ISO 13485:2016: Medical devices — Quality management systems — Requirements for regulatory purposes
Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK
Procedure No. EVL/MD-QMS/C-A/1200/C-3
ISO 13485:2016 is an International Standard published from ISO which specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations of Medical Devices 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.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization (outsourced), are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.
If applicable regulatory requirements permit exclusions (non-applicability) of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization and its Management to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.
If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.
Regulatory requirements are increasingly stringent, specially for Medical Devices, throughout every step of a product’s life cycle, including service and delivery. Increasingly, organizations in the industry are expected to demonstrate their quality management processes and ensure best practice in everything they do. This internationally agreed standard sets out the requirements for a quality management system specific to the medical devices industry.
ISO 13485:2016 is based on the ISO 9001:2015 process model approach and is a management systems standard specifically developed for the manufacture of medical devices. Though the structure of ISO 13485:2016 is not as per Annex SL (Annex L).
Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for:
• Documentation and Implementation of a Quality Management System with several enhancements
• Risk Management approach to product development and product realization
• Validation of processes
• Compliance with statutory and regulatory requirements
• Effective product traceability and recall systems.
Is ISO 13485 certification right for me?
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. Though ISO 13485:2016 standard does not follow the High Level Structure- Annex SL / Annex L.
There are many terms in ISO 13485 unique to medical devices. ISO 13485 also retained the role of a quality representative to top management.
For Organizations who are into Medical Devices manufacturing, or any services related to Medical Devices, ISO 13485:2016 is needed to be implemented and certified to from Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK.
Who is this standard- ISO 13485:2016 applicable to?
ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device< IVD 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.
Documents Required for ISO 13485:2016 Implementation and Certification
In order to ensure that the audits (Certification or Surveillance or Revalidation) from Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK proceeds smoothly, the following documents and records should be maintained:
1. Quality manual
2. Medical Device File
3. Company organization chart
4. Controlled list of procedures
5. Internal auditing procedure
6. CAPA procedure
7. Management review procedure
8. Internal audit schedule
9. CAPA log
10. Management review minutes
Obtaining an ISO 13485 certification Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK can be explained as a simple process. Follow these steps to get started:
1. Create a quality plan - certification starts with developing a quality plan to meet the requirements of the standard. Plan out how your quality system will function, what roles /responsibilities/authorities/accountabilities are required and who will perform them.
2. Identify target markets and work toward compliance - determine where you would like to market your medical devices and establish compliance with other medical device regulations in those jurisdictions.
3. Implement design controls - design controls are needed from the beginning of the product development process and should be established and documented as early on as possible.
4. Establish document controls - train your staff to follow a consistent and uniform system for updating the QMS and maintaining its compliance with ISO 13485.
5. Build a CAPA system - along with Design Controls, CAPA forms the core processes of your QMS. Ensure that your CAPA procedures are well defined and functional.
6. Schedule audits with Certification Body- Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK - assigned to audit medical device companies for compliance with ISO 13485. Certification audits are conducted in two stages, and manufacturers are expected to be fully compliant with the standard following the Stage 2 audit.
Benefits of Certification
The benefits of ISO 13485 certification from Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK include demonstration of regulatory compliance and more effective risk management. Certification aids compliance to national or international regulatory requirements. Certification also confirms to customers, suppliers and other stakeholders that the organization is in a state of control over its operations.
Third-party certification is preferred in many international markets, and is the accepted basis and starting point to achieve the medical device CE mark. It can also be used as a bench mark to meet good manufacturing practice (GMP) compliance in the United States. An ISO 13485 certified quality management system can aid access to U.S. and international markets.
In addition, certification from Euro Veritas, UK (www.euroveritas.com) accreditated from BAR-UK generally provides the following benefits:
• Enables your organization to prepare for product-to-market regulatory requirements for the medical device markets of Europe, Australia, Asia and all major developed as well as emerging markets
• Provides confidence of quality risk management and good manufacturing practices within the medical device supply chain throughout the medical device product life cycle
• Provides assurance that appropriate regulatory requirements are implemented within your organizational processes
• Provides confidence that best practice validation and GMP have been implemented and evaluated
• Enhances Organization’s Market Reputation.
