Consultancy for ISO/IEC 17025 Accreditation
SHAPYPRO provides consultancy for implementing, maintaining and improving management systems and technical competence in accordance with ISO/IEC 17025.
The service is intended for testing and calibration laboratories that need to define their scope, control methods and equipment, demonstrate personnel competence, ensure the validity of results and prepare for an accreditation assessment.
- ISO/IEC 17025
- Technical competence
- Metrological traceability
- Accreditation assessment
Consultancy for ISO/IEC 17025 Accreditation
ISO/IEC 17025 is the international reference for demonstrating the competence, impartiality and consistent operation of testing and calibration laboratories.
Implementation requires both management and technical requirements to be integrated. Procedures alone are not sufficient: the laboratory must demonstrate suitable methods, controlled equipment, competent personnel and evidence supporting the validity of results.
SHAPYPRO supports the laboratory from initial diagnosis through preparation for external assessment, adapting the work to the activities, matrices, quantities, methods and ranges to be included in the scope.
When It Can Help
Initial Accreditation
Laboratories that need to create the system, define the scope and prepare technical activities for an accreditation application.
Scope Extension or Modification
Addition of new methods, matrices, quantities, facilities, equipment or sampling activities.
Existing System Requiring Review
Update of procedures, records, technical criteria or arrangements for assuring result validity.
Assessment Preparation
Advance review before initial, surveillance, reassessment or extraordinary visits.
Treatment of Findings
Support with cause analysis, corrective-action planning and evidence of effectiveness.
What ISO/IEC 17025 Is and What Accreditation Recognises
ISO/IEC 17025:2017 specifies general requirements for the competence, impartiality and consistent operation of laboratories.
Accreditation does not recognise a laboratory in general or certify a product. It recognises competence to perform specific activities within a defined scope covering methods, types of test or calibration, matrices, quantities, ranges and locations.
Accreditation decisions are made by an external accreditation body. Laboratories should apply to the competent body in the country or economy concerned.
Technical Competence
Demonstrated ability of personnel and the laboratory to perform activities within scope and produce technically valid results.
Impartiality
Continuous identification of commercial, organisational, personal or financial risks that may affect objectivity.
Confidentiality
Protection of customer information and control of disclosure, including information obtained from sources other than the customer.
Consistent Operation
Controlled application of methods, resources and processes so activities are performed consistently.
Validity of Results
Use of internal controls, monitoring data, interlaboratory comparisons, proficiency testing and other appropriate tools.
Accreditation Scope and Laboratory Strategy
The scope defines the activities for which the laboratory seeks formal recognition of competence. It should be defined before the system is developed and the assessment is planned.
An excessively broad scope can create validation, personnel, equipment and comparison requirements that the laboratory cannot yet sustain. A scope that is too narrow may not support commercial or regulatory objectives.
SHAPYPRO helps define a realistic, defensible scope aligned with current and planned laboratory activities.
Laboratory Activities
Testing, calibration and, where applicable, sampling associated with subsequent testing or calibration.
Methods and Procedures
Published standards, in-house methods, modified methods and the versions to be used.
Matrices, Products or Items
Materials, products, samples or equipment to which methods will be applied.
Quantities, Ranges and Parameters
Measured characteristics, working ranges and technical capabilities to be demonstrated.
Facilities and Locations
Permanent activities, mobile facilities or work performed away from the laboratory’s premises.
Fixed or Flexible Scope
Assessment of the model permitted by the accreditation body and the controls required to manage changes.
Accreditation is granted for a specific scope. Use of an accreditation symbol or claim outside that scope may be misleading and should be avoided.
ISO/IEC 17025 Consultancy Services
The service may cover full implementation, a focused technical review, a scope extension or periodic support.
The scope of the consultancy is defined after reviewing the laboratory’s real situation and the applicable accreditation-body requirements.
Diagnosis and GAP Analysis
Comparison of the current system with ISO/IEC 17025 and with technical criteria or policies applicable to the intended scope.
Scope Definition
Review of methods, matrices, quantities, ranges, facilities and activities to be accredited.
System Development
Preparation or review of policies, procedures, instructions, records and technical controls.
Personnel Competence and Authorisation
Definition of requirements, training, supervision, evaluation and authorisation for specific activities.
Methods, Verification and Validation
Planning and review of evidence demonstrating that methods are fit for their intended use.
Equipment and Metrological Traceability
Control of inventory, calibrations, intermediate checks, reference materials and acceptance criteria.
Measurement Uncertainty
Definition of the evaluation approach and review of calculations where relevant to the activity.
Validity of Results
Design of quality controls, trend analysis, proficiency testing and interlaboratory comparisons.
Internal Audit
Independent evaluation of management and technical requirements before external assessment.
Accreditation Preparation
Review of evidence, interviews, document traceability and potential critical points in the scope.
Nonconformities and Corrective Action
Support with cause investigation, action planning and effectiveness verification.
Maintenance and Extensions
Support for surveillance, method changes, equipment, personnel, facilities or scope extensions.
Initial Diagnosis and GAP Analysis
Initial diagnosis determines which requirements are implemented, which exist only in documents and which technical elements need to be developed.
The review should include actual evidence. A procedure does not demonstrate competence by itself if there are no records, results, authorisations and controls confirming its use.
Compliance Matrix
Relationship between requirements, available evidence, gaps and technical observations.
Risk and Priority Map
Tasks ordered by their impact on result validity and the accreditation assessment.
Implementation Plan
Activities, owners, deliverables, dependencies and indicative deadlines.
Maturity Assessment
Evaluation of the system’s ability to operate consistently and maintain the scope.
Management System Implementation
The system should be integrated into routine laboratory activities. A parallel collection of documents produced only for assessment adds bureaucracy and generally collapses as soon as someone asks how the work is actually performed.
Documented information should be proportionate to the size, complexity and risks of the activities.
Policies and Responsibilities
Definition of commitments, authority, functions and communication arrangements.
Document and Record Control
Approval, identification, access, modification, archiving, retrieval and protection of information.
Review of Requests and Contracts
Confirmation of capability, method, scope, customer requirements and external providers before accepting work.
Purchasing and External Services
Selection, evaluation, monitoring and communication of requirements to critical suppliers.
Risks and Opportunities
Identification of factors that may affect competence, impartiality, results or system sustainability.
Improvement and Corrective Action
Treatment of issues, cause analysis, actions, owners and effectiveness verification.
Internal Audit and Management Review
Periodic evaluation of the system, results, resources, changes and improvement needs.
Data and Information Management
Control of software, spreadsheets, LIMS systems, data transfers, access, backups and functional validation.
Technical Competence, Resources and Laboratory Conditions
Technical competence depends on the combination of personnel, facilities, equipment, materials, methods and controls.
The laboratory should define requirements for each function and retain evidence of training, experience, supervision, evaluation and authorisation.
Personnel
Competence criteria, training, supervision, periodic evaluation and authorisation for methods, equipment, review and reporting.
Facilities and Environmental Conditions
Identification, monitoring and control of factors that may affect result validity.
Equipment
Selection, identification, maintenance, calibration, verification, status, protection and records.
Reference Materials and Reagents
Receipt, identification, storage, expiry, preparation, traceability and acceptance criteria.
External Providers
Control of calibrations, subcontracted tests, materials, maintenance and other services affecting results.
Technical Knowledge
Access to standards, methods, regulatory criteria and expertise needed for correct interpretation and application.
Methods, Validation, Uncertainty and Metrological Traceability
Methods should be fit for their intended use and applied within the conditions and ranges for which the laboratory has demonstrated capability.
The depth of verification, validation and uncertainty evaluation depends on the method, activity, customer requirements and the influence of the result on subsequent decisions.
Method Selection
Selection of appropriate methods, current versions and criteria for managing changes or deviations.
Verification of Standard Methods
Demonstration that the laboratory can achieve the required performance before routine use.
Method Validation
Evaluation of characteristics such as selectivity, precision, bias, range, detection limit, robustness or other relevant parameters.
Measurement Uncertainty
Identification of significant contributions, calculation model, source data, review and application to results.
Metrological Traceability
Documented relationship to appropriate references through calibrations, reference materials and technically valid procedures.
Decision Rules
Definition and communication of the criterion used when statements of conformity are made against specifications or limits.
Technical Records
Sufficient information to reconstruct conditions, calculations, observations, responsible personnel and factors affecting the result.
Assurance of the Validity of Results
The laboratory should plan monitoring activities appropriate to each method and use the resulting data to identify trends, deviations or loss of control.
Participation in proficiency testing or interlaboratory comparisons should be planned according to scope, risk, programme availability and accreditation-body policies.
Internal Controls
Blanks, duplicates, spiked samples, positive or negative controls, standards and control materials.
Charts and Trend Analysis
Statistical monitoring to identify changes before they generate invalid results.
Proficiency Testing
External evaluation of performance through programmes organised by competent providers.
Interlaboratory Comparisons
Comparison of results between laboratories where no suitable proficiency testing programme exists or as a complementary activity.
Retesting and Repetition
Defined criteria for repeating activities without selecting results arbitrarily.
Review of Reports and Data
Technical checks, independent calculations, data transfers and review before results are authorised.
Reports, Complaints and Nonconforming Work
The final result should be communicated clearly, accurately, objectively and traceably. Report content depends on the activity, method, customer agreement and regulatory requirements.
The system should also manage complaints and any work that does not comply with procedures or agreed requirements.
Test Reports and Calibration Certificates
Identification, method, results, units, uncertainty where applicable, conditions and required statements.
Opinions and Interpretations
Issued only by authorised personnel and supported by an appropriate documented basis.
Statements of Conformity
Application of the agreed decision rule and consideration of the risk of incorrect acceptance or rejection.
Report Amendments
Clear identification of corrections, supplements or replacements and their relationship to the original document.
Complaints
Receipt, validation, investigation, tracking, communication and independent decision on the subject of the complaint.
Nonconforming Work
Stopping or repeating activities, assessing impact, notifying the customer, recalling reports and applying corrective action where needed.
Preparation for the Accreditation Assessment
External assessment combines document review, interviews, observation of activities and analysis of technical evidence.
Preparation should demonstrate real system operation. Creating retrospective records to fill folders usually produces more questions than reassurance, a small bureaucratic miracle best avoided.
Review of the Requested Scope
Confirmation of methods, matrices, ranges, facilities, personnel, equipment and available evidence.
Complete Internal Audit
Coverage of management and technical requirements, including observation of representative activities.
Management Review
Evaluation of performance, resources, changes, risks, audit results and improvement needs.
Technical File Verification
Review of validations, uncertainty, traceability, controls, proficiency testing and reports.
Personnel Preparation
Confirmation of authorisations and ability to explain methods, controls and technical decisions.
Treatment of Findings
Cause analysis, proportionate actions, implementation evidence and effectiveness verification.
Coordination with the Accreditation Body
Preparation of the application, documentation, scope, schedule and responses to requests.
The accreditation assessment examines both the management system and technical competence for the specific activities included in the requested scope.
Working Methodology
Each project is organised around the starting point, scope, available resources and organisational objectives.
The methodology aims to implement a proportionate and maintainable system with clear deliverables and participation from the internal team.
Initial Review
Collection of information on structure, methods, personnel, equipment, facilities, customers and objectives.
GAP Analysis
Comparison with ISO/IEC 17025 and criteria applicable to the scope.
Scope Definition and Planning
Selection of activities and organisation of tasks, owners, evidence and deadlines.
Development and Implementation
Preparation or review of documents, technical controls and records.
Technical Evaluation
Review of methods, validations, uncertainty, traceability, competence and result validity.
Internal Audit and Management Review
Verification of implementation and decision-making before external assessment.
Accreditation Preparation
Final review, closure of gaps and documentary support.
Maintenance and Extension
Ongoing support for surveillance, changes and new activities.
Independence and Scope of the Service
SHAPYPRO provides consultancy and technical support but does not act as an accreditation body.
Engaging the service does not guarantee accreditation or a specific assessment outcome. The decision remains with the competent accreditation body.
The work focuses on helping the laboratory understand requirements, implement controls, demonstrate competence and prepare robust technical evidence.
ISO/IEC 17025 Consultancy Adapted to Each Laboratory
Each laboratory has different methods, equipment, personnel and risks. The service may range from a focused review to full implementation and maintenance.
SHAPYPRO adapts the work to the laboratory’s real operation and intended accreditation scope.
