Laboratories and testing · ISO and GRC consulting
ISO certification for laboratories and testing: accreditation that makes your results count.
Most laboratory standards are met through accreditation, not certification, and your customers, regulators and clinicians check the scope behind every result. Sterling's expert and experienced consultants build the management system and the technical evidence with your staff, then stay with you through the assessment and after it. We ensure successful accreditation for our clients.
- One all-inclusive proposal for a defined scope: consulting, Effivity software, Sterling Academy access and internal auditor training, as applicable to your standard, in one proposal
- A team of expert and experienced laboratory accreditation consultants, advising on management systems across sectors and countries since 2003
- The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements. Sterling does not accredit or certify; the accreditation body, or the certification body where a standard is certified, assesses and decides
- Results accepted beyond your wallsA defined scope of accreditation that customers and regulators can check on the body's public register.
- Methods you can defendVerification and validation files and uncertainty budgets that answer the technical assessor's questions.
- Traceability you can drawAn equipment register and a calibration chain back to the SI, with intermediate checks on record.
- A laboratory that stays accreditedProficiency testing, internal audits and management reviews planned for every year after the first decision.
What laboratories and inspection bodies are asked for
Choose the standard by what you do, not by the sector you serve.
A testing or calibration laboratory works to ISO/IEC 17025, a medical laboratory to ISO 15189 and an inspection body to ISO/IEC 17020. Proficiency testing providers, reference material producers and bodies that certify products have standards of their own. ISO 10012 controls measurement across a whole organisation, and test facilities producing non-clinical safety data for regulators follow OECD GLP. Many clients need two of these; one management system can carry both.
Why now
Why laboratories are being asked for accreditation now.
The pressure rarely comes from one place. These are the six we hear most often from testing, calibration, medical and inspection clients.
- Customers read the scheduleBuyers of test and calibration work check the scope, not the logo. A method outside your scope is not accredited, even in an accredited laboratory.
- Regulators rely on competenceRegulatory authorities are among those the standards name as users. For non-clinical safety studies, receiving authorities review a study's GLP status.
- Recognition has a new nameSince 1 January 2026, Global ACI's MRA has replaced the ILAC MRA and the IAF MLA as the route to international acceptance of accredited results.
- Editions have movedISO/IEC 17020:2026 was published in March 2026, the ISO 15189:2022 transition ended in December 2025 and ISO 10012:2026 replaced the 2003 edition.
- In-house laboratoriesISO/IEC 17025 applies regardless of headcount, so a manufacturer's own test or calibration room can be accredited when customers need to rely on its results.
- A result is challengedA complaint or a disputed report tests whether your technical records let the result be reconstructed. Accreditation makes that discipline routine.
Scope and evidence
What assessors look for in a laboratory, and the evidence that answers them.
Assessors watch the work, then examine the records behind the numbers. These six areas decide most first assessments.
| Requirement area | What it looks like in a laboratory | Evidence assessors ask for |
|---|---|---|
| Impartiality and confidentiality | Commercial pressure, ownership links and staff relationships with customers; for inspection bodies, the declared Type A or Type non-A independence | An impartiality risk assessment with actions; confidentiality commitments from staff and contractors |
| Competent, authorised people | Competence requirements and authorisation for each method, examination or type of inspection | Training, competence and authorisation records per person and per method |
| Equipment and traceability | Calibration programmes, intermediate checks and monitored environmental conditions | An equipment register, calibration certificates and a traceability chain to the SI you can draw |
| Methods and uncertainty | Standard methods verified, in-house methods validated, uncertainty evaluated before results are reported | Verification and validation files and uncertainty budgets |
| Validity of results | Quality control during routine work plus proficiency testing, or external quality assessment in medical laboratories | Control charts and a proficiency testing plan with results and what was done about them |
| Reports, complaints and nonconforming work | Reports with every required element and a decision rule for statements of conformity | Sample reports, complaint and nonconforming work records, technical records that reconstruct a result |
The table follows ISO/IEC 17025:2017; ISO 15189:2022 and ISO/IEC 17043:2023 share its structure with their own emphasis. A "17025 certificate" from a certification body or a consultant is not accreditation and appears on no register.
The engagement
What happens between the first call and the accreditation decision.
The six steps hold whatever the standard. For most clients the primary standard is ISO/IEC 17025, and the independent assessment is the accreditation body's, with technical assessors witnessing your tests or calibrations.
- 01Define what the accreditation needs to cover.Confirm the tests, calibrations, examinations or inspections, methods, ranges, sites and who will accept the results, then the intended scope of accreditation.
- 02Gap analysis: review the current system against the requirements.The gap analysis identifies what is missing, preserves effective practice and agrees actions, owners, dates and resources.
- 03Implement and collect meaningful evidence.Put controls into use, train the relevant people and keep the records that show how the system operates.
- 04Audit, review and address the findings.Internal audit and management review evaluate implementation; findings are raised by us first and closed with evidence.
- 05Complete the independent assessment.The accreditation body's document review and on-site assessment, with technical assessors witnessing your work; findings are closed by its deadline and its committee decides. Certified standards such as ISO 10012 follow the certification body's Stage 1 readiness review and Stage 2 audit.
- 06Maintain the system after the decision.Proficiency testing, internal audits, reviews and improvement continue, alongside the body's surveillance, normally each year, and reassessment on the cycle it sets.
What you receive
Everything a working, assessment-ready system needs. Nothing charged separately.
- Scope and gap analysis reportThe scope of the certificate and every shortfall against the standard, with an owner and a date.
- Implementation planMilestones, responsibilities, the weekly session calendar and the target audit window.
- The documented management systemPolicies, processes, procedures, forms and records on Sterling's template sets, tailored to your operation.
- Effivity workspace, configuredDocuments, registers, audits, actions, training records and management review in one place, included at no additional cost.
- Trained peopleAwareness e-learning for everyone, practitioner courses for the people who run the system, internal auditor training for your audit team, as applicable to your standard, with Certificates of Completion.
- Internal audit and management reviewProgramme, checklists, report, corrective actions closed with evidence, and a management review record with decisions.
- Assessment readinessThe accreditation body chosen and its recognition checked, the application and document review prepared, and support through the on-site assessment until the body decides.
- The Sustain™ calendarThe year after the decision planned: surveillance dates, proficiency testing rounds, internal audits, refreshers, new-hire training and any transition to a revised edition.
Effivity · included with the engagement
Your system runs in software from the first workshop.
Effivity is the ISO and GRC automation platform built by the Sterling group and used in 50+ countries. Your consultant configures it within the agreed scope, so evidence accumulates as people do their work and the assessor reviews a live system rather than a binder. Sterling consulting clients get their subscription included with the engagement, at no additional cost.
ISO & GRC softwareSterling Academy · included with the engagement
Your people learn the standard, not just the forms.
E-learning with practice checkpoints, a final exam and a numbered Certificate of Completion for each learner, verifiable online, with progress by department for the assessment. Sterling consulting clients get preferential course access and special pricing, including complimentary awareness training for their people as part of the engagement.
Contact us about Academy accessStandards
Standards for Laboratories and testing
- ISO/IEC 17025ISO/IEC 17025 accreditation consulting for testing and calibration laboratories: competence, impartiality and evidence ready for accreditation assessment.
- ISO 15189ISO 15189 accreditation consulting for medical laboratories: quality and competence for reliable, timely results, prepared for the accreditation assessment.
- ISO/IEC 17020ISO/IEC 17020 accreditation consulting for inspection bodies: competence, impartiality and consistent operation, prepared for the accreditation assessment.
- ISO 17034ISO 17034 accreditation consulting for reference material producers: competence and consistent operation evidenced and prepared for accreditation assessment.
- ISO/IEC 17065ISO/IEC 17065 accreditation consulting for product, process and service certification bodies: competence and impartiality ready for accreditation assessment.
- ISO 10012ISO 10012 Measurement Management certification consulting: measurement processes and equipment controlled for valid results, ready for a certification audit.
- 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 17043ISO/IEC 17043 accreditation consulting for proficiency testing providers: competent, impartial PT schemes prepared for the accreditation body's assessment.
Laboratory and testing client experience
On the record: what testing and inspection clients say about working with Sterling.
The ISO manager writes that the quality of Sterling's service exceeded the company's expectations.
The operations manager reports that implementation gave the company a more structured approach to its inspection activities, with better process consistency, documentation control and operational effectiveness, and a clear framework for competence management and continual improvement.
Each account is drawn from a signed letter or e-mail on file and reported in our words, with the signatory's role and organisation attached; the original letters are available on request. Ask for references in your sector before you decide.
- 60+countries where Sterling has delivered certification
- 21countries with a Sterling office, eight regions, one coordinated team
- 2003the year the group began implementing ISO management systems; the same method, refined, since
- 8,100+client engagements across the group, from single-site SMEs to multinationals
FAQs
Questions laboratories ask before they engage us.
The specific answers for your organisation come from the discovery call. These are the general ones.
Is it ISO certification or accreditation for a laboratory?
For most laboratory standards it is accreditation. An accreditation body working to ISO/IEC 17011 assesses the laboratory, witnesses tests, calibrations, examinations or inspections, and grants accreditation for a defined scope on a public schedule. ISO/IEC 17025, ISO 15189, ISO/IEC 17020, ISO/IEC 17043 and ISO 17034 all work this way. ISO 10012 and ISO 9001 are certified by a certification body, and OECD GLP compliance is monitored by national authorities.
Should a hospital or clinical laboratory choose ISO 15189 or ISO/IEC 17025?
A laboratory examining samples from patients normally works to ISO 15189, the standard for quality and competence in medical laboratories, including the point-of-care testing it is responsible for. ISO/IEC 17025 covers testing and calibration more generally. Some groups run both, for example a clinical laboratory alongside a calibration service. We confirm the fit with you and with the accreditation body before the gap analysis starts.
Our calibration room only serves our own factory. Which standard fits?
If customers or regulators need to rely on the results, ISO/IEC 17025 accreditation, which applies regardless of the number of personnel. If the aim is control of measurement across the plant, ISO 10012 gives a certifiable measurement management system. ISO 10012 states that it neither replaces nor adds to ISO/IEC 17025, so the two answer different questions, and some manufacturers use both.
How long does a first laboratory accreditation take?
Plan on six to twelve months for ISO/IEC 17025, eight to fourteen for ISO 15189 and five to ten for ISO/IEC 17020, depending on maturity and scope. Three things cannot be compressed: validating methods and evaluating uncertainty, proficiency testing rounds that run on the provider's calendar, and the body's document review, assessor scheduling and closure of findings.
Will our accredited results be accepted in other countries?
Often, but check before you apply. Since 1 January 2026, Global ACI's MRA has replaced the ILAC MRA and the IAF MLA; its signatories recognise each other's accreditation as equivalent, except where regulation or law prevents it. Choose an accreditation body that is a signatory for your scope, and confirm it on the Global ACI list of recognised bodies.
Does Sterling accredit laboratories or issue certificates?
No. Sterling does not accredit or certify. The accreditation body, or for ISO 10012 the certification body, assesses and decides. Our expert and experienced consultants build the management system and the technical evidence with your staff, run the internal audit and management review, prepare you for the assessment and stay with you until the body decides, then under Sustain™.
Does OECD GLP work the same way as ISO/IEC 17025 accreditation?
No. OECD GLP is not accreditation and carries no certificate. Test facilities producing non-clinical safety studies are inspected under national GLP compliance monitoring programmes, which the OECD lists as participating in its Mutual Acceptance of Data system. We prepare the facility, the study director and quality assurance roles and the records; the national authority inspects.
Talk to a consultant
Plan accreditation for your laboratory with confidence.
Tell us your goals, locations and target date. We’ll help you define the scope, timeline and next steps.
hello@sterling-grc.com+1 201 263 4443 (global headquarters) · your nearest office and its number are at the top of this page
What would you like to achieve?
Choose a starting point. The enquiry form takes about a minute.
Book my free discovery callContinue to the enquiry form to share your details. Please do not include passwords, sensitive personal information or confidential files. A Sterling consultant replies within one working day. Privacy notice