Quality Systems
Quality audit that identifies and corrects problems before certification
ISO 9001 Lead Auditor certified auditors with experience in multiple industries. Complete, focused or follow-up internal audits that prepare your company for successful certification.
Types of Audit
Systematic and independent evaluation of your quality system
A quality audit is a systematic, independent and documented evaluation of your quality management system to determine whether related activities and results meet planned requirements, and whether these requirements are effectively implemented and adequate to achieve quality objectives.
Types of audit: Internal audit (performed by independent personnel for evaluation and improvement), second-party audit (supplier evaluation) and third-party audit (performed by certification body for ISO certification).
Main objective: Identify non-conformities, improvement opportunities and verify quality system effectiveness before external certification audit, minimizing risks and ensuring first audit approval.
When do you need a quality audit?
Certified company needs internal audits
ISO 9001 requires annual internal audits. You need an independent auditor to evaluate system effectiveness.
Preparation for certification
Before certification audit, you need a complete internal audit that identifies and corrects non-conformities.
System effectiveness diagnosis
Your quality system exists but you don't know if it works well. You need objective evaluation from an expert auditor.
Detect problems before external audit
External audit coming and you want to ensure no surprises. Prior internal audit is essential.
Follow-up audit
You had non-conformities in previous audit. You need to verify that corrective actions were effective.
Supplier evaluation
You need to audit critical suppliers to ensure they meet your quality requirements.
Audit services we offer
Complete Internal Audit
Comprehensive evaluation of the entire quality system according to ISO 9001:2015. Reviews all clauses and processes.
- Review of all ISO 9001 clauses
- Critical process evaluation
- Detailed findings report
- Corrective action plan
Focused Audit (by process)
Specific audit of one or several critical processes. Ideal when you need deep evaluation of specific areas.
- Focus on selected processes
- Detailed effectiveness analysis
- Identification of specific improvements
- Less time and cost
Follow-up Audit
Verification that implemented corrective actions resolved previously identified non-conformities.
- Verification of corrective actions
- Validation of NC closure
- Confirmation of improvements
- Follow-up report
5-phase audit process
Review of quality system documentation. Definition of scope, objectives and audit criteria. Preparation of checklist and audit plan. Coordination with areas to audit.
Presentation of audit team and methodology. Confirmation of scope and schedule. Establishment of communication channels and expectations.
Evidence collection through interviews, record review and process observation. Identification of non-conformities, improvement opportunities and best practices.
Presentation of preliminary findings. Discussion of identified non-conformities. Confirmation of facts and improvement opportunities.
Preparation of detailed report with findings, classified non-conformities (major/minor), improvement opportunities and recommended action plan. Delivery and presentation of report.
Complete audit service
Preparation
Documentation review, scope definition, checklist preparation and customized audit plan.
Execution
Field audit with interviews, record review, process observation and objective evidence collection.
Report
Detailed report with findings, classified non-conformities, improvement opportunities and actionable recommendations.
Action Plan
Prioritized corrective action plan with responsible parties, dates and follow-up for non-conformity closure.
Findings classification
Non-conformities are classified according to their impact on the quality system's ability to meet requirements.
Major Non-Conformity
Absence or total failure of a quality system requirement. Significant impact on ability to provide conforming products/services.
Examples:
Minor Non-Conformity
Partial failure or inconsistency in meeting a requirement. Does not compromise system capability but requires correction.
Examples:
Measurable results from our audits
Proven experience in multiple industries
Companies prepared by us
After audit and corrective actions
Of all findings and actions
Typical time for complete audit
Certified auditors
Frequently Asked Questions
Depends on organization size and complexity. For small companies (50-100 employees): 3-5 days. Medium (100-500): 5-7 days. Large (500+): 7-10 days. Includes planning, execution, reporting and meetings.
Internal audit is performed by independent personnel (can be external) to evaluate system effectiveness and prepare for certification. External audit is performed by certification body to grant or maintain ISO certification. Internal is preparatory, external is for certification.
It's normal to find non-conformities in internal audits, especially if it's the first time. What matters is having a prioritized corrective action plan. We help classify (major vs minor), prioritize and develop correction plan with responsible parties and dates. Goal is to correct before external audit.
Not necessarily. You can do internal audit to: (1) Evaluate existing quality system even if not certified, (2) Prepare for future certification, (3) Diagnose process effectiveness. Internal audit is an improvement tool, doesn't require prior certification.
Yes, we offer focused audits by process. Ideal when you need deep evaluation of specific areas like: document management, non-conformity control, management review, or critical business processes. Faster and more economical than complete audit.
The report includes: (1) Executive summary, (2) Detailed findings with objective evidence, (3) Classified non-conformities (major/minor) with ISO 9001 references, (4) Improvement opportunities, (5) Identified best practices, (6) Recommended corrective action plan with responsible parties and dates. All documented and traceable.
Do you need a quality audit?
Tell us about your need. We assign a certified ISO 9001 Lead Auditor in 48-72 hours with a work proposal.