Quality Risk Management: Ensuring Compliance for 2023

Changes in industry regulations can be one of the top business disruptors for the life sciences and pharmaceutical industries. As regulations advance, ensuring that patients and consumers are provided with an innovative network of solutions can be challenging. As we enter a new year, it is imperative that you evaluate your current risk management strategy, identifying gaps in technology and equipment so that your team can adjust accordingly. Here, our team of life sciences equipment professionals at Tritech discuss new industry-specific compliance requirements, as well as strategies to ensure you have an exceptional risk management strategy in place.

Regulation Today: The Importance of Compliance

For the life sciences and pharmaceutical industries, compliance is an exceptionally complex subject. While compliance is essential for all industries to ensure quality and safety are maintained, the healthcare industry has stringent requirements. For scientists, engineers, technicians, and more, there is a constant pull between two sides – focusing on finding efficient and innovative therapies and healthcare solutions and ensuring adequate time is spent in the regulatory process to ensure the quality of products is exceptional. According to Deloitte’s 2025 Life Sciences Regulation Outlook, there are key challenges for both regulators and the industry as a whole, including the following.

For Regulators:

• Ensure that regulations keep pace with the technological expansion
• Developing new approaches to regulating increasingly complex products
• Engage more actively with patients regarding the development of new products
• Collaborate more effectively with other regulators, such as health technology assessment agencies or HTAs

For the Industry:

• Drug development is extremely complex, and new regulatory requirements only lengthen the development and market preparation time
• Automation is disrupting the entire research and development timeline, requiring teams to adapt to new technology and automation tools
• Information from technology such as wearables, social media, and smart devices are impacting the positive or negative outcome results of clinical trials

ISO Certifications: The Importance for Medical & Pharmaceutical Organizations

If you are involved in almost any aspect of life sciences, you have likely heard of or have been directly involved with ISO. ISO, or the Internal Organization for Standardization, is a worldwide federation of standardization organizations. ISO officers from across the globe collaborate on standards for scientific testing, technology, and more. For the life sciences and pharmaceutical industries, there are four ISO requirements we want to focus on – ISO 13485, ISO 9001, ISO 17025, and ISO 31000, broken down below.

ISO 13485 & 9001 – Medical Devices

ISO 13485 refers to the safety and quality of medical devices, ensuring that there are non-negotiables met to prioritize the safety of public health. This certification involves the design, production, installation, and servicing of medical devices and related services. Compared to ISO 9001, this focuses on the continued maintenance and quality of medical devices, whereas ISO 9001 focuses on customer satisfaction based on using these medical devices.

ISO 17025 – Testing & Calibration Laboratories

Enacting a proactive maintenance strategy for your medical devices and equipment is key and a significant part of mitigating risk for your organization. ISO 17025 allows laboratories to demonstrate that they are competent in generating valid results, therefore establishing trust in their work both nationally and internationally, as well as promoting international trade by mitigating the need to re-test. At Tritech, we are proud to be ISO 17025 certified for analytical balances, timers, RPM measurement, and temperature.

ISO 31000 – Risk Management

While ISO 31000 is not centered specifically around the healthcare industry, we believe that it is a worthwhile addition, providing a comprehensive strategy for long-term risk management. ISO 31000 is not a specific certification but provides guidelines, resources, and benchmarks to minimize risk potential and non-compliance penalties, which can be detrimental to healthcare, life sciences, and pharmaceutical organizations.

Equipment, Maintenance, and Calibrations with Tritech

At Tritech, we’ve been serving the life sciences community for over 30 years, and make it our mission to ensure that each customer has efficient, reliable, and state-of-the-art service when they work with us. Whether you are looking to purchase new or refurbished equipment, enact a proactive maintenance strategy, or obtain calibrations for your medical devices, our team has you covered. We understand the need for a secure and thorough risk management strategy, and work to provide your organization with comprehensive life sciences equipment solutions. To learn more about our services, contact us today.