Overview of ISO 13485 Certification
Safety and quality are not negotiated in the case of medical devices, and so there is a requirement of ISO 13485, which specifies the requirement of a Quality Management System, where an organisation requires to show its abilities to provide medical devices and related services to meet applicable regulatory requirements. These organisations are indulged in one or more life-cycle stages such as design, storage and distribution, production, development, installation or servicing of a medical device and design and development or provision of any associated activities/ services. This ISO 13485 is also used by suppliers or external parties in providing a product with Quality Management System related services to the organisations.
ISO 13485 aligns with the earlier version of ISO 9001, which is an internationally recognised standard for Quality Management Systems established by ISO. The requirements set by ISO are recognised around the world for implementing a Quality Management System. Although ISO 13485 standard came out after the major update of ISO 9001, it does not align with a new revision of ISO 9001, as it was determined that the most recent changes in ISO 9001 were unnecessary for medical devices.
The ISO 13485 is the medical device organisation that mostly accepts international standards for quality management. The third-party Certification of ISO 13485 is required to prove that the Organisation is complying with the standard's requirements because the International Organisation issues it for Standardisation (ISO), which is an effective solution to meet the comprehensive requirements for Quality Management systems in the medical device organisations.
ISO 13485 is divided into eight sections; the first three are introductory, and the last five are mandatory requirements for the Quality Management System (QMS), which are Quality Management System, Management Responsibility, Resource Management, Product Realisation and Measurement, Analysis and Improvement.
Significant revisions of ISO 13485 standard are as follows:
- ISO 13485:2016 has replaced ISO 13485:2003 and 13485:2012.
- The revised ISO 13485:2016 got published on 1st March 2016
- ISO 13485:2016 is aligned with ISO 9001:2008 and not with ISO 9001:2015
- The changes are managed by ISO technical committee 210, ensuring that the Quality Management System (QMS)standard remains fit.
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 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.
Documents required for ISO 13485 Certification
Mandatory documents needed for compliance with ISO 13485 are related to the following:
- Roles that the Organisation undertakes under the applicable regulatory requirements
- Quality Manual
- Medical device file
- Records for validation of the application of the computer software
- Procedure for documents control
- Procedure for record control
- Quality Policy
- Quality objectives
- Responsibilities and authorities
- Procedure and records for management review
- Procedure for training
- Requirements for infrastructure and maintenance activities
- Arrangements for control of the contaminated or potentially contaminated product
- Outputs of product realisation planning
- Requirements of the work environment
- Records of the results of customer requirements review and actions arising from it
- Arrangements for communication with the customers
- Procedure for design and development
- Process for risk management in product realisation
- Design and development planning
- Design and developments outputs
- Records of design and development review
- Design verification plans, results and conclusions
- Design validation plans, results and conclusions
- Process of transfer of design and development outputs to manufacturing
- Process and records for control of design and development changes
- Design and development file
- Procedure for purchasing
- Criteria and records for the evaluation and selection of suppliers
- Record of verification of purchased product
- Record for medical device or batch that provides traceability
- Requirements for the cleanliness of the product
- Requirements for medical device installation and verification of installation
- Process and records for servicing of the medical device
- Records of the sterilisation procedure
- Procedure and records of production as well as service provision process validation
- Procedure and records for validation of a process for sterilisation and sterile barriers systems
- Procedure for product identification
- Procedure for traceability
- Records of traceability with the name and address of the shipping package consignee
- Report on changes in customer property
- Procedure for preserving the conformity of the product
- Process of monitoring and measuring
- Record of calibration
- Procedure and records for validation of the application of computer software used for monitoring and measuring
- Procedure for customer feedback
- Procedure and records for complaint handling
- Records of reporting to regulatory authorities
- Procedure for internal audit
- Records of audits and their results
- Identity of the person authorising the release of the product
- Procedure and record of control of non-conforming product
- Record of rework
- Procedure and records for data analysis
- Procedure and records for corrective action
- Procedure and records for preventive action
Procedure to obtain ISO 13485 Certification
There are four essential steps to be followed to get ISO 13485 Certification:
- Optional Preliminary Audit
Voluntary Site inspection is conducted, and quality management documents are reviewed, assessing the Organisation's readiness for the full-scale I and II Auditing Phase.
- Audit: Stage I
Assessment of the eligibility for Certification is determined by results of on-site Auditing, business assessment and quality management documents analysis.
- Audit: Stage II
On-site evaluation of the Quality Management System (QMS) for excellence in areas of applied practice and efficiency.
Official confirmation certifies your quality management system's integrity and compliance with the standards.
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Frequently Asked Questions
The ISO 13485 is adapted to provide a practical foundation for manufacturers to address the EU Medical Device Directive, EU Medical Device Regulation and other regulations, as well as to commit to the safety and quality of medical devices.
The latest version of ISO 13485 is ISO 13485:2016, which was adopted in March 2016.
Designers, manufacturers and distributors of medical devices are eligible to be certified under ISO 13485.
ISO is a short form for International Organisation for Standardisation, a worldwide federation of national standards bodies.
ISO 13485 requires the Organisation to identify the role under the regulatory requirements and regulatory requirements applicable to activities under the roles and incorporate these regulatory requirements within the quality management system.
ISO 13485:2016 is the third edition of ISO 13485 standards titled Medical Device: Quality Management Systems: Requirements for regulatory purposes.
The ISO 13485 certification is not done under ISO; rather, by a third party, an organisation can obtain such Certification.