Accredited Laboratory
What is an Accredited Laboratory?
An accredited laboratory is a testing facility that has been formally recognised by a national accreditation body as competent to carry out specific tests, measurements, or calibrations to an internationally recognised standard. In the context of product compliance, accredited laboratories are used by manufacturers to generate test reports and technical evidence that demonstrate a product meets the applicable safety, performance, or chemical requirements of EU and UK legislation. The primary international standard for laboratory accreditation is ISO/IEC 17025.
Why It Matters
Test reports generated by accredited laboratories carry significant weight with market surveillance authorities, Notified Bodies, and Approved Bodies. Accreditation provides assurance that the laboratory operates to a recognised standard of competence and impartiality, and that its test results are reliable and reproducible.
For manufacturers, using an accredited laboratory is one of the most effective ways to ensure that the technical evidence supporting their compliance claims will withstand scrutiny from regulators and conformity assessment bodies. Test reports from non-accredited laboratories may be considered insufficient or unreliable by competent authorities, potentially undermining the validity of a CE mark, UKCA mark, or other conformity declaration.
For manufacturers, importers, and brands across all regulated product categories, understanding the role of accredited laboratories and selecting the right testing partner is an important part of building a robust compliance file.
Key Requirements
When Is an Accredited Laboratory Required?
The use of an accredited laboratory may be required or strongly recommended when:
- Specific EU or UK regulations or harmonised standards require testing to be carried out by an accredited facility
- A Notified Body or Approved Body requires test reports from an accredited laboratory as part of the conformity assessment process
- A manufacturer wishes to demonstrate the reliability and independence of their technical evidence to competent authorities
This applies across multiple regulatory frameworks covering product categories including:
- General product safety
- Electrical and electronic equipment
- Medical devices and in vitro diagnostics
- Cosmetics and personal care products
- Toys and children’s products
- Machinery and industrial equipment
Responsibilities Relating to Accredited Laboratory Testing
While specific obligations depend on the product category and applicable legislation, responsibilities commonly include:
- Identifying the tests required under applicable EU or UK legislation and harmonised standards for the product
- Selecting a laboratory accredited for the specific tests required and confirming their accreditation scope
- Ensuring test samples are representative of the finished product as it will be placed on the market
- Retaining test reports as part of the technical documentation and making them available to competent authorities upon request
- Repeating testing where the product formulation, design, or manufacturing process changes in a way that may affect compliance
- Confirming that the accredited laboratory used holds current accreditation from a recognised national accreditation body
Accredited Laboratory vs. Third-Party Testing
These terms are related but not identical. Third-party testing refers broadly to testing carried out by an independent organisation rather than the manufacturer themselves. Accredited laboratory testing is a subset of third-party testing where the testing facility has been formally recognised by a national accreditation body as competent to carry out specific tests to a recognised standard. Not all third-party testing is carried out by accredited laboratories, and where regulations or conformity assessment bodies require accredited test reports, general third-party testing may not be sufficient.
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