ISO13485 auditing is a one-time assessment of quality system compliance, whereas quality assurance is an ongoing process that includes all measures to ensure the quality of products and services. In health technology, both are critical, but they serve different purposes in ensuring patient safety and regulatory compliance.
Why are ISO13485 auditing and quality assurance often confused with each other?
In the health technology field, ISO13485 auditing and quality assurance are often confused with each other because both are closely related to quality systems and regulatory compliance. Particularly medical device manufacturers and procurement organizations face challenges in distinguishing between these concepts.
The confusion arises because auditing is part of a broader quality assurance process. Additionally, health technology auditing requires specialized expertise in MDR and IVDR regulations as well as patient safety. Confusing these concepts can lead to incorrect decisions in resource allocation and compliance requirement fulfillment.
What does ISO13485 auditing mean in practice?
ISO13485 auditing is a systematic and objective assessment of an organization’s quality system compliance. It focuses on a specific moment in time and evaluates whether the organization meets the requirements of the ISO13485 standard.
The auditing process includes document review, process evaluation, and personnel interviews. Auditing can be internal, external, or supplier auditing depending on the purpose and performer.
The difference from general quality assurance is clear: auditing is a one-time inspection, while quality assurance is a continuous activity. In health technology, auditing specifically considers risk management according to ISO 14971 and patient safety requirements.
Experienced specialists can provide independent and fair auditing as well as training for preparing for audit situations.
How does quality assurance differ from ISO13485 auditing in health technology?
Quality assurance is a continuous process that covers all measures to ensure quality throughout the product’s entire lifecycle. It includes planning, implementation, monitoring, and improvement.
In health technology, quality assurance is particularly critical for patient safety. It includes risk management, usability testing, clinical evaluation, and continuous monitoring after market introduction.
Auditing provides momentary information about the system’s state, while quality assurance builds the organization’s long-term capability to produce high-quality and safe products. Quality assurance also includes CE marking processes, certification, and continuous compliance maintenance.
Expert services can support quality assurance by providing expertise in standards such as MDR, IVDR, ISO 14971, and IEC 62304.
Summary: which does your organization need – ISO13485 auditing or quality assurance?
In practice, most health technology organizations need both. The choice depends on the organization’s situation and objectives.
ISO13485 auditing is suitable for situations where you want to evaluate the current quality system’s state, prepare for certification, or want an objective view of compliance. It is particularly useful before significant decisions or investments.
Quality assurance is essential for all medical device manufacturers and developers. It builds the organization’s ability to operate in compliance and continuously produce safe products.
The best results are achieved by integrating regular audits as part of a comprehensive quality assurance process. Expert services can support both by providing experience in medical devices and quality systems.
Related Articles
- How to choose the right partner for healthcare technology quality development and regulation
- Why health technology product development fails – 4 most common pitfalls
- MDCG 2019-11
- What are health technology standards and why are they important?
- How can companies ensure compliance with health technology standards?
