1
1
Setting up a Quality Management System
By Abhishek Harde, PMP, RAC
Introduction
Building a quality management system (QMS) from
scratch can be challenging, especially when the appro-
priate regulatory standards or compliance guidelines
are not followed. Management system standards make
best practices available to organizations of all sizes, in
all sectors. Any organization can implement a system to
improve efficiency and effectiveness and manage its way
of doing things by:
• ensuring nothing important is omitted
• clearly defining who is responsible
• describing what to do, why, when, how and where
• ensuring people are not just “doing their own thing”
• ensuring the organization goes about its business in
an orderly way1
Quality management is the set of coordinated activities
to direct and control an organization with regard to
quality.2 Quality management systems are central to the
medical device regulatory process in many countries to
ensure safe products entering the market perform as
intended. Streamlining and automating design docu-
mentation and quality processes to align with major
industry regulations and standards are key criteria for
setting up a quality management system. In this chapter,
the focus is on ISO 9001 and ISO 13485,3,4 and sub-
sequently, US FDA’s Quality System Regulation (QSR)5
contained in 21 CFR 820. ISO 13485:2016 Medical
Devices—Quality Management Systems—Requirements
for Regulatory Purposes is a QMS standard based on ISO
9001 Quality Management Systems Requirements. The
ISO 9000 series, originally published in 1987, was based
on the British Standards Institution’s (BSI) BS 5750
series of standards.6 ISO 9001 covers both product
quality assurance (providing confidence that quality
requirements will be fulfilled) and enhanced customer
satisfaction. Key differences between ISO 9001 and
ISO 13485 are shown in Table 1-1.7 Similarities
between ISO 9001 and ISO 13485 are shown in Table
1-2. The standard can be applied to all products and
services. ISO 9001 is based on the eight quality man-
agement principles:
1. process approach
2. system approach to management
3. continual improvement
4. factual approach to decision making
5. mutually beneficial supplier relationship
6. customer focus
7. leadership
8. involvement of people8
Table 1-1. Key Differences Between ISO 9001 and ISO 13485
ISO 9001 ISO 13485
6 documents 27 documents
Aims for customer satisfaction through continuous
improvement
Does not include customer satisfaction and continuous
improvement as objectives
Covers all products Different requirements for different types of products
Basis for voluntary certification Basis for regulatory certification
1
Setting up a Quality Management System
By Abhishek Harde, PMP, RAC
Introduction
Building a quality management system (QMS) from
scratch can be challenging, especially when the appro-
priate regulatory standards or compliance guidelines
are not followed. Management system standards make
best practices available to organizations of all sizes, in
all sectors. Any organization can implement a system to
improve efficiency and effectiveness and manage its way
of doing things by:
• ensuring nothing important is omitted
• clearly defining who is responsible
• describing what to do, why, when, how and where
• ensuring people are not just “doing their own thing”
• ensuring the organization goes about its business in
an orderly way1
Quality management is the set of coordinated activities
to direct and control an organization with regard to
quality.2 Quality management systems are central to the
medical device regulatory process in many countries to
ensure safe products entering the market perform as
intended. Streamlining and automating design docu-
mentation and quality processes to align with major
industry regulations and standards are key criteria for
setting up a quality management system. In this chapter,
the focus is on ISO 9001 and ISO 13485,3,4 and sub-
sequently, US FDA’s Quality System Regulation (QSR)5
contained in 21 CFR 820. ISO 13485:2016 Medical
Devices—Quality Management Systems—Requirements
for Regulatory Purposes is a QMS standard based on ISO
9001 Quality Management Systems Requirements. The
ISO 9000 series, originally published in 1987, was based
on the British Standards Institution’s (BSI) BS 5750
series of standards.6 ISO 9001 covers both product
quality assurance (providing confidence that quality
requirements will be fulfilled) and enhanced customer
satisfaction. Key differences between ISO 9001 and
ISO 13485 are shown in Table 1-1.7 Similarities
between ISO 9001 and ISO 13485 are shown in Table
1-2. The standard can be applied to all products and
services. ISO 9001 is based on the eight quality man-
agement principles:
1. process approach
2. system approach to management
3. continual improvement
4. factual approach to decision making
5. mutually beneficial supplier relationship
6. customer focus
7. leadership
8. involvement of people8
Table 1-1. Key Differences Between ISO 9001 and ISO 13485
ISO 9001 ISO 13485
6 documents 27 documents
Aims for customer satisfaction through continuous
improvement
Does not include customer satisfaction and continuous
improvement as objectives
Covers all products Different requirements for different types of products
Basis for voluntary certification Basis for regulatory certification