ISO 9001

ISO 9001 training is available as a Foundation course or an Internal Auditor course. Select the focus with your facilitator during the needs analysis.

Introduces the structure, terminology, and core tenets of the ISO 9001:2015 Quality Management System (QMS) standard.

Builds directly on the ISO 9001:2015 standard to equip delegates with the skills required to plan, execute, and report first-party (internal) and second-party (supplier) audits under ISO 19011:2018 guidelines.

What we cover

• Foundation: Module 1: Definition and Fundamentals Standards Framework: Background on ISO, the IEC, and the BSI Group. ISO 9001 Overview: Process-driven quality requirements; distinction between organizational certification and individual credentialing. QMS Core Terminology: Benchmarking, Customer Satisfaction, Continual Improvement, Effectiveness, Interested Parties, KPIs, Nonconformity, and Records. The Seven Quality Management Principles (QMPs): Customer Focus, Leadership, Engagement of People, Process Approach, Improvement, Evidence-Based Decision Making, and Relationship Management. ISO 9000 Family Structure: Relationships between ISO 9000 (Fundamentals/Vocabulary), ISO 9001 (Requirements), ISO 9004 (Guidance for Sustained Success), ISO 10012 (Measurement Management), and ISO 19011 (Auditing Guidelines).
• Foundation: Module 2: Structure & High-Level Clauses The High-Level Structure (Annex SL Clauses 1–10): Clauses 1–3: Scope, Normative References, Terms and Definitions (Contextual foundation). Clause 4 (Context of the Organisation): Internal and external issues, interested parties, QMS scope, and process interactions. Clause 5 (Leadership): Leadership commitment, Quality Policy creation, and organizational roles and responsibilities. Clause 6 (Planning): Actions to address risks and opportunities (Risk-Based Thinking) and measurable Quality Objectives. Clause 7 (Support): Infrastructure, work environment, monitoring/measuring resources, competence, awareness, communication, and Documented Information. Clause 8 (Operation): Operational planning, customer requirements review, design and development controls, external provider controls (procurement), production control, traceability, and nonconforming output handling. Clause 9 (Performance Evaluation): Customer satisfaction tracking, data analysis, internal audit programs, and executive Management Reviews. Clause 10 (Improvement): Corrective action pipelines and continual improvement execution. The Process Approach & PDCA Integration: Mapping QMS clauses directly into the Plan-Do-Check-Act cycle. Implementation Realities: Scope boundaries, common adoption pitfalls, and organizational business benefits.
• Internal Auditor: Module 1: Definition and Fundamentals Core concepts of ISO, Quality Management System (QMS) terminology, and the 7 Quality Management Principles. ISO 9000 family structure and the role of ISO 19011:2018 auditing guidelines.
• Internal Auditor: Module 2: Structure of ISO 9001:2015 Detailed review of Clauses 4 through 10 from an audit-evidence perspective. Evaluating process interactions, leadership engagement, risk-based thinking, operational controls, and performance reviews.
• Internal Auditor: Module 3: Internal Audit Structure & Planning Audit Classifications: First-party (internal), Second-party (supplier/customer), and Third-party (certification body) audits. The Audit Lifecycle: Audit Preparation: Objectives, scope, document review, and checklist drafting. Audit Performance: Opening meetings, evidence collection, and interview processes. Audit Reporting: Documenting findings and non-conformance reports. Follow-up and Closure: Validating corrective action implementation. Audit Techniques: Judgment-based vs. statistical sampling (attribute vs. variable), direct observation, process testing, employee interviews, and remote vs. on-site audits. Evidence Requirements: Mandatory documented records vs. discretionary non-mandatory procedures.
• Internal Auditor: Module 4: The Internal Auditor Auditor Roles & Ethical Conduct: Independence, objectivity, confidentiality, and professional skepticism. Core Responsibilities: Factual evidence evaluation, constructive auditee engagement, and unbiased reporting. Auditor Leadership Skills: Interview management, conflict de-escalation, and driving organizational value.
• Internal Auditor: Module 5: Audit Programme Establishing an Audit Programme: Setting program objectives, assessing risk, determining frequency, and allocating qualified auditors. The Process Audit Checklist: Applying standard audit checklists covering Clauses 4 through 10, evaluating inputs, activities, outputs, resources, KPIs, and PDCA alignment.
• Internal Auditor: Module 6: Audit Reporting & Follow-Ups Audit Report Architecture: Documenting client details, objectives, scope, criteria, executive summaries, and findings. Grading Audit Findings: Compliant: Meets standard and process criteria. Opportunity for Improvement (OFI): Low-risk process inefficiencies. Minor Non-Conformance (Minor N/C): Single or low-risk process deviations. Major Non-Conformance (Major N/C): Systemic failures impacting customer requirements or QMS integrity. Follow-up Auditing: Monitoring corrective action plans, validating risk mitigation, and closing out audit actions.
• Internal Auditor: Module 7: Procedures & Documentation Document Hierarchy: Process (What/Why) vs. Procedure (How) vs. Work Instruction (Step-by-Step Execution). Managing Documented Information: Formatting, distribution, version control, access security, and disposal (Clause 7.5). Structuring Quality Objectives: Translating Quality Policy into departmental S.M.A.R.T. objectives. Drafting Quality Policies & Turtle Diagrams: Identifying inputs, outputs, equipment, personnel, methods, and performance indicators.

Every session is customized to your organization's needs. The final agenda is confirmed with your facilitator before delivery.