Chapter 1: Setting up a Quality Management System
12
Regulatory requirements for the region where
products are being sold would be part of an organiza-
tion’s ongoing ISO 13485 certification assessment.
Compliance to ISO 13485 is assessed by a cer-
tification body, and CE marking, where required, is
assessed by a notified body (NB). These entities are
regulated differently: NBs by competent authorities
and QMS certification by an accreditation body, e.g.,
United Kingdom Accreditation Service (UKAS) and the
Standards Council of Canada (SCC). The scope of the
QMS certificate and CE certificate are dependent on
the organization’s activities and must be demonstrated
by the organization before they can be included in the
certificate’s scope.
Process Approach
The organization shall:
• identify the processes needed for the quality man-
agement system and their application throughout
the organization
• determine the sequence and interaction of these
processes
• determine criteria and methods needed to ensure
that both the operation and control of these pro-
cesses are effective
To implement an ISO 13485 QMS (or any kind of
QMS, voluntary or mandatory), the following steps may
be followed (discussed in more detail below and shown
in Figure 1-4):
1. gain top management commitment
2. appoint implementation team
3. promote awareness
4. perform gap analysis
5. develop an implementation plan
6. approve the implementation plan
7. implement the plan
8. operate and assess the system
9. continually improve the system
10. certification and registration
Gain Top Management Commitment
Top management must provide a commitment to
develop, implement and maintain an effective QMS.
Management is responsible for ensuring customer
requirements are determined and met. Management
also is responsible for creating the organization’s quality
policy and ensuring it is appropriate, effective, complete,
communicated and maintained. In addition to the policy,
management should set measurable quality objectives
consistent with the policy. Management also should
ensure adequate resources are available during planning
to meet requirements and the company’s objectives,
including changes to the QMS. Top management
should establish the responsibilities, authorities and
relationships within the organization.
Table 1-4. Applicability of ISO 13485 in Various Global Jurisdictions
Australia Requires an audited quality system.
ISO 13485 meets those requirements.
Canada Requires an ISO 13485 registered system for CMDCAS certification for Class II or higher devices.
Allows permissible exclusions depending on class of device.
EU A QMS is required for CE marking that must accompany any medical device sold in the EU.
A registered ISO 13485 system is recognized as proof of a QMS for CE marking when the certificate is issued by a
Notified Body.
Japan Requires establishment of a QMS that conforms to MO No. 169, which is similar to ISO 13485.
ISO 13485 is an option but not a requirement.
Taiwan The GMP requirements for Taiwan are based on ISO 13485.
US Medical device companies are required to establish a QMS that conforms to FDA Quality System Regulations.
ISO 13485 is an option but not a requirement (and does not connote full conformity with the QSR).
12
Regulatory requirements for the region where
products are being sold would be part of an organiza-
tion’s ongoing ISO 13485 certification assessment.
Compliance to ISO 13485 is assessed by a cer-
tification body, and CE marking, where required, is
assessed by a notified body (NB). These entities are
regulated differently: NBs by competent authorities
and QMS certification by an accreditation body, e.g.,
United Kingdom Accreditation Service (UKAS) and the
Standards Council of Canada (SCC). The scope of the
QMS certificate and CE certificate are dependent on
the organization’s activities and must be demonstrated
by the organization before they can be included in the
certificate’s scope.
Process Approach
The organization shall:
• identify the processes needed for the quality man-
agement system and their application throughout
the organization
• determine the sequence and interaction of these
processes
• determine criteria and methods needed to ensure
that both the operation and control of these pro-
cesses are effective
To implement an ISO 13485 QMS (or any kind of
QMS, voluntary or mandatory), the following steps may
be followed (discussed in more detail below and shown
in Figure 1-4):
1. gain top management commitment
2. appoint implementation team
3. promote awareness
4. perform gap analysis
5. develop an implementation plan
6. approve the implementation plan
7. implement the plan
8. operate and assess the system
9. continually improve the system
10. certification and registration
Gain Top Management Commitment
Top management must provide a commitment to
develop, implement and maintain an effective QMS.
Management is responsible for ensuring customer
requirements are determined and met. Management
also is responsible for creating the organization’s quality
policy and ensuring it is appropriate, effective, complete,
communicated and maintained. In addition to the policy,
management should set measurable quality objectives
consistent with the policy. Management also should
ensure adequate resources are available during planning
to meet requirements and the company’s objectives,
including changes to the QMS. Top management
should establish the responsibilities, authorities and
relationships within the organization.
Table 1-4. Applicability of ISO 13485 in Various Global Jurisdictions
Australia Requires an audited quality system.
ISO 13485 meets those requirements.
Canada Requires an ISO 13485 registered system for CMDCAS certification for Class II or higher devices.
Allows permissible exclusions depending on class of device.
EU A QMS is required for CE marking that must accompany any medical device sold in the EU.
A registered ISO 13485 system is recognized as proof of a QMS for CE marking when the certificate is issued by a
Notified Body.
Japan Requires establishment of a QMS that conforms to MO No. 169, which is similar to ISO 13485.
ISO 13485 is an option but not a requirement.
Taiwan The GMP requirements for Taiwan are based on ISO 13485.
US Medical device companies are required to establish a QMS that conforms to FDA Quality System Regulations.
ISO 13485 is an option but not a requirement (and does not connote full conformity with the QSR).