Chapter 1: Setting up a Quality Management System
18
procedures required by the standard. Large, multi-na-
tional organizations may need several manuals at the
global, national or regional levels, and a more complex
hierarchy of documentation. When implementing the
plan, the following should be considered in relation to
the documentation:
• What is the value?
• What is required?
• What is needed to support the QMS?
• How extensive should it be?
• What is the format?
º procedures
º flow charts
º work instructions
º forms
º electronic
º hard copy
ISO 13485 has 50 references to required records, gen-
erated by executing a process and providing evidence of
conformity. Examples of records are completed forms,
audit reports, meeting minutes and test data.
The project team should report to top management
on the project’s overall status from the plan owner, and
progress should be reported by process owners (so the
project does not appear to only be a quality department
initiative). The project tracking data can be used to share
a high-level summary of completed activities, show
progress, maintain interest and keep the project visible.
Involving management ensures the project remains a
priority and demonstrates management’s ownership and
commitment to the system.
During implementation, the certification body
typically is contacted if certification is sought. Three to
six months of records and metrics usually are required
for the certification body to assess and certify the QMS.
A few months of lead-time should be factored into the
schedule before the certification process is initiated.
Operate and Assess the System
Once the system is operational, it should be assessed con-
tinually by monitoring and measurement, documentation,
internal audits and management reviews to evalu-
ate whether the QMS is working as intended and is
achieving defined goals and objectives. Processes can be
implemented as they become ready for release, as long as
users are trained and ready to operate their parts of the
system. Not all processes need to be implemented con-
currently, only those with certain interdependencies. It is
important to control documents and records as required
by ISO 13485 and internal procedures. Records pre-dat-
ing QMS implementation will not be considered by
auditors except to check record retention times. Typically,
at least three months of evidence of the management
system’s operation will be required for the certification
body to assess conformity before the initial audit.
It is important to determine what to measure,
how to measure, who will be responsible and the fre-
quency of measurements to be performed before the
implementation project team can begin monitoring
and measuring activities. Suitable monitoring methods
should be applied. Where applicable, process measure-
ments then can be used as evidence of the processes’
ability to achieve planned results. Top management can
use the implementation project team to begin its QMS
reviews. The tracking meetings probably will not qualify
as management reviews, as they may not meet all of the
requirements of the relevant regulation clause (Clause
5.6), but they will be good practice in setting agendas,
identifying issues, taking actions and recording minutes.
Regular review meetings can be the precursor to manage-
ment review meetings and system reviews. Meetings with
core team members should be held frequently to review
progress. The review meetings should be short and feed-
back schedules agreed with top management. Progress
and achievements should be communicated to top
management. Monitoring and measurements should be
performed as soon as processes are in place, with processes
reviewed and updated as needed during implementation.
Internal audits also are used to monitor and
measure the system. The internal audit program should
conform to planned arrangements (implemented and
maintained effectively) and meet ISO 13485, organi-
zational, customer and regulatory requirements. Ideally,
18
procedures required by the standard. Large, multi-na-
tional organizations may need several manuals at the
global, national or regional levels, and a more complex
hierarchy of documentation. When implementing the
plan, the following should be considered in relation to
the documentation:
• What is the value?
• What is required?
• What is needed to support the QMS?
• How extensive should it be?
• What is the format?
º procedures
º flow charts
º work instructions
º forms
º electronic
º hard copy
ISO 13485 has 50 references to required records, gen-
erated by executing a process and providing evidence of
conformity. Examples of records are completed forms,
audit reports, meeting minutes and test data.
The project team should report to top management
on the project’s overall status from the plan owner, and
progress should be reported by process owners (so the
project does not appear to only be a quality department
initiative). The project tracking data can be used to share
a high-level summary of completed activities, show
progress, maintain interest and keep the project visible.
Involving management ensures the project remains a
priority and demonstrates management’s ownership and
commitment to the system.
During implementation, the certification body
typically is contacted if certification is sought. Three to
six months of records and metrics usually are required
for the certification body to assess and certify the QMS.
A few months of lead-time should be factored into the
schedule before the certification process is initiated.
Operate and Assess the System
Once the system is operational, it should be assessed con-
tinually by monitoring and measurement, documentation,
internal audits and management reviews to evalu-
ate whether the QMS is working as intended and is
achieving defined goals and objectives. Processes can be
implemented as they become ready for release, as long as
users are trained and ready to operate their parts of the
system. Not all processes need to be implemented con-
currently, only those with certain interdependencies. It is
important to control documents and records as required
by ISO 13485 and internal procedures. Records pre-dat-
ing QMS implementation will not be considered by
auditors except to check record retention times. Typically,
at least three months of evidence of the management
system’s operation will be required for the certification
body to assess conformity before the initial audit.
It is important to determine what to measure,
how to measure, who will be responsible and the fre-
quency of measurements to be performed before the
implementation project team can begin monitoring
and measuring activities. Suitable monitoring methods
should be applied. Where applicable, process measure-
ments then can be used as evidence of the processes’
ability to achieve planned results. Top management can
use the implementation project team to begin its QMS
reviews. The tracking meetings probably will not qualify
as management reviews, as they may not meet all of the
requirements of the relevant regulation clause (Clause
5.6), but they will be good practice in setting agendas,
identifying issues, taking actions and recording minutes.
Regular review meetings can be the precursor to manage-
ment review meetings and system reviews. Meetings with
core team members should be held frequently to review
progress. The review meetings should be short and feed-
back schedules agreed with top management. Progress
and achievements should be communicated to top
management. Monitoring and measurements should be
performed as soon as processes are in place, with processes
reviewed and updated as needed during implementation.
Internal audits also are used to monitor and
measure the system. The internal audit program should
conform to planned arrangements (implemented and
maintained effectively) and meet ISO 13485, organi-
zational, customer and regulatory requirements. Ideally,