ISO 13485:2003 Medical devices-Quality management systems
ISO 13485 is the quality management system standard for organizations engaged in medical device manufacturing.
ISO 13485 is based on ISO 9001 and supplemented with additional quality management requirements relating to design, special processes, documentation, records, traceability, documentation records, and regulatory actions. Unlike ISO 9001, which requires organizations to demonstrate continual improvement, ISO 13485 requires only that an organization demonstrate that the quality system for medical device manufacturing is implemented and maintained.
Although being registered does not fulfill the requirements of the various industry regulators, such as those of the U.S. Food and Drug Administration (FDA), ISO 13485 is commonly used as the basis for regulatory requirements. As such, the ISO 13485 standard is an essential consideration not only for exporters but also for the local market, global suppliers, and subcontractors to prove that their medical device products are of the highest quality.
ISO 13485 international standard 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 requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of this international standard is to facilitate medical device regulatory requirements for quality management systems. As a result, It includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory Requirements. Because of these exclusions, organizations whose quality management a system conforms to this international standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
ISO 13485 IMPLEMENTATION BENEFITS
ISO 13485 implementation improves / leads to
- POLICIES & OBJECTIVES set by 'top management'
- Conformance to Legal and Regulatory Requirements
- Recognition by regulators around the world of ISO 13485:2003 as a good basis for addressing medical device design and manufacturing regulatory requirements
- Controlled consistency of manufactured products
- Managed productivity and efficiency, controlling costs
- Competitive advantage and increased marketing and sales opportunities.
- Improved customer perception of the organization’s image, culture and performance.
- improved internal and external Communications
- greater understanding of the organization's processes
- clear responsibilities and authorities agreed for all staff
- improved use of time and resources
- reduced wastage
- greater consistency and traceability of products and services
- Customer Confidence, Satisfaction and TRUST
- Level of Assurance in Organisational QUALITY
- Organisational PROFITABILITY
- Ability to Differentiate Organisation for Competitive Advantage
- Organisational Credibility & Reputation