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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.
Chairman
Mr. Rajiv Nath Association of Indian Medical Device Industry (AIMED)
Members Representing
Dr. Ganesh K. Mani Association of Healthcare Providers (India)
Dr. Jitendra Kumar Sharma National Health Systems Resource Centre (NHSRC)
Mr. Mohammad Ameel
Member – Secretary
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Table of Contents
Technical Committee for QCI – AIMED Voluntary Initiative on Medical Devices ........ 1
1. Scope .............................................................................................................. 4
6.1 Organization shall have appropriate and adequate human resources ......................... 9
6.2. Organization shall have defined & documented policy and procedure for training the
personnel ................................................................................................................ 9
6.2.1 Organization ensures good health of staff against occupational hazards ............ 10
6.3.1 The organization has appropriate infrastructure to achieve quality product ......... 10
6.3.2 The organization shall maintain an environment that supports product quality ... 11
6.3.3 Resources (manmade or natural) required to maintain appropriate environment
shall be available in proper quality & quantity .................................................... 12
7. Product realization................................................................................................ 13
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
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.
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6. Resource management
6.1 Organization shall have appropriate and adequate human resources
a) the organization shall have documented information
about the minimum number of personnel required for 6.2
each phase of production;
b) the organization shall have documented information on
the skills, trainings and experience required by each
6.2
category of personnel required in the production
process;
c) the organization shall have a documented procedure
for selection, induction, training and performance
6.2
monitoring and appraisal of each category of
personnel;
d) the organisation shall comply with statutorily required
qualifications and competence levels for performing 6.2
specific tasks;
e) the organisation shall ensure that personnel hired on
temporary basis/daily wages/short term contract are
competent for product manufacturing process and this 6.2
is measured before their involvement with the
manufacturing process;
f) the personnel shall be made aware of duties,
responsibilities and expectations so as to promote 6.2
product quality;
g) there shall be defined and documented procedures to
take appropriate action for negligence of duty,
6.2
especially when such negligence adversely affects
product quality;
h) there shall be defined procedures to address personnel
6.2
grievances.
6.2. Organization shall have defined & documented policy and procedure for
training the personnel
a) there shall be a procedures to identify training
requirements and a documented training 6.2
schedule/calendar for various categories of personnel;
b) records of trainings shall be maintained for a specified
6.2
time period;
c) there shall be procedures to monitor and measure the
6.2
performance of personnel after the training programs;
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production;
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7. Product realization
7.1 Planning of product realization
7.1.1 Organization shall plan for all the phases of product realization
a) there shall be a system to identify and provide all inputs
7.1
required for the various phases of product realization;
b) the organisation shall provide resources specific to the
6.1
product;
c) the organisation shall document verification, validation,
monitoring, measurement, inspection and test activities
7.1/8.2.4
specific to the product and the criteria for product
acceptance;
d) the objectives of Quality Management System shall be
7.1
integrated throughout product realization;
e) there shall be a system to identify risks to product
quality during the phases of product realization and 7.1
documented procedures for risk minimization;
f) the organization shall maintain a production schedule;
7.1
g) the records of past production schedules shall be
maintained as per a defined and documented policy of 7.1
the organization;
h) the organization shall keep records needed to provide
evidence that the realization processes and resulting 7.1
product meet requirements.
7.1.2 Organization has established criteria for product acceptance
a) there shall be system to measure conformance of 7.1/ 8.2.4
products throughout the product realization process;
b) the product shall be verified and validated against pre- 7.1/8.2.4
determined standards;
c) there shall be documented acceptance and rejection 7.1/ 8.2.4
criteria for all products;
d) there shall be system of monitoring and testing of all
processes that can influence product quality, 7.1/ 8.2.4
acceptance and rejection.
7.1.3 Product realization meets intended and implied requirements
a) customer requirements related to the products shall be 7.2.1/ 7.2.2
defined, reviewed and documented;
b) the products shall meet the requirements of the
customer from the point of completion of the products 7.2.1
till the point of final use and is documented;
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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 pre-
defined 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.
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Bibliography
1. ISO 9001 :2008, Quality management systems – Requirements
5. ISO 11135, Medical devices - Validation and routine control of ethylene oxide
sterilization (Corrigendum 1 published 1994)
10. ISO 14155-2, Clinical investigation of medical devices for human subjects -
Part 2: Clinical investigation plans
11. ISO 14160, Sterilization of medical devices - Validation and routine control of
sterilization of Single-use medical devices incorporating materials of animal
origin by liquid chemical sterilants
12. ISO 14937, Sterilization of health care products - General requirements for
characterization of a sterilizing agent and the development, validation and
routine control of a sterilizing agent
15. ISO 15223-1, Medical devices -- Symbols to be used with medical device
labels, labeling and information to be supplied -- Part 1: General requirements
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16. ISO 19011, Guidelines for quality and/or environmental management systems
auditing.
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Amendment Sheet
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