ISO 13485 is not mandatory. You can build a Quality Management System (QMS) that meets your business needs, as long as the QMS processes comply with the technical and regulatory specifications for medical devices you plan to produce and sell.
ISO 13485 is an autonomous specification issued by the International Organization for Standardization (ISO), which provides for quality management systems (QMS) specifications of companies engaged in the medical equipment field. This standard is based on ISO 9001 (not industry-specific or product type) globally recognised QMS standard and contains additional elements applicable to the process of medical devices.
What is the ISO 13485 objective?
What is a Quality Management System (QMS)?
What is the new ISO 13485 version?
What are ISO 13485 requirements?
Additional Requirements of ISO 13485
What is the ISO 13485 objective?
The implementation of the ISO 13485 is the functional basis for businesses to discuss, and demonstrate a commitment to safety and to the standard of medical equipment, an EU Medical Device Directive (MDD), an EU Medical Devices Regulation (MDR) and other regulations.
You will start developing documents, including quality policy, quality priorities and quality handbook, beginning with management support and defining customer requirements for QMS.
These jointly describe the overall scope of the Quality Management Framework and its implementation. You need, in addition, to produce and deliver your product or service properly, the obligatory and supplementary processes and procedures needed by your organisation. Please see the list of compulsory documents needed by ISO 13485:2016 for a good description of this issue.
What is a Quality Management System (QMS)?
A QMS is a structured series of internal rules that record the structure and sequence of the processes, roles and responsibilities, policies, procedures, work instructions and
forms/templates which regulate the management of a company’s customers and regulatory requirements.
The quality management approach is the basis of QMS standards like ISO 9001 and ISO 13485. Any operation receiving input and converting it into output is called a process. The deployment and management of a matrix of interrelated processes to achieve the desired result is the process approach.
What is the new ISO 13485 version?
As of March 2016, ISO 13485 is being tested for medical ISO products. The following changes include: a risk focus, clarifying management responsibilities, clarifying the training responsibilities, enhancing facilities requirements, clearer coordination of design and construction requirements with certain regulatory requirements, greater emphasis on supplier regulation, traceability requirements, additional complaint handling and improved procedures.
What are ISO 13485 requirements?
The framework of ISO 13485 is divided into eight parts with the first three implementing and the last five compelling the quality control system. The five main parts are concerned here:
Section 4: Quality Management System – this section addresses general QMS needs as well as standard documentation specifications. The quality manual, record control and registry control requirements are all required in the QMS.
Section 5: Accountability for Management – the management obligation criteria include the need for top managers to play their role in implementing and sustaining QMS.
Section 6: Resource Management – The section on Resource Management is short but addresses the need for control of all capital, including human resources, construction and infrastructure.
Section 7: Product success – Product specifications cover all aspects of product or service planning and development. This section involves planning specifications, product requirement analysis, design, purchase, product or service development and the control of the instruments used for product or service monitoring and measurement.
Section 8: Measurement, Review and Improvement – The last section comprises the needs to ensure that you can track the proper functioning of your QMS. They include customer satisfaction assessment, internal evaluations, product and process control, non-conformance product management, and corrective and preventive steps.
Additional Requirements of ISO 13485
For ISO medical devices, some additional specifications of ISO 13485 include:
- Requirements for reporting in medical device files,
- Conditions of the working environment,
- Requirements for contamination prevention,
- Cleanliness of goods production criteria,
- Development needs of sterile medical equipment and
- Regulatory authorities reporting standards.
As can be seen, these further criteria only apply to manufacturers of medical devices.