As already mentioned in previous blog articles, ISO 15189 is the ISO standard that shines a light on medical laboratories. This standard covers a wide array of topics dealing from employee management and competency, equipment testing and even management systems. One additional topic that this standard covers is complaint handling procedures. This article goes over
Clause 10 Continual Improvement of ISO 9001 IS ALL ABOUT… …Kicking the habit and starting afresh. It is the continuous development of goods, services, or procedures through innovative and significant advancements. Although it might seem challenging, replacing outdated procedures with modernized ones is critical in the ISO 9001 standard. Continual improvement ensures that the organisation
The purpose behind ISO 15189 has already been established in previous blogs, but here is a short reminder… ISO 15189 is specific to medical laboratories and sets out the requirements for quality and competence in medical laboratory testing. It covers all aspects of the laboratory, including management, personnel, infrastructure, and the laboratory’s processes and procedures
Misconceptions about ISO Earlier versions of all ISO standards placed a greater emphasis on documentation. As a result, in the past, ISO standards pushed firms to focus on having as many processes as possible, which did not supply much value to the organization. However, in recent revisions of the standard, the standard has been altered
What are Corrective and Preventive Actions in ISO 9001? How are such actions going to guide an organisation into continual improvement? ISO 9001:2015 is a widely recognized standard for quality management systems that provides organizations with a framework for improving the quality of their products and services. One of the critical components of this standard
The Continuation of the ISO 17025 How-To Series… How-To: Clause 8 Management System Options in ISO 17025 – Why are we given such options? For Clause 8 of ISO 17025, the organization has to choose from either Option A or Option B. But what are these options, and why are there even options in the
“What does this ISO standard do and what is the difference between those two?”… This might be a common question that you might encounter when looking at all the different ISO standards that exist in today’s virtual world. As your organization gets exposed to further standards, misconceptions might form. As a Management System Specialist with
What are the Differences Between ISO 15189 and ISO 17025? How will these differences affect an organization? ISO 15189 and ISO 17025 are both international standards that relate to the competence and quality of testing and calibration laboratories. In this article, we shall be covering the the differences between ISO 15189 and ISO 17025. What
As a medical laboratory, providing accurate, reliable, and timely results is crucial for patients’ effective diagnosis and treatment. ISO 15189 accreditation for medical laboratories is an international standard that helps ensure the competence of medical laboratories and the quality of their results. Introduction to ISO 15189 Accreditation for Medical Laboratories ISO 15189 is focused on
Discussions about an audacious goal in the laboratory world, especially from a regulatory standpoint, may seem inconsequential. Measurement and Uncertainty in ISO 17025 Standard may not seem to have a noticeable impact on our day-to-day life. But it does. The use of uncertainty measurements renders information calculable and allows for more precise decisions. In uncertain
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