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Posted on 14 May,2025

The Step-by-step process of getting Accredited: A complete Guide?

Here's a step-by-step guide to getting a laboratory accredited, typically to standards like ISO/IEC 17025, which is the most common accreditation standard for testing and calibration laboratories worldwide. Accreditation ensures your lab meets internationally recognized quality and competence standards.

✅ Step-by-Step Guide to Getting a Laboratory Accredited

Step 1: Understand the Accreditation Standard

• ISO/IEC 17025 is the most widely recognized standard for testing and calibration labs.
• It covers two main requirements:
• Management requirements: Quality system, document control, corrective actions.
• Technical requirements: Staff competence, calibration, testing methods, equipment.

Step 2: Perform a Gap Analysis

• Compare your current lab practices against ISO/IEC 17025 requirements.
• Identify gaps or deficiencies in processes, documentation, or equipment.
• This helps determine what needs to be improved or changed.

Step 3: Develop and Implement a Quality Management System (QMS)

• Create the required documentation:
• Quality Manual
• Standard Operating Procedures (SOPs)
• Forms and records
• Implement processes for:
• Internal audits
• Management reviews
• Handling non-conformities and corrective actions

Step 4: Train Staff

• Train all personnel on:
• ISO/IEC 17025 standard
• The lab’s QMS
• Technical competence for specific tests or calibrations
• Ensure all staff are competent in their roles.

Step 5: Perform Internal Audit and Management Review

• Conduct an internal audit to assess compliance with the QMS and ISO standard.
• Hold a management review meeting to evaluate the QMS effectiveness and audit results.
• Take corrective actions where necessary.

Step 6: Choose an Accreditation Body (AB)

• Select a recognized national or international body (e.g., IQAS etc.).
• Accreditation bodies must be recognized by APAC and ILAC (International Laboratory Accreditation Cooperation).

Step 7: Apply for Accreditation

• Submit the application form and relevant documentation to the accreditation body.
• Pay applicable fees.
• Provide details of:
• Scope of accreditation (what tests/calibrations you want accredited)
• QMS documents
• Lab capabilities

Step 8: Pre-assessment (Optional but Recommended)

• An AB May offer a pre-assessment audit to identify potential issues before the formal assessment.
• It's a useful way to fix gaps before the full audit.

Step 9: On-site Assessment

• The accreditation body sends a team of technical assessors.
• They:
• Review documentation and records
• Observe staff performing tests/calibrations
• Check equipment, traceability, and lab conditions
• Any non-conformities are documented.

Step 10: Corrective Actions

• If any non-conformities are found:
• Submit a Corrective Action Plan (CAP) within the timeframe given.
• Implement the corrections and provide evidence to the AB.

Step 11: Accreditation Decision

• If all requirements are met and non-conformities are resolved, the AB grants accreditation.
• You'll receive:
• Accreditation certificate
• Scope of accreditation document

Step 12: Maintain Accreditation

• Accreditation is not permanent — typically valid for 2–4 years with surveillance assessments.
• You must:
• Maintain your QMS
• Conduct regular internal audits
• Participate in proficiency testing
• Keep training and equipment updated
• Undergo periodic reassessments