What do you mean by ISO 13485?
ISO 13485, also referred to as Medical devices- Quality Management system specifies standards and requirements for quality management the system that can be used by any organization is concerned with designing, manufacturing provision or support of a medical device. In any stage of its life cycle by certifying an organization as conforming to the ISO Certification standard, an accredited third-party body of auditors attests to the organization conforming to the quality management requirements of the standard including.
What are the requirements of ISO 13485?
In compliance with regulatory requirements that must be identified within the quality management system or QMS. If you are familiar with ISO 9001 you will see that there is a lot of overlap across these two standards. The several numbered segments are stated as sections after some overview and definitions. The actual requirements of the ISO 13485:2016 standard are in clauses 4 to 8.
What things are explained under clause 4?
Clause 4 is an introductory section describing some general requirements starting with the need to have an effective quality management system or QMS meeting regulatory requirements for the type of medical device and the requirements of ISO certification13485 standard itself.
Then you should identify the processes making up QMS, show how they are interconnected and controlled. Using a risk-based approach, you should document your QMS or references to it. In a quality manual, each medical device type or family must be documented. In a medical device file, you should keep records where appropriate and all relevant documentation and records must be controlled according to a documented procedure.
What is included in clause 5?
The first requirement in clause 5 is for top management to show its commitment to establishing, maintaining an effective quality management system. This means establishing a quality policy and setting quality objectives for the whole organization. The top management has to define, document responsibilities, and authorities for effectively operating organization in conformity with its QMS including appointing a management representative who among other things shall report on the effectiveness of the QMS at management reviews conducted at planned intervals.
What does clause 6 speak?
Clause 6 sets out the requirement for providing resources necessary for an effective QMS. Firstly, identify people and jobs affecting product quality and ensure that these people are competent. You have to provide the infrastructure and work environment needed to ISO 13485 certificate to ensure medical device safety and performance such as health cleanliness and clothing requirements where these could affect product quality where applicable you have to establish arrangements to prevent contamination.
What are the requirements explained in clause 7?
Clause 7 contains a large set of requirements covering the whole of operations starting with having to plan and develop the processes needed for product realization. So, you have to add product quality objectives, identify product realization requirements, and establish arrangements for communicating with customers and medical device regulators. Also establish, design, and development procedures and organize design and development activities, effective verification and validation is a very important requirement at this stage prior to design transfer to manufacturing. Then document procedures to control purchasing like controlling the selection of suppliers to monitor supplier performance, to plan product purchases, and to verify that purchase product conform to specifications.
It requires planning, monitoring, and controlling production and service provision, define requirements for contamination control if that is applicable in manufacturing and storage and document product installation and verification requirements. Finally, develop servicing procedures and reference materials validate processes used for production and service provision where inspection is not feasible and facilitate product identification and traceability which may be vital in recalls.
What does clause 8 talks of?
Section 8 relates to quantitative analysis and development. Firstly, you should plan how your organization will monitor, measure, and analyze processes to ensure product, QMS conformity, and QMS effectiveness. You have to establish methods to obtain and monitor customer feedback and processes to investigate complaints, review risk and report results including two regulatory authorities where appropriate the organization should plan and conduct internal audits to determine if QMS is in conformity and processes are achieving planned results. Also, monitor and measure products during the manufacturing process to identify the non-conforming products, take appropriate action to isolate such products and prevent unintended delivery. Finally, you are required to analyze data about your organization’s QMS for evaluating its suitability, effectiveness, and improvement where indicated, where appropriate you need to take corrective and preventive action for maintaining QMS suitability adequacy, effectiveness and ensure medical device safety and performance.