When ISO/IEC 17021-1 was updated in 2015, certification bodies worldwide had to re-evaluate their systems. What seemed like a minor revision turned out to be a major realignment of how competence, impartiality, and risk are managed across certification activities.
This guide provides a complete roadmap for certification bodies preparing, executing, or reviewing their transition to ISO/IEC 17021-1:2015. It brings together the practical steps, tested tools, and lessons learned from real transition projects — including one certification body that achieved a successful transition within 90 days through structured planning and early verification.
Understanding the Shift – What Changed in ISO/IEC 17021-1:2015
The 2015 revision was not a simple rewrite. It was designed to align ISO/IEC 17021-1 with the High-Level Structure (Annex SL), ensuring consistency with other management system standards such as ISO 9001 and ISO 14001.
Key areas of change include:
Competence: Continuous evaluation for auditors, decision-makers, and technical experts is now mandatory.
Impartiality: Certification decisions must be structurally independent from audit execution.
Risk-based thinking: Certification bodies must identify and control factors that could compromise consistency or objectivity.
Continual improvement: The management system must actively monitor performance, not just maintain documentation.
Transitioning effectively means more than adjusting clause numbers — it means embedding these new expectations into daily practice.
The foundation of any transition is a clear gap analysis. It highlights which parts of your current system already meet 2015 requirements and where changes are required.
A strong analysis template should include:
Clause reference and short requirement summary.
Description of current practice.
Objective evidence available.
Gap identified.
Action plan with responsible person and completion date.
Verification record.
Use this document as your transition control tool — not a one-time checklist but a live tracker until every clause is verified.
Pro Tip: Prioritize clauses involving competence, impartiality, and process control; these areas cause most non-conformities during accreditation.
Once the gaps are known, focus on revising the procedures that underpin your system. The 2015 version demands more clarity, measurable performance, and built-in risk awareness.
Core procedures to review include:
Audit-Program Planning and Control: Add criteria for risk, scope, and auditor competence.
Competence Evaluation: Define qualification, witnessing, and ongoing review processes.
Impartiality Management: Separate roles between auditing and certification decisions.
Document Control: Simplify revision control and ensure traceability.
Management Review: Integrate risk, performance, and improvement indicators.
Keep updates concise and practical. Procedures should guide action, not overwhelm users with detail.
Pro Tip: Include verification steps in each procedure — “who checks it works” is just as important as “who does it.”
Step 3 – Verify Readiness Through Internal Audits
Internal audits are the proof of transition effectiveness. They show whether your new procedures and systems function as intended.
Plan the audit program to:
Evaluate revised clauses and processes.
Confirm competence records are updated and verified.
Check that impartiality and decision independence are maintained.
Test that risk controls are in place and effective.
Audit by process sequence, not clause order. This approach exposes real workflow issues that may not appear in document reviews.
Pro Tip: Schedule your transition audit at least two months before the accreditation assessment to allow time for corrective actions.
Step 4 – Strengthen Competence and Impartiality Management
Competence and impartiality are the backbone of ISO/IEC 17021-1:2015. Strengthening both ensures credibility and reduces risk of accreditation findings.
For competence:
Maintain a matrix linking each auditor or expert to relevant scopes.
Record training, witnessed audits, and evaluations.
Conduct periodic performance reviews based on audit outcomes.
For impartiality:
Keep clear separation between audit execution and certification decisions.
Document impartiality reviews and conflict-of-interest resolutions.
Demonstrate committee involvement and monitoring.
Pro Tip: Integrate impartiality verification into certification decisions — a short, documented check is powerful evidence.
Step 5 – Embed Risk-Based Thinking Across the System
Risk-based thinking underpins many 2015 changes. It requires certification bodies to anticipate and prevent problems rather than react to them.
Integrate risk consideration into:
Auditor assignment: Assess conflicts or technical limitations before approval.
Audit planning: Evaluate factors affecting duration, sampling, or consistency.
Management review: Analyze risks and opportunities for improvement.
Keep it simple. A brief “risk note” section in each procedure or record is often enough to meet intent and demonstrate awareness.
Step 6 – Manage the Transition Through Leadership and Review
Leadership involvement determines how smoothly a transition proceeds. Top management must plan, monitor, and evaluate the transition as part of their management review.
Include in every review:
Progress on gap-closure actions.
Internal audit and corrective-action results.
Competence status and training needs.
Impartiality performance and risk updates.
Opportunities for system improvement.
Pro Tip: Use visual tools — summary tables or color-coded dashboards — to show management at a glance where the system stands.
One medium-sized certification body achieved its transition within 90 days by applying these principles. They mapped clauses early, verified competence records first, and used internal audits to confirm readiness — completing accreditation with zero major findings.
These outcomes highlight that the 2015 revision rewards clarity, consistency, and leadership engagement.
Common Pitfalls to Avoid
Even well-prepared teams encountered issues during transition. The most common were:
Updating documents without updating forms or records.
Conducting internal audits too late to correct findings.
Neglecting subcontracted auditor competence.
Treating impartiality as an annual committee task rather than continuous oversight.
Overcomplicating risk management with unnecessary paperwork.
Each of these can be avoided through early verification and routine management follow-up.
FAQs – Key Questions About Transition
Q1: How long does a typical transition take? Between 3 and 6 months, depending on organization size, resource allocation, and documentation readiness.
Q2: Do we need to revise our Quality Manual? Yes. The manual must reflect 2015 clause numbering and demonstrate integration of risk-based and competence-driven approaches.
Q3: When should we schedule the transition internal audit? Two to three months before the accreditation body’s assessment to ensure time for corrective-action closure.
Building a Stronger Certification System
The ISO/IEC 17021-1:2015 transition was more than an administrative update. It reshaped how certification bodies demonstrate trustworthiness and technical competence.
Moving to the 2015 version is an opportunity to strengthen the foundation of your management system — to make processes more transparent, evidence-based, and resilient.
By conducting a thorough gap analysis, updating key procedures, verifying through internal audits, and embedding risk-based thinking, your organization can not only meet 2015 requirements but also operate with greater confidence and consistency long after the transition is complete.
Melissa Lavaro is a seasoned ISO consultant and an enthusiastic advocate for quality management standards. With a rich experience in conducting audits and providing consultancy services, Melissa specializes in helping organizations implement and adapt to ISO standards. Her passion for quality management is evident in her hands-on approach and deep understanding of the regulatory frameworks. Melissa’s expertise and energetic commitment make her a sought-after consultant, dedicated to elevating organizational compliance and performance through practical, insightful guidance.
