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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Quality Objectives

Introduction Quality objectives are measurable goals established by companies according to ISO Quality Management System standards. They are used to focus the goals from the Quality Policy into quantifiable plans of action. Companies should first set their quality objectives when planning a Quality Management System and review them periodically...
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The 12 Quality System Essentials (QSEs): QMS Building Blocks

Introduction The role of Quality Management Systems (QMS)  in ensuring Patient safety and Customer satisfaction in Clinical and Public Health laboratories in now well understood and embraced.  Quality Management Principles form the foundation of a QMS. The Quality System Essentials have been described by CLSI as 12 important elements...
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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 the Deming Cycle?

Introduction A quality management system (QMS) is a collection of business processes as well as technical processes focused on consistently meeting customer requirements as well as regulatory and legal requirements. It is aligned with an organization’s purpose and strategic direction. Quality Management System requirements include a commitment to continuously...
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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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ISO 9001 Certification Requirements

Introduction We have referred to the ISO 9001 Quality Management System in a number of previous posts, you may know a company that is ISO 9001 certified or you may have seen the certification emblem on some of your favorite products. I’m sure you understand by now why organizations...
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ISO Certification Definition

ISO 9001 certification has become an important part of businesses worldwide as a seal of approval from a 3rd party body that a company runs to an internationally recognized Quality Management System. It can be used as proof of a company’s credibility and to install confidence in potential clients....
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The Quality Management Principles

Introduction ISO 9000 family – Quality management The ISO 9000 family is the family of standards produced by the International Organisation for Standardisation (ISO) that is responsible for Quality Management.  Depending on the industry or sector a company may adopt one of the various standards in the ISO 9000...
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