What is ISO 9001?
ISO 9001:2015 is the international standard for quality management systems (QMS). It provides a framework for consistently meeting customer requirements, enhancing customer satisfaction, and driving continual improvement through effective process management and risk-based thinking.
Whether you're pursuing ISO 9001 certification for the first time or preparing for surveillance and recertification audits, our internal audits ensure your QMS is effective, conformant, and ready for your certification body.
What We Audit
Our ISO 9001 audits take a process-based approach across all requirements in Clauses 4–10, assessing three dimensions of every process:
- 1Intent: "Have you said what you do?" We review your documented processes, quality policy, quality objectives, and how risk-based thinking is embedded in your planning
- 2Implementation: "Have you done what you said?" We observe actual practices, trace processes from input to output, and interview personnel at every level
- 3Effectiveness: "Have you achieved what you intended?" We evaluate results against your stated objectives, KPIs, customer satisfaction data, and process performance metrics
- 4Evidence is gathered through interviews, direct observation, document review, and representative record sampling, in accordance with ISO 19011 guidelines for auditing management systems
Key Focus Areas
ISO 9001 is built on the process approach and customer focus. Our audits give particular attention to:
- Customer requirements and satisfaction: how requirements are determined, reviewed, communicated, and met, and how customer perception is monitored and acted on
- Process performance: inputs, outputs, interactions, ownership, resources, and measurable objectives for each process in your QMS
- Risk-based thinking: how risks and opportunities are identified, addressed, and integrated into process planning and decision-making
- Operational controls: design and development, supplier management, production and service provision, release activities, and control of nonconforming outputs
- Continual improvement: how nonconformities drive root cause analysis, corrective action, and systemic improvement across the QMS
Our Process
Most internal audits are completed within days of fieldwork, with the report delivered 3–5 business days after.
Inquiry & Scoping
We start with a discovery call and intake questionnaire to understand your organization, QMS maturity, and audit objectives. This results in a clear scope agreement and engagement letter.
Audit Planning
We define audit objectives, criteria, and a schedule. You receive a document request list so your team can prepare QMS documentation and evidence ahead of fieldwork.
Document Review
We review your QMS documentation against ISO 9001 requirements: quality policy, quality objectives, process procedures, work instructions, and process maps. We identify risk areas and prepare annotated working papers to guide efficient fieldwork.
Fieldwork
Starting with an opening meeting, we conduct interviews with process owners and staff, review documents and records, observe processes, and trace end-to-end workflows (e.g., customer order through delivery and feedback). We conclude with a closing meeting to share preliminary findings.
Reporting
Within 3–5 business days post-fieldwork, you receive a formal audit report with findings classified as Major NC, Minor NC, Opportunity for Improvement (OFI), or Positive Finding, along with the full audit package including working papers and evidence references.
Corrective Action Support
We issue Corrective Action Requests for each nonconformity and support your team through root cause analysis and remediation. We verify corrective-action effectiveness through evidence review and confirm closure of each finding, with the number of verification rounds set in your statement of work. This typically takes 2–6 weeks.
Certification Readiness
Once all major nonconformities are closed and minor findings are addressed, we confirm your readiness to proceed with the external certification audit, including what to expect from the Stage 1 (documentation review) and Stage 2 (implementation assessment) process.
Who We Work With
Our ISO 9001 internal audit services support organizations across:
- Professional and consulting services
- Healthcare and life sciences
- Technology and SaaS
- Manufacturing and production
- Construction and engineering services
We work with organizations at every stage, from first-time certification through ongoing surveillance audit readiness, and coordinate regularly with certification bodies including Prescient Assurance and other leading audit firms.
Book Your Audit
Ready to get started? Book a 30-minute scoping call.