Certification & Registration Audit Support
Prepare With the Perspective of Experienced Auditors
Learn the ins and outs of certification and product licensing audits from the pros at QSI.
External audits can be demanding. Preparation should begin well before the auditor arrives.
QSI helps organizations prepare for certification, registration, surveillance, recertification, API, customer, and other external audits.
Our consultants and auditors bring extensive experience with management-system requirements and the auditing process to help organizations identify and address potential issues before they become audit findings.
Prepare Before the Auditor Arrives
QSI can perform a readiness assessment or pre-assessment designed to evaluate your system from an auditor’s perspective.
Depending on your needs, we can review:
- Applicable management-system requirements
- Documentation
- Implementation
- Records
- Internal audit results
- Corrective actions
- Management review
- Personnel competence
- Supplier controls
- Risk management
- Technical requirements
- Regulatory requirements
- Customer-specific requirements
API Audit Preparation
QSI has extensive experience with API requirements and can assist organizations preparing for API audits.
Services may include:
- API Spec Q1 readiness assessments
- API Spec Q2 readiness assessments
- API licensing audit preparation
- API product specification requirements
- API audit finding response
- API special follow-up audit
- Corrective action assistance
- Management-system gap analysis
- Internal audits
- Transition to revised API requirements
Mock & Pre-Assessment Audits
A simulated external audit can provide your organization with an opportunity to identify potential weaknesses before the formal audit.
QSI can conduct an assessment using an approach appropriate to the applicable standard, specification, or certification criteria.
The objective is to identify areas requiring attention while there is still time to address them.
Audit Finding Assistance
If an external auditor identifies a nonconformity, QSI can help your organization understand the issue and develop an appropriate response.
Assistance may include:
- Understanding the finding
- Determining the extent of the issue
- Root-cause analysis
- Corrective action development
- Objective evidence
- Effectiveness evaluation
- Response preparation
Audit Readiness Is More Than Documentation
Being audit-ready means more than having procedures available.
Personnel must understand their responsibilities. Processes must be implemented. Records must demonstrate conformity. Requirements must flow into the appropriate activities.
QSI evaluates the relationship between these elements to help organizations prepare for external scrutiny.
Prepare With QSI
Don't wait until the audit begins to discover what needs attention.
Supply Chain Audits
Supply-process evaluations to track trends, improve decisions, and enhance performance