MASTERING THE IMPLEMENTATION AND MANAGEMENT OF A QUALITY MANAGEMENT SYSTEM (QMS) BASED ON ISO 13485

1. CERTIFIED ISO 13485
LEAD IMPLEMENTER
MASTERING THE IMPLEMENTATION AND MANAGEMENT OF A QUALITY MANAGEMENT
SYSTEM (QMS) BASED ON ISO 13485
SUMMARY
This five-day intensive course enables the participants to develop the necessary expertise to support an organization
in implementing and managing a Quality Management System (QMS) based on ISO 13485. Participants will also gain
a thorough understanding of best practices used to implement quality processes based on requirements from ISO
13485. This training is consistent with the project management practices established in ISO 10006 (Quality Management
Systems – Guidelines for Quality Management in Projects). This training is fully compatible with ISO 14969 guidance’s
(Medical devices – Quality Management Systems – Guidance on the application of ISO 13485).
COURSE AGENDA
DURATION: 5 DAYS
DAY 1
Introduction to Quality Management System
(QMS) concepts as required by ISO 13485
and initiation of a QMS
▶▶ ntroduction to management systems and the process
I
approach
▶▶ ormative frameworks and methodologies related to
N
Quality and Medical Devices
▶▶ nderstanding the requirements of ISO 13485
U
▶▶ undamental principles of Quality and Medical Devices
F
▶▶ nitiating the QMS implementation
I
DAY 3
Implementing a QMS based on ISO 13485
▶▶ mplementation of a document management
I
framework
▶▶ esign of controls and writing of procedures
D
▶▶ evelopment of a training and awareness program
D
and communicating about the quality
▶▶ roduct realization processes
P
▶▶ perations management of a QMS
O
DAY 5
DAY 2
Planning the implementation of a QMS
based on ISO 13485
▶▶ riting a business case and a project plan for the
W
implementation of a QMS
▶▶ efinition of the scope of the QMS
D
▶▶ evelopment of a QMS policy
D
DAY 4
Controlling, monitoring and measuring a
QMS and the certification audit of a QMS
in accordance with ISO 13485
▶▶
▶▶
▶▶
▶▶
▶▶
C
ontrolling and monitoring a QMS
I
SO 13485 internal audit
M
anagement review of a QMS
I
mplementation of an improvement program
P
reparing for an ISO 13485 certification audit
Certification Exam
www.pecb.org

2. WHO SHOULD ATTEND?
▶▶ roject managers or consultants wanting to prepare and to support an organization in the implementation of a
P
Quality Management System (QMS)
▶▶ uality executives
Q
▶▶ SO 13485 auditors who wish to fully understand the Quality Management System implementation process
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▶▶ ersons responsible for the quality or conformity in an organization
P
▶▶ embers of a quality team
M
▶▶ xpert advisors in Quality Management Systems
E
▶▶ egulatory affairs managers
R
▶▶ echnical experts wanting to prepare for a quality function or for a QMS project management function in the
T
medical device industry
LEARNING OBJECTIVES
▶▶ o understand the implementation of a Quality Management System in accordance with ISO 13485
T
▶▶ o gain a comprehensive understanding of the concepts, approaches, standards, methods and techniques
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required for the effective management of a Quality Management System
▶▶ o understand the relationship between the components of a Quality Management System and the compliance
T
with customer and regulatory requirements
▶▶ o acquire necessary expertise to support an organization in implementing, managing and maintaining a QMS as
T
specified in ISO 13485
▶▶ o acquire necessary expertise to manage a team implementing an ISO 13485
T
▶▶ o develop knowledge and skills required to advise organization on best practices in the management of quality
T
▶▶ o improve the capacity for analysis and decision making in the context of quality management
T
▶▶ o prepare an organization for an ISO 13485 audit
T
PECB
www.pecb.org
Certified
ISO 13485
Lead Implementer

3. EXAMINATION
▶▶ he “Certified ISO 13485 Lead Implementer” exam fully meets the requirements of the PECB Examination and
T
Certification Program (ECP). The exam covers the following competence domains:
DOMAIN 1: FUNDAMENTAL PRINCIPLES AND CONCEPTS IN MEDICAL DEVICES QUALITY MANAGEMENT
1
Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can understand, interpret and illustrate the
main Medical Devices Quality Management concepts related to a Medical Devices Quality Management System (MDQMS)
DOMAIN 2: MEDICAL DEVICES QUALITY MANAGEMENT BEST PRACTICES BASED ON ISO 13485
2
Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can understand, interpret and provide
guidance on how to implement and manage Medical Devices Quality Management requirements based on best
practices of ISO 13485
3
DOMAIN 3: PLANNING A MDQMS BASED ON ISO 13485
4
DOMAIN 4: IMPLEMENTING A MDQMS BASED ON ISO 13485
5
6
7
Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can plan the implementation of a
MDQMS in preparation for an ISO 13485 certification
Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can implement the processes of a
MDQMS required for an ISO 13485 certification
DOMAIN 5: PERFORMANCE EVALUATION, MONITORING AND MEASUREMENT OF A MDQMS BASED ON
ISO 13485
Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can evaluate, monitor and measure
the performance of a MDQMS in the context of an ISO 13485 certification
DOMAIN 6: CONTINUAL IMPROVEMENT OF A MDQMS BASED ON ISO 13485
Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can provide guidance on the continual
improvement of a MDQMS in the context of ISO 13485
DOMAIN 7: PREPARATION FOR A MDQMS CERTIFICATION AUDIT
Main Objective: To ensure that the ISO 13485 Lead Implementer candidate can prepare and assist an
organization for the certification of a MDQMS against the ISO 13485 standard
▶▶ The “Certified ISO 13485 Lead Implementer” exam is available in different languages, including English, French,
Spanish and Portuguese
▶▶ Duration: 3 hours
▶▶ For more information about the exam, please visit: www.pecb.org
www.pecb.org

4. CERTIFICATION
▶▶ After successfully completing the exam, participants can apply for the credentials of Certified ISO 13485
Provisional Implementer, Certified ISO 13485 Implementer or Certified ISO 13485 Lead Implementer, depending on
their level of experience
▶▶ A certificate will be issued to participants who successfully passed the exam and comply with all the other
requirements related to the selected credential:
Credential
Exam
Professional
Experience
QMSMD
Audit
Experience
QMSMD Project
Experience
Other
Requirements
ISO 13485
Provisional
Implementer
ISO 13485 Lead
Implementer
Exam
None
None
None
Signing the
PECB
code of ethics
ISO 13485
Implementer
ISO 13485 Lead
Implementer
Exam
Two years
One year of Medical
Devices
Management work
experience
None
Project activities
totaling
200 hours
Signing the
PECB
code of ethics
ISO 13485
Lead
Implementer
ISO 13485 Lead
Implementer
Exam
Five years
Two years of Medical
Devices
Management
work experience
None
Project activities
totaling
300 hours
Signing the
PECB
code of ethics
GENERAL INFORMATION
▶▶
▶▶
▶▶
▶▶
C
ertification fees are included in the exam price
P
articipant manual contains over 450 pages of information and practical examples
A participation certificate of 31 CPD (Continuing Professional Development) credits will be issued to participants
In case of failure of the exam, participants are allowed to retake it for free under certain conditions
For additional information,
please contact us at info@pecb.org
www.pecb.org
PECB
Certified
ISO 13485
Lead Implementer