Global Medical Device Regulatory Strategy
59 Regulatory Affairs Professionals Society
5
Setting up a Quality Management System
Susumu Nozawa, RAC-EU, RAC-US, FRAPS
Introduction
Manufacturers seeking to build a Quality Management
System (QMS) from scratch can face challenges,
especially when they fail to follow the appropri-
ate regulatory standards or compliance guidelines.
Management system standards make best practices
available to organizations of all sizes, in all sectors. Any
organization can implement a system to improve effi-
ciency 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 that people are not just doing their
own thing and
• Ensuring that the organization goes about its
business in an orderly way.1
Quality management is the set of coordinated
activities to direct and control an organization with
regard to quality.2 QMSs are central to the medical
device regulatory process to ensure that safe prod-
ucts entering the market perform as intended. Key
criteria for setting up a QMS include streamlining
and automating design documentation and quality
processes to align with major industry regulations
and standards. This chapter focuses on International
Organization for Standardization (ISO) 9001 and
ISO 13485,3,4 and subsequently, US Food and Drug
Administration (FDA) Quality Management System
Regulation (QMSR)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 (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 5-1. Similarities
Table 5-1. 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
59 Regulatory Affairs Professionals Society
5
Setting up a Quality Management System
Susumu Nozawa, RAC-EU, RAC-US, FRAPS
Introduction
Manufacturers seeking to build a Quality Management
System (QMS) from scratch can face challenges,
especially when they fail to follow the appropri-
ate regulatory standards or compliance guidelines.
Management system standards make best practices
available to organizations of all sizes, in all sectors. Any
organization can implement a system to improve effi-
ciency 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 that people are not just doing their
own thing and
• Ensuring that the organization goes about its
business in an orderly way.1
Quality management is the set of coordinated
activities to direct and control an organization with
regard to quality.2 QMSs are central to the medical
device regulatory process to ensure that safe prod-
ucts entering the market perform as intended. Key
criteria for setting up a QMS include streamlining
and automating design documentation and quality
processes to align with major industry regulations
and standards. This chapter focuses on International
Organization for Standardization (ISO) 9001 and
ISO 13485,3,4 and subsequently, US Food and Drug
Administration (FDA) Quality Management System
Regulation (QMSR)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 (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 5-1. Similarities
Table 5-1. 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