ISO/IEC 17025 Consultant

Wintersmith Advisory’s ISO/IEC 17025 consulting services provide end-to-end support for laboratory accreditation, including gap analysis, documentation development, process implementation, and audit preparation. Our structured approach and expert insights ensure your lab achieves and maintains global recognition, data accuracy, and continual improvement.

A diverse ISO/IEC 17025 consultant presents accreditation criteria on a screen to three laboratory technicians in white coats.

Why ISO/IEC 17025 Matters

  • Global Recognition: Demonstrate technical competence and reliable results to clients and regulatory bodies.

  • Improved Quality: Standardize testing procedures and calibration methods to ensure data accuracy.

  • Risk Reduction: Identify and mitigate sources of error through documented quality control processes.

  • Market Advantage: Expand your lab’s accreditation scope and win new business opportunities.

Our ISO/IEC 17025 Consulting Services

  • Gap Analysis & Readiness: Evaluate your current lab processes against ISO/IEC 17025 requirements.

  • Quality Manual & Documentation: Develop or refine scope statements, quality manuals, procedures, and record templates.

  • Process Implementation: Establish documented testing methods, calibration practices, and equipment maintenance schedules.

  • Internal Audit Preparation: Train internal auditors, conduct mock assessments, and resolve nonconformities.

  • Accreditation Support: Liaise with accreditation bodies, prepare audit packages, and support on-site assessments.

  • Continuous Improvement: Implement corrective/preventive actions and monitor key performance indicators.

Our Structured Approach

  1. Initiation & Planning: Define lab scope, accreditation targets, timeline, and project team.

  2. Initial Assessment: Conduct detailed gap analysis and risk assessment of lab operations.

  3. Documentation Development: Create or update quality manuals, method validation protocols, and records.

  4. Implementation & Training: Guide lab staff in new procedures, calibration, and quality control.

  5. Internal Audits & Reviews: Perform mock audits, management reviews, and corrective actions.

  6. Accreditation Audit Support: Facilitate Stage 1 and Stage 2 assessments with accreditation bodies.

Key Differentiators

  • Laboratory Expertise: Consultants with hands-on experience in testing, calibration, and method validation.

  • Accreditation Authority Insights: Former assessors who understand accreditation body expectations.

  • Customized Solutions: Tailored to chemical, mechanical, biological, or calibration lab environments.

  • End-to-End Support: From initial gap analysis through post-accreditation continuous improvement.

Industries We Serve

  • Chemical & Petrochemical Laboratories

  • Calibration & Metrology Services

  • Environmental & Water Testing Labs

  • Food & Beverage Quality Labs

  • Pharmaceutical & Biotech Testing Centers

Contact us.

info@wintersmithadvisory.com
(801) 558-3928