization shall have following minimum documents
a)
b)
c)
d)
e)
f)
g)
4.3.2
4.2.2
4.2.1/5.3/5.4.1
4.2.1
4.2.1/7.1/7.2
5.6.1
5.6
4.2.3
Control of records
b)
c)
d)
e)
4.2.4
4.2.4
4.2.4
4.2.4
4.2.4
4.2.4
(ii)
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a)
b)
c)
d)
e)
f)
g)
h)
i)
j)
k)
8.2.4
8.3
4.2.4
4.2.4
6.2/ 7.5
7.2.3/8.5.1
8.5.2/ 8.5.3
4.2.4/ 7.5 /7.6/8.2.4
7.2.3
8.2.4
7.5.1
b)
c)
5.1
5.6.1
5.2
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d)
e)
5.3/ 5.4
5.6.1
6. Resource management
6.1 Organization shall have appropriate and adequate human resources
a)
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d)
6.2
b)
c)
6.3/ 7.5.3/8.3
6.3/ 6.4
6.3/ 6.4
10
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production;
d)
b)
c)
6.3/ 6.4
6.1
6.3/ 6.4
11
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d)
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e)
6.3/
7. Product realization
7.1 Planning of product realization
7.1.1 Organization shall plan for all the phases of product realization
a)
b)
c)
d)
e)
f)
g)
h)
7.1
6.1
7.1/8.2.4
7.1
7.1
7.1
7.1
7.1
7.1/ 8.2.4
7.1/8.2.4
7.1/ 8.2.4
7.1/ 8.2.4
7.2.1/ 7.2.2
7.2.1
13
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c)
7.2.1
d)
b)
c)
d)
e)
f)
g)
h)
i)
j)
k)
7.2.1
7.2.3
7.5.1
7.5.1
7.5.1
7.3.1/ 7.5.1
7.5.3
7.5.1
7.6
7.6
7.6
7.5.2
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b)
c)
d)
e)
5.5.3
7.2.3
7.2.3
7.2.3
b)
c)
d)
e)
7.5.3
7.5.3.2
7.5.3.2
7.5.3
7.5.3/7.5.5
7.5.3
7.5.5/7.2.3
7.5..2.3/7.5.5
7.5.3
Formatted: Not Highlight
b)
7.5.1.2
7.5.1.2
15
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c)
d)
e)
f)
7.5.1.2
7.5.1.2/7.5.5
7.5.1.2/7.5.5
7.4.3/7.5.1
b)
c)
8.2.4
7.3.7
7.2.3/ 7.3.7/5.5.3
c)
d)
e)
f)
g)
7.5.1.2.2
7.5.5
7.5.3.2
7.5.1.2.2
7.5.4
7.5.1.2.2
7.5.1.2.2
16
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h)
i)
j)
k)
7.5.1.2.2
7.5.1.2.2
7.5.1.2.2
7.5.1.2.2
17
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g)
7.5.5/8.3
c)
d)
e)
f)
8.2.4
8.2.4
7.3.6
8.2.4/ 8.3
8.3
8.3
7.5 Purchase
7.5.1 Organization shall have a procurement system that supports product
quality
a)
there shall be a system to select and evaluate suppliers
based on their ability to supply product as per product/
7.4.1
organisation requirements;
b)
purchase requirements including purchase product
specification shall be adequately specified before
7.4.2
placing order to the suppliers;
c)
there shall be a system to check the quality and
specifications of input components that are used in the
7.4.3/8.2.4
manufacturing of the final product;
d)
the input components shall be selected based on predefined and documented criteria and undergo
7.4.3/8.2.4
verification before usage;
e)
there shall be a system to identify and separate the
non-conforming input components and to prevent their
8.3
unintended use in the manufacturing process;
f)
there shall be a system to ensure the use of proper
instruments and equipment for the manufacturing
7.5.1
process of all products.
18
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c)
d)
8.2.2
8.2.2
8.2.2
8.2.2
c)
d)
e)
7.5.5
8.4
7.2.3
8.2
7.2.1
19
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of any legal dispute that may arise about the product;
f)
g)
h)
i)
j)
8.5.1
8.5.1
7.3.6
7.2.3
8.4/ 8.5
c)
d)
5.6/8.5
5.6/ 8.4
8.2.3/8.2.4
8.5.2
20
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Bibliography
1.
2.
3.
4.
5.
ISO 11135, Medical devices - Validation and routine control of ethylene oxide
sterilization (Corrigendum 1 published 1994)
6.
7.
8.
9.
ISO 14155-1, Clinical investigation of medical devices for human subjects Part 1: General requirements
10.
ISO 14155-2, Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans
11.
12.
13.
14.
15.
21
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16.
22
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Amendment Sheet
RECORD OF CURRENT STATUS OF THE
Technical Criteria for Certification of Medical Devices
The current status of each page and the history of change of the Technical Criteria
for Certification of Medical Devices are set out below.
Sl. Date Of
Page No.
Amendment details
No. Amendment
23