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What is ISO 13485:2016?
ISO 13485 is an internationally published standard that defines requirements within quality management systems for manufacturers, suppliers, contract service and distributors 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 Cerification Standard has been based on the requirements of ISO 9001 standard and has the same structure in terms of clauses. Even some clauses of ISO 13485 have been referred to ISO 9001.
The ISO 13485 standard is for medical devices – quality management systems – requirements for regulatory purposes, is the basis for regulatory compliance in local and most global markets. Exporting medical Devices to various countries is mandatory. ISO 13485 Certification is an objective evidence of compliance of the requirements, regardless of the type or size of the organization.
This standard 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
It is the “de facto” standard for global medical device QMS compliance for medical devices, and is a prerequisite for access to most major markets worldwide.
ISO 13485 Benefits
- Meet Regulatory Requirements
- Demonstrate that medical devices are produced safely & Communicate your high standards of quality
- Gain a competitive edge
- Reducing operating costs
- Establishing business credentials
- Improved stakeholder relationships
- Ensuring Legal compliance
- Ensuring Customer satisfaction
- Improving risk management
Requirements for ISO 13485
The ISO 13485 structure is split into eight sections, with the first three being introductory, and the last five containing the mandatory requirements for the Quality Management System. Here is what the five main sections are about:
Section 4: Quality Management System – This section talks about general QMS requirements, as well as the documentation requirements of the standard. It includes the requirements for the Quality Manual, Control of Documents, and Control of Records, all of which are required documents in the QMS.
Section 5: Management Responsibility – The management responsibility requirements cover the need for top management to be instrumental in the implementation and maintenance of the QMS. Along with planning for the QMS, there is a need for top management to be involved in the ongoing review of the system to ensure customer satisfaction and improvement.
Section 6: Resource Management – The section on management of resources is short, but covers the necessity to control all resources, including human resources, buildings, and infrastructure and the working environment.
Section 7: Product Realization – The product requirements deal with all aspects of the planning and creation of the product or service. This section includes requirements on planning, product requirements review, design, purchasing, creating the product or service, and controlling the equipment used to monitor and measure the product or service. ISO 13485 allows for requirements in the section to be excluded if they are not applicable to the company (such as a company that does not design products or services).
Section 8: Measurement, Analysis and Improvement – This last section includes the requirements needed to make sure that you can monitor whether your QMS is functioning well. It includes assessing customer satisfaction, internal audits, monitoring products and processes, dealing with non-conforming product, and corrective and preventive actions.