ISO 13485:2003 Standard for Medical Devices Management System
ISO 13485: 2003 Medical devices – Quality management systems – 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, 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place is an emphasis 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-preeminently-various global regulators. While being certified to iso 13485 does not fulfill the requirements of either the FDA or 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 13485:2003 standard certification serves to create a management system that can be thought of as a framework on which to build compliance to various regulatory and customer requirements.
This standard can be implemented by the industry, who wishes to;
- Establish, implement, maintain and improve an Quality management systems – Requirements for regulatory purposes,
- Assure itself of conformity with its stated customer and regulatory re,
- Demonstrate conformity with ISO 13485:2003 by
- 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.
Benefits of ISO 13485 System
- Customer satisfaction – through delivery of products that consistently meet customer requirements as well as quality, safety and legal requirements.
- Reduced operating costs – through continual improvement of processes and resulting operational efficiencies.
- Improved stakeholder relationships – including staff, customers and suppliers.
- Legal compliance – by understanding how statutory and regulatory requirements impact the organization and its customers.
- Improved risk management – through greater consistency and traceability of products and use of risk management techniques.
- Proven business credentials – through independent verification against recognized standards.
- Ability to win more business – particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.
ISO 13485 Certification
ISO 13485 Certification is offered by Roots Management Services. ISO 13485:2003 certificate is issued by Certifying body, which is accredited to provide certificate under the ISO 13485:2003. 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 years cycle.
Steps involved in ISO 13485 Consultancy
Roots Management Services in India is having vast industrial experience in the ISO 13485 consultancy and implementation of ISO 13485 system for all types of industries, such as surgical instruments, Orthopedic implants, etc.
Leading ISO 13485 consultants in India develops the system for its customers by the following steps:
- Micro–level survey for each and every activity of the organization and preparation of detail Gap analysis report,
- Preparation of applicable documents required by ISO 13485:2003 based on detail study of all activities of the Organizations, such as;
- ISO 13485 Quality Manual,
- ISO 13485 Quality Procedures (Mandatory procedures required by the standard),
- Identification of applicable regulatory requirements and ensure compliance with the regulatory requirements,
- Standard Operating Procedures (SOPs) to control identified activities having risk potential to the human during the use of such medical devices,
- Formats to establish the objective evidence of implementation and to ensure control over all the activities.
- ISO 13485 training to all levels of employees within the Organization,
- Helps in effective implementation of iso 13485 system by periodic visit till ISO 13485:2003 certification,
- Conduct internal audit to check readiness for the certification.
- 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,
- Conduct mockdrill for traceability of product as well as production re–call etc.