Quality Management Systems for Drugs and Devices
19
the majority of the QMS should be implemented before
internal audits are initiated.
The word ‘audit’ may have negative connotations
in some organizations because it often is associated
with financial audits. However, audits (a team might be
more receptive to the term “inspections”) can have great
benefits to an organization, its product, services and
employees, and this ideally should have been communi-
cated in the earlier promotion of implementation project
awareness. Audits help an organization investigate any
quality problems and verify solutions are implemented
effectively. Management needs factual information
to make informed decisions. Audits provide impar-
tial, objective results for management action. Periodic
audits keep the quality awareness level high and foster
improved internal communication.
Internal audits are expected to examine all areas and
shifts, some areas more often, based on previous results (a
risk-based approach) and show audit scope (coverage) as
part of the schedule. Internal audits should be conducted
by properly qualified staff members who are independent
from the areas being audited (i.e., not auditing their own
work) and impartial. Many auditor training and certi-
fication programs are available and recommended for
personnel responsible for this task. Programs provided
by recognized quality standards organizations (e.g., the
American Society for Quality’s (ASQ) Certified Quality
Auditor (CQA) proficiency qualification) should be
considered. Other organizations also train and certify
auditors to specific ISO regulations.
Internal audits must follow a documented auditing
procedure (Clause 8.2.2). The organization must follow
its documented corrective action procedure to resolve
any findings in audit reports. A follow-up audit verifies
actions taken and reports the results (see ISO 19011 for
guidance).20 Management reviews should be conducted to
ensure continuing QMS suitability, adequacy and effec-
tiveness. New or revised regulatory requirements should
be included in the review. Opportunities for improve-
ment to maintain QMS effectiveness and QMS changes,
including policy and objectives, should be assessed in the
management review. Such meetings can be used to review
implementation process activities and make immediate
improvements. Review outputs should include resource
needs and product improvements related to customer
requirements. Review records must be controlled and
maintained. The reviews analyze several metrics, including
audit results, customer feedback and process performance
and product conformity.
Based on the system review, improvements or
corrections may be proposed. This may result in taking
appropriate corrective or preventive action, improv-
ing products or processes and determining resource
needs or changes. These improvements should be
implemented, communicated and fed back into the
next planning stage. Improvements should follow a
documented procedure for corrective action and the
results recorded (Clause 8.5.2). In addition to initiating
the corrective action process, quickly identifying any
findings in one area potentially can help remaining
areas avoid a similar problem (and reduce the number
of reported nonconformities).
Continuous System Improvement
Organizations must recognize the management system
will need continuous improvement to keep meeting
quality expectations. ISO 13485 requires organizations
to improve their quality management systems continu-
ously these are audited by the certification body as part
of ISO 13485 certification. The system can be improved
in a number of ways, including:
• QMS auditing
• monitoring processes, products and services
• collecting customer feedback
• monitoring customer complaints, nonconfor-
mances, other inputs to CAPA
• monitoring supplier performance
• reviewing required competencies
• reviewing training needs
• reviewing training effectiveness
• maintaining QMS effectiveness
The Plan-Do-Check-Act (PDCA) cycle is an itera-
tive process that is refined continuously as the QMS
19
the majority of the QMS should be implemented before
internal audits are initiated.
The word ‘audit’ may have negative connotations
in some organizations because it often is associated
with financial audits. However, audits (a team might be
more receptive to the term “inspections”) can have great
benefits to an organization, its product, services and
employees, and this ideally should have been communi-
cated in the earlier promotion of implementation project
awareness. Audits help an organization investigate any
quality problems and verify solutions are implemented
effectively. Management needs factual information
to make informed decisions. Audits provide impar-
tial, objective results for management action. Periodic
audits keep the quality awareness level high and foster
improved internal communication.
Internal audits are expected to examine all areas and
shifts, some areas more often, based on previous results (a
risk-based approach) and show audit scope (coverage) as
part of the schedule. Internal audits should be conducted
by properly qualified staff members who are independent
from the areas being audited (i.e., not auditing their own
work) and impartial. Many auditor training and certi-
fication programs are available and recommended for
personnel responsible for this task. Programs provided
by recognized quality standards organizations (e.g., the
American Society for Quality’s (ASQ) Certified Quality
Auditor (CQA) proficiency qualification) should be
considered. Other organizations also train and certify
auditors to specific ISO regulations.
Internal audits must follow a documented auditing
procedure (Clause 8.2.2). The organization must follow
its documented corrective action procedure to resolve
any findings in audit reports. A follow-up audit verifies
actions taken and reports the results (see ISO 19011 for
guidance).20 Management reviews should be conducted to
ensure continuing QMS suitability, adequacy and effec-
tiveness. New or revised regulatory requirements should
be included in the review. Opportunities for improve-
ment to maintain QMS effectiveness and QMS changes,
including policy and objectives, should be assessed in the
management review. Such meetings can be used to review
implementation process activities and make immediate
improvements. Review outputs should include resource
needs and product improvements related to customer
requirements. Review records must be controlled and
maintained. The reviews analyze several metrics, including
audit results, customer feedback and process performance
and product conformity.
Based on the system review, improvements or
corrections may be proposed. This may result in taking
appropriate corrective or preventive action, improv-
ing products or processes and determining resource
needs or changes. These improvements should be
implemented, communicated and fed back into the
next planning stage. Improvements should follow a
documented procedure for corrective action and the
results recorded (Clause 8.5.2). In addition to initiating
the corrective action process, quickly identifying any
findings in one area potentially can help remaining
areas avoid a similar problem (and reduce the number
of reported nonconformities).
Continuous System Improvement
Organizations must recognize the management system
will need continuous improvement to keep meeting
quality expectations. ISO 13485 requires organizations
to improve their quality management systems continu-
ously these are audited by the certification body as part
of ISO 13485 certification. The system can be improved
in a number of ways, including:
• QMS auditing
• monitoring processes, products and services
• collecting customer feedback
• monitoring customer complaints, nonconfor-
mances, other inputs to CAPA
• monitoring supplier performance
• reviewing required competencies
• reviewing training needs
• reviewing training effectiveness
• maintaining QMS effectiveness
The Plan-Do-Check-Act (PDCA) cycle is an itera-
tive process that is refined continuously as the QMS