What is ISO 13485?
ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for:
- Implementation of a Quality Management System with several enhancements
- Risk Management approach to product development and product realisation
- Validation of processes
- Compliance with statutory and regulatory requirements
- Effective product traceability and recall systems.
Helps you with
- Quality Control
- Risk Management
- Legal Compliance
- Traceability and Recall
- Process Improvement
- Product Improvement
- Operational Efficiency
Benefits of ISO 13485 Certification
Deliver products that consistently meet customer requirements and a service that is dependable and can be relied on.
Reduced operating costs
Continual improvement of processes and resulting operational efficiencies mean money saved.
Improved stakeholder relationships
Improve the perception of your organization with staff, customers and suppliers.
Understand how statutory and regulatory requirements impact your organization and its customers.
Proven business credentials
Independent verification against a globally recognized industry standard speaks volumes.
Ability to win business in regulated sectors
Certification helps to win business – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.
Improved risk management
Greater consistency and traceability of products and services means problems are easier to avoid and rectify.
Is ISO 13485 certification right for me?
Please note: You can still apply for either 2012 or 2016 versions of ISO 13485. Certificates issued for 2012 version will have validity up to the end of the transition period (March 2019).
ISO 13485:2016 is based on the ISO 9001 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Its primary objective is to facilitate harmonized medical device regulatory requirements.
Annex B of the ISO 13485:2016 standard includes a comparison with ISO 9001 for reference. Importantly, neither can be used to make a QMS that is automatically compliant to the other and both need auditing.
Further, there are many terms in ISO 13485 unique to medical devices. ISO 13485 also retained the role of a quality representative to top management where ISO 9001 removed this in many aspects. Interestingly ISO 9001 has a lot more requirement for monitoring external providers for performance than the old version and this is something always required by ISO 13485.
Who is it applicable to?
ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain.
ISO 13485 certification is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.
Facts about the transition
ISO 13485:2016 is a standard that focuses on the importance of the life-cycle of a medical device, including its design, development, production, storage, distribution, installation, servicing and final decommissioning. The standard is designed to assist organizations in focusing their management system and therefore practices on strengthening its risk management approach and meeting regulatory requirements. The following is a major revision of the ISO 13485:2016 standard.
ISO 13485:2016 replaces ISO 13485:2003 and ISO 13485:2012. The revised ISO 13485:2016 was published on 1st March 2016.
The standard is aligned with ISO 9001:2008 and not ISO 9001:2015. This misalignment is due to the revision of both standards being completed in parallel to one another.
- The changes were managed by the ISO technical committee 210. Its role was to ensure that this quality management system standard remains fit for purpose given developments over recent years with product specific requirements outlined in device directives such as; the In Vitro Diagnostic Medical Devices Directive (IVDD) 98/79/EC and the Medical Devices Directive (MDD) 93/42/EEC.
The standard is in line with the 3 Medical Device Directives, and the Z annexes at the front demonstrate where they align. However, the Medical Device Regulations are now live and will replace the Directives in 2020 (Medical Devices) and 2022 (in-vitro diagnostic devices). It is therefore very likely that an amendment or corrigendum to ISO 13485:2016 will be released in the near future to incorporate 2 new Z annexes demonstrating how it aligns to the new Regulations.
Clients who currently hold accredited certification against ISO 13485 have until 28th February 2019 to successfully transition to ISO 13485:2016. To find out more on your specific transition requirements click here.
Steps to Certification
Complete a Quote Request Form so that we can understand your company and requirements. You can do this by completing either the online quick quote or the online formal quote request form. We will use this information to accurately define your scope of assessment and provide you with a proposal for certification.
Once you’ve agreed your proposal, we will contact you to book your assessment with an NQA Assessor. This assessment consists of two mandatory visits that form the Initial Certification Audit. Please note that you must be able to demonstrate that your management system has been fully operational for a minimum of three months and has been subject to a management review and full cycle of internal audits.
Following a successful two stage audit, a certification decision is made and if positive, then certification to the required standard is issued by NQA. You will receive both a hard and soft copy of the certificate. Certification is valid for three years and is maintained through a programme of annual surveillance audits and a three yearly recertification audit.
ISO 13485 Toolkit
ISO 13485 Transition Checklist
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ISO 13485 Gap Guide