ISO 13485 Certification
in Riyadh

The International Organization for Standardization, ISO, has developed ISO 9001, 13485 and 14001 standards. Focusing on the quality management system of medical device firms which design, manufacture or supply products or services in support of these devices, ISO 13485 is. To become certified to ISO 13485 means that a third party auditor verifies this company meets the quality management rules and follows relevant regulations that must be part of their quality management system (QMS).

If you are familiar with ISO 9001 you will see many similarities with ISO 13485. The “2016” in ISO 13485:2016 indicates the year this version of the standard was released. The main requirements for ISO 13485:2016 are covered by clauses numbered from four to eight in accordance with sections established within these standards.

Clause 4: it is explained about general requirements for QMS that meet regulatory standards for medical devices and those found in ISO 13485 itself. Organizations need to employ a risk based approach towards identification and control of processes required by their QMS; have a Quality manual documenting their QMS; and keep necessary documents and records.

Clause 5: Requires top management to show its commitment through development of quality policies as well as setting quality objectives indicating clear roles, responsibilities among others. In addition during regular Management Review meetings there should be someone who reports on how effective the QMS is.

Clause 6: encompasses resource management, guaranteeing that workforce impacting product quality are competent and also that the requisite infrastructure together with working environment is offered. Such policies refer to health, hygiene and dress codes, as well as precautions to be taken in case of contamination

Clause 7: handles all the activities from planning to output, such as developing processes for manufacturing products, specifying quality objectives and liaising with customers and regulators. Companies must also have procedures for design and development; they should verify and validate before production starts while acquiring products’ supplies will be subjected under purchasing control; supplier performance should be reviewed against laid down requirements while purchased products available for use must satisfy specifications provided. Production and service operations are planned; monitored; controlled with written instructions regarding infection prevention, product commissioning or reprocessing.

Clause 8: focuses on measurement, analysis, and improvement. Companies must plan how to monitor, measure, and analyze processes to ensure product and QMS quality and effectiveness. This includes getting customer feedback, investigating complaints, reviewing risks, reporting to regulators when needed, conducting internal audits, identifying and addressing non-conforming products, and analyzing QMS data to evaluate and improve its effectiveness. Corrective and preventive actions must be taken to maintain the QMS and ensure medical device safety and performance.

By following these rules, companies can maintain a quality management system that ensures compliance with regulations and high-quality medical devices.