Five Most Important ISO Certificates for Medical Devices Industry

To ensure consistency in their products and compliance with required specifications or criteria, medical device manufacturers should comply with some standards. The manufacturing of medical devices is subject to some quality management requirements. Continue reading for a concise summary of the most urgent ISO certificates, and find out more on how PT Inspiry Indonesia Konsultan can help you with it!

ISO 9001:2015 Quality Management System

The ISO 9001 is not industry-specific, but a general standard for quality management across industries. The ISO 9001 manufacturing standard focuses on building and maintaining procedures, thus producing the same performance and great quality results. ISO 9001 helps medical device manufacturers implement organizational-wide improvements, which benefits the business by (1) lowering costs, (2) supporting growth, (3) simplifying regulatory compliance, and (4) fostering accountability through transparency. The latest edition of ISO 9001, released in 2015, is based on the high-level Annex SL directive.

ISO 13485:2016 Medical Devices – Quality Management System

The quality management system, known as ISO 13485, was created for companies that manufacture medical devices. ISO 13485 is the refinement of ISO 9001 in order to harmonize regulatory requirements. Compliance with Overall quality control, traceability, process validation, and risk management are all facilitated by ISO 13485 standards.

Manufacturers will find it easier to sell their goods on worldwide markets if they achieve ISO 13485 conformity. Additionally, compliance can help you streamline your operations, so you can manage risks more effectively and run a more profitable, efficient business.

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ISO 14001:2015 Environmental Management System

For leaner operational activities, sustainability is an essential problem. Medical device manufacturers can gain profits from implementing an ISO 14001-compliant environmental management system, such as reducing waste, conserving energy, and their total carbon footprint—all crucial factors when working with intricate worldwide supply networks.

As a result, implementing ISO 14001 can be rather simple if you already have a quality management system that has been certified. When your environmental, health and safety, and other practices adhere to the required standards; your business can face the competitive industry.

ISO 45001/ OHSAS 18001: Occupational Health and Safety Management Systems

A set of specifications known as ISO 45001/OHSAS 18001 governs occupational safety and health management in the medical device business. Particular occupational risks are frequently present in the manufacturing of pharmaceutical and medical devices, especially when dealing with cutting-edge technology found in imaging equipment and other items. It is important to protect your team's safety, but companies should also focus on operational efficiency.

By developing and upholding stringent safety regulations, the ISO 45001/OHSAS 18001 standards safeguard your production team while boosting output and lowering the chance of mishaps, accidents, and legal troubles. Use it regularly to lower accident rates and associated liability risks.

ISO/IEC 27001:2022 Information–Security techniques–Information security management systems

Cybersecurity is becoming crucial as medical equipment gets more complex. Information security standards are necessary due to the expanding market for smartphone-based health monitoring apps and connected equipment in diagnostic and operating rooms. It is easy to see why ISO 27001 has evolved into a vital standard for health care and medical device manufacturers when there is a possibility that your intellectual property is on a cyberattack.

Thereby, ISO 27001 is a crucial manufacturing standard that enables your company to identify, evaluate, and prevent cybersecurity breaches. It is based on global best practices for protecting your organization from cyberattacks. ISO 27001 protects three aspects of information: confidentiality, integrity, and availability.

ISO certificate will be released after the company is confirmed to meet ISO standards requirements. There are only limited authorized institutions for ISO certificate issuances. We, PT Inspiry Indonesia Konsultan, can assist you in certifying various types of ISO. We have been trusted to serve 100+ clients in fulfilling ISO certificates. Certification with PT Inspiry Indonesia Consultants is guaranteed to be safe, precise, and fast!