ISO App Development

ISO/IEC 17025 Documentation & Accreditation Support for Laboratories

Achieving ISO/IEC 17025 accreditation is a critical step for laboratories aiming to establish credibility, ensure technical competence, and comply with international standards. I specialize in helping both newly established and long-standing laboratories develop and implement robust quality management systems that meet the requirements of ISO/IEC 17025.

Whether your organization is pursuing accreditation for the first time or strengthening its existing quality system, I provide end-to-end support—from document development to audit preparation and method validation.

Services Offered:

• Development of Nonconformity (NC) Documentation: Assist in identifying, documenting, and resolving nonconformities in accordance with ISO 17025 requirements.

• Internal Reporting and Records Management: Establish standardized templates and procedures for consistent and compliant reporting.

• Measurement Uncertainty Analysis: Determine and document uncertainty budgets based on recognized statistical models and best practices.

• Corrective and Preventive Action (CAPA): Implement systems to address issues and prevent recurrence, ensuring continual improvement.

• Standard Operating Procedures (SOPs): Develop SOPs tailored to your laboratory's operations, ensuring clarity and compliance.

• Quality Policies & Manuals: Create custom quality manuals and policy documents in line with ISO/IEC 17025 clauses.

• Internal Audit Planning: Design comprehensive internal audit master plans to monitor performance and identify areas of improvement.

• Training Materials: Develop training resources to educate staff on QMS requirements, SOPs, and audit preparedness.

• Management Review Reports: Prepare structured, comprehensive annual management review reports that align with accreditation body expectations.

• Method Development & Validation: Support scientific and technical teams in developing, validating, and documenting analytical methods.

• Consultation on Internal Audits: Provide expert advice and walkthroughs for planning, executing, and evaluating internal audits.

Additional Services:

• Conducting live internal audits to assess readiness

• Clarifying and interpreting the technical requirements of ISO/IEC 17025

• Tailored consultancy for technical disciplines including calibration, testing, and sampling

By working closely with your team, I ensure that your laboratory not only achieves ISO/IEC 17025 accreditation but also maintains an effective, efficient, and continuously improving quality management system.