Quality Management Systems for Drugs and Devices
13
• Top management should appoint a management
representative to manage the QMS, report on
performance, promote QMS awareness within the
organization and interact with regulatory bodies.
• Management should establish internal commu-
nication procedures, including those about QMS
effectiveness and changes. It also should review the
QMS at planned intervals (management review) to
determine whether the QMS is effective and fit for
its purpose.
• The management review has required inputs and out-
puts that must be documented (e.g., new regulatory
requirements, resource needs and internal audits).
Before implementing the QMS, management must
answer the following questions:
Why ISO 13485?
• What is the business need?
• What are the expected benefits?
• How much employee time is necessary?
• What is the operational impact?
• What is the estimated cost?
• Is certification to ISO 13485 required and/or desired?
At this stage, management is making a commitment
to proceed with planning, and the plan itself is subject
to approval or revisions before a final implementation
process decision occurs. Management must commit
resources to the implementation effort, which could
include the following:
assigning a manager as a project lead
developing a high-level implementation plan
ensuring adequate project resources
approving ISO 13485 and related training requirements
classifying implementation as a high-priority project
communicating the decision and plan
To gain commitment and support, the organization’s top
management must understand the implications of their
decisions and the need for continued personal involve-
ment. One way to demonstrate commitment is to assign
a key management member, perhaps the management
representative, to lead the project. Management should
be given an initial estimate of the people, time and costs
Figure 1-4. Implementing an ISO 13485:2016 QMS
Resource
Management
Product
Realization
Management
Responsibility
Measurement
,Analysis and
Improvement
Customer
and
Regulatory
Authorities
Feedback
Customer
and
Regulatory
Authorities
Product
Maintaining the effectiveness of the Quality Management System
ISO 13485 processes
Requirements
Output
13
• Top management should appoint a management
representative to manage the QMS, report on
performance, promote QMS awareness within the
organization and interact with regulatory bodies.
• Management should establish internal commu-
nication procedures, including those about QMS
effectiveness and changes. It also should review the
QMS at planned intervals (management review) to
determine whether the QMS is effective and fit for
its purpose.
• The management review has required inputs and out-
puts that must be documented (e.g., new regulatory
requirements, resource needs and internal audits).
Before implementing the QMS, management must
answer the following questions:
Why ISO 13485?
• What is the business need?
• What are the expected benefits?
• How much employee time is necessary?
• What is the operational impact?
• What is the estimated cost?
• Is certification to ISO 13485 required and/or desired?
At this stage, management is making a commitment
to proceed with planning, and the plan itself is subject
to approval or revisions before a final implementation
process decision occurs. Management must commit
resources to the implementation effort, which could
include the following:
assigning a manager as a project lead
developing a high-level implementation plan
ensuring adequate project resources
approving ISO 13485 and related training requirements
classifying implementation as a high-priority project
communicating the decision and plan
To gain commitment and support, the organization’s top
management must understand the implications of their
decisions and the need for continued personal involve-
ment. One way to demonstrate commitment is to assign
a key management member, perhaps the management
representative, to lead the project. Management should
be given an initial estimate of the people, time and costs
Figure 1-4. Implementing an ISO 13485:2016 QMS
Resource
Management
Product
Realization
Management
Responsibility
Measurement
,Analysis and
Improvement
Customer
and
Regulatory
Authorities
Feedback
Customer
and
Regulatory
Authorities
Product
Maintaining the effectiveness of the Quality Management System
ISO 13485 processes
Requirements
Output