Laboratories, inspection & accreditation: standards and frameworks

This family covers conformity assessment bodies: the laboratories, inspection bodies, certification bodies, proficiency testing providers, reference material producers and biobanks whose results other people rely on. The route here is accreditation, not certification. An accreditation body assesses your competence, impartiality and consistent operation against the relevant standard and grants accreditation for a defined scope of tests, calibrations, examinations, inspections or schemes, maintained through surveillance and reassessment. Requests come from regulators that accept only accredited results, from clients and tenders that name a standard, and from organisations that want their reports accepted across borders. Since 1 January 2026, accreditation bodies are recognised internationally through Global ACI, which replaced the IAF MLA and the ILAC MRA.

The standards divide by what you do, not by preference. ISO/IEC 17025 covers testing and calibration laboratories; ISO 15189 covers medical laboratories, with ISO 15190 setting their safety requirements. ISO/IEC 17020 covers inspection bodies, ISO/IEC 17065 bodies that certify products, processes and services, ISO/IEC 17021-1 bodies that certify management systems and ISO/IEC 17024 bodies that certify persons. ISO/IEC 17029 sets the general principles for validation and verification bodies, and ISO 14065 applies them to environmental information such as greenhouse gas statements. ISO/IEC 17043 covers proficiency testing providers, ISO 17034 reference material producers and ISO 20387 biobanks. Much of their structure is shared, with impartiality, confidentiality, resources, processes and the management system recurring across them, so a group that tests, inspects and certifies can run one management system with the technical requirements of each activity evidenced separately. Sterling engages in one of two ways, as alternatives: Design™, where we develop the system and you implement it under our advice and supervision, or Drive™, where we design it and implement it under your approval. Either way, Effivity is included at no additional cost, holding methods, competence records, equipment and calibration, findings and corrective actions in one place. Sterling does not accredit; the accreditation body assesses and decides.

• ISO/IEC 17025ISO/IEC 17025 accreditation consulting for testing and calibration laboratories: competence, impartiality and evidence ready for accreditation assessment.
• ISO/IEC 17020ISO/IEC 17020 accreditation consulting for inspection bodies: competence, impartiality and consistent operation, prepared for the accreditation assessment.
• ISO 15189ISO 15189 accreditation consulting for medical laboratories: quality and competence for reliable, timely results, prepared for the accreditation assessment.
• ISO/IEC 17065ISO/IEC 17065 accreditation consulting for product, process and service certification bodies: competence and impartiality ready for accreditation assessment.
• ISO/IEC 17024ISO/IEC 17024 accreditation consulting for bodies certifying persons: impartial schemes, valid exams and consistent decisions, ready for assessment.
• ISO/IEC 17043ISO/IEC 17043 accreditation consulting for proficiency testing providers: competent, impartial PT schemes prepared for the accreditation body's assessment.
• ISO 17034ISO 17034 accreditation consulting for reference material producers: competence and consistent operation evidenced and prepared for accreditation assessment.
• ISO 10012ISO 10012 Measurement Management certification consulting: measurement processes and equipment controlled for valid results, ready for a certification audit.
• ISO/IEC 17021-1ISO/IEC 17021-1 accreditation for certification bodies: clause 4 to 10 requirements, the accreditation route, cost and timeline factors, and how Sterling helps.
• ISO/IEC 17029ISO/IEC 17029 accreditation and requirements for validation and verification bodies: impartiality, competence, the route and what moves cost and timing.
• ISO 14065ISO 14065 accreditation and requirements for bodies verifying environmental information: GHG statements, footprints, the route, cost and timing factors.
• ISO 20387ISO 20387 accreditation and requirements for biobanks: competence, impartiality and sample quality, with expert consultants, Effivity and an all-inclusive proposal.
• ISO 15190ISO 15190 laboratory safety for medical labs: gap and risk assessment, procedures, training and internal audit alongside ISO 15189. No separate certificate.
• OECD GLPOECD GLP compliance and requirements for test facilities: the Principles in plain language, the national monitoring route, cost factors and an all-inclusive plan.
• ISO/IEC 42006ISO 42006 explained: the requirements for bodies that audit and certify ISO/IEC 42001 AI management systems, how accreditation works and what to check.
• CAP accreditation readinessCAP accreditation readiness for laboratories: checklist gap analysis, method records, self-inspection and peer inspection support. CAP accredits; we prepare.

Some of these standards also belong to another family, such as ISO 14065 in environment, energy and climate, and appear in both. Not sure which applies to you? The Select the Standard™ tool and the readiness check help you choose.