MEDICAL DEVICES QUALITY MANAGEMENT SYSTEMS

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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 and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

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.

Benefit of ISO 13485:2016- MDQMS 

Promotes harmonization of regulatory requirements for the manufacturers of medical devices on an international scale.

ISO 13485 is a quality system standard for organizations include in design and development, production, storage and distribution, installation, or servicing of a medical device.   All requirements of ISO 13485 are specific to organizations manufacturing medical devices, regardless of the type or size of the organization.

Companies that achieve ISO 13485 certification enjoy the benefits of an increased amount of customers who have more reason to trust and purchase products of consistent high quality.

ISO 13485 certification is advantageous to medical device 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.

ISO 13485 compliant management systems 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.

Assures the customers that the product complies with all relevant product & service-oriented technical standards & regulations.

Certification process of ISO 13485:2016 (MDQMS):- The certification process is a multiple-step process. The certification cycle is described briefly:

• Application for certification from client
• Offer from Skymoon Management Services PVT.LTD.
• Offer acceptance from client and order confirmation by Skymoon
• Pre audit (optional)
• Certification audit - (Stage 1 + Stage 2)
• Issue of certificate on successful completion of certification audit
• Surveillance audits at defined interval
• Recertification audit after 3 years