ISO 13485 : 2016 Medical Devices Quality Management System (MDQMS)
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.
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.
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.
ISO 13485 and Quality Management
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.
This is a guidance to help producers with responsibility to design, develop and manufacture medical devices. From identification to control of risks as integral part from design through delivery medical devices for use. ISO 14971 provides as structured process to identify, assess, categorize and control risks. Risks analysis need to be part of design validation. The Risk Management done for devices for ISO 13485 (MDQMS) is done as per the International Standard ISO 14971 which is included in the implementation of ISO 13485
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Our assessment-audit approach includes:
- Phase I is an adequacy assessment-audit.
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- Recommendation protocol that involves not only reviewer from the point- of- origin but also from the point-of sales, and
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- Internal auditing program.
- FMECA, risk analysis, fault trees…. Et al effectiveness of action taken.
- Verify that the audit protocol minimizes liability exposure, and that does not adversely polarizes the organization,
- Appropriateness on the use of guidance checklist for regulatory compliance
- That the internal audits programs assess regulatory requirements and legal obligations through ISO 13485.