What is the difference between ISO 9001 and ISO 17025?

ISO/IEC 17025 was introduced in 1999 by the International Organization of Standardization (ISO) and the International Electrotechnical Commissions (IEC) as an internationally recognised standard for laboratory competence. But what is the difference in value between ISO/IEC 17025 and ISO 9001 and does having the ISO/IEC 17025 certification mean that I also have the ISO 9001 certification?

The main difference between ISO/IEC 17025 and ISO 9001 is that ISO 9001 applies to all kinds of businesses in all types of industries and sectors. ISO/IEC 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, quality, and service. The ISO/IEC 17025 differs because it stored necessary measurements and records that your business may need to create an efficient and effective process.

What is the latest version of ISO/IEC 17025?

The latest version of ISO/IEC 17025 aims to give certification to businesses wanting to achieve reliable results when laboratories perform tests, sampling or calibration. This version of ISO 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/IEC 17025 certification, 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/IEC 17025 will only further demonstrate the company’s validity, quality, consistency, and confidence when it comes to testing, sampling, or calibrating.

ISO/IEC 17025 establishes a quality system and will direct calibration labs 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/IEC 17025 is growing, and all laboratories must conform to general requirements for competence in laboratory environments. The ISO/IEC 17025 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 results can include:

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

The ISO/IEC 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/IEC 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/IEC 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 the company to be open to opportunities on a global scale resulting in increased consumer interest.

What value can ISO/IEC 17025 bring to my business?

• ISO/IEC 17025 can boost the reputation of your laboratory in the domestic and overseas markets, which will increase new trade opportunities and international certification 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
• Eliminates the need for independent supplier audits, which saves time and money

Does ISO/IEC 17025 include ISO 9001?

ISO/IEC 17015 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/IEC 17025 will only benefit any business further as it is a necessity for all businesses to guarantee consistent validity of and ethical operation.

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

Many businesses will find value in implementing both ISO 9001 and ISO/IEC 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 certification in ISO. This is because ISO 9001 used alongside ISO/IEC 17025 will give businesses the quality management it needs, which is also a requirement for ISO 9001 certification.

How do I get ISO/IEC 17025 and ISO 9001 certification?

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