ISO 13485:2012 si ISO 13485:2016
In compliance with resolution IAF 2015-12 the transition period to the new edition of ISO 13485:2016 standard is of 3 years since the date of its publication (01.03.2016).
During this period, ISO 13485:2012 and ISO 13485:2016 shall coexist, in order to give enough time for the transition to the new standard, to the producers, certification/accreditation bodies and the regulatory authorities.
For the transition on the new standard SRAC has elaborated the Transition policy, code SRAC-P-43:
ISO 13485 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 services. ISO 13485 is the most accepted standard worldwide for manufacturers of medical devices. ISO 13485 supports the reduction of unexpected risks companies that construct, produce and service medical devices, but also to organizations distributing and using them, both during production process and later.
Advantages of the quality management for medical devices system certification
- meeting the customer and business partners requirements and the legal requirements
- evidence of adherence to legal and regulatory or contractual requirements
- minimize and manage risks
- Error prevention instead of error correction
- Improved performance quality
- Transparency and clarity of internal processes
- Time and cost savings
This standard is addresses to:
- private companies who currently manufacture medical devices for medical laboratories;
- companies that produce medical components;
- specialists who design, manufacture, and assemble medical devices for medical laboratories.
Upon the certification process successfully completed, SRAC certified organizations:
- have the right to use SRAC and IQNet conformity marks for advertising purposes;
- are regularly informed on the evolutions in the quality for medical devices and certification areas, by accessing SRAC website, events organized by SRAC.
Every successful organization should:
- identify and satisfy the needs and expectations of its customers, as well as of its stakeholders, respectively employees, suppliers, owners, society, in order to obtain a competitive advantage, and to achieve this in an effective way;
- obtain, maintain and improve on a continuous basis its general performances and capabilities;and the strong commitment to achieve the quality is the key.