ISO 13485:2011 Certification Service is a quality system standard for organizations that design, develop, produce or service medical devices. It intends to promote harmonization in the medical device industry and set a basis for quality system regulations worldwide. All requirements of ISO13485 are specific to organizations manufacturing medical devices, regardless of the type or size of the organization. The certification of a quality management system, specifically for medical devices to ISO13485 proves advantageous, and in many cases essential, for medical companies which export their products to global markets.
Some of the additional requirements relate to design controls, process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are more critical for the medical device industry. An ISO13485 compliant management system adopt a risk management approach which includes assessment to identify & estimate risk, uses risk controls and techniques with a view to eliminate hazardous situations throughout product realization. Adopting this standard is beneficial to the organization in many ways: It demonstrates the manufacturer's ability to supply medical devices & related services that are compliant with all regulatory requirements Assures the customers that the product complies with all relevant product & service-oriented technical standards & regulations Emphasizes the cleanliness & sterility in the production area, which in turn increases efficiency & enhances safety at the workplace Organization establishes for risk management throughout the product realization.
Shamkris Global certifications under ISO13485 standard is accredited by QASL (Canada) and is open for all medical device manufacturers subscribing to ISO13485 International Standards. Apply for Certification Shamkris Global offers various services worldwide and these services with accreditation where applicable, whilst following uniform management system, are operated by separate legal entities within the group. For status of individual scheme and accreditation, contact, etc.
A successful implementation will demonstrate a company’s ability to supply medical devices and related service to customers that comply with regulatory requirements ISO 13485 is not just products focused. but it focuses instead on the processes. used to develop medical devices. Keep in mind that you also need to comply with all relevant product and service oriented technical standards and regulations in this area of expertise. Although ISO 13485 is based on ISO 9001 quality management standard and uses the same numbering system. ISO 13485 doesn‘t include the ISO 9001 requirements related to continual improvement and customer satisfaction ISO 13485 also focuses more on how procedures regulate and control activity and process performance.