Continually improve your business with the general requierements for the competence of testing and calibration laboratories

General requirements for the competence of testing and calibration laboratories

In a world where decisions on product safety, human health, environmental protection, and justice depend on the results of laboratory tests, the reliability of these results is not optional – it is an imperative. Every day, laboratories around the world analyze the water we drink, the food we eat, the medicines that heal us, the materials from which bridges are built, and the samples that determine the outcome of legal disputes.

In this critical context, the ISO/IEC 17025 standard emerges as a globally recognized framework that defines the requirements for the competence of testing and calibration laboratories. For laboratories in the EU – whether they deal with chemical analyses, microbiological testing, mechanical testing, instrument calibration, or any other field – this standard represents the key to international recognition of results, access to accreditation, and proof of technical competence.

ISO/IEC 17025 accreditation is not just an administrative requirement – it is a fundamental demonstration that a laboratory possesses the technical capability, impartiality, and quality system necessary to produce reliable and accurate results.

What is the ISO/IEC 17025 standard

The ISO/IEC 17025 standard, with the full name “ISO/IEC 17025 – General requirements for the competence of testing and calibration laboratories”, represents an internationally recognized document that defines the criteria that laboratories must meet to demonstrate their technical competence and ability to produce valid results.

The standard was jointly developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). The current version is from 2017 (ISO/IEC 17025:2017), which replaced the previous version from 2005 and brought significant changes in structure and requirements.

The main purpose of ISO/IEC 17025 is to:

• Demonstrate the technical competence of the laboratory
• Ensure the consistency and reliability of results
• Enable international recognition of results through mutual recognition
• Define requirements for the management system and technical operations
• Provide confidence in testing and calibration results

The scope of application covers:

• Testing laboratories
• Calibration laboratories
• Laboratories that perform both activities
• Laboratories of different sizes and types of ownership
• All fields of testing (chemistry, biology, physics, microbiology, NDT, etc.)

The difference between ISO/IEC 17025 and ISO 9001: Although both standards cover the quality management system, ISO/IEC 17025 is specific to laboratories and includes detailed technical requirements for personnel competence, method validation, measurement uncertainty, metrological traceability, and many other aspects that are not covered by ISO 9001. A laboratory accredited according to ISO/IEC 17025 automatically fulfills the principles of ISO 9001 as well.

The key difference between certification and accreditation: ISO/IEC 17025 is not “certified” in the traditional sense – laboratories are accredited by national accreditation bodies. Accreditation is a formal recognition by a third party (accreditation body) that a laboratory is competent to perform specific tests or calibrations.

Key benefits of the ISO/IEC 17025 standard

The implementation of the ISO/IEC 17025 standard brings numerous concrete benefits to laboratories:

• International recognition of results is perhaps the most significant benefit. Through international mutual recognition agreements (ILAC MRA, EA MLA), results from accredited laboratories are accepted worldwide without the need for re-testing. This is critical for exporters and international trade.
• Market advantage and competitiveness – accreditation distinguishes your laboratory from the competition. Many clients, especially large industrial buyers and government agencies, require or prefer accredited laboratories.
• Increased client confidence – accreditation gives clients independent confirmation that your laboratory can produce reliable results. In an era where data reliability is increasingly questioned, this is invaluable.
• Access to tenders and contracts – many tenders, especially public procurement and regulatory requirements, require testing to be performed in an accredited laboratory. Without accreditation, these doors are closed.
• Improved technical competence – the ISO/IEC 17025 implementation process systematically increases the technical capability of the laboratory through method validation, personnel training, equipment control, and robust quality procedures.
• Reduction of errors and re-testing – a systematic approach to quality dramatically reduces the frequency of errors, which means lower costs, shorter turnaround times, and more satisfied clients.
• Legal protection – in the event of disputes, results from an accredited laboratory carry more weight and credibility before courts and regulatory bodies.
• Access to regulated markets – many fields (pharmacy, food, environment, construction) have regulatory requirements that include testing in an accredited laboratory.

Why the ISO/IEC 17025 standard is important

The ISO/IEC 17025 standard has a deeper significance that goes beyond commercial benefits:

• Protection of public health and safety – laboratory test results determine whether water is safe to drink, whether food contains pathogens, whether medicines are effective and safe. Inaccurate results can have deadly consequences. ISO/IEC 17025 systematically ensures the accuracy of results.
• Fairness and justice – in forensic laboratories, results can determine whether someone will be convicted or acquitted. In product quality disputes, testing determines who is right. The reliability of these results is an imperative for justice.
• Economic impact – international trade depends on trust in testing results. The harmonization of standards and mutual recognition eliminates trade barriers and enables global business.
• Environmental protection – monitoring air, water, and soil pollution requires accurate measurements. Remediation decisions, fines for polluters, and protective measures depend on reliable results.
• Trust in science – in a time where science is often questioned, rigorous standards for laboratories help maintain trust in scientific data and evidence.
• Regulatory efficiency – government agencies cannot inspect every product or process. Instead, they rely on results from accredited laboratories, making the regulatory system more efficient.
• Technological development – reliable measurements and testing are the foundation for innovation. From the development of new materials to pharmaceutical products, everything depends on accurate laboratory data.
• Global harmonization – ISO/IEC 17025 contributes to the harmonization of practices and standards worldwide, facilitating cooperation, trade, and knowledge exchange.

Key principles of the ISO/IEC 17025 standard

The ISO/IEC 17025 standard is based on fundamental principles:

• Principle 1: Impartiality – the laboratory must be impartial and act independently. This means that results must not be influenced by commercial pressures, conflicts of interest, or any form of bias. The laboratory must identify risks to impartiality and manage them.
• Principle 2: Confidentiality – the laboratory must protect information about clients and results. Results are issued only to authorized parties, and information is not used for commercial purposes without permission.
• Principle 3: Technical competence – personnel must have the necessary education, training, experience, and competencies for the tasks they perform. This is demonstrated through formal education, internal training, external courses, and competence assessment.
• Principle 4: Validity of results – all results must be technically valid, which is achieved through:
  • Use of validated methods
  • Calibrated and appropriate equipment
  • Appropriate environmental conditions
  • Competent personnel
  • Quality control
• Principle 5: Metrological traceability – measurement results must be traceable to SI units (International System of Units) through an unbroken chain of calibrations. This ensures that measurements performed in different laboratories and at different times can be comparable.
• Principle 6: Evaluation of measurement uncertainty – every measurement has an uncertainty. ISO/IEC 17025 requires laboratories to identify, evaluate, and report on measurement uncertainty, enabling users to understand the reliability of the results.
• Principle 7: Continuous improvement – the laboratory must continuously improve its system through data analysis, corrective actions, learning from mistakes, and monitoring best practices.
• Principle 8: Risk-based approach – the laboratory must identify risks that can affect the validity of results and take measures to manage them.

Structure of the ISO/IEC 17025 standard

ISO/IEC 17025:2017 is organized into two main sections:

Section 4: General Requirements

• 4.1 Impartiality
  • Identification of risks to impartiality
  • Management of conflicts of interest
  • Independence of decision-making
• 4.2 Confidentiality
  • Protection of client information
  • Obligations of personnel
  • Exemptions (legal requirements)

Section 5: Structural Requirements

• 5.1 – 5.7 cover organizational structure, responsibilities, authorities, and resources.

Section 6: Resource Requirements

• 6.1 General – the laboratory must have available all necessary personnel, equipment, conditions, and external services.
• 6.2 Personnel
  • Competencies
  • Training
  • Authorization
  • Supervision
• 6.3 Facilities and environmental conditions
  • Appropriate spaces
  • Control of conditions (temperature, humidity, cleanliness)
  • Separation of incompatible activities
  • Access to and use of space
• 6.4 Equipment
  • Procurement and verification
  • Calibration
  • Maintenance
  • Handling and transport
  • Intermediate checks
  • Status labeling
• 6.5 Metrological Traceability
  • Calibration according to national/international standards
  • Reference materials
  • Unbroken chain of traceability
• 6.6 Externally provided products and services
  • Selection and evaluation of suppliers
  • Contracts and specifications
  • Review of external results

Section 7: Process Requirements

• 7.1 Review of requests, tenders and contracts
  • Understanding client requirements
  • Capability assessment
  • Informing the client
• 7.2 Selection, verification and validation of methods
  • Use of appropriate methods
  • Validation of non-standard methods
  • Verification of standard methods
• 7.3 Sampling
  • Sampling plans
  • Handling and transport
  • Records
• 7.4 Handling of test or calibration items
  • Receipt
  • Storage
  • Protection
  • Disposal or return
• 7.5 Technical records
  • Sufficient information for repetition
  • Identification of personnel
  • Observations and data
  • Amendments
• 7.6 Evaluation of measurement uncertainty
  • Identification of sources
  • Quantification
  • Reporting
• 7.7 Ensuring the validity of results
  • Quality controls (QC)
  • Interlaboratory comparisons
  • Control samples
  • Retesting
  • Correlation of different characteristics
• 7.8 Reporting of results
  • Report content
  • Opinions and interpretations
  • Report amendments
• 7.9 Complaints
  • Handling process
  • Investigation
  • Actions
• 7.10 Nonconforming work
  • Identification
  • Significance evaluation
  • Corrective actions
• 7.11 Control of data and information management
  • Data integrity
  • Protection
  • Backup

Section 8: Management System Requirements

• Option A: Management system requirements in accordance with ISO/IEC 17025
• Option B: Management system requirements in accordance with ISO 9001 Covers:
• System documentation
• Control of documents
• Control of records
• Actions to address risks and opportunities
• Improvement
• Corrective actions
• Internal audits
• Management reviews

Key concepts of the ISO/IEC 17025 standard

Understanding the key concepts is essential:

• Method validation is the process of demonstrating that a method produces results that are fit for the intended use. For non-standard methods, laboratory-developed methods, or standard methods used outside their intended scope, the laboratory must validate the method. Validation includes determining performance characteristics such as:
  • Specificity/selectivity
  • Range
  • Linearity
  • Limit of detection (LOD)
  • Limit of quantification (LOQ)
  • Accuracy
  • Precision (repeatability/reproducibility)
  • Robustness
• Method verification is applied to standard methods to confirm that the laboratory can achieve the performance specified in the standard.
• Measurement Uncertainty is a parameter associated with the result of a measurement that characterizes the dispersion of the values that could reasonably be attributed to the measurand. Every measurement has an uncertainty due to various factors:
  • Imperfection of measuring equipment
  • Sample variability
  • Environmental influences
  • Operator variability
  • Method imperfection ISO/IEC 17025 requires the evaluation and, where relevant, reporting of measurement uncertainty.
• Metrological Traceability is the property of a measurement result whereby the result can be related to a reference through a documented unbroken chain of calibrations, each contributing to the measurement uncertainty. For testing laboratories, this means that equipment must be calibrated, and the calibration must be traceable to national or international standards.
• Quality Control (QC) are techniques and activities of an operational nature used to fulfill requirements for quality. Examples include:
  • Control samples (control charts)
  • Blank samples
  • Spike/recovery tests
  • Duplicates
  • Reference materials
  • Interlaboratory comparisons (proficiency testing)
• Proficiency Testing (PT) or interlaboratory comparisons are the evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons. The laboratory tests the same samples as other laboratories, and the results are compared. This is a powerful tool for checking competence.
• Personnel competence is defined as the ability to apply knowledge and skills to achieve intended results. It must be based on appropriate education, training, experience, and demonstrated skills.
• Impartiality and conflict of interest – the laboratory must identify situations that may compromise impartiality (e.g., financial pressures, commercial relationships, personal relationships) and manage them.

Fields of application of the ISO/IEC 17025 standard

ISO/IEC 17025 is applied in a wide range of laboratories:

• Chemical laboratories:
  • Water analysis (drinking, wastewater, process)
  • Food analysis (nutritional composition, contaminants, additives)
  • Soil and sediment analysis
  • Air and emissions analysis
  • Pharmaceutical analyses
  • Oil and petroleum products analysis
  • Chemicals and raw materials
• Microbiological laboratories:
  • Food microbiology
  • Water microbiology
  • Clinical microbiology
  • Pharmaceutical microbiology
  • Environmental microbiology
• Material testing laboratories:
  • Mechanical testing (tensile, hardness, impact)
  • Construction materials (concrete, asphalt, steel)
  • Polymers and plastics
  • Textiles
  • Paper
• Calibration laboratories:
  • Calibration of measuring equipment
  • Dimensional measurements
  • Mass and force
  • Temperature and humidity
  • Pressure
  • Electrical quantities
  • Time and frequency
• Non-destructive testing (NDT) laboratories:
  • Ultrasonic testing
  • Radiography
  • Penetrant testing
  • Magnetic particles
  • Visual inspection
• Environmental laboratories:
  • Air monitoring
  • Waste analysis
  • Soil analysis
  • Noise and vibrations
  • Radioactivity
• Forensic laboratories:
  • DNA analysis
  • Toxicology
  • Drug analysis
  • Ballistics analyses
  • Document analysis
• Medical laboratories:
  • Clinical chemistry
  • Hematology
  • Immunology
  • Molecular diagnostics
• Product testing laboratories:
  • Electrical safety
  • EMC (electromagnetic compatibility)
  • Product performance
  • Durability

Benefits of implementing the ISO/IEC 17025 standard

The concrete benefits are manifold:

• International recognition through the ILAC MRA (International Laboratory Accreditation Cooperation Mutual Recognition Arrangement) allows results from your laboratory to be accepted in over 100 countries without the need for re-testing. This is critical for exporters.
• Increasing the number of clients – many industrial clients, government agencies, and international organizations require or prefer accredited laboratories. Accreditation opens up new markets.
• Higher service prices – accredited laboratories can often charge a premium because they offer additional value through international recognition and demonstrated competence.
• Reduction of complaints – a systematic approach to quality dramatically reduces errors and client complaints.
• Improved technical performance – the method validation process, quality control, and measurement uncertainty evaluation directly improve technical capability.
• Clearer organization and responsibilities – ISO/IEC 17025 requires clearly defined roles, responsibilities, and procedures, eliminating confusion.
• Easier recruitment and retention of quality staff – experts want to work in accredited laboratories where they can develop their skills.
• Protection against liability – in the event of disputes or problems, accreditation shows that you have taken reasonable precautions.
• Access to public procurement – many public procurements require testing in an accredited laboratory.
• Regulatory compliance – in many fields (food, pharmacy, environment), regulators require or recognize accreditation.

ISO/IEC 17025 standard implementation process

Implementation requires a systematic approach through several phases:

• Phase 1: Commitment and planning (Month 1)
  • Formal commitment from management
  • Defining the scope of accreditation (which methods, which analyses)
  • Appointment of a Quality Manager or team
  • Allocation of resources
  • Creation of a project plan
• Phase 2: GAP analysis (Month 1-2)
  • Detailed assessment of the current state vs ISO/IEC 17025 requirements
  • Check of technical competencies
  • Check of equipment (calibration, maintenance)
  • Review of methods (validation, verification)
  • Assessment of the quality system
  • Identification of shortcomings
  • Estimation of required investments and time
• Phase 3: Training and competence development (Month 2-3)
  • Management training on standard requirements
  • Quality Manager training
  • Technical staff training on specific requirements (validation, QC, measurement uncertainty)
  • Internal auditor training
• Phase 4: System documentation development (Month 2-4)
  • Quality Policy
  • Quality Manual
  • Organizational structure
  • Management system procedures:
    • Control of documents
    • Control of records
    • Internal audits
    • Management review
    • Corrective actions
    • Handling complaints
    • Handling nonconforming work
  • Technical procedures for all methods
  • Forms and checklists
• Phase 5: Method validation/verification (Month 3-6) For each method in the accreditation scope:
  • Defining performance characteristics
  • Design of validation experiments
  • Conducting experiments
  • Data analysis
  • Documenting (validation report)
  • Creating/updating technical procedures
• Phase 6: Establishing metrological traceability (Month 3-5)
  • Inventorying all equipment requiring calibration
  • Creating a calibration plan
  • Organizing calibrations at accredited laboratories
  • Checking calibration certificates
  • Equipment labeling
• Phase 7: Measurement uncertainty evaluation (Month 4-6) For each method:
  • Identification of uncertainty sources
  • Quantification of components
  • Combining components
  • Calculation of expanded uncertainty
  • Documenting
• Phase 8: Quality control implementation (Month 4-7)
  • Design of the QC program (control samples, blank samples, spike/recovery)
  • Establishment of control charts
  • Participation in proficiency testing programs
  • Documenting results
• Phase 9: Trial application of the system (Month 6-8)
  • Conducting analyses according to new procedures
  • Completing all records
  • System testing
  • Adjusting where necessary
• Phase 10: Internal audits (Month 8-9)
  • Checking all system elements and technical requirements
  • Documenting findings
  • Corrective actions
• Phase 11: Management review (Month 9)
  • Formal review of the system by management
  • Evaluation of readiness for accreditation
  • Decision on application

The total implementation time is usually 9-18 months depending on the number of methods, complexity, and the existing level of the system.

ISO/IEC 17025 standard certification process

For ISO/IEC 17025, the formal process is accreditation (not certification), which is carried out by national accreditation bodies:

• Step 1: Selection of the accreditation scope The laboratory decides which methods/analyses it wants to accredit. It is not necessary to accredit everything the laboratory does – you can start with a few key methods.
• Step 2: Application to the national accreditation body Submitting an application with:
  • Information about the laboratory
  • List of methods for accreditation (scope)
  • Evidence of the implemented system
• Step 3: Administrative check The accreditation body checks whether the application is complete and whether the required fees have been paid.
• Step 4: Initial office assessment (optional) Some bodies offer a preliminary document review where they provide feedback before the official assessment.
• Step 5: Appointment of the assessment team The accreditation body appoints an assessor team (usually a lead assessor + technical experts for specific fields).
• Step 6: On-site assessment The team comes to the laboratory. The assessment lasts 2-5 days depending on the number of methods and complexity. During the assessment:
  • Review of the management system:
    • Quality Policy
    • Organization and responsibilities
    • Control of documents and records
    • Handling complaints
    • Nonconforming work
    • Corrective actions
    • Internal audits
    • Management review
  • Review of technical operations:
    • Personnel competence (checking CVs, training records, authorizations)
    • Facilities and environmental conditions (visit to laboratory premises)
    • Equipment (checking calibrations, maintenance, intermediate checks)
    • Metrological traceability (checking calibration certificates, reference materials)
    • Method validation/verification (review of validation reports)
    • Witness testing (observing the performance of analyses)
    • Sample handling (receipt, storage, identification)
    • QC (checking control charts, PT results)
    • Measurement uncertainty (checking calculations)
    • Reporting results (review of reports)
    • Records (raw data, calculations, chain of custody)
• Step 7: Assessment report The assessors prepare a detailed report with findings:
  • Non-conformities – areas where requirements are not met
  • Comments – observations that do not prevent accreditation but can be improved
• Step 8: Laboratory response The laboratory must address all non-conformities through:
  • Root cause analysis
  • Corrective actions
  • Evidence of implementation
  • Preventive measures The deadline is usually 3-6 months.
• Step 9: Evaluation of the response The lead assessor evaluates the responses. If the non-conformities are resolved, they recommend accreditation. If not, they may require additional documentation or a re-visit.
• Step 10: Accreditation decision The accreditation body (through its accreditation committee) makes a formal decision on granting accreditation.
• Step 11: Issuance of accreditation The laboratory receives:
  • Accreditation certificate
  • Annex (Schedule/Scope) that details the accredited methods
• Step 12: Surveillance assessments Accreditation is usually valid for 4-5 years, but during that time, regular surveillance assessments are conducted (usually annually) to confirm continuous compliance.
• Step 13: Re-accreditation Before the expiration of the accreditation, a complete re-accreditation is conducted, similar to the initial one.

EU certificate ISO/IEC 17025 – characteristics and significance

The ISO/IEC 17025 accreditation certificate has specific characteristics:

• Certificate content:
  • Name and address of the laboratory
  • Unique accreditation number
  • Date of issue
  • Expiry date
  • Statement that the laboratory is accredited according to ISO/IEC 17025
  • Signature of the authorized person of the accreditation body
  • Logo of the accreditation body and international organizations (ILAC, EA, etc.)
• The Annex/Scope is a key document that details:
  • Specific methods that are accredited (e.g., “Determination of heavy metals in water by ICP-MS according to EPA 200.8”)
  • Matrices (sample types – water, soil, food, etc.)
  • Measurement range
  • Techniques/instruments
  • Measurement uncertainty (where applicable)
• The accreditation number is a unique identifier used on accredited reports.
• The scope of accreditation is critical – the laboratory can issue accredited reports ONLY for the methods listed in the annex. Work outside the scope is not covered by accreditation.
• Expanding the scope – if a laboratory wishes to add new methods, it must apply for an expansion and undergo an assessment for those methods.
• Validity – usually 4-5 years with surveillance assessments.
• Suspension or withdrawal can occur if the laboratory fails to meet requirements during surveillance or has serious issues (non-conformities, unsatisfactory PT results, inadequate response to findings).

Importance of the ISO/IEC 17025 certificate

Accreditation carries exceptional significance:

• International recognition – the most important advantage. Through the ILAC MRA, results from accredited laboratories are accepted in over 100 countries. For exporters, this eliminates the need for re-testing in the destination country.
• Regulatory acceptability – many regulators (FDA, EPA, EU agencies) require or prefer results from accredited laboratories.
• Legal weight – in legal disputes, results from accredited laboratories carry more weight as evidence.
• Market access – many clients simply will not consider non-accredited laboratories. Accreditation is the entry ticket.
• Premium pricing – accredited laboratories can charge more because they offer additional value.
• Proof of competence – independent, third-party confirmation of technical capability.
• Client trust – clients can be confident in the accuracy and reliability of results.
• Differentiation from the competition – in a crowded market, accreditation sets you apart.
• Internal benefit – improved organization, clearer procedures, better quality control, fewer errors.

Cost of the ISO/IEC 17025 standard

The costs of accreditation depend on several factors:

• Factors affecting costs:
  • Number of methods for accreditation
  • Complexity of methods
  • Need for validation vs verification
  • Number and condition of equipment (need for calibration)
  • Existing level of documentation and system
  • Size of the laboratory
  • Consulting support
• Components of total costs:
  • Preparation:
    • Consulting support (GAP analysis, documentation development, validations, training)
    • Staff training (internal auditors, Quality Manager, technical training)
    • Validation experiments (reagents, standards, instrument time)
    • Calibration of equipment at accredited laboratories
    • Reference materials (CRM)
    • Proficiency testing programs
    • Procurement or upgrade of equipment (if necessary)
    • Improvement of facilities/conditions (if necessary)
  • Accreditation:
    • Application fee to the accreditation body
    • Assessment fee – usually charged per assessor day
    • Assessor travel expenses (if applicable)
  • Maintenance:
    • Annual fees to the accreditation body
    • Surveillance assessments
    • Continuous calibration of equipment
    • PT programs
    • Re-validations/verifications
    • Training
  • Internal costs:
    • Employee time
    • Materials for validation and QC
• Return on investment:
  • Access to new clients and markets
  • Premium service pricing
  • Reduction of errors and rework
  • Improved efficiency Most laboratories report that the investment pays off in 2-3 years through new business and operational savings.

If you are interested in the price of the ISO 17025 standard, fill out the REQUEST FOR QUOTE and our team will provide you with a personalized price for the ISO 17025 standard in the shortest possible time.

Based on your inquiry, you will receive:

• clear information on the price and duration of the process,
• explanation of the steps for implementing the standard,
• expert support throughout the entire certification process.

Fill out the form and take the first step towards compliance with the ISO 17025 standard and business improvement.

EU certificate ISO/IEC 17025

Accreditation according to ISO/IEC 17025 is available and recognized in the EU:

• The national accreditation bodies in EU member states (operating under Regulation (EC) No 765/2008) are responsible for the accreditation of laboratories according to ISO/IEC 17025. These bodies are members of ILAC and EA (European co-operation for Accreditation), which means that the accreditations are internationally recognized.
• Growing application – more and more EU laboratories are obtaining accreditation:
  • Water testing laboratories
  • Food testing laboratories
  • Construction laboratories
  • Environmental laboratories
  • Medical laboratories
  • Calibration laboratories
• Export orientation – EU companies that export globally (food, construction materials, etc.) increasingly use accredited laboratories because international markets require results from accredited laboratories.
• The European market – government agencies, large industrial clients, and public procurement also increasingly require accreditation.
• Availability of consulting support – specialized consulting firms such as Mobes Group provide local support in the English language, which significantly facilitates the process.
• Local successes – numerous EU laboratories have been successfully accredited, showing that this is achievable in our conditions as well.
• Regional connectivity – accreditations in the EU are recognized in other countries of the region and globally through international agreements.

ISO/IEC 17025 standard in the EU – legal framework and support

ISO/IEC 17025 in the EU functions in a specific environment:

• Legal framework – Regulation (EC) No 765/2008 regulates the accreditation bodies and accreditation in the EU.
• Regulatory requirements – different sectors have different requirements:
  • Food – General Food Law Regulation (EC) No 178/2002
  • Environment – EU Environmental Directives (e.g., Water Framework Directive, Air Quality Directive)
  • Construction – Construction Products Regulation (CPR)
  • Pharmacy – European Medicines Agency (EMA) regulations and Directive 2001/83/EC Many of these regulations require or prefer testing in accredited laboratories.
• Compliance with EU standards – harmonization with global regulations means that accreditation requirements are growing.
• Public procurement – more and more tenders, especially those financed from EU funds, require results from accredited laboratories.
• Professional associations – various chambers and associations (chemists, builders, doctors) promote accreditation.
• Education – universities offer courses on accreditation and laboratory quality.

Maintaining the ISO/IEC 17025 certificate

Maintaining accreditation requires continuous effort:

• Surveillance assessments are mandatory and are conducted annually or at other intervals determined by the accreditation body. The focus is on:
  • Changes since the previous assessment
  • Status of the QC program and results
  • PT participation and results
  • Complaints and non-conformities
  • Internal audits and corrective actions
  • Calibration status
  • Competence of new personnel
• Continuous QC:
  • Regular monitoring of control charts
  • Trend analysis
  • Actions when QC indicates problems
• Proficiency Testing:
  • Regular participation (usually 1-2 times a year per method)
  • Results analysis
  • Actions if results are not satisfactory
• Calibrations:
  • Adherence to the calibration plan
  • Timely dispatch of equipment for calibration
  • Verification of certificates
  • Intermediate checks
• Validation/verification:
  • Periodic re-validation or re-verification
  • When reagents, instruments, or personnel change
• Personnel competence:
  • Continuous training
  • Periodic competence assessment
  • Training of new employees
• Internal audits:
  • Annual plan covering all areas
  • Documenting findings
  • Monitoring corrective actions
• Management review:
  • Annual formal review of the system
  • Evaluation of performance data
  • Decisions on improvements
• Change management:
  • Formal process for all changes (personnel, equipment, methods, facilities)
  • Assessment of impact on accreditation
  • Notifying the accreditation body when necessary
• Documentation:
  • Updating procedures
  • Retaining records according to requirements
• Maintaining metrological traceability:
  • Tracking calibration expiration dates
  • Ensuring that standards and reference materials are valid

Integration with other management systems

ISO/IEC 17025 can be integrated with:

• ISO 9001 standard (Quality Management System): ISO/IEC 17025:2017 is designed to be compatible with ISO 9001. A laboratory can choose Option A (management system according to ISO/IEC 17025) or Option B (management system according to ISO 9001). Many laboratories maintain both certificates through an integrated system.
  • Overlap:
    • Control of documents and records
    • Internal audits
    • Corrective actions
    • Management review
    • Procurement
    • Handling non-conformities
  • The ISO/IEC 17025 standard additionally covers:
    • Technical requirements (validation, QC, measurement uncertainty, traceability)
    • Impartiality
    • Confidentiality
• ISO 15189 standard (Medical laboratories): For medical laboratories, ISO 15189 is a sector-specific standard that combines the requirements of ISO/IEC 17025 with additional requirements for medical practice. Laboratories can have both or only ISO 15189.
• ISO 14001  standard (Environmental Management): Laboratories (especially environmental) can integrate with ISO 14001 through common elements such as waste management, emissions control, resource efficiency.
• ISO 45001 standard (Occupational Health and Safety): Laboratory work involves risks (chemicals, biohazards, electrical equipment). ISO 45001 complements ISO/IEC 17025.
• GLP (Good Laboratory Practice): In pharmaceutical and toxicological laboratories, GLP and ISO/IEC 17025 can be combined.

Advantages of integration:

• Unified documentation
• Combined audits
• Holistic approach
• Less bureaucracy

Challenges:

• Complexity
• The need to maintain the specificity of ISO/IEC 17025 technical requirements

Mobes Group – your partner for ISO/IEC 17025 standard certification

Mobes Group d.o.o. is a specialized consulting organization that provides comprehensive support to laboratories in the EU on the path to ISO/IEC 17025 accreditation.

Expertise in different types of laboratories:

• Chemical laboratories
• Microbiological laboratories
• Material testing laboratories
• Environmental laboratories
• Calibration laboratories

Complete service:

• Initial GAP analysis
• Development of complete system documentation
• Method validation/verification
• Measurement uncertainty evaluation
• Establishment of QC programs
• Training for all levels
• Preparation for accreditation
• Mock audit
• Support during assessment
• Assistance in maintaining accreditation

Technical depth – our team includes experts with:

• Scientific backgrounds (chemistry, biology, physics)
• Experience in accredited laboratories
• Knowledge of validation and statistical analysis
• Expertise in measurement uncertainty

Practical approach – we do not offer theoretical solutions. Our validations are designed to work in your laboratory, our procedures are applicable, not academic.

Knowledge transfer – the goal is for your team to become independent. Through hands-on support and training, we empower your people.

Understanding of small laboratories – we provide solutions tailored to your resources.

Local partner – communication in the English language, understanding of the local context, availability.

Why choose Mobes Group?

Mobes Group offers unique advantages:

• Proven track record – our clients successfully obtain ISO/IEC 17025 accreditation in various fields.
• Technical expertise – we combine understanding of the standard with practical laboratory experience.
• Individualized approach – every laboratory is unique (different methods, instruments, matrices). We adapt the methodology to you.
• Efficiency – our experience allows us to optimize the process without sacrificing quality.
• Transparency – from the beginning you receive a clear plan, realistic deadlines, and transparent costs.
• Practical training – our trainings are hands-on, focused on your equipment and methods.
• Support in validation – we assist in designing validation experiments, statistical data analysis, and preparing validation reports.
• Expertise in measurement uncertainty – measurement uncertainty is often the most challenging part for laboratories. Our experts have deep knowledge and can help you.
• Availability – when you have a technical question, you get a quick answer.
• Long-term partnership – we do not abandon you after accreditation. We are here for surveillance support, re-validations, scope expansions.
• Connectivity – our connections with the accreditation body, standards providers, and equipment suppliers benefit our clients.

Most common challenges and how to overcome them

Laboratories on the path to accreditation face common challenges:

• Method validation – especially complex for non-standard or modified methods.
  • Solution: A systematic approach through defining performance characteristics that are relevant to your application, designing experiments that match your resources, statistical analysis. Mobes Group can help in all phases.
• Measurement uncertainty evaluation – many laboratories are unfamiliar with this concept.
  • Solution: Training on the basics (GUM – Guide to Uncertainty in Measurement), identification of sources for each method, use of available tools and software, step-by-step approach. It doesn’t have to be perfect from the start – it can be improved.
• Equipment calibration – calibration costs at accredited laboratories can be significant.
  • Solution: Prioritization – not all equipment must be calibrated externally (some things can be verified internally), grouping calibrations, planning ahead to avoid express costs.
• Proficiency Testing – PT costs can be an issue, especially for laboratories with many methods.
  • Solution: Focusing on key methods first, looking for affordable PT providers, grouping with other laboratories (if possible).
• Documentation – the volume of required documents can be daunting.
  • Solution: Use templates, focus on what is truly needed (no excessive documentation), integration of documentation with daily work.
• QC program – designing an effective QC program that is not overwhelming.
  • Solution: Risk-based approach – more QC for critical/problematic methods, use of control charts for trend monitoring, automation where possible.
• Personnel competence – demonstrating and maintaining competencies.
  • Solution: Formal training program, records, periodic assessment, peer review, job rotation for a variety of experience.
• Traceability – especially for testing (not calibration) laboratories.
  • Solution: Use of CRM (Certified Reference Materials) where available, calibrated equipment, documented chain.
• Resources and costs – especially for smaller laboratories.
  • Solution: Phased approach – accredit a few key methods first, then expand later, realistic budget planning, use of existing resources.

The future and the ISO/IEC 17025 standard

The ISO/IEC 17025 standard is evolving:

• Digitalization and automation:
  • Electronic laboratory notebooks (ELN)
  • Laboratory Information Management Systems (LIMS)
  • Automated report generation
  • Digital signatures
  • Blockchain for traceability
• Artificial intelligence:
  • AI for detecting outliers in data
  • Predictive QC
  • Automated validation
  • Method optimization
• Remote assessment:
  • Following COVID-19, accreditation bodies increasingly use remote/virtual assessments
  • Combination of on-site and remote
• Focus on measurement capability:
  • Shifting focus from procedures to results – what a laboratory can measure with what uncertainty
• Flexible scopes:
  • Accreditation of “method families” instead of individual methods
  • Accreditation of technical competence for specific techniques
• Integration with other standards:
  • Closer harmonization with ISO 9001, ISO 14001, etc.
  • Sector-specific upgrades (ISO 15189 for medicine, ISO 13485 for medical devices)
• Focus on sustainability:
  • Environmental footprint of laboratories
  • “Green chemistry” principles
  • Waste reduction
• Globalization:
  • Increasing harmonization of accreditation systems worldwide
  • Expansion of ILAC MRA

For EU laboratories this means:

• The need to invest in digital systems
• Continuous training for new technologies
• Tracking international trends
• Early adopters have an advantage

How to Get Started?

If you want to implement the ISO 17025 standard in your company, the process is simple:

• Contact Mobes Group – Contact page or send a request for a quote
• Initial Consultation – Our team will analyze your needs and current situation
• Tailored Plan – You will receive a detailed implementation plan tailored to your enterprise
• Implementation – With our support, you will execute all necessary changes
• Certification – We will help you successfully navigate the certification process

ISO 17025 standard

ISO/IEC 17025 accreditation represents the gold standard for laboratories worldwide. It is not just a recognition of technical competence – it is fundamental proof that your laboratory has the knowledge, skills, equipment, and systems needed to produce results that can be trusted.

In a world where decisions on safety, health, justice, and the economy depend on laboratory results, accreditation is not a luxury – it is a necessity. For laboratories in the EU that want to work with international clients, participate in public procurement, or simply prove their excellence, ISO/IEC 17025 accreditation is a crucial investment.

The journey to accreditation requires commitment, technical expertise, and a systematic approach. With the right partner, this path becomes not only feasible but also transformative for your laboratory.

Your path to business excellence begins here. Contact Mobes Group today and discover how the ISO 17025 standard can improve your business.

Mobes Europe – Elite Consulting Services for ISO Standard Implementation & Certification

Email: info@mobes.eu