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What is the difference between ISO 17025 and ISO 9001?

May 31st, 2022 By Amywright

ISO 17025 was introduced in 1999 by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) as an internationally recognised standard for laboratory competence, but what is the difference in value between the two standards, and does having the ISO 17025 accreditation mean that you also need ISO 9001 certification?

The main difference between ISO 17025 and ISO 9001 is that ISO 9001 applies to all kinds of businesses in all types of industries and sectors. ISO 17025 only holds value for businesses that include testing and calibration laboratories, such as pharmaceuticals, cosmetics, universities, etc.

ISO 9001 is a quality management system that will allow your business to keep records, set policies and procedures, and organise production, and service. The ISO 17025 accreditation differs because it stores necessary measurements and records that your business may need to create an efficient and effective process.

What is the latest version of ISO 17025?

The latest version of ISO 17025 aims to give accreditation to businesses wanting to achieve reliable results when laboratories perform tests, sampling, or calibration. This version of the standard will give businesses the professional confidence it needs to build increasing relationships with the global market.

Any laboratory that performs tests, sampling or calibrations would benefit from ISO 17025 accreditation, as this would demonstrate a business’s competency and validity to consumers and the global market. Laboratory environments must be strictly regulated for their quality, and the ISO 17025 accreditation will only further demonstrate the company’s validity, quality, consistency, and confidence when it comes to testing, sampling, or calibrating.

ISO 17025 establishes a quality system and will direct calibration laboratories to:

  • Investigate the uncertainty of each measurement of tests
  • Incorporate the uncertainty into the test procedure and/or test limits
  • Provide the uncertainties with the calibration certificate and results
  • Oversee the production of electronic results and reports

The number of industries requiring ISO 17025 is growing, and all laboratories must conform to general requirements for competence in laboratory environments. The ISO 17025 accreditation will ensure that industries adhere to these requirements, ensuring professionality.

Consistent validity and accuracy are top priorities for testing laboratories, which means it is important to reduce the external factors and variables that cause inconsistent and unreliable results. Possible variables that can weaken the validity of the results can include:

  • The instruments used
  • External laboratory environmental factors
  • The competency of the employees performing the test

The ISO 17025 being implemented will enhance the validity of testing and remove any variables which could cause manipulation of the results. This will in return increase the market value, quality, capability, and expertise of your laboratory.

ISO 17025 can introduce a variety of benefits for any business that involves some form of testing, sampling, or laboratory procedures. These can be beneficial for any business regarding the number of employees or what sector the business aims to establish itself in. This includes, but is not limited to automotive, microelectronics, petrochemical, cosmetics, pharmaceutical, and power generation.

With ISO 17025, any laboratory-based business can boost their reputation in domestic and overseas markets due to the evaluation of a company’s staff, methods, equipment, calibration, and reporting, which will guarantee test result validity. This will allow a company to be open to opportunities on a global scale resulting in increased consumer interest.

What are the benefits of ISO 17025 to my business?

  • ISO 17025 can boost the reputation of your laboratory in the domestic and overseas markets, which will increase new trade opportunities and international verification of a high quality laboratory
  • Will demonstrate your commitment to operational efficiency and quality management practices
  • Can help to evaluate staff, the method used, equipment, and reporting validity to assure test and calibration result validity
  • Helps to outline individual responsibility and increases staff accountability
  • Eliminates the need for independent supplier audits, which saves time and money

Does ISO 17025 include ISO 9001?

ISO 17025 does include some aspects related to the requirements of ISO 9001, but it does not include all of the ISO 9001 requirements. ISO 9001 is a quality management system that requires businesses to set policies, records, and to ensure quality and service. Having ISO 9001 alongside ISO 17025 will only benefit any business further as it is a necessity for all businesses to guarantee consistent validity and ethical operation.

Most businesses that do not implement ISO 9001, will find that ISO 17025 needs a set of minimum quality management system requirements. Therefore, if a business has only met the minimum requirements of ISO 17025 and does not have ISO 9001 included as part of its accreditation, will still have to address the other factors included in ISO 9001. For example, ISO 9001 includes factors such as the formulation of quality objectives, whereas ISO 17025 does not.

Many businesses will find value in implementing both ISO 9001 and ISO 17025 in their company as they both complement each other very well. ISO 9001 holds its value as a popular choice for many businesses looking to receive accreditation in ISO. This is because ISO 9001 used alongside ISO 17025 will give a business the quality management it needs, which is also a requirement for ISO 9001 certification.

How do I get ISO certification

You can schedule a free consultation with one of our experts here at IMSM and discuss in greater detail the best way you can reach your goals and requirements by providing a fully tailored, fixed fee quote with a flexible arranged appointment.

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Contact Us

For a free quotation or remote presentation by an ISO specialist, contact us today.

IMSM Ltd Head Office
The Gig House
Oxford Street
SN16 9AX

Tel: +44 1793 296704

Contact Us

For a free Quotation or On-Site presentation by an ISO Specialist, contact us today!

IMSM Ltd Head Office The Gig House
Oxford Street
SN16 9AX

Tel: 01666 826 065