ISO 13485:2016 Medical devices - Quality Management System Requirements for regulatory purposes represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488. Though based on ISO 9001, ISO 13485 removes 9001's emphasis on continual improvement and customer satisfaction. In its place, emphasis is on meeting regulatory as well as customer requirements, risk management and maintaining effective processes. ISO 13485 standard is in part designed to produce a management system that facilitates compliance to the requirements of customers and, pre-eminently, various global regulators.
While being certified to ISO 13485 does not fulfill the requirements of either the FDA or other foreign regulators, the certification aligns an organization's management system to the requirements of the FDA's Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world. Therefore, ISO 13485:2016 certification serves to create a management system that can be thought of as a framework on which compliance to various regulatory and customer requirements have to be build.
This standard can be implemented by the industry, who wishes to:
1. Establish, implement, maintain and improve an Quality management systems Requirements for regulatory purposes;
2. Assure itself of conformity with its stated customer and regulatory requirements;
3. Demonstrate conformity with ISO 13485:2016 by
Punyam.com offersISO 13485 Certification consultancy services. ISO 13485:2016 certificate is issued by Certifying body, which is accredited to provide certificate under the ISO 13485:2016. The certificate is issued for the period of 3 years after successful completion of pre�assessment and registration (final) assessment. The certificate is valid till 3 years from the date of issue. Surveillance audits are conducted by the Certifying body within the period of 3 years at the interval of 9 Months or 12 Months depending upon the nature and size of the organization. Upon completion of 3 years, renewal audit is done for new 3-year cycle.
Punyam.com is a leading ISO 13485 consultant in India, having vast industrial experience in ISO 13485 consultancy and implementation of ISO 13485 system for all types of medical device manufacturing industries, such as surgical instruments, orthopedic implants, etc manufacturing companies.
Punyam.com follows below-mentioned steps to develop the ISO 13485:2016 Medical devices – Quality management system for its customers
1 .Micro level survey for each and every activity of the organization and preparation of detailed gap analysis report;
2. Preparation of applicable documents required by ISO 13485:2016, based on detailed study of all activities of the organizations, such as:
3. ISO 13485 training to all levels of employees within the organization,
4. Help in effective implementation of ISO 13485 system by periodic visit till ISO 13485:2016 certification,
5. Conduct internal audit to check readiness for the certification.
6. Conduct management review meeting in presence of Top Management to guide the organization for effective implementation on all the issues related to Quality management systems Requirements for regulatory purposes,
7. Conduct mock drill for traceability of product as well as production recall, etc.