ISO 9001:2015 Quality Management System Auditor Course
Upgrade your career by learning how to implement and audit a quality management system according to ISO 9001
ISO 9001:2015 Course Description
My course explains in “plain English” all the requirements of ISO 9001:2015 discussing the intent of each sub-clause of the standard, offering solutions that can be used for the implementation of a quality management system along with examples and, of course, providing guidance on how to audit a quality management system – be it internal or external audit.
After going through all the lessons in the course you will have a perfect understanding of ALL the requirements of ISO 9001:2015. You will be able to conduct or participate in the implementation or the assessment of a Quality Management System.
The structure of the course includes 3 parts:
– the first part is introductive – it discusses concepts like “quality” and quality management system, it presents the most relevant standards in the ISO 9000 series, a short history of ISO 9001 and it also covers two very important concepts for understanding a quality management system – process approach and risk-based thinking;
– the second part of the course is a detailed presentation of all clauses and sub-clauses in ISO 9001:2015 – it follows the structure of the standard so we will be discussing about the context of the organization, the scope of the QMS, about leadership and the involvement of the top management in the QMS, about the quality policy, about roles, responsibilities and authorities, about risks and opportunities, quality objectives and plans for their achievement, about the resources needed for the QMS, including infrastructure, environment for the operation of processes, competent people or organizational knowledge, about the documentation that supports the QMS and its control, about the process that the organization should follow for the design and development of its products and services, about customer communication, purchasing and the control of processes, products and services obtained from external providers, about identification and traceability, the control of goods property of customers and external providers, about preservation requirements, about post delivery activities and the management of non-conforming outputs, about the requirements for monitoring customer satisfaction about internal audits of the QMS, about the management review, the management of nonconformities in the QMS or the continual improvement of the management system.
– the third and last part of my course is about management system auditing in general – it discusses subjects such as the principles of auditing and the different types of management system audits, audits scope, objectives and criteria, conducting a QMS audit, audit plan and report or how nonconformities and opportunities for improvement should be managed.
All the key requirements of ISO 9001:2015 are being explained like: context of the organization; risks and opportunities; QMS scope; quality policy and objectives; infrastructure; competence; awareness; measuring and monitoring resources; documented information; design and development; customer communication; reviewing customer requirements; property belonging to customers or external providers; preservation; control of externally provided processes, products and services; identification and traceability; post-delivery; release of products and services; nonconforming outputs; customer satisfaction; internal audit; nonconformity and corrective action or management review.
The course DOES NOT ONLY READ THE REQUIREMENTS OF ISO 9001:2015 but it speaks about the intent of each requirement, gives examples and solutions for the implementation. It is a great tool for auditing or implementing a Quality Management System.
If you are working with ISO 9001 in your day-to-day business or you want to know about quality management and take advantage of the opportunities in this sector – this course is what you need.
If you want to apply for certification as a QMS auditor or practitioner then here you have all the information that you need to pass the exam and achieve your goals.
You have in this online course condensed information. You will get in 5 hours all the information that you may obtain by attending a 5-day in-class training. Plus you have lifetime access to the information here. You learn when you want, where you want and come back to the videos whenever you want.
Its a great offer that you should take advantage!
Enroll now!
Who the ISO 9001:2015 Course is for:
- Quality Managementy System Auditors
- Management system consultants
- People involved with quality management in their companies
- Quality engineers
- QA/QC specialists
- Quality managers
- Quality professionals looking to become certified as QMS auditors or implementers
- Quality analysts
- Beginners in the field of quality management and QMS auditing
What you’ll learn on the ISO 9001:2015 Course
- The requirements for a Quality Management System according to ISO 9001
- How to audit a Quality Management System
- Plan, perform and report QMS Audits
- How to implement a Quality Management System and comply to the requirements of ISO 9001:2015
- Auditing a management system according to ISO 19011:2018
ISO 9001:2015 Course Program
9 sections • 67 lectures • 4h 57m total length
Introduction
About the intent of the course and its structure.
What is quality?
What is the definition of “quality”? What is the first step for an organization that wants to offer “quality” products and services.
A Quality Management System (QMS)
What represents a management system and what is a QMS.
ISO 9001 and the ISO 9000 series of standards
About the standards in the ISO 9000 series. The timeline of ISO 9001.
About the certification to ISO 9001
Information about the certification of organizations to ISO 9001 and the certification of persons as quality management system professionals.
Process approach
What is a process. What are the characteristics of a process. What is the process-approach.
WHat is the PDCA (Plan-Do-Check-Act)
Risk based thinking
About the concept of risk-based thinking and its application within the QMS.
The structure of ISO 9001:2015
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)
Understanding the organization and its context
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.
Needs and expectations of interested parties
Who are the interested parties (or stakeholders) that an organization should identify. Examples of interested parties.
Determining the scope of the management system
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
Quality management system and its processes
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.
Leadership and commitment
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.
Customer focus
How to maintain a focus on customers and their requirements. How to audit the requirements of ISO 9001:2015 for customer focus
Establishing and communicating the quality policy
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.
Organizational roles, responsibilities and authorities
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.
Actions to address risks and opportunities
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.
Quality objectives and planning to achieve them
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 of changes
Planning to control changes in the organization and mitigate their negative consequences.
Resources
Generic information about the resources needed for the establishment, implementation and improvement of the quality management system.
People
About the requirements in ISO 9001 to provide sufficient people to control processes and for the effective implementation of the quality management system.
Infrastructure
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.
Environment for the operation of processes
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.
Monitoring and measuring resources
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.
Organizational knowledge
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.
Competence
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.
Awareness
The requirements of ISO 9001:2015 for ensuring the awareness of the persons working for the organization. How to achieve awareness and why.
Communication
The requirements of ISO 9001 for effective communication processes. What is the organization required to ensure. Auditing the requirements of ISO 9001 for communication.
Documented information
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.
Operational planning and control
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.
Customer communication
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.
Determining the requirements for products and services
About the requirements to determine the requirements for products and services to be offered to customers.
Reviewing the requirements for products and services
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.
Design and development of products and services
General aspects about the design and development processes in an organization, according to ISO 9001:2015
Design and development planning
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.
Design and development inputs
About input elements to design and development – like functional requirements, information from previous similar projects, etc.
Design and development controls
Controls to design and development – review, verification, validation.
Design and development outputs
Elements generated from the design and development processes. The outputs of design and development.
Design and development changes
How to control the changes to design and development.
Auditing the requirement of ISO 9001:2015 Design and development of products and services.
Control of externally provided processes, 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.
Type and extent of control
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.
Information for external providers
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.
Control of production and service provision
General requirements to ensure production and service provision processes are performed in controlled conditions.
Identification and traceability
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.
Property belonging to customers or external providers
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.
Preservation
About the requirements to preserve the conformity of products and services.
Post-delivery activities
About post-delivery activities – like customer communication, installation, warranty, maintenance or recycling.
Auditing the post-delivery activities during a QMS audit.
Control of changes
About the actions to control changes to the production and service provision processes to ensure products and services continue to conform to requirements.
Release of products and services
How to ensure products and services meet requirements before releasing them.
Auditing the release of products and services.
Control of nonconforming outputs
About the management of nonconforming products and services.
How to audit the process to handle nonconforming products and services during a QMS audit.
Monitoring, measurement, analysis and evaluation
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.
Customer satisfaction
About monitoring customer perception.
Collecting information on customer satisfaction.
Review the information on customer satisfaction.
Auditing customer satisfaction as per ISO 9001:2015.
Analysis and evaluation
About analysing and evaluating the data collected through monitoring and measuring.
Internal audit
Planning and performing internal audits of the quality management system.
Requirements for the auditors performing internal audits.
Management review
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.
Improvement
General aspects on the improvement of the Quality management system.
Nonconformity and corrective action
The process of managing nonconformities.
Implementing corrective actions and evaluating their effectiveness.
Auditing the requirements of ISO 9001 about nonconformities and corrective actions.
Continual improvement
About the continual improvement of the suitability, adequacy and effectiveness of the quality management system.
Management system auditing
What is a management system audit.
Principles of management system auditing.
Types of management system audits
About internal audits, second party audits and third party audits.
Definition of audit client and audit.
Audit scope, objectives and criteria
Key elements of any management system audit – objectives, scope and criteria.
Audit team
A few aspects about the audit team performing a management system audit.
The audit plan
What information should be included in the audit plan for a management system audit.
Conducting the 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.
Nonconformities
How are the nonconformities to be addressed by the audited organization. Different types of nonconformities. The difference between nonconfomrity and opportunity for improvement
The audit report
What information should be included in the audit report for a management system audit. Who is responsible to elaborate the audit report.
Thank you and good bye!
Thank you for participating in my ISO 9001:2015 Quality Management System Auditor course.
ISO 9001:2015 Quality Management System Auditor Quiz – 6 questions
Perhaps you will be interested
