Quality Management
ISO 9001:2015 Quality Management Readiness Checklist
A clause-aligned checklist to help teams establish a Quality Management System, demonstrate process control, and prepare for ISO 9001:2015 Stage 1 and Stage 2 audits.
- Estimated time
- 3–6 Months
- Audience
- Quality Managers, Operations Leaders, and Growing Product Organizations
- Last updated
Operational reference guide for QMS implementation. Certification is issued only after a successful audit by an accredited certification body.
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Phase 1: Context, Scope & Leadership
Phase 2: Planning & Risk-Based Thinking
Phase 3: Support & Competence
Phase 4: Operation & Process Control
Phase 5: Performance Evaluation & Improvement
FAQ
Who issues ISO 9001:2015 certification?+–
An accredited certification body (registrar) issues the certificate after Stage 1 and Stage 2 audits. This site provides an internal readiness checklist only.
Is a quality manual still required?+–
ISO 9001:2015 does not mandate a quality manual by name, but organizations must maintain documented information necessary for QMS effectiveness. Many still keep a concise manual or process map.
Can we exclude design and development?+–
Clause 8.3 may be excluded only if the organization does not perform design and development and the exclusion does not affect conformity or customer/regulatory requirements. The exclusion must be justified in the scope.
How often are surveillance audits?+–
After initial certification, registrars typically perform annual surveillance audits and a recertification audit on a three-year cycle.
Does ISO 9001 cover information security?+–
ISO 9001 focuses on quality of products and services. Information security is covered by ISO 27001. Organizations often run both management systems with shared leadership and audit processes.
Related field notes
The checklists and field notes provided on this website are for educational and informational purposes only. They do not constitute legal, financial, or professional advice. Completing a checklist does not guarantee compliance, certification, or immunity from audits. Always consult with a certified auditor or legal counsel for your specific organizational needs. Full disclaimer