Chapter 1: Setting up a Quality Management System
14
(resources) expected for the project, and a more accurate
estimate provided after the plan is developed (before final
approval). Resources should be assigned to implement the
QMS and maintain its effectiveness and ability to meet
customer and regulatory requirements. Personnel perform-
ing work affecting product quality must be competent and
have the relevant education, training, skills and experience
for the jobs they are performing, and this information
should be recorded and maintained. The infrastructure
(e.g., IT systems, manufacturing equipment) needed to
operate the QMS and ensure product conformity also
must be determined. Environmental requirements (e.g.,
cleanliness and contamination controls) to achieve product
conformity also must be outlined.
Appoint Implementation Team
Most organizations will require more than one per-
son to fulfil the implementation initiative successfully.
Implementation team members should be trained to
ensure they understand the standard’s requirements. The
project lead typically will be the management represen-
tative (who is often the company’s quality manager) and
should have sufficient organizational influence. Duties
may include:
• developing and managing the implementation plan
• ensuring all needed processes are established
• promoting awareness of customer and regulatory
requirements
• monitoring QMS performance
• identifying any needs for improvement
• reporting on performance to top management
• communicating with external parties (e.g., suppli-
ers, customers, regulatory bodies) about the QMS
Team members, particularly the project lead, should
review and familiarize themselves with guidance
documents from global standards organizations and
regulatory agencies, including International Medical
Device Regulators Forum (IMDRF), International
Accreditation Forum (IAF), US Food and Drug
Administration (FDA), EU Medical Devices Directives
(MEDDEVs), guidance on ISO 13485 (ISO/TR
14969) and related standards, such as ISO 19011 (prin-
ciples of auditing).
Promote Awareness
To promote awareness within the organization, the
implementation team should inform employees of
the intent to implement the standard, including its
benefits, to staff, the organization and customers. Top
management ensures communication throughout the
organization by:
• announcing implementation plans
• describing benefits to the company
• explaining benefits to the employees
• developing a communications plan
• making progress visible
• conducting an ISO 13485 overview
• encouraging wide participation
It would be a mistake for the implementation team to
proceed in near secrecy to avoid interfering with current
business activities. Employees should be informed of
the plan, why it is happening, how it will impact them,
who is involved and scheduled key activities. If employ-
ees are kept in the dark about the project, they will be
less supportive when their help is needed to imple-
ment required practices. Another mistake would be to
announce the project and not communicate the status.
Employees should be kept informed of progress and
how they might be needed. Keeping the project visible,
with plans for regular project updates, will ensure man-
agement support and encourage everyone to keep to
the schedule. Ongoing personnel training is key to the
success of any QMS.
Perform Gap Analysis
During this stage, the current system should be reviewed
and compared with the standard’s requirements, and
any gaps should be identified. Gap analysis should be a
cross-functional activity. Every organization will have a
management system in place at some level. The current
system should be understood before defining the new
system. Existing quality systems may not be documented
14
(resources) expected for the project, and a more accurate
estimate provided after the plan is developed (before final
approval). Resources should be assigned to implement the
QMS and maintain its effectiveness and ability to meet
customer and regulatory requirements. Personnel perform-
ing work affecting product quality must be competent and
have the relevant education, training, skills and experience
for the jobs they are performing, and this information
should be recorded and maintained. The infrastructure
(e.g., IT systems, manufacturing equipment) needed to
operate the QMS and ensure product conformity also
must be determined. Environmental requirements (e.g.,
cleanliness and contamination controls) to achieve product
conformity also must be outlined.
Appoint Implementation Team
Most organizations will require more than one per-
son to fulfil the implementation initiative successfully.
Implementation team members should be trained to
ensure they understand the standard’s requirements. The
project lead typically will be the management represen-
tative (who is often the company’s quality manager) and
should have sufficient organizational influence. Duties
may include:
• developing and managing the implementation plan
• ensuring all needed processes are established
• promoting awareness of customer and regulatory
requirements
• monitoring QMS performance
• identifying any needs for improvement
• reporting on performance to top management
• communicating with external parties (e.g., suppli-
ers, customers, regulatory bodies) about the QMS
Team members, particularly the project lead, should
review and familiarize themselves with guidance
documents from global standards organizations and
regulatory agencies, including International Medical
Device Regulators Forum (IMDRF), International
Accreditation Forum (IAF), US Food and Drug
Administration (FDA), EU Medical Devices Directives
(MEDDEVs), guidance on ISO 13485 (ISO/TR
14969) and related standards, such as ISO 19011 (prin-
ciples of auditing).
Promote Awareness
To promote awareness within the organization, the
implementation team should inform employees of
the intent to implement the standard, including its
benefits, to staff, the organization and customers. Top
management ensures communication throughout the
organization by:
• announcing implementation plans
• describing benefits to the company
• explaining benefits to the employees
• developing a communications plan
• making progress visible
• conducting an ISO 13485 overview
• encouraging wide participation
It would be a mistake for the implementation team to
proceed in near secrecy to avoid interfering with current
business activities. Employees should be informed of
the plan, why it is happening, how it will impact them,
who is involved and scheduled key activities. If employ-
ees are kept in the dark about the project, they will be
less supportive when their help is needed to imple-
ment required practices. Another mistake would be to
announce the project and not communicate the status.
Employees should be kept informed of progress and
how they might be needed. Keeping the project visible,
with plans for regular project updates, will ensure man-
agement support and encourage everyone to keep to
the schedule. Ongoing personnel training is key to the
success of any QMS.
Perform Gap Analysis
During this stage, the current system should be reviewed
and compared with the standard’s requirements, and
any gaps should be identified. Gap analysis should be a
cross-functional activity. Every organization will have a
management system in place at some level. The current
system should be understood before defining the new
system. Existing quality systems may not be documented