Benefit of Getting ISO 13485 Certified

Following are benefits of getting ISO certification are as follows:

• Includes an internationally recognised EN ISO 13485 certified Quality Management System (QMS)
• More product opportunities
• Extensive market access approval
• Manufacturers or other sub-contractors of the medical devices have a chance to leverage their certified Quality Management System (QMS) status for a smooth and seamless transition into specialised Certification
• Meaningful feedback on the effectiveness of the Quality Management System (QMS)
• Confidence in compliance with regulations
• Identification of areas requiring attention
• Identification of areas of non-compliance and risk
• Future growth and expansion
• Valuable and recognised reporting and Certification
• More opportunities
• A clear understanding of devices

Pre-Requisites for ISO 13485 Certification

The list of pre-requisites required to get ISO 13485 Certification is as follows:

• General Requirements: Include adherence to the standard, Documents that need to be Documented, maintaining what is required for the Organisation, written procedures in place and ensuring the effectiveness of a system that the Organisation implement, considering risk factors in all activities, introducing steps to minimise the risk identified and aim not to cause catastrophic events, identify how things should be done to generate medical device and stick to the processes, tracking activities, collecting any process failures or oversights and generate records to show all activities are being done, determining the requirements that the Organisation is legally bound to and ensure to maintain responsibility even in case of outsourcing work and also to ensure that the manufacturing processes are working effectively.
• Documentation Requirements: Include Quality Manual, commitment with policy or objective statement, specific requirements for both procedures and records of medical device creation including its file, products specification and guidelines on intended use, plan for controlling Documents and control records.
• Management Responsibility: It is where the Organisation’s management show and commits that they can be held liable or accountable for the operations within the Organisation and must ensure that their focus does not deter consumers’ needs. It also ensures that the management is following proper laws in the manufacturing process. Management has an absolute responsibility to support the quality policy, proper alignment with the laws of the country of work and the employees’ aims. Management of an Organisation is responsible for planning, delegating authority and communicating effectively. Management also conducts a periodic review of operations and improvement within the Organisation.
• Resource Management: Includes the management’s responsibility to ensure that the Quality Management System (QMS) is compliant with ISO 13485 and other regulatory requirements. The management must ensure adequate resources are available to perform the Organisation’s promised work. Provide personnel, infrastructure, consumables, equipment, succession planning, etc.
• Product Realisation: Means an organisation must plan for a journey from conceptualisation to implementation. It includes developing a process for Documenting how thoughts are initiated and verified, and products are designed, developed, verified, and validated to ISO 13485 requirements.
• Measurement, Analysis and Improvement: Meaning the product of the Organisation is manufactured and released for general use. It must include handling complaints, reporting events to regulatory authorities, undergoing internal evaluations through Auditing, continual process and product evaluation internally, identifying and controlling products that don’t meet original design requirements, analysing data generated, and continually improving the process.