1. Understand the Requirements
Before seeking ISO 9001 certification, organizations should understand the requirements of the standard. ISO 9001, published by the International Organization for Standardization (ISO) outlines the structure and key principles of a Quality Management System (QMS).
Leadership commitment is a core requirement of the standard, as effective implementation depends on involvement at a strategic level. Depending on organizational size and complexity, responsibility for certification may be assigned to a cross-functional team or a small number of individuals.
A structured approach is typically established, including defined quality objectives, required resources, and an implementation timeline.
2. Gather Documentation To Build Your QMS
Proper documentation is crucial for your QMS. It helps standardize operations and serves as a guide for maintaining quality across the entire QMS and organization.
You’ll need to outline your Quality Policy, define the scope of your QMS, set quality goals, and clarify team roles and responsibilities, procedures, and risk assessments.
3. Implement Your QMS
For certification, the QMS is expected to be integrated into day-to-day operations, with processes applied consistently across the organization.
Employees are made aware of relevant procedures, and appropriate training and resources are provided to support effective implementation
4. Run Internal Audits
Internal audits are used to evaluate whether the QMS is operating as intended.
A management review is also required, enabling senior leadership to assess QMS performance and determine priorities for improvement.
These activities provide evidence of monitoring and continual improvement.
5. Stage 1 Audit (Readiness Review)
Stage 1 is designed to confirm readiness for Stage 2. The auditor will typically:
- Review key documented information
- Confirm scope and site details
- Identify any areas not yet demonstrating conformity with ISO 9001 requirements that would prevent an effective Stage 2 audit.
You’ll receive an audit report outlining any concerns that need to be addressed before Stage 2.
6. Stage 2 Audit (Certification Audit)
Stage 2 evaluates how effectively your QMS is implemented day-to-day.
The auditor will:
- Interview team members and process owners
- Review objective evidence (records)
- Observe processes in operation
- Evaluate conformity to ISO 9001 requirements
If nonconformities are identified, corrective action is required. Evidence of these actions may be reviewed remotely or may require additional audit activity, depending on the nature of the findings.
7. Certification Decision and Certification
Following the audit (and closure of any required items), an independent review is completed before the certificate is issued.
