ISO 13485
Medical Device
Quality Management System
What is ISO 13485 ?
ISO 13485:2016 sets the standards for a quality management system that allows organizations to showcase their ability to consistently provide medical devices and related services that meet customer requirements and adhere to applicable regulatory standards in the medical device industry.
Requirements of ISO 13485 ?
Clause 1: Scope
Clause 2: Normative Reference
Clause 3: Terms and Definition
Clause 4: General Requirements
Clause 5: Management Responsibility
Clause 6: Resource Management
Clause 7: Product Realization
Clause 8: Measurement, Analysis, and Improvement
Benefits of ISO 13485:2016
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Improve your company’s credibility and identity
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Evidence -based decision making
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Continual Improvement
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Increased employee improvement
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Enhanced customer satisfaction
How can Nixan assist you?
At Nixan, we specialize in providing management system training and consultancy services. With our extensive expertise and practical experience, we assist clients in developing effective management systems, from conceptualization to successful implementation.
Our consultation approach is designed to help you achieve certification by following these key steps:
01
Identify areas within your current Management System that require improvement or development.
02
Collaborate with your company personnel to create a strategic action plan that addresses these improvement areas and effectively communicates the requirements to key personnel at all levels.
03
Deliver system-related trainings to your company personnel, raising awareness and equipping them with the necessary knowledge and skills for system implementation.
04
Help and guidance in developing and implementing the systems, including the preparation of documentation.
05
Offer advice and support, if needed, in preparing and submitting applications to your certification body.
06
Assist in the development of internal auditing procedures and provide training to ensure effective implementation of the management system.
07
Conduct internal audits to verify the successful implementation of the management system prior to the final audit by your certification body.
08
Facilitate Management Review Meetings to evaluate the performance of the management system and identify areas for improvement prior to the final audit by your certification body.