It also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade. This includes all types of laboratories, whether they be owned and operated by government, industry or, in fact, any other organization. The standard is also useful to universities, research centres, governments, regulators, inspection bodies, product certification organizations and other conformity assessment bodies with the need to do testing, sampling or calibration.
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No matter if you are new or experienced in the field, this book gives you everything you will ever need to learn more about certification audits.
In this book Dejan Kosutic, an author and experienced ISO consultant, is giving away his practical know-how on managing documentation. No matter if you are new or experienced in the field, this book gives you everything you will ever need to learn on how to handle ISO documents. No matter if you are new or experienced in the field, this book gives you everything you will ever need to learn about preparations for ISO implementation projects.
No matter if you are new or experienced in the field, this book gives you everything you will ever need to learn and more about internal audits. Mark Hammar July 11, In this article, you will find out what the ISO standard is about, and how it relates to the ISO standard requirements. This standard is intended to be used as requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories of all sizes or numbers of employees, regardless of industry.
The requirements of the standard include general requirements regarding impartiality and confidentiality clause 4 , structural requirements clause 5 , and requirements for resources needed such as personnel and facilities, as well as technical resources such as equipment and environmental conditions clause 6.
These requirements give you the detail to show competency in the laboratory activities you perform, according to international standards. In clause 8, management requirements are specified. However, how is this similar and different from ISO ? For more on what ISO says about calibration of monitoring and measurement equipment, see this article: Monitoring and Measurement Equipment Control.
ISO is applicable to all types of companies in all industries, whereas ISO is only applicable to testing and calibration laboratories. For instance, the requirements of ISO on resources and processes are general for any industry, whereas ISO is more specific and detailed for testing and calibration laboratories. Similarities are found in clause 8 of ISO regarding management system requirements.
The ISO standard explains that an overall management system is necessary to ensure consistent functioning of a laboratory, and gives laboratories the option of addressing those requirements within an existing ISO management system or another quality standard option B.
So, while ISO implementation and certification are nice to have, it is not required to comply with ISO These minimum management requirements are very similar to those found in ISO , and include:. Here is a quick top-level list:. Containing the operation clauses of ISO , the ISO standard is basically a set of how-to instructions for calibration laboratories to address these requirements.
This is the reason that Option B exists within the calibration standard, as some companies will find it helpful to implement all of ISO rather than just the minimum.
There are numerous added benefits if you include all the ISO requirements or principles, at least , rather than only meeting the minimum management requirements. For example, the clauses and language of ISO make understanding risk, context of the organization, documented information, quality objectives, and leadership clearer. This empowers laboratories to apply risk-based thinking and a process approach to address the requirements of ISO , to manage risks and to drive improvement more efficiently.
Remember, the choice is up to you to find the best way for your company to comply with their chosen standards, so think carefully when making these decisions. For a better understanding of how the implementation process works, see this downloadable Diagram of ISO Implementation Process. You may unsubscribe at any time. For more information on what personal data we collect, why we need it, what we do with it, how long we keep it, and what are your rights, see this Privacy Notice.
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What is ISO/IEC 17025:2017?
In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. There have been three releases; in , and The most significant changes between the and release were a greater emphasis on the responsibilities of senior management, explicit requirements for continual improvement of the management system itself, and communication with the customer. It also aligned more closely with the version of ISO . The version of the standard comprises five elements; Normative References, Terms and Definitions, Management Requirements, and Technical Requirements. Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements include factors that determine the correctness and reliability of the tests and calibrations performed in the laboratory.
ISO is the main international standard for general requirements for the competence of testing and calibration laboratories. This international ISO standard is applicable to all or any laboratory regardless of size or the extent of the scope of testing and calibration practices. It is also the basis for accreditation from an accreditation body. Since the standard is about competence, accreditation is simply the formal recognition of a demonstration of that competence. A prerequisite for a lab to become accredited is to have a documented QMS. Buy ISO
ISO 17025 vs. ISO 9001 – Main differences and similarities