What is ISO 13485: 2016?
ISO 13484 is derived from the ISO 9000 quality management standard series and it is a stand-alone one. ISO 13485 follows the ISO 9000 process-based model for a regulated medical apparatus manufacturing environment. This is more regulatory nature and requiring a thorough documented QMS.
ISO 13485 supports medical apparatus manufacturers in designing a quality management system that ascertains and maintain their processes of effectiveness. The constant design, development, production, installation and delivery of medical equipment are ensured and confirm the safety of their proposed purpose.
Who needs ISO 13485:2016 Certification?
It is being a condition of doing business; so many companies adapt ISO 13485. It aligns with many global regulations which include CE marking of medical equipment under U.S. Food and Drug Administration (FDA) and European directive requirements that medical apparatus manufacturers’ set up and comply with the quality systems.
The most apparent candidates for ISO 13485:2016 certification are Medical apparatus manufacturers and suppliers of medical devices, medical device distributors and importers, service providers for medical devices such as installation, technical support or QMS services.
How does ISO 13485:2016 Certification benefit your organization?
Promote your organization’s image and credibility:
ISO 13485 is the gold standard for quality in the medical apparatus industry. This certification shows your clients that you are looking at the quality meticulously and you have a proper system to ensure it. Your QMS is a powerful marketing tool and it is being mandatory in many countries for suppliers to show your compliance which leads to a huge opportunity.
Improve your processes:
With this process approach, it is easier to discover opportunities for improvements. You will be able to spot and eliminate waste within and between the processes, mitigate errors, avoid rework that facilitates greater efficiency and cost savings.
Better employee engagement:
When employees are asked to improve their own processes, they not only provide their best insight, but also they will feel happier and more invested in the company’s success. The employees’ understandability in delivering quality products, services, and their full commitment helps in increasing efficiency and productivity.
Increase customer satisfaction:
The ISO 13485:2016 standard is designed on the basis of ensuring customer satisfaction. It can be achieved by analyzing customer needs, expectations. Customers know about their wants and needs and many of them certainly not entertain a supplier without proper certification. Above all, ensuring the satisfaction of your existing customers make them come back, supports to sell your services to new customers which leads to the increased revenue ultimately.
ISO 13485:2016 compliant management systems comply with a risk management approach that includes an assessment to identify and estimate the risk, uses risk controls and techniques with a vision of eliminating hazardous situations throughout the product realization.
Strongly emphasizes the sterility and cleanliness in the production area which in turn increases efficiency and improves safety at the work spot.
How to get ISO 13485:2016 Certification?
Planning your quality system:
ISO 13485 section 5.4.2 encompasses a quality planning requirement. It is not only sufficient to write quality manual whereas you require a documented quality plan for implementing changes to QMS. Selecting an ISO Consultant is a part of your quality plan. The consultant whom you choose must be well-knowledge in your industry.
Meeting regulatory requirements
While developing your quality plan, U.S medical device companies should comply with FDA 21 CFR 820.
- Fill ISO 13485 application form either soft or hard copy and submit
- Your application form will be reviewed by an ISO 13485 auditor and on acceptance, a quotation for ISO 13485 certification will be issued
- After the receipt of ISO 13485:2016 Certification fee, an ISO 13485 audit plan will be sent and the audit will be conducted subsequently (stage-1).
- After the successful completion of stage -1 audit, you will be called out for stage –II audit plan.
- Once the audit is completed successfully, your organization will be recommended for ISO 13485:2016 certification by the auditor.
- Based on the auditor’s recommendation and audit findings, the Certification authority will take a decision to grant for ISO 13485:2016 certification.
The new version 13485:2016 greatly emphasis on risk management and risk-based decision making and changes connected to the increased regulatory requirements for organizations in the supply chain.