ISO 13485: Quality Management System for Medical Device Industries
ISO 13485 Medical devices – Quality management systems requirements for regulatory purposes is an ISO standard i.e.International Organization for Standardization (ISO), it was published for the first time in 1996, that represents the requirements for a comprehensive quality management system for the design and manufacturing of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the previously published standard were ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).
The latest ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design & development, production, storage, distribution, installation, servicing of a medical device or provision of associated activities (e.g. technical support). The standard provides an effective framework to meet the comprehensive requirements for a medical devices quality management system.
For manufacturers and service providers both comply and demonstrate their compliance to regulatory requirements. The requirements in ISO 13485 are used by suppliers or other external parties providing products or services to medical device manufacturers.
ISO 13485 Standard Benefits:
- Increase access to more markets worldwide with certification.
- Outline how to review and improve processes across your organization.
- Increase efficiency, cut costs and monitor supply chain performance.
- Demonstrate that you produce safer and more effective medical devices.
- Meet regulatory requirements and customer expectations.
The standard supports the design of a quality management system that establishes and maintains the effectiveness of a manufacturer’s processes to ensure the consistent design, development, production, installation, and delivery of medical devices, or related services, that are safe for their intended purpose. The new edition is applicable across the whole supply chain and seeks to address the entire lifecycle of a medical device
Requirements of ISO 13485:2016
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
While implementing the system, it is necessary to know the local applicable regulatory requirements and also any additional regulatory requirements, which you may have to comply due to an export of the product. When designing the QMS are per ISO 13485, it is also necessary to understand the size of the company, the risk classification of the product and applicable exclusions and non-applicabilities
We Operon Strategist helps to create the documents as per ISO 13485. In the first phase, Our special screen sharing module helps the client to create that documentation and provide adequate training. This includes the creation of the SOP,s work instructions, Quality Manuals, VMP’s, Validation documentation etc. In the second phase, we provide assistance to implement the system at Shop Floor and provide the need-based training to make sure that the system is adequately implemented. On a routine basis, we monitor the system including the Management review meetings, Internal quality audits, Customer Complaints, CAPA’s, Handling of Non confirming Products etc. We assist to maintain the complaint system and continual preparedness for the audits.