MASTERING THE IMPLEMENTATION AND MANAGEMENT OF A QUALITY MANAGEMENT SYSTEM (QMS) BASED ON ISO 13485 DAY 1 DAY 2 DAY 3 DAY 4 DAY 5 DURATION: 5 DAYS COURSE AGENDA WHO SHOULD ATTEND? SUMMARY ▶ Project managers or consultants wanting to prepare and to support an organization in the implementation of a Quality Management System (QMS) ▶ Quality executives ▶ ISO 13485 auditors who wish to fully understand the Quality Management System implementation process ▶ Individuals responsible for the quality or conformity in an organization ▶ Members of a quality team ▶ Expert advisors in Quality Management Systems ▶ Regulatory affairs managers ▶ Technical experts wanting to prepare for a quality function or for a QMS project management function in the medical device industry Introduction to Quality Management System (QMS) concepts as required by ISO 13485 and initiation of a QMS ▶ Introduction to management systems and the process approach ▶ Normative frameworks and methodologies related to Quality and Medical Devices ▶ Understanding the requirements of ISO 13485 ▶ Fundamental principles of Quality and Medical Devices ▶ Initiating the QMS implementation Implementing a QMS based on ISO 13485 ▶ Implementation of a document management framework ▶ Design of controls and writing of procedures ▶ Development of a training and awareness program and communicating about the quality ▶ Product realization processes ▶ Operations management of a QMS Certification Exam ▶ PECB’s 3 Hour Certified ISO 13485 Lead Implementer Exam is available in different languages. The candidates who do not pass the exam will be able to retake it for free within 12 months from the initial exam date. Planning the implementation of a QMS based on ISO 13485 ▶ Writing a business case and a project plan for the implementation of a QMS ▶ Definition of the scope of the QMS ▶ Development of a QMS policy Controlling, monitoring and measuring a QMS and the certification audit of a QMS in accordance with ISO 13485 ▶ Controlling and monitoring a QMS ▶ ISO 13485 internal audit ▶ Management review of a QMS ▶ Implementation of an improvement program ▶ Preparing for an ISO 13485 certification audit www.pecb.org 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 Management processes based on requirements from of the 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). CERTIFIED ISO 13485 LEAD IMPLEMENTER
MASTERING THE IMPLEMENTATION AND MANAGEMENT OF A QUALITY MANAGEMENT SYSTEM (QMS) BASED ON ISO 13485
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1. CERTIFIED ISO 13485 LEAD IMPLEMENTER MASTERING THE
IMPLEMENTATION AND MANAGEMENT OF A QUALITY MANAGEMENT SYSTEM (QMS)
BASED ON ISO 13485SUMMARY 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
Management processes based on requirements from of the 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 guidances (Medical devices Quality Management
Systems Guidance on the application of ISO 13485).WHO SHOULD
ATTEND? Project managers or consultants wanting to prepare and to
support an organization in the implementation of a Quality
Management System (QMS) Quality executives SO 13485 auditors who
wish to fully understand the Quality Management System
implementation process I ndividuals responsible for the quality or
conformity in an organization I embers of a quality team M xpert
advisors in Quality Management Systems E Regulatory affairs
managers Technical experts wanting to prepare for a quality
function or for a QMS project management function in the medical
device industryCOURSE AGENDADURATION: 5 DAYSDAY 1 Introduction to
Quality Management System (QMS) concepts as required by ISO 13485
and initiation of a QMS Introduction to management systems and the
process approach Normative frameworks and methodologies related to
Quality and Medical Devices Understanding the requirements of ISO
13485 Fundamental principles of Quality and Medical Devices
Initiating the QMS implementationDAY 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 Operations management of a QMSDAY 5DAY 2
Planning the implementation of a QMS based on ISO 13485 Writing a
business case and a project plan for the implementation of a QMS
efinition of the scope of the QMS D evelopment of a QMS policy DDAY
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 Preparing for an ISO
13485 certification auditCertification Exam PECBs 3 Hour Certified
ISO 13485 Lead Implementer Exam is available in different
languages. The candidates who do not pass the exam will be able to
retake it for free within 12 months from the initial exam
date.www.pecb.org
2. EXAMINATION The Certified ISO 13485 Lead Implementer exam
fully meets the requirements of the PECB Examination and
Certification Program (ECP). The exam covers the following
competence domains: omain 1: Fundamental principles and concepts of
quality and medical devices D omain 2: Quality Management System
best practice based on ISO 13485 D omain 3: Planning a QMS based on
ISO 13485 D omain 4: Implementing a QMS based on ISO 13485 D omain
5: Performance evaluation, monitoring and measurement of a QMS
based on ISO 13485 D omain 6: Maintaining the effectiveness of a
QMS based on ISO 13485 D omain 7: Preparing for a QMS certification
audit D or more information about the exam, please visit:
www.pecb.org FCERTIFICATION After successfully completing the exam,
the 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 pass the exam and comply with all the other
requirements related to the selected credential:
CredentialExamProfessional ExperienceQMSMD Audit ExperienceQMSMD
Project ExperienceOther RequirementsISO 13485 Provisional
ImplementerISO 13485 Lead Implementer ExamNoneNoneNoneSigning the
PECB code of ethicsISO 13485 ImplementerISO 13485 Lead Implementer
ExamTwo years One year of Medical Devices work
experienceNoneProject activities totaling 200 hoursSigning the PECB
code of ethicsISO 13485 Lead ImplementerISO 13485 Lead Implementer
ExamFive years Two years of Medical Devices work
experienceNoneProject activities totaling 300 hoursSigning the PECB
code of ethicsGENERAL INFORMATION Certification fees are included
in the exam price Participant manual contains over 450 pages of
information and practical examples A participation certificate of
31 CPD (Continuing Professional Development) credits will be issued
to participantsFor additional information, please contact us at
[email protected] www.pecb.orgPECBCertified ISO 13485 Lead
Implementer
