ISO/IEC 17025:2017 Accreditation & Lab Consultancy Services
• We have a proven track record of successfully assisting laboratories in achieving ISO/IEC 17025:2017 accreditation. Our expertise extends to a thorough understanding of the standard, encompassing its implementation requirements. We offer extensive experience in conducting internal audits, gap analyses, and pre-accreditation audits, which are pivotal for assessing compliance with the standard. In addition to our technical knowledge, we excel in training and capacity-building, enabling laboratory staff to implement essential practices effectively. Furthermore, our strong communication skills and ability to engage with accreditation bodies are crucial in facilitating the accreditation process and addressing any queries or concerns that may arise.
Gap analysis: Initial assessment of current lab processes vs. ISO 17025 requirements.
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Action
Plan Report: Identifies steps to fill system gaps.
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Consultancy
services include guidance on implementation, documentation, and system setup.
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Developing
compliant documentation: Quality manual, procedures, forms, SOPs.
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Implementation
of Laboratory Information Management System (LIMS) as per ISO 17025.
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Training
on ISO 17025 awareness for lab personnel.
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Internal
auditor training for compliance.
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Technical
training specific to test/calibration procedures.
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Procedure
preparation for method validation and uncertainty calculation; training for lab
supervision.
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Internal
audit process to fulfill ISO 17025 requirements.
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Assistance
in closing non-conformities and supporting system implementation.
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Post-certification
assistance provided.
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Internal
resource needs: Additional personnel or outsourcing QA and calibration
specialists.
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Regular
equipment calibration and maintenance.
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Participation
in inter-laboratory proficiency tests.
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Facility
upgrades and resource supply as needed.
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Post-accreditation
support: periodic reviews, continuous training, and updates in line with
ISO/IEC 17025:2017 standards.
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Conducting
a comprehensive Gap Analysis and submitting a detailed action plan with
corrective measures.
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Guiding
the Laboratory Supervision/Team in addressing gaps identified.
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Assisting
in the creation of a Laboratory Quality Manual covering all current activities
and ISO 17025 elements, alongside preparing or revising critical Quality System
Procedures across a range of laboratory functions, which include validation,
monitoring, incident investigation, maintenance, and confidentiality protocols.
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Reviewing
existing manuals and procedures to ensure they meet ISO 17025 standards and provide
templates for necessary forms.
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Establishing
a Proficiency Testing Plan and helping with compliance checks through
inter-laboratory cross-check programs.
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Providing
ISO 17025 awareness training for staff members and training Laboratory
Supervision on uncertainty calculations.
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Facilitating
internal auditor training and method validation templates to ensure alignment
with ISO requirements.
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Conduct a
well-planned internal audit to address non-conformities prior to external
audits.
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Submit
readiness reports and assist with final documentation for accreditation
submissions.
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Mobilize
external auditors and provide ongoing support during certification audits.
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Address
concerns raised during reviews and ensured accessibility of all records.
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Close
non-conformities from external audits and submit action plans as needed.
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Deliverables:
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Initial
assessment report with recommendations.
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System
documentation, including quality manual, procedures, and work instructions.
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Training
materials and records of training sessions.
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Comprehensive
internal audit report detailing nonconformities and corrective actions.
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System
compliance review report indicating readiness for accreditation application.
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Complete
set of documents prepared for submission to the accreditation body.
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Support
and guidance documentation for both preliminary and final external audits.
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Action
plan addressing and closing all non-conformities identified during external
audits.
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Documentation
for the reassessment process, if applicable, includes subsequent guidance.
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Risk
assessment documentation specific to the accreditation scope.