Category: All about Quality and ISO Standards

Quality Management Software

Introduction Quality Management within a laboratory involves managing the 12 Quality System Essentials according to the requirements stated in the ISO 15189 standard. Initiatives like SPLITA and SLMTA have made great strides in improving laboratory quality and helping laboratories work towards accreditation in resource-limited settings e.g. Sub-saharan Africa.  Since...
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SMART Objectives

Introduction Objectives are important for individuals and organisations to achieve goals and improve processes. They give you something to work towards, they focus attention, help to direct energy and effort, and stimulate the need to act. They can be defined in: project management, performance management, business management, quality management,...
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What is a Quality Policy?

Introduction If you are here you have probably come across the term ‘Quality Policy’ and may be wondering what exactly this is. So, what is a Quality Policy? One of the first documents that an organization formulates when starting to implement a Quality Management System,  it essentially communicates the...
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The ISO/IEC 17025 quality management system

The ISO/IEC 15189 standard for medical laboratories is based upon the ISO 9001 standard, and the ISO/IEC 17025 standard which is the focus of this post. Understanding these two standards will make it easier to understand the requirements of the ISO/IEC 15189 standard. The ISO/IEC 17025 and ISO/15189 being...
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The Importance of Quality

  Quality/ˈkwɒlɪti/noun ……the standard of something as measured against other things of a similar kind; the degree of excellence of something.”an improvement in product quality”synonyms:standard, grade, class, classification, caliber, status, condition, character, nature, constitution, make-up, form, rank, worth, value, level” The definition of Quality according to the English Oxford...
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Quality Management System definition

Introduction ISO/IEC 15189 is the Quality Management System(QMS) standard specific to Medical Laboratories. It is one of several Quality Management System standards produced by ISO (International Organisation for Standardisation). Although there are many approaches to achieving quality, the principles of QMS remain the same. It is important therefore that...
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