ISO13485 : 2016 Internal Auditing
Duration 2 days. For enquiries about this course, email admin@medsociate.com
INTRODUCTION
Medical Device manufacturing is a regulated industry with stringent requirements to control processes aimed at ensuring safety & effectiveness of medical devices. Such good manufacturing practices are met through the implementation of ISO 13485. The new ISO 13485:2016 extends the scope to the entire medical device supply chain, greater emphasising risk management with increased focus on the organisations ability to meet applicable customer and regulatory requirement.
The need for self-assessment is specified and achieved through internal auditing of the ISO 13485 Quality Management System which aids regulatory compliance as well as identifies opportunities for improvement. This course is designed to give participants the knowledge and skills needed to undertake an unbiased and constructive ISO 13485 Quality Management System audit in line with the generic guidelines laid down in ISO 19011. Participants will learn the skills and techniques of a process audit and how to communicate the findings so as to increase the effectiveness of the organisation’s management system
Participants will be led by an experienced tutor with over 2 decades of auditing, training and quality assurance as well as management system development experience. Participants will engage in small group activities and lively debate, along with instructor led segments to gain the knowledge needed to effectively manage changes to the new standard. Participants will learn how to apply these principles to produce effective internal audits of medical device manufacturing firms and supply chain.
Medical Device manufacturing is a regulated industry with stringent requirements to control processes aimed at ensuring safety & effectiveness of medical devices. Such good manufacturing practices are met through the implementation of ISO 13485. The new ISO 13485:2016 extends the scope to the entire medical device supply chain, greater emphasising risk management with increased focus on the organisations ability to meet applicable customer and regulatory requirement.
The need for self-assessment is specified and achieved through internal auditing of the ISO 13485 Quality Management System which aids regulatory compliance as well as identifies opportunities for improvement. This course is designed to give participants the knowledge and skills needed to undertake an unbiased and constructive ISO 13485 Quality Management System audit in line with the generic guidelines laid down in ISO 19011. Participants will learn the skills and techniques of a process audit and how to communicate the findings so as to increase the effectiveness of the organisation’s management system
Participants will be led by an experienced tutor with over 2 decades of auditing, training and quality assurance as well as management system development experience. Participants will engage in small group activities and lively debate, along with instructor led segments to gain the knowledge needed to effectively manage changes to the new standard. Participants will learn how to apply these principles to produce effective internal audits of medical device manufacturing firms and supply chain.
COURSE OUTLINE
COURSE BENEFITS
Upon completion of the training, participants will be able to:
TARGET AUDIENCE
This course is designed for company staff with audit responsibility for the organisation’s ISO 13485 Quality System or will be undertaking Internal Quality Audits. It is suitable for all functions and levels tasked:
PRE-REQUISITES
It is recommended that participants have knowledge of ISO 9001 and/or ISO 13485 prior to attendance of this course.
DURATION
Two (2) full days
PAYMENT
Payment is required before/ on training date. Please choose from below options.
Option 1 : Direct Bank-in or via E-Banking upon receipt of Invoice
Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice.
Please refer the following bank account details:
Beneficiary Name: Medsociate Sdn Bhd
Bank Account Number: 800 3930 348
Bank: CIMB Bank
Swift Code: CIBB MYKL
Please email us (admin@medsociate.com) the bank-in slip / remittance slip once the payment is made.
For Government Sector
A Local Order (LO) or letter of approval to participate must be presented before the training.
Option 2 : Direct Online Payment
You can choose to make payment via Paypal upon receipt of invoice. When making payment, in the email section, please key in our Paypal Account : admin@medsociate.com
SUBSTITUTION
Substitution is allowed for a registered participant. No refund will be made for cancellation.
CANCELLATION
Medsociate Sdn Bhd (AMMI Authorised Training Provider) reserves the right to cancel or postpone any training or event but with due notice to the registered participants / company(s). Any payment made will be refunded if the cancellation is made by training provider. Cancellation of attendance and refund will not be entertained as all bookings would have been reserved and confirmed.
CONTACT
For enquiries, please email to admin@medsociate.com.
Medsociate Sdn Bhd
(HRDF Approved Training Provider - Registration No. 4195)
(AMMI Authorised Training Provider and Secretariat)
Tel: +6010 4040 662 Fax: +603 2178 4347
- Overview of Internal Auditing
- The requirements of ISO 13485:2016
- Differences between ISO 13485:2016 and ISO 13485:2003 – terms, definitions, audit principles & approach
- The role of Risk Management in ensuring a well-structured and adequate QMS
- Pre-Audit Preparation
- Conducting the Audit
- Reporting the Audit
- Follow-up after the Audit
- The interrelationships between ISO 13485:2016 and the selected medical device regulations – EU, Malaysia, ASEAN Medical Device Directive.
- Role of the Medical Devices Single Audit Program (MDSAP).
- Transition timelines and strategies
COURSE BENEFITS
Upon completion of the training, participants will be able to:
- perform ISO 13485 auditing with the skills and methodology acquired
- apply the process-based approach in auditing
- have a clear understanding of the ISO 13485:2016 standard and what auditors look for
- understand conformity and compliance that need to be demonstrated
- conduct assessment on conformity & compliance of audited ISO 13485 QMS
- plan, manage & maintain a compliant ISO 13485 QMS
- confirm as to whether existing organisational practices and documentation are adequate or require changes and enhancements to meet the requirements of the standard and the ever changing regulatory environment.
TARGET AUDIENCE
This course is designed for company staff with audit responsibility for the organisation’s ISO 13485 Quality System or will be undertaking Internal Quality Audits. It is suitable for all functions and levels tasked:
- to carry out internal audits
- to organise the audit program for their ISO 13485 or integrated management system
- to train or guide other internal auditors.
PRE-REQUISITES
It is recommended that participants have knowledge of ISO 9001 and/or ISO 13485 prior to attendance of this course.
DURATION
Two (2) full days
PAYMENT
Payment is required before/ on training date. Please choose from below options.
Option 1 : Direct Bank-in or via E-Banking upon receipt of Invoice
Please note that any Early Bird Discounts (for registration within validity period) will be reflected in the invoice.
Please refer the following bank account details:
Beneficiary Name: Medsociate Sdn Bhd
Bank Account Number: 800 3930 348
Bank: CIMB Bank
Swift Code: CIBB MYKL
Please email us (admin@medsociate.com) the bank-in slip / remittance slip once the payment is made.
For Government Sector
A Local Order (LO) or letter of approval to participate must be presented before the training.
Option 2 : Direct Online Payment
You can choose to make payment via Paypal upon receipt of invoice. When making payment, in the email section, please key in our Paypal Account : admin@medsociate.com
SUBSTITUTION
Substitution is allowed for a registered participant. No refund will be made for cancellation.
CANCELLATION
Medsociate Sdn Bhd (AMMI Authorised Training Provider) reserves the right to cancel or postpone any training or event but with due notice to the registered participants / company(s). Any payment made will be refunded if the cancellation is made by training provider. Cancellation of attendance and refund will not be entertained as all bookings would have been reserved and confirmed.
CONTACT
For enquiries, please email to admin@medsociate.com.
Medsociate Sdn Bhd
(HRDF Approved Training Provider - Registration No. 4195)
(AMMI Authorised Training Provider and Secretariat)
Tel: +6010 4040 662 Fax: +603 2178 4347