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ISO 9001 - Why it Matters

The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from 167 countries. ISO is an independent, non-governmental organization and its mission is to promote the development of standardization and related activities in the world; to facilitate the international exchange of goods and services; and to develop cooperation in intellectual, scientific, technological and economic activity. ISO's work results in international agreements, which are published as International Standards and other types of ISO documents. Today, there are over 24,000 international standards that cover almost all aspects of technology and manufacturing.

These international standards help to make products compatible, so that they fit and work well with each other, identify safety issues of products and services and are a means to share technological know-how and management best practices. For example, there is an ISO standard for laboratory round-bottomed flasks (RBFs), which tightly controls the tolerances related to the flask shape and dimensions. Buying an RBF that conforms to these standard means that the chemist can be sure the flask will be compatible with aluminium heating blocks that also conform to the relevant ISO standards.

AM Technology are proud to have held ISO 9001 accreditation (certificate number: 12703) since December 2014 and recently had our annual inspection by Alcumus ISOQAR. Having ISO 9001 accreditation demonstrates clearly to our customers that we invest time and effort into ensuring that our organisation has efficient and organised processes in place, such as having clear traceability for all of the components in our Coflore systems. Some of the areas covered by the standard are:

  • Requirements for a Quality Management System (QMS), including documented information, planning and determining process interactions

  • Responsibilities of management

  • Management of resources, including human resources and an organization’s work environment

  • Product realization, including the steps from design to delivery

  • Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action

Our ISO 9001 must be recertified every 3 years, and we also have an annual inspection by Alcumus ISOQAR on behalf of the UKAS accreditation body. We wish to thank our team for all of their hard work and efforts related to our quality management system.


“One of today's most important tools for modernizing the pharmaceutical industry is a process known as continuous manufacturing”

Director of the FDA’s Centre for Drug Evaluation and Research,

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