What Is ISO 13485:2016
Is an International Organization for Standardization (ISO) standard published for the first time in 1996. It represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes previous documents such as EN 46001 and EN 46002 (both 1997), ISO 13485 published earlier (1996 and 2003), and ISO 13488 (also 1996). The current edition of ISO 13485 was published on March 1, 2016.
Although adjusted to industry quality system expectations and regulatory requirements, an organization does not need to actively manufacture medical equipment or its components to obtain certification to this standard, in contrast to the ISO / TS 16949 automotive sector, where only companies with active demand for quotation, or are on the list bidding, from the supply chain manufacturer International Automotive Task Force may request registration.
Requirements – requirements
- Context Organization
- Leadership
- Planning
- Support
- Operation
- Performance
- Evaluation
- Improvement
Benefits Implementation
Companies will get many benefits by implementing this international standard management system, including :
- More management in controlling the operational risk of medical equipment
- Demonstrate organizational commitment to compliance with health equipment legislation
- Increased trust of customers who have collaborated and are new
- Clarify cooperation contracts with brand holders
- Improve the after-sales management system
- Traceable operational record management
- Improve product quality control from manufacture, storage and distribution
Consultation program
1. Gap Analysis
- Review the maturity level of the current management system implemented by the company and to determine gaps with standard requirements
2. Management system creation
- Creating a management system with a system level that aims to facilitate the implementation and understanding of employees in implementing this management system standard
3. Training
- Equip employees with a thorough understanding of a good quality management system so that they can maintain consistency in implementation even though they are no longer accompanied by a consultant
Preparation for consultation
Several things that need to be prepared by the company before the consultation process, namely :
- Forming a committee team for the implementation of the quality management system consisting of representatives from each department
- Collect all documents currently used in managing the company
- Company legality data for registration requirements to the certification body