Medical Device Quality Management System - ISO 13485:2016
ISO 13485 is an Internationally published Standard that defines requirements within quality management systems for manufacturers of medical devices and equipment. The main objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical devices sector.
ISO 13485:2016 is an International Standard that specifies the quality management system requirements for organizations involved with medical devices at any stage of the product lifecycle. This would include the design, development, production, storage, distribution, installation, service and technical support of the device.
The ISO 13485:2016 Certification is a Proof of Quality Management System compliance to the standard for organizations involved in the Medical Device industry. This approach is not only followed by Medical Device Manufacturers but also Supporting Organizations such as Subcontractors, Suppliers, Specialized Consulting firms etc.,
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).
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 Standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements and that quality is consistently improved. The ISO 13485:2016 documentation toolkit contains a quality manual, procedures, SOPs, forms, quality plan and ISO 13485 Audit Checklist in an editable format.
Documents Required for ISO 13485:2016
All Documents should be Self Attested.
1. Personal PAN Card Copy.
2. AADHAR Card Copy.
3. Company Registration Copy or Incorporation Certificate or Electricity Bill.
4. Scope of Work on Company Letter Head (With any 1 Director).
5.Medical Device File.
6. Quality Manual.
7. Quality Objectives and Policies.
8. Procedure for Design and Development.