INSTITUTE FOR STANDARD AND QUALITY DEVELOPMENT STUDIES
ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide medical devices and related services that meet customer requirements and applicable regulatory requirements.
These organizations may be involved in one or more stages of the medical device life cycle, including design and development, production, storage and distribution, installation, servicing of medical devices, as well as the design and development or provision of related activities (such as technical support).
The ISO 13485 standard set – Medical Device Safety Management System – has been developed and applied by many organizations. Therefore, to effectively implement this certification system, it is necessary to clearly understand the certification and the requirements of the standard. For this reason, participating in the ISO 13485:2016 training course – Medical Device Quality Management System is essential.
To help enterprises better understand and access the standard, the ISSQ Institute of Quality organizes ISO 13485 training courses. Below is some information about the course.
The ISO 13485 standard was issued by the International Organization for Standardization (ISO) in March 2016. This certification has been widely recognized and widely applied as an effective quality management system for medical devices.
It provides requirements for organizations, enterprises, and manufacturing facilities in implementing quality management systems for medical devices. It helps ensure control of production processes based on risks throughout the entire product life cycle, from storage to delivery of medical device products and services.
Enterprises need to conduct training and establish a team of personnel with strong expertise in ISO 13485 in order to effectively build a quality management system for medical devices.
The ISSQ Institute of Quality provides training on awareness, internal auditor, and lead auditor courses according to ISO 13485:2016.
ISO 13485:2016 is a Quality Management System standard for medical devices issued by ISO in March 2016. It provides requirements for organizations, enterprises, and manufacturing facilities to control production processes based on risks throughout the entire product life cycle, including storage, transportation, handling, and provision of medical device products and services.
In the context of increasing national legal requirements and growing consumer confidence in medical device quality, manufacturers are encouraged to demonstrate compliance with standards. This helps ensure safety and minimize risk factors.
The course enhances awareness among organizations, enterprises, and manufacturing facilities in effectively applying and continuously improving the ISO 13485:2016 medical device quality management system.
Individuals in the following roles should participate in ISO 13485 awareness training:
Senior managers
Quality directors
Legal and compliance directors
Auditors
Enterprises preparing to implement ISO 13485
Individuals wishing to participate in building management systems
Overview of ISO 13485 – Medical device quality management system
Terms and definitions of ISO 13485 certification
Structure of the certification
Interpretation and analysis of standard requirements
Overview of the standard and assessment criteria
Differences between standards
Vietnamese legal framework
Exercises related to the standard
Documented procedures and internal audit procedures
Audit planning
Auditing skills
Conducting audits
Interpretation of nonconformities and preparation of nonconformity reports
Skills and requirements for an ISO 13485 internal auditor
Preparation of audit checklists
Interviewing techniques
Presentation of audit results
Recommendations and corrective/preventive actions
Factors to become a competent auditor
Summary and knowledge review
Trainers answer participants’ questions
Final test
Opportunity to learn in a professional environment with a team of trained experts possessing knowledge, skills, and experience.
Master the requirements of the standard, enabling participants to understand and apply necessary procedures and documentation in practical work.
Ensure you have sufficient knowledge to communicate with employees, helping them understand how additional knowledge will benefit them and create more opportunities in their current jobs.
Know how to handle arising issues or unexpected quality management results, thereby proposing appropriate measures to solve current organizational challenges.
Save time and improve productivity and work efficiency while increasingly enhancing quality management performance.
Above are the sharing insights from the ISSQ Institute of Quality regarding the ISO 13485:2016 Training Course – Medical Device Quality Management System.
We hope this article provides useful information for you and your enterprise.
The ISSQ Institute of Quality is always ready to accompany companies during integration and development.
Please contact the hotline: (+84) 981 851 111 or email: vienchatluong@issq.org.vn | tcvn@issq.org.vn
We are honored to serve our valued customers.
Posted date: 27/07/2023
