Chapter 1: Setting up a Quality Management System
4
Plan
Define what
training is needed
so people can
do the job
Check
How well are
people doing
their jobs?
Do
Carry out the
training
Act
Improve training
as necessary
Figure 1-2. PDCA Cycle in Resource Management
management systems (e.g., environmental or health
and safety), but it allows an integrated approach with
those standards (e.g., ISO 14001).14 ISO 13485 specifies
requirements for organizations that:
• design, develop, produce, install or service medical
devices
• design, develop or provide related services15
ISO 13485 certification is available to organizations
producing products regulated as medical devices in at
least one country in the world (ISO 13485 certificates
should not be issued to pharmaceutical or cosmetic
product manufacturers). For example, human tissue,
although not medical devices in the EU, are covered
under Japanese MHLW Ministerial Ordinance 16916
and could be covered by an ISO 13485 QMS. Examples
of related services that can be certified to ISO 13485
include contract sterilizers and packers, manufacturers
of significant medical device components (e.g., machin-
ing implants) and warehouses.17
Exclusions and non-applications to ISO 13485
should be listed and justified in the organization’s
quality manual. Exclusions are limited to design
and development controls (Clause 7.3). Regulations
may be considered a justification for exclusion, e.g.,
93/42/EEC, Annex V). Parts of Clause 7 may not be
applicable due to the medical device’s nature (e.g., a
non-sterile, non-implantable, non-active device).
ISO 13485 is structured as follows (Clauses 4
through 8 are the auditable requirements and are shown
in more detail):
0. Introduction
1. Scope
2. Normative References
3. Terms and Definitions
4. Quality Management System
4.1 General Requirements
4.2 Documentation Requirements
4.21 General documentation specified by national
or regional regulations: each type or model
of medical device requires a file containing
product specification and QMS requirements.
These shall define the complete manufacturing
process.
4.22 Quality Manual
4.23 Medical Device File
4.24 Control of Documents
4.25 Control of Records
5. Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6 Management Review
5.6.1 Management Review General
5.6.2 Management Review Input
5.6.3 Management Review Output
6. Resource Management
4
Plan
Define what
training is needed
so people can
do the job
Check
How well are
people doing
their jobs?
Do
Carry out the
training
Act
Improve training
as necessary
Figure 1-2. PDCA Cycle in Resource Management
management systems (e.g., environmental or health
and safety), but it allows an integrated approach with
those standards (e.g., ISO 14001).14 ISO 13485 specifies
requirements for organizations that:
• design, develop, produce, install or service medical
devices
• design, develop or provide related services15
ISO 13485 certification is available to organizations
producing products regulated as medical devices in at
least one country in the world (ISO 13485 certificates
should not be issued to pharmaceutical or cosmetic
product manufacturers). For example, human tissue,
although not medical devices in the EU, are covered
under Japanese MHLW Ministerial Ordinance 16916
and could be covered by an ISO 13485 QMS. Examples
of related services that can be certified to ISO 13485
include contract sterilizers and packers, manufacturers
of significant medical device components (e.g., machin-
ing implants) and warehouses.17
Exclusions and non-applications to ISO 13485
should be listed and justified in the organization’s
quality manual. Exclusions are limited to design
and development controls (Clause 7.3). Regulations
may be considered a justification for exclusion, e.g.,
93/42/EEC, Annex V). Parts of Clause 7 may not be
applicable due to the medical device’s nature (e.g., a
non-sterile, non-implantable, non-active device).
ISO 13485 is structured as follows (Clauses 4
through 8 are the auditable requirements and are shown
in more detail):
0. Introduction
1. Scope
2. Normative References
3. Terms and Definitions
4. Quality Management System
4.1 General Requirements
4.2 Documentation Requirements
4.21 General documentation specified by national
or regional regulations: each type or model
of medical device requires a file containing
product specification and QMS requirements.
These shall define the complete manufacturing
process.
4.22 Quality Manual
4.23 Medical Device File
4.24 Control of Documents
4.25 Control of Records
5. Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communication
5.6 Management Review
5.6.1 Management Review General
5.6.2 Management Review Input
5.6.3 Management Review Output
6. Resource Management