ISO/IEC 17025:2017
Preparing Laboratories for ISO/IEC 17025 Accreditation
ISO/IEC 17025 sets out the requirements for the competence of testing and calibration laboratories. Accreditation under this standard is international confirmation that your laboratory's results are technically valid and reliable.
What is ISO/IEC 17025:2017?
Unlike management-system certification, this is accreditation: the national accreditation body (in Montenegro, ATCG) assesses both the management system and technical competence — methods, equipment, staff and the validity of results. Accredited reports are recognised internationally through ILAC arrangements.
We prepare laboratories of every kind — chemical, microbiological, construction-materials, metrological — from setting up the system through to a successful assessment, including method validation and measurement-uncertainty calculations.
Implementation phases
The real phases we guide every project through — from preparation to the certificate, which comes only at the end:
Management System
Preparation follows the structure of the standard: Not sure whether you already meet these requirements? Check with the short self-assessment at the bottom of this page.
Impartiality, confidentiality and organisation
We organise structure, responsibilities and mechanisms that protect the impartiality of results.
Resources: staff, premises, equipment
Staff competence and authorisation, environmental conditions, equipment with calibration and metrological traceability.
Methods and validation
Selection, verification and validation of methods, with measurement-uncertainty assessment.
Ensuring the validity of results
Control charts, inter-laboratory comparisons (PT schemes) and internal quality control.
From request to report
Reviewing client requirements, sample handling, records and reporting of results.
Management system
Documentation, risks, internal audit and management review — preparing for the ATCG assessment.
The path to certification
Accreditation is carried out by the national accreditation body:
The prerequisite for everything: the system is implemented and applied in practice — every requirement of the standard met, the internal audit carried out and the management review completed.
Submitting an application to ATCG with the scope of accreditation (methods) and system documentation.
A team of assessors (including technical experts) checks the system and observes methods being performed.
Corrective actions within set deadlines; we help with responses and evidence.
Regular surveillance assessments and reassessment through the accreditation cycle.
Benefits of Adopting the Standard
ILAC MRA arrangements mean reports are accepted without repeat testing.
Many tests for authorities and inspectorates may only be performed by accredited laboratories.
Method validation and PT schemes objectively demonstrate the quality of results.
An accredited scope opens markets and tenders unavailable to non-accredited laboratories.
An illustrative, typical scenario we often hear from clients — it does not represent a specific, named client.
“Our results were accurate, but we could not prove it in strictly formal terms — there was no estimate of measurement uncertainty and no evidence of method validation. Through accreditation we introduced measurement uncertainty for every method and regular interlaboratory comparisons — now, when a client disputes a result, we have proof rather than just our word.”
— a common scenario among our clients
Related standards
ISO 15189 is the counterpart for medical laboratories, and ISO/IEC 17065 for product certification bodies. ISO 9001 principles are built into the standard's management-system requirements.
ISO/IEC 17025 training — from a basic understanding of the standard to internal auditor training. Delivered at your premises, online or as a combination of both.
FAQ about ISO/IEC 17025:2017
What's the difference between accreditation and certification?
Certification confirms a management system; accreditation also confirms technical competence for specific methods — which is why it's more demanding and is carried out by the national accreditation body.
Who accredits laboratories?
Each country has its own national accreditation body — ATCG in Montenegro, ATS in Serbia, BATA in Bosnia and Herzegovina, HAA in Croatia — and their laboratory accreditations are recognised internationally through the EA and ILAC arrangements.
How long does preparation take?
Usually 6 to 12 months, depending on the number of methods in scope and the laboratory's maturity. For large systems — over 500 employees, multiple locations or an integrated system of several standards — a project realistically runs beyond a year; we handle those clients too.
Are inter-laboratory comparisons mandatory?
Yes — participation in PT schemes is key evidence of the validity of results and is planned for every area within scope.
How much does ISO 17025 implementation cost?
There is no fixed price that applies to everyone — the cost depends on the organisation's field of activity, its size and number of employees, the chosen standard and the current state of the system. Send us a short description of your organisation and we will prepare a free, tailored estimate.
Standards that fit together like a honeycomb
Each standard keeps its own shape, but together they form a single solid, integrated management system (IMS) — with no gaps or overlaps. Click a hexagon to open that standard.
More about the integrated management system
An integrated management system (IMS) combines two or more ISO standards — for example ISO/IEC 17025 with ISO 9001 or ISO 14001 — into one shared framework of documentation, objectives and internal reviews, instead of each standard living in its own parallel procedure.
A single structure (the High-Level Structure — HLS) shared by every modern ISO standard. Thanks to it, the quality policy, risk management, internal audits and management review can be common to several standards at once.
Each standard on its own addresses one part of the business — quality, environment, safety, information. When an organisation introduces several of them, separate systems quickly duplicate the same documentation and the same auditors.
Less duplicated procedure work, simpler management, stronger process oversight, more efficient use of resources and easier preparation for the accreditation assessment and other audits.
ISO/IEC 17025 can be implemented on its own or as part of an integrated system — the decision depends on how many standards you're targeting and whether you're introducing them at once or gradually.
Check your organization's readiness
Answer a few questions and receive an indicative assessment of your organization's current level of readiness for ISO/IEC 17025.
This self-assessment provides an indicative readiness result only. It does not constitute certification, an official audit, or formal confirmation of compliance.
The EU, the US and other markets
ISO/IEC 17025 is the same standard wherever you certify it — what differs is the designation, the accreditation behind the certificate and what your customers ask for.
In the European Union the standard is adopted with an EN prefix, and what your buyer in the Netherlands, Germany or France looks at is not the prefix but the accreditation behind the certificate: a body accredited by a signatory of the international recognition arrangement (Global Accreditation Cooperation, formerly IAF) is recognised in other markets too. What EU partners and EU regulation expect is on the page about the EU market.
For companies with customers in the United States — supplier audits, security questionnaires and how ISO sits alongside SOC 2 — see the page about the US market.
Wherever your customer is, we run the project remotely in English — over Teams, WhatsApp or Viber, with documentation and records in English — and on site when that is easier.
Montenegro and the region: MEST EN ISO/IEC 17025:2018
When people ask about a MEST EN ISO/IEC 17025:2018 certificate (or a ISO/IEC 17025:2017 certificate), they usually mean accreditation: a testing or calibration laboratory working to this standard does not receive a certificate but accreditation from the national accreditation body — in Montenegro, the Accreditation Body of Montenegro (ATCG) — which assesses its competence for a precisely defined scope. Montenegro's national edition of the standard carries identical content to the international edition — the same requirements, the same clauses, just under a national designation — which is why both designations turn up in tenders for the same standard.
Why do the designations differ if it's the same standard?
Every member country of the European and international standardisation system adopts the same standard into its own national catalogue and adds a national prefix — in Montenegro, that's MEST. The content, structure, clauses and every requirement an auditor checks during certification remain completely identical regardless of which designation appears on the document. That's why a certificate issued under one designation fully covers the other — it isn't two standards, but one and the same, simply under two names.
Our core activity is standards implementation and rollout: we prepare your organisation so the accreditation assessment goes without surprises, and we explain terms like "ISO/IEC 17025:2017 certification" and "MEST EN ISO/IEC 17025 certificate" because that's exactly how clients search for them. What certification, accreditation, IAF and surveillance audits involve — read the Certification / ISO Certificate page, and about tender designations on the ISO Standards in Tenders page.
Montenegro is where we work from: our consultants are based in Podgorica, Budva and Bijelo Polje, documentation and training come in Montenegrin or in English, and accreditation itself is granted by the national accreditation body — not by us. We work on site in Serbia, Bosnia and Herzegovina, Croatia, North Macedonia, Albania and Kosovo as well — more about what we do in Montenegro.
Some of our references
More than 400 organisations in Montenegro and the region have gone through implementation with us — from banks and public bodies to manufacturing, IT, laboratories and hospitality.
These are only some of our clients. More about us →
Request a free consultation
We will assess the scope of work and propose a realistic plan and budget for your organisation. Call us or send an inquiry — we reply within 24 hours.