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ISO 13485:2016 certification

ISO 13485:2016 specifies necessities for a quality management system where an organization requirements to demonstrate its ability to provide medical devices and related services that are constantly compliant with the ISO 13485 Standards / guidelines and meet applicable regulatory necessities. 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.

ISO 13485:2016 focuses on what the manufacturer does to deliver safe and effective medical devices. The revision places more emphasis on risk-based thinking and decision-making while also offering stronger intra-operability between the clauses and necessities. Well-known medical quality management programs like the Medical Device Single Audit Program (MDSAP) and the Canadian Medical Devices Conformity Assessment System (CMDCAS) identify and use ISO 13485:2016 as a framework.

Benefits of ISO 13485:2016

  • ISO 13485:2016 is internationally recognized as the “best quality practices” from organizations within the medical device industry.
  • This certification gives a Shorter Sales Cycle – less time is required to earn prospective customers’ trust and confidence.
  • ISO 13485:2016 certification means higher client satisfaction. The delivery of products that consistently meet customer needs as well as quality, safety and legal needs satisfies the client.
  • Striking development is noticed in stakeholder relationships – including staff, clients, and suppliers.
  • ISO 13485:2016 supports the organization to understand how statutory and regulatory needs impact an organization and its clients. Thus it helps in legal compliance.
  • An organization needs this certification to provide enhanced performance in areas like as increasing sales, timeliness in getting products to the global marketplace, reducing costs, reducing number of errors, lessening wastage, better utilization of time and resources, and lowering product failures.
  • Certification like ISO 13485:2016 enhances the image of the company in the eyes of clients, employees, and shareholders and all.
  • Supports in improved risk management – this is done through greater stability and traceability of products and using risk management techniques.
  • ISO 13485:2016 is a framework for implementation of actions which confirms achievement of planned result and maintaining efficiency of those procedures which are applicable to customer, quality and regulatory needs.

Some of the key changes between the 2003 and 2016 version include:

  • Incorporation of risk-based approaches beyond product realization. Risk is considered in the context of the safety and performance of the medical device and in meeting regulatory needs
  • Improved linkage with regulatory requirements, particularly for regulatory documentation
  • Application to organizations throughout the life cycle and supply chain for medical devices
  • Harmonization of the requirements for software validation for different software applications (QMS software, process control software, software for monitoring and measurement) in different clauses of the standard
  • Emphasis on appropriate infrastructure, particularly for production of sterile medical devices, and addition of needs for validation of sterile barrier properties
  • Additional necessities in design and development on consideration of usability, use of standards, verification and validation planning, design transfer and design records
  • Emphasis on complaint handling and reporting to regulatory authorities in accordance with regulatory needs, and consideration of post-market surveillance
  • Planning and documenting corrective action and preventive action, and applying corrective action without undue delay

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