ISO 9001:2026. Quality Management System (QMS) Lead Auditor

Determining internal and external issues, the role of climate change, and how an auditor assesses context under ISO 9001:2026.

Identifying relevant interested parties and their requirements, which to address through the QMS, and the audit perspective.

Setting QMS boundaries and applicability, justifying non-applicable requirements, and documenting the scope of ISO 9001.

Determining QMS processes, their inputs, outputs, sequence and interactions, and how an auditor evaluates the process approach.

A summary of Clause 4 of ISO 9001:2026: context, interested parties, scope, and processes.

Top management's role in the QMS, quality culture and ethical behaviour (new in 2026), accountability, and the audit perspective.

How top management ensures customer and statutory/regulatory requirements are met and customer satisfaction is enhanced.

Establishing, documenting and communicating the ISO 9001 quality policy, and how an auditor checks it is understood and applied.

Assigning and communicating QMS responsibilities and authorities under ISO 9001:2026, and the audit perspective.

A summary of Clause 5 of ISO 9001:2026: leadership and commitment, customer focus, quality policy, and roles and responsibilities.

Determining QMS risks and opportunities from context and interested parties, the four purposes, and the audit perspective.

Planning and integrating actions for risks and opportunities, risk treatment options, and evaluating their effectiveness.

Setting measurable quality objectives consistent with the policy, SMART objectives, and what ISO 9001 requires you to document.

Planning what will be done, resources, responsibilities, timing and evaluation — and how an auditor assesses quality objectives.

Making planned changes to the QMS while maintaining its integrity, what to consider, and the audit perspective.

A summary of Clause 6 of ISO 9001:2026: risks and opportunities, quality objectives, and planning of changes.

The general requirement to determine and provide QMS resources, internal capabilities vs. external providers, and the audit perspective.

Providing the people needed to operate the QMS, capacity vs. competence, understaffing and turnover, and how an auditor assesses this.

Determining, providing and maintaining infrastructure — buildings, equipment, software, IT — and auditing maintenance under ISO 9001.

Physical, social and psychological factors in the work environment, their link to quality, and the audit perspective.

Monitoring vs. measurement, suitability and calibration, measurement traceability, and how an auditor evaluates these resources.

Determining, retaining and sharing organizational knowledge, the risk of losing critical know-how, and the audit perspective.

Determining required competence, ensuring and evaluating it, documented evidence, and how competence is audited across the QMS.

What people under the organization's control must be aware of — policy, objectives, their contribution — and the audit perspective.

Planning internal and external QMS communication — what, when, with whom, how, who — and how an auditor tests effectiveness.

What documented information ISO 9001:2026 requires, plus what the organization determines it needs; no quality manual required.

Creating, reviewing and controlling documents — version control, access, retention — and the audit perspective on documented information.

A summary of Clause 7 of ISO 9001:2026: resources, competence, awareness, communication, and documented information.

Planning and controlling operations to meet requirements, acceptance and process criteria, change management, and the audit perspective.

Communicating with customers — product information, enquiries, feedback and complaints, customer property, contingency — and the audit perspective.

Determining statutory/regulatory and organizational requirements, and ensuring the organization can meet its product and service claims.

Reviewing requirements before committing to the customer, resolving differences, and documenting the review under ISO 9001.

Introduction to design and development in ISO 9001:2026, applicability, and why service organizations often design too.

Planning design and development — stages, reviews, verification, validation, responsibilities and resources.

Determining complete, unambiguous and adequate design inputs, resolving conflicts, and documenting them.

Design review, verification and validation — what each checks and how they differ — in ISO 9001:2026.

What design outputs must deliver — meeting inputs, acceptance criteria, essential characteristics — for the processes that follow.

Controlling and authorizing design changes, preventing adverse impacts, and the audit perspective on design and development.

Controlling external providers, evaluation and re-evaluation, and why ISO 9001 doesn't require suppliers to be certified.

Risk-based control of external providers, controls on the provider and the output, and keeping outsourced processes within the QMS.

Communicating requirements to external providers, plus the audit perspective on purchasing and externally provided processes.

Controlled conditions for production and service provision, and the validation of special processes such as welding and sterilization.

Preventing human error, release and post-delivery activities, and how an auditor assesses controlled conditions on the shop floor.

Identifying outputs and their inspection status, controlling traceability where required, and testing traceability during an audit.

Identifying, verifying, protecting and safeguarding customer and external-provider property, and reporting loss or damage.

Preserving outputs through handling, storage, packaging and transport to maintain conformity, and the audit perspective.

Determining post-delivery obligations — installation, warranty, support, disposal — and using post-delivery data for improvement.

Reviewing and controlling changes to production and service provision to maintain conformity, and the audit perspective.

Verifying requirements are met before release, release authority and evidence, and how an auditor traces a release.

Identifying and controlling nonconforming outputs — correction, concession, informing the customer — and the audit perspective.

A summary of Clause 8 of ISO 9001:2026: operational planning, requirements, design, purchasing, production, release, and nonconforming outputs.

Determining what to monitor and measure, the methods and timing, and evaluating QMS performance and effectiveness under ISO 9001.

Monitoring customer perception, sources of satisfaction data, and how an auditor assesses whether the data is meaningful and used.

Turning monitoring data into evidence — what ISO 9001 requires you to evaluate — and the audit perspective on analysis and evaluation.

Planning and conducting internal audits, the risk-based audit programme, impartiality, and how internal audit itself is audited.

Top management review of the QMS — inputs, outputs and decisions — and how an auditor confirms it is real, not a formality.

A summary of Clause 9 of ISO 9001:2026: monitoring and measurement, customer satisfaction, analysis, internal audit, and management review.

Continually improving the suitability, adequacy and effectiveness of the QMS, where opportunities come from, and the audit perspective.

Reacting to nonconformities, eliminating their cause, correction vs. corrective action, root-cause analysis, and how an auditor assesses this.

A recapitulation of all key requirements for a quality management system according to ISO 9001:2026

What a management system audit is, the ISO 19011 guidance standard, and the three audit types — first-, second- and third-party.

Forming the audit team, auditor competence at team level, technical experts, impartiality, and the role of the audit team leader.

Preparing for a specific audit, feasibility, document review, risk-based planning, and building the audit plan.

The opening meeting, coordinating fieldwork, communicating with the auditee, and handling issues during a QMS audit.

Reviewing documents, observing, interviewing and sampling — how auditors gather and evaluate audit evidence.

Evaluating evidence against criteria, grading nonconformities, opportunities for improvement, and the closing meeting.

What information should be included in the audit report for a management system audit. Who is responsible to elaborate the audit report.

Certification of organizations and of persons, accredited certification bodies, and the surveillance and recertification cycle.

Thank you for participating in my ISO 9001:2026 Quality Management System Auditor course.