Compliance to Certification: Your Blueprint for Sustained Quality and Global Trust.
At Accredix Certification Private Limited, we don't just audit—we partner with you to embed a culture of quality. Our integrated approach covers both the internal framework your business needs (Compliance) and the external validation required for market confidence (Certification).
We leverage the robust, risk-based principles of the ISO framework, specifically the Plan-Do-Check-Act (PDCA) cycle, to ensure your system drives continual improvement, whether you seek the global quality standard of ISO 9001 or the critical regulatory assurance of ISO 13485 for medical devices.
1. Internal Compliance: Building a World-Class QMS
This is your continuous, internal cycle of quality management, powered by the globally recognized Plan-Do-Check-Act (PDCA) methodology.
| PDCA Stage | Focus Area | Accredix Value Proposition |
|---|---|---|
| PLAN | Strategy & Risk Management (ISO Clauses 4-6) | The Foundation of Excellence: We help you define your organizational context, establish regulatory mandates (crucial for ISO 13485), and set strategic Quality Objectives aligned with risk-based thinking. This ensures your QMS is a strategic tool, not just a document. |
| DO | Execution & Technical Integrity (ISO Clauses 7-8) | Operationalizing Quality: Implement and control your core processes, from Design & Development to Production and Service Delivery. This includes deploying our specialized Shop & Site Inspections, QA/QC oversight, and Expediting Services to guarantee product and process conformity. |
| CHECK | Monitoring & Evaluation (ISO Clause 9) | Data-Driven Performance: Measure the effectiveness of your QMS through planned Internal Audits, performance analysis, and gathering customer feedback. Top Management Review ensures the system remains suitable and effective. |
| ACT | Improvement & Innovation (ISO Clause 10) | Sustaining Momentum: Address nonconformities promptly with robust Corrective Actions (CAPA). This final stage ensures your system constantly evolves, moving beyond compliance to drive true continual improvement. |
2. External Certification: Validating Your Commitment
This is the rigorous, impartial validation process conducted by Accredix to formally recognize your QMS conformity to the ISO standard.
Phase 1: Preparation and Readiness
- Application & Scoping: We work with you to clearly define the boundaries of your QMS (products, sites, processes) to ensure a precise audit focus.
- Stage 1 Audit (Documentation Review): Our expert auditors review your documented QMS information against the standard’s requirements, verifying design integrity and regulatory readiness (especially for the strict requirements of ISO 13485).
Phase 2: On-Site Validation
- Stage 2 Audit (On-Site Assessment): A comprehensive, on-site audit where we interview personnel, observe operations, and examine records. We verify that your processes are fully implemented, consistently followed, and achieving their intended results.
- Nonconformity Resolution: If deviations are found, you take timely Corrective Action (the 'ACT' stage of PDCA). Our team verifies that these actions effectively eliminate the root cause.
Phase 3: Certification & Partnership
- Certification Issuance: Upon successful closure of all findings, Accredix grants the official ISO 9001 or 13485 certificate, validating your global commitment to quality and safety.
- Annual Surveillance: We partner with you beyond the initial certification through annual audits, ensuring your QMS effectiveness is maintained, improved, and continually validated throughout the three-year cycle.
- Re-Certification: A comprehensive re-audit guarantees the sustained robustness of your QMS for the next certification cycle, protecting your investment and market standing.
Accredix: Where Trust is Certified and Excellence is Assured.