Technical Articles

What is BS EN ISO 116645:2012

BS EN ISO 116645:2012 is a technical standard that provides guidelines and requirements for the implementation and maintenance of a quality management system in laboratories. This standard, developed by the British Standards Institution (BSI) and the International Organization for Standardization (ISO), aims to ensure that the quality of laboratory operations meets international standards and achieves consistent and reliable results.

The Scope and Purpose of BS EN ISO 116645:2012

The scope of BS EN ISO 116645:2012 encompasses all types of laboratories, regardless of their size or the nature of the activities they perform. It covers not only testing and analysis laboratories but also calibration facilities and other organizations that conduct scientific research and experiments. The purpose of this standard is to establish a framework for effective management systems, emphasizing accurate testing procedures, competent personnel, proper documentation, equipment calibration, and continuous improvement.

The Key Requirements of BS EN ISO 116645:2012

BS EN ISO 116645:2012 sets out several key requirements that laboratories must adhere to in order to achieve and maintain accreditation. These requirements include a strong focus on customer satisfaction, conducting internal audits and management reviews, implementing corrective actions when necessary, and ensuring the competence and training of staff. The standard also emphasizes the importance of complying with relevant legal and regulatory requirements, maintaining confidentiality of information, and managing the risks associated with laboratory activities.

Benefits of Implementing BS EN ISO 116645:2012

By implementing BS EN ISO 116645:2012, laboratories can reap a wide range of benefits. Firstly, it helps improve the overall quality and reliability of test results, increasing confidence in laboratory data among clients and stakeholders. Secondly, it enhances the efficiency of laboratory operations by providing a systematic approach to documentation, record-keeping, and data management. Additionally, compliance with this standard can facilitate international recognition and acceptance of test results, fostering opportunities for collaboration and mutual recognition amongst laboratories worldwide.

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