
About the intent of the course and its structure.
What is the definition of "quality"? What is the first step for an organization that wants to offer "quality" products and services.
What represents a management system and what is a QMS.
About the standards in the ISO 9000 series. The timeline of ISO 9001.
Information about the certification of organizations to ISO 9001 and the certification of persons as quality management system professionals.
What is a process. What are the characteristics of a process. What is the process-approach.
WHat is the PDCA (Plan-Do-Check-Act).
About the concept of risk-based thinking and its application within the QMS.
About the clauses and sub-clauses of ISO 9001:2015. The High Level Structure of the standard and how it facilitates the integration of more standards into an IMS (Integrated Management System).
About the internal and external issues relevant to the purpose and strategic direction of the organization.
How to audit the requirements of ISO 9001 that refer to the context of the organization.
Who are the interested parties (or stakeholders) that an organization should identify. Examples of interested parties.
What represents the scope of the quality management system. How to define the scope of the QMS. About the requirements of ISO 9001 that can be considered as not-applicable. How to audit the requirements of ISO 9001 about the scope of the QMS
About the identification of QMS processes. Classification of processes into different categories. The difference between maintain and retain documented information, according to ISO 9001:2015.
About the amendement related to climate change published by ISO in February 2024. This is a mandatory amendment with immediate application
About the top management as a key factor for the succes of the QMS. How should the top management demonstrate leadership and commitment for the quality management system. Auditing the requirements of ISO 9001:2015 for leadership and commitment.
How to maintain a focus on customers and their requirements. How to audit the requirements of ISO 9001:2015 for customer focus
What is the quality policy and what it should include. How to communicate the quality policy to interested parties (inside and outside the organization). Auditing the requirements of ISO 9001 for the quality policy.
About the requirements in ISO 9001 to define responsibilities and authorities for the different roles in the organization. About the persons responsible for the QMS.
Auditing the requirements of ISO 9001 about roles, responsibilties and authorities.
About risk management as part of a QMS. How to identify and address risks and opportunities. Examples of risks and opportunities that an organization may consider. Options to treat risks.
Auditing the requirements of ISO 9001 for risks and opportunities.
What are the quality objectives. Requirements for the quality objectives established by an organization. How to plan for the achievement of quality objectives. Auditing the requirements of ISO 9001:2015 for quality objectives.
Planning to control changes in the organization and mitigate their negative consequences.
Generic information about the resources needed for the establishment, implementation and improvement of the quality management system.
About the requirements in ISO 9001 to provide sufficient people to control processes and for the effective implementation of the quality management system.
About the requirements of ISO 9001:2015 about the infrastructure needed to ensure conforming products and services. What infrastructure includes and how to audit the requirements of the standard for infrastructure.
About the human and physical factors that make up the environment for the operation of processes.
Auditing the requirements of ISO 9001 for the environment to operate processes.
About the requirements of ISO 9001:2015 on the resources needed to monitor and measure processes, products and services. The difference between monitoring and measuring. Different forms of monitoring. About measurement traceability and the requirements for the equipment used to measure product and/ or service conformity.
Auditing the requirements of ISO 9001 for monitoring and measuring resources.
About the knowledge that an organization needs to operate processes and obtain conforming products and services. Sources for organizational knowledge.
Auditing the requirements in ISO 9001 for organizational knowledge.
About the requirements of ISO 9001 for determining the necessary competence for the persons in the organization and ensuring that the required competence is available. Methods to achieve the required competence.
Auditing the requirements for competence in ISO 9001:2015.
The requirements of ISO 9001:2015 for ensuring the awareness of the persons working for the organization. How to achieve awareness and why.
The requirements of ISO 9001 for effective communication processes. What is the organization required to ensure. Auditing the requirements of ISO 9001 for communication.
About the documented information that supports the quality management system. Requirements for the documentation of the QMS. Controls for the documented information (distribution, access, preservation, availability, version control).
Auditing the requirements of ISO 9001:2015 for documented information.
Generic requirements of ISO 9001 to plan, implement and control the processes that are necessary for production and service provision. Maintaining and retaining the necessary documented information, controlling outsourced processes and changes.
About the requirements in ISO 9001 for customer communication. What and how is the organization required to communicate with its customers. The auditing of customer communication requirements.
About the requirements to determine the requirements for products and services to be offered to customers.
About reviewing customer requirements to reduce the risk of making commitments without proper care.
How to audit the process of customer requirements reviiew during a QMS audit.
General aspects about the design and development processes in an organization, according to ISO 9001:2015
About the planning of design and development to determine stages and controls of this process.
Verification, validation, resources, interfaces and other elements to take into consideration when planning the design and development processes.
About input elements to design and development - like functional requirements, information from previous similar projects, etc.
Controls to design and development - review, verification, validation.
Elements generated from the design and development processes. The outputs of design and development.
How to control the changes to design and development.
Auditing the requirement of ISO 9001:2015 Design and development of products and services.
Determining and applying controls for externally provided products and services.
Supplier evaluation, selection and monitoring.
Communication with external providers with regards to the products and serivces ordered.
Auditing the control of externally provided processes, products and services during a Quality Management System audit according to ISO 9001:2015.
About the requirements of ISO 9001 for controls to be applied to the products, services and processes obtained from external providers. The connection between the type and extent of control and the risks involved.
About the requirements in ISO 9001 to provide clear information to external providers with regards to the processes, products and services that the organization intends to purchase.
Auditing the requirements of ISO 9001 on the control of products, services and processes obtained from external providers.
General requirements to ensure production and service provision processes are performed in controlled conditions.
How to ensure the identification and traceability of products and services.
Auditing the organization's capability to ensure identification and traceability of its products and services.
About the requirements to protect goods that represent property of customers or external providers and actions in case this property is lost, damage or found unuseful.
Auditing the controls on the property of customers and external providers.
About the requirements to preserve the conformity of products and services.
About post-delivery activities - like customer communication, installation, warranty, maintenance or recycling.
Auditing the post-delivery activities during a QMS audit.
About the actions to control changes to the production and service provision processes to ensure products and services continue to conform to requirements.
How to ensure products and services meet requirements before releasing them.
Auditing the release of products and services.
About the management of nonconforming products and services.
How to audit the process to handle nonconforming products and services during a QMS audit.
Determining what to measure and monitor.
Evaluating the performance and the effectiveness of the QMS.
Auditing the process to monitor, measure, analyze and evaluate during a QMS audit.
About monitoring customer perception.
Collecting information on customer satisfaction.
Review the information on customer satisfaction.
Auditing customer satisfaction as per ISO 9001:2015.
About analysing and evaluating the data collected through monitoring and measuring.
Planning and performing internal audits of the quality management system.
Requirements for the auditors performing internal audits.
On the periodic review of the QMS performed by top management.
Input and output elements to the management review.
How to audit the management review requirement of ISO 9001:2015.
General aspects on the improvement of the Quality management system.
The process of managing nonconformities.
Implementing corrective actions and evaluating their effectiveness.
Auditing the requirements of ISO 9001 about nonconformities and corrective actions.
About the continual improvement of the suitability, adequacy and effectiveness of the quality management system.
What is a management system audit.
Principles of management system auditing.
About internal audits, second party audits and third party audits.
Definition of audit client and auditee.
Key elements of any management system audit - objectives, scope and criteria.
A few aspects about the audit team performing a management system audit.
What information should be included in the audit plan for a management system audit.
About the process for conducting management system audits. The tasks of the lead auditor. The role of guides. How to minimize the disturbance to the audited organization.
How are the nonconformities to be addressed by the audited organization. Different types of nonconformities. The difference between nonconfomrity and opportunity for improvement
What information should be included in the audit report for a management system audit. Who is responsible to elaborate the audit report.
Thank you for participating in my ISO 9001:2015 Quality Management System Auditor course.
A presentation of the draft for the new edition of ISO 9001 and a comparison to ISO 9001:2015
A presentation of my other courses on Udemy
This course explains, in plain English, all the requirements of ISO 9001 — the world's most widely used quality management standard. It goes through the intent of each sub-clause, offers solutions and examples for implementing a quality management system (QMS), and provides guidance on auditing one, in internal or external audits.
The course does not simply read out the requirements of the standard: it explains what each requirement is for, and how organizations meet it in practice. After completing all the lessons you will have a thorough understanding of every requirement of ISO 9001:2015, and you will be able to conduct or participate in the implementation or the auditing of a quality management system.
Course structure
Introduction to quality management — the concepts of quality and the quality management system, the most relevant standards of the ISO 9000 series, a short history of ISO 9001, and the two concepts at the heart of the standard: the process approach and risk-based thinking
All the clauses and sub-clauses of ISO 9001 — the core of the course, following the structure of the standard: the context of the organization and the QMS scope; leadership and the involvement of top management; the quality policy; roles, responsibilities and authorities; risks and opportunities; quality objectives and the plans to achieve them; resources — infrastructure, process environment, monitoring and measuring resources, competence and organizational knowledge; documented information and its control; design and development of products and services; customer communication and the review of customer requirements; the control of externally provided processes, products and services (purchasing); identification and traceability; property belonging to customers or external providers; preservation; post-delivery activities; the release of products and services; nonconforming outputs; customer satisfaction; internal audits; management review; and nonconformity, corrective action and continual improvement
Management system auditing — the principles of auditing, the types of management system audits, audit scope, objectives and criteria, conducting a QMS audit, the audit plan and the audit report, and how nonconformities and opportunities for improvement are managed
The course is updated to account for the 2024 Amendment to ISO 9001:2015 on climate change.
Condensed, practical, always available
You get in 5 hours the information you would obtain from a 5-day in-class training — with lifetime access, so you learn when you want, where you want, and return to the videos whenever you need them.
Who this course is for
Internal auditors and candidates for QMS auditor or lead auditor roles
Quality managers, quality assurance (QA) professionals and QMS implementers
Professionals working with ISO 9001 in their day-to-day business
Consultants supporting organizations with quality management systems
Anyone preparing for certification as a QMS auditor or practitioner — this course gives you the information you need to pass the exam
If you work with ISO 9001, or you want to enter quality management and take advantage of the opportunities in this field — this course is what you need.