Accreditation of certification bodies, laboratories and inspection bodies
ISO/IEC 17025:2017
Accreditation of laboratories that demonstrate the competence to perform tests and produce valid results.
Accreditation to ISO/IEC 17025 confirms that a laboratory has competent staff, suitable equipment and valid methods, and that it consistently produces reliable results.
The scope of accreditation is precise: it states exactly which tests and methods the laboratory performs as accredited.
Who it is for
Testing laboratories — independent, in-house at manufacturers or within healthcare institutions — that want formally confirmed competence for specific methods.
What we assess
Accreditation number format
DCS-TL-0000
Fields of testing
A laboratory's scope of accreditation lists the materials or products, the tests and the methods. The standards shown are examples of methods.
Biological and chemical indicators, Bowie-Dick tests, D-values and validation of moist heat sterilization processes.
Example methods
Seal integrity, peel characteristics, accelerated ageing and suitability for storage and transport.
Example methods
Bioburden determination, sterility testing and antibacterial efficacy of surfaces.
Example methods
Quantitative suspension tests for bactericidal, virucidal and fungicidal activity in medical, food and industrial use.
Example methods
Concentration of alcohols, peroxides, hypochlorites, quaternary ammonium compounds, chlorhexidine and iodine compounds by GC and HPLC.
Example methods
Biological evaluation of medical devices: cytotoxicity, irritation, sensitization, genotoxicity, pyrogenicity and systemic toxicity.
Example methods
Ethylene oxide and ethylene chlorohydrin residuals, detergent and oil residues, corrosion of surgical instruments and catheters.
Example methods
Electromagnetic compatibility (emissions, immunity and ESD) and safety of lithium batteries for portable devices.
Example methods
Filtering half masks, surgical gowns and drapes, medical and protective gloves — including resistance to microbial and chemical penetration.
Example methods
Validation of software used in medical device production and measurement, ICP-MS elemental analysis and migration from food contact materials.
Example methods
Path to accreditation
Accreditation is granted after a document assessment and an on-site assessment, and is maintained through regular surveillance.
Application and review
Document assessment
On-site assessment
Decision and certificate
ISO/IEC 17025:2017
Send us the basics about your body and the scope you are seeking — we will reply with application guidance and a quote.