Quality Management System : Changing Scenario & Challenges
In Medical Device Regulations
Mr. Sanjay Shah
Unikal Consultants, Ahmedabad
The impact of changing world
scenerio vis-à-vis consumer awareness & requirement as
also advancement in medical science is substantial but
not significant as far as medical device industry is
concerned especially in Indian context.
Reasons are many but mainly due to
lack of appropriate regulations and consumer
As for manufacturers world over
including India, basic of the requirement, drawing a
simile to c-GMP, requirement is QMS (Quality
Management System) as per ISO:13485.
Lot of change is happening the
It is important to know what is
meant by Quality, various definations:
• In manufacturing, a measure of
excellence or a state of being free from defects,
deficiencies and significant variations. It is brought
about by strict and consistent commitment to certain
standards that achieve uniformity of a product in
order to satisfy specific customer or user
• Quality of something can be determined by comparing a
set of inherent characteristic with a set of requirements.
If those inherent characteristics meet all requirements,
high or excellent quality is achieved. If those
characteristics do not meet all requirements, a low or
poor level of quality is achieved.
• According to this definition, quality is a relative
concept. By linking quality to requirements,ISO 9000
argues that the quality of something cannot be established
in a vacuum.Quality is always relative to a set of
requirements. Quality is therefore a question of degree,
as a result, ISO 8402-1986 standard defines quality as
”the totality of features and characteristics of a product
or service that bears its ability to satisfy stated or
So what is QMS:
QMS is collection of business processes focused on
consistently meeting customer requirements and enhancing
What is the basis for current trend in changes in
regulations of Medical Devices?
EU Directive says,
Whereas medical devices should provide patients, users and
third parties with a high level of protection and attain
the performance levels attributed to them by the
manufacturer; whereas, therefore, the maintenance or
improvement of the level of protection attained in the
Member States is one of the essential objectives of this
This means world is moving towards Risk based regulations.
What is the risk involved in using the Medical Device, how
to mitigate or reduce the risk to the user. Since this is
continuous process, changing with enhancement of knowledge
and technology, regulatory requirements is also a dynamic
process. It keeps on changing with time.
In India scenerio, there is still no special Act for
medical devices. It is covered under Drugs & Cosmetics Act
& Rules and defined as drug. Also the medical devices
included in the Act are very few and included by specific
name and NOT by genral Harmonized defination of Medical
So almost un-regulated it is in the hands of either non
qualified & unregulated manufacturers or foreign
manufacturers from whom they are imported.
Neither there is found need or encouragement to
manufacture in India, medical device industry is in the
nascent stage. Except in a few cases of low cost devices
like IV Sets, Syringes etc. or manufactured by struggling
but enterprising Indian companies producing Intra Ocular
Lensees or coronary stents, rest of them ranging from
catheters to MRI Scanning machines are imported.
What are changes in medical device QMS based on ISO
Following are excerpts from various sources:
The International Organization for Standardization (ISO)
late last month released its long-awaited revision to ISO
13485, the global standard for medical device quality
management systems (QMS), which replaces the previous
version from 2003.
The new revision places a greater emphasis on QMS
throughout the supply chain and product lifecycle, as well
as device usability and post-market surveillance
Over the next three years, ISO 13485:2003 and ISO
13485:2016 will coexist, allowing manufacturers,
accreditation/certification bodies and regulators time to
transition to the new standard.
According to a draft transition planning guidance,
organizations will still be able to be accredited for
either ISO 13485:2003 or ISO 13485:2016 for the first two
years of the transition period; however, after the second
year, new accreditation will only be given for ISO
After the third year, the guidance says, “any existing
certification issued to ISO 13485:2003 will not be valid.”
Many organizations involved with medical device
development, including manufacturers and service providers
use ISO 13485 to “demonstrate [their] ability to provide
medical devices and related services that consistently
meet customer and applicable regulatory requirements.”
Regulators worldwide have integrated ISO 13485 into their
regulatory systems, including those in the US, EU, Canada,
Australia and Japan. The standard is sometimes adapted to
meet local requirements, for example, EN ISO 13485:2012 in
the EU adds a forward and several annexes to the standard
specific to the region.
ISO 13485 is also used for the Medical Device Single Audit
Program (MDSAP), an international effort to reduce
redundant audits of medical device manufacturers.
“Many jurisdictions have got quality management system
requirements for medical device manufacture and supply, so
it’s really important that there’s a common
understanding between the regulator and the industry as to
what’s required for that quality management system,” said
Eamonn Hoxey, former chair of ISO’s technical committee
for quality management and corresponding general aspects
for medical devices in a video interview on ISO’s website.
What are ISO 13485:2016 Major Revisions ?
The new edition of the ISO 13485 standard was published on
March 1 2016, concluding almost five years of intense
discussion and development by experts around the world to
improve and update the standard with new international
regulatory changes, implemented since its previous
revision in 2003.
ISO representative Maria Lazarte, relayed a list of major
changes from the technical committee for ISO 13485.
Some of the biggest changes between the 2003 and 2016
Incorporation of risk-based approaches beyond product
realization. Risk is considered in the context of the
safety and performance of the medical device and in
meeting regulatory requirements;
Increased linkage with regulatory requirements,
particularly for regulatory documentation;
Application to organizations throughout the lifecycle and
supply chain for medical devices;
Harmonization of the requirements for software validation
for different software applications (QMS software, process
control software, software for monitoring and measurement)
in different clauses of the standard;
Emphasis on appropriate infrastructure, particularly for
production of sterile medical devices, and addition of
requirements for validation of sterile barrier properties;
Additional requirements in design and development on
consideration of usability, use of standards, verification
and validation planning, design transfer and design
Emphasis on complaint handling and reporting to regulatory
authorities in accordance with regulatory requirements,
and consideration of post-market surveillance; and
Planning and documenting corrective action and preventive
action, and implementing corrective action without undue
“it’s important to bear in mind that ISO 13485 does deal
with the whole lifecycle from design and development,
through manufacture, transport … and on to the end of
Quote from Mr. Hoxey.
The new ISO 13485:2016 focuses on how companies should
manage risk-based decisions related to purchasing, design,
development, manufacturing, production control activities
and other aspects of the quality management system..