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:
Benefit of Getting ISO 13485 Certified
Following are benefits of getting ISO certification are as follows:
Pre-Requisites for ISO 13485 Certification
The list of pre-requisites required to get ISO 13485 Certification is as follows:
Necessary Papers Required for ISO 13485 Certification
Mandatory necessary papers needed for compliance with ISO 13485 are related to the following:
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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 necessary papers 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 necessary papers analysis.
Audit: Stage II
On-site evaluation of the Quality Management System (QMS) for excellence in areas of applied practice and efficiency.
Certification
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.