The certification process for ISO 22716 is divided into two distinct phases. While both are mandatory for initial certification, their objectives, outcomes, and the nature of their findings differ significantly.
Stage 1: The Documentation & Readiness Review
The primary objective of a Stage 1 audit is to evaluate the “design” of your management system. It is a high-level review conducted to determine if the organisation is prepared for the full assessment.
- Focus: Review of the GMP manual, SOPs, site layout, and the status of internal audits and management reviews.
- The Nature of Findings: Non-conformities (NCs) identified at this stage are classified as Potential Non-Conformities. * Implications: These findings serve as a formal warning that the current system, if left unchanged, will fail the Stage 2 assessment. They do not prevent the process from moving forward, but they dictate the areas of focus for the next phase.
Stage 2: The Effectiveness & Implementation Audit
Stage 2 is the “Audit of Fact.” This is where the auditor verifies that the documented system is actually being followed on the factory floor.
- Focus: Live production observation, traceability challenges, hygiene practices, and personnel interviews.
- The Nature of Findings: Non-conformities raised at Stage 2 are Actual Non-Conformities.
- Implications: These findings have direct implications for certification. A “Major” NC will prevent the issuance of a certificate until corrective action is verified. A “Minor” NC will require a documented action plan before the certificate can be released.
Summary Table: The Evolution of Findings
| Feature | Stage 1 Audit | Stage 2 Audit |
| Primary Goal | System Design & Readiness | System Effectiveness & Evidence |
| Location | Often Desktop or Partial Site Tour | Full Site & Production Assessment |
| NC Status | Potential NCs (Warnings) | Actual NCs (Barriers to Certification) |
| Outcome | Recommendation to proceed to Stage 2 | Recommendation for Certification |
