The importance of having an ISO 9001:2008 and ISO 17025:2005 accredited

ISO 17025:2005 accredited
It is important to have an ISO 9001:2008 and ISO 17025:2005 accredited calibration and repair supplier for Scales and balances

Finding a trustworthy and reliable calibration and repair company for the biotechnology and manufacturing industry can be hard to come by. Different regulatory organizations/institutes such as the FDA-USP, GLP, CLEA, ASTM, NIST, SQF and BRC set strict guidelines for accreditation. The accredited supplier will need to follow any regulatory guidelines in all calibration and repair procedures. Using ISO 9001:2008 and/or ISO 17025:2005 accredited suppliers will guarantee that all of your scales, balances, and pipettes are calibrated and repaired. All procedures done by your accredited supplier will meet the specific standards set forth by your regulatory organization/institute. Learn more about the accreditation process and meaning below.

What is ISO & how can I ensure it meets my regulatory requirements?

ISO or the International Organization of Standards is a non-governmental organization that represents the international standards of nearly 162 countries worldwide (ISO). The standards developed by ISO are derived from experts within each industry to ensure that all standards meet the requirements needed. Learn what this mean below.

What is ISO 9001:2008 and ISO 17025:2005 Accredited Mean?

What is ISO 9001:2008? ISO 9001:2008 “sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement).” (ISO)

What is ISO 17025:2005? ISO 17025:2005 “specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods” (ISO)

Take a closer look by learning what the advantages are of using an accredited supplier in the next section.

The advantage of an ISO 9001:2008 and ISO 17025:2005 accredited calibration and repair supplier
  1. Industry Understanding-Having an ISO 9001:2008 and ISO 17025:2005 accredited vendor indicates that your supplier understands and supports industry recognized standards
  2. Assurance– All ISO 9001:2008 and ISO 17025:2005 accredited suppliers are subject to ongoing compliance surveillance by the ISO register. This means that your accredited suppliers are required to be up to date with all new standards enforced within each industry that they are working in.
  3. Quality– All suppliers accredited by ISO have made and continue to make a significant investment in resources to achieve the ISO recognition.

The Lab People, Inc. is proud to be A2LA ISO/IEC 17025:2005 accredited through the American Association for Laboratory Accreditation. Please click here to view our full certification.

Regulatory Organizations/ Institutes defined below:

FDA-USP: Food and Drug Administration-U.S. Pharmacopeia

GLP: Good laboratory practice

CLEA: Clinical Laboratory Improvement Amendment

ASTM: American Society for Testing and Material

NIST: National Institute of Standards and Technology

SQF: Safe Quality Food Institute

BRC: British Retail Consortium

Works Cited

ISO. (n.d.). About ISO. Retrieved June 15, 2014, from ISO: http://www.iso.org/iso/home/about.htm

ISO. (n.d.). ISO 9000 – Quality managment . Retrieved June 15, 2014, from ISO: http://www.iso.org/iso/home/standards/management-standards/iso_9000.htm

ISO. (n.d.). ISO/IEC 17025:2005. Retrieved June 15, 2014, from ISO: http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=39883