Quality Management Systems for Drugs and Devices
17
• start and completion dates
• activities and deliverables
• responsibilities and authorities
• resources and estimated costs
• tracking and reporting methods
• expected benefits and returns
The implementation plan should be clearly defined and
formally agreed by top management. The plan may need
revisions before finally gaining approval.
Plan Implementation
Implementation is where the work to meet the stan-
dard’s requirements takes place. It is not unusual for
the management system to be implemented in stages.
The approved plan should be carried out, and training
should be provided as needed. The implementation
team should be given the resources and support needed
to complete assigned activities successfully. Progress
should be monitored frequently (not just at the points
defined in the plan), and encouragement and assistance
should be offered. Tracking data should be collected
to report to top management. Some activities will be
dependent on earlier activities. If delays are anticipated,
the impact on later activities should be considered to
minimize problems. Documentation is important at this
stage, so policies can be created, procedures developed
and records kept.
Training on ISO 13485 should be conducted early
in the project to aid in planning. Managers and other
employees should be included, as appropriate, to ensure
staff are aware of the standard, the importance and
relevance to their jobs and how the standard is applica-
ble to the organization’s products and services. Expertise
should be developed to assist and guide implementation
activities. The training budget should cover needed
courses and travel, and records should be maintained as
evidence. Further training will be needed as the QMS is
implemented and procedures and policies are developed.
The QMS should be documented, including:
• quality policy and objectives
• quality manual and documented procedures
• necessary planning operation and control documents
• required records, including regulatory
Documents and records required by the QMS should be
controlled and maintained. A typical QMS document
hierarchy is shown in Figure 1-7. The quality manual
describes the QMS in accordance with the company’s
policies and objectives. Procedures define interrelated
processes and activities (who, what, why, when and
where). Work instructions and other documents needed
to plan, operate and control processes are the detailed
work documents (how). Records are the evidence of
results achieved and activities performed.
The draft quality policy should now be formalized
to ensure it is communicated and understood within
the organization and reviewed for continuing suitabil-
ity. Objectives also should be formalized along with
measures. The quality manual should include the QMS
scope, details and justification for any exclusion or
non-applications, documented procedures (or references
to them), description of interaction between QMS
processes and an outline of the QMS documentation
structure. Each organization must choose the manual’s
format, which will depend on the organization’s size,
culture and complexity. A small organization may find it
appropriate to include a description of the entire QMS
within a single manual, including all the documented
Figure 1-7. Typical QMS Document Hierarchy
Quality manual
Quality procedures
Work instructions
Records
Level 1
Level 2
Level 3
Level 4
17
• start and completion dates
• activities and deliverables
• responsibilities and authorities
• resources and estimated costs
• tracking and reporting methods
• expected benefits and returns
The implementation plan should be clearly defined and
formally agreed by top management. The plan may need
revisions before finally gaining approval.
Plan Implementation
Implementation is where the work to meet the stan-
dard’s requirements takes place. It is not unusual for
the management system to be implemented in stages.
The approved plan should be carried out, and training
should be provided as needed. The implementation
team should be given the resources and support needed
to complete assigned activities successfully. Progress
should be monitored frequently (not just at the points
defined in the plan), and encouragement and assistance
should be offered. Tracking data should be collected
to report to top management. Some activities will be
dependent on earlier activities. If delays are anticipated,
the impact on later activities should be considered to
minimize problems. Documentation is important at this
stage, so policies can be created, procedures developed
and records kept.
Training on ISO 13485 should be conducted early
in the project to aid in planning. Managers and other
employees should be included, as appropriate, to ensure
staff are aware of the standard, the importance and
relevance to their jobs and how the standard is applica-
ble to the organization’s products and services. Expertise
should be developed to assist and guide implementation
activities. The training budget should cover needed
courses and travel, and records should be maintained as
evidence. Further training will be needed as the QMS is
implemented and procedures and policies are developed.
The QMS should be documented, including:
• quality policy and objectives
• quality manual and documented procedures
• necessary planning operation and control documents
• required records, including regulatory
Documents and records required by the QMS should be
controlled and maintained. A typical QMS document
hierarchy is shown in Figure 1-7. The quality manual
describes the QMS in accordance with the company’s
policies and objectives. Procedures define interrelated
processes and activities (who, what, why, when and
where). Work instructions and other documents needed
to plan, operate and control processes are the detailed
work documents (how). Records are the evidence of
results achieved and activities performed.
The draft quality policy should now be formalized
to ensure it is communicated and understood within
the organization and reviewed for continuing suitabil-
ity. Objectives also should be formalized along with
measures. The quality manual should include the QMS
scope, details and justification for any exclusion or
non-applications, documented procedures (or references
to them), description of interaction between QMS
processes and an outline of the QMS documentation
structure. Each organization must choose the manual’s
format, which will depend on the organization’s size,
culture and complexity. A small organization may find it
appropriate to include a description of the entire QMS
within a single manual, including all the documented
Figure 1-7. Typical QMS Document Hierarchy
Quality manual
Quality procedures
Work instructions
Records
Level 1
Level 2
Level 3
Level 4