ISO 13485 — Medical Quality Management System
What is ISO 13485?
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.
If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.
Why is Medical Devices Quality Management System important for you?
Being an ISO 13485 certified professional imposes your determination to offer qualitative products and services to your company and/or clients. Attaining the necessary knowledge and skills to operate an ISO 13485 framework demonstrates your commitment to helping your company ensure continuous improvement and better work processes. It also indicates that you understand the importance of the safety and performance of medical devices and how a medical devices quality management system can assure just that, consequently leading to customer satisfaction. Similarly, it can introduce you to new opportunities, such as working for large companies that offer quality products and services. These companies will value your knowledge and expertise on this standard, while enabling you to maximize your earning potential.
Benefits of ISO 13485 Medical Devices Quality Management System
By becoming an ISO 13485 certified professional, you will be able to:
- Increase the number of job opportunities
- Create new business connections
- Gain competitive advantage
- Increase effectiveness and lower costs
- Offer expertise on improving work processes
- Offer safer and more efficient medical devices
- Increase customer satisfaction
Benefits of ISO13485 for organizations
After completion of this Online course for ISO 13485 lead auditor training, the users will be able to:
- Familiarize yourself with ISO 13485:2016 requirements in detail.
- Know about the resource requirements and process requirements.
- Understand the documentation required by ISO 13485:2016.
- Understand documentation and list of procedures to be maintained, and to check them as lead auditor.
- Get the knowledge of internal auditing and use of audit checklist.
- Know about the types of auditing and questioning techniques.
- Familiarize yourself with principles & implementation of ISO 13485:2016 lead audit programs in detail.
- Get the ready-to-use audit checklist with clause-wise questions to perform an effective audit.
How do I get started with ISO 13485 Training?
Becoming ISO 13485 certified is a key factor, which clients are putting an emphasis on when conducting business. That is why Megademi’s accredited courses offer you the best practices and tools on how to improve your medical devices management and at the same time boost your profits.
Megademi ISO 13485 training courses
Learn more about Medical Devices Quality Management Systems by attending Megademi’s ISO 13485 training courses. Check the training courses below and find the one that suits you best.
ISO 13485 Introduction/Foundation/Internal Auditor/Lead Auditor/Lead Implementer
Megademi is approved training partner by Exemplar Global for ISO Courses.
Exemplar Global has been accredited for Management System Auditor courses and personnel accreditation. Formerly known as RABQSA, Exemplar Global has over 30 years of expertise building certification programs for the conformity community. RABQSA was established in 2004 from the merger of the personnel certification activities of the U.S Registrar Accreditation Board (RAB) with the Australia-based Quality Society of Australasia (QSA).