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, offering guidance on how to audit a quality management system - be it internal or external audit.
After going through all the lessons in my course you will have a perfect understanding of ALL the requirements of ISO 9001:2015, will be able to implement a Quality Management System or to make an audit for a quality management system.
My course has a structure that includes 3 parts:
- the first part is an introduction - it speaks about the ISO 9000 family, a short history of the quality management and two concepts from ISO 9001 that I find to be the most relevant - process approach and risk based thinking;
- the second part of the course is a detailed explanation of all requirements of ISO 9001:2015 - it follows the structure of the standard so we will be discussing about the: context of the organization, leadership, planning, support, operation, performance evaluation and improvement
- the third and last part of my course is about management system auditing in general - it speaks about the principles and types of management system audits, concepts like audit scope and criteria, audit teams, audit objectives, non-conformity, audit plans and reports.
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 the full package that you need.
You will get from here condensed information (in almost 4 hours you get all the key information that you would obtain from classical training in 5 days), you learn in your own time and you can get back to the information whenever you need it.
Short history of ISO 9001 and quality management.
ISO standards related to ISO 9001 - ISO 9000, ISO 9002, ISO 9004, ISO 19011.
The APG - Audit Practices Group.
What is a process.
What is the Plan-Do-Check-Act (PDCA) cycle.
What is risk and what is the concept of risk based thinking in the view of ISO 9001.
About the internal and external issues relevant to the purpose and strategic direction of the organization.
How to audit the context of the organization.
Identify the interested parties and their needs and expectations.
How to define the scope of the QMS.
What requirements can be considered not applicable.
The auditor's approach on the scope of the QMS.
The elements of a QMS process.
The difference between maintain and retain documented information.
About top management involvement for the QMS.
How to audit top management commitment.
About ensuring that customer requirements are understood and met and the focus on customer satisfaction is maintained.
How to audit customer focus during QMS audits.
The requirements for the quality policy.
Auditing the quality policy.
About assigning roles and responsibilities for the quality management system and how to audit this requirement.
Risk management concept.
Examples of techniques to identify risks and take actions to address them.
Examples of risks and opportunities.
What options an organization has to address risks and opportunities.
How to audit risks and opportunities during a QMS audit.
Setting quality objectives.
Requrements for the quality objectives.
Plans to achieve quality objectives.
How to audit quality objectives during a QMS audit.
A few words about the management of change in an organization.
General aspects about the resources needed for the quality management system.
Providing the needed human resources for the operation of processes.
Providing and maintaining the infrastructure.
Auditing the requirements about infrastructure during a Quality Management System audit.
About the human factors and physical factors that form the environment for the operation of processes.
Auditing the environment for process operation.
Resources to monitor the conformity of products and services.
Equipment for monitoring and measuring - including requirements about traceability including calibration and verification.
Auditing monitoring and measuring resources.
Sources of knowledge in an organization.
Determining the needed competence for personnel of the organization.
Ensure that persons are competent.
Taking actions to acquire needed competence and evaluating the effectiveness of those actions.
Auditing the competence aspects during a QMS audit.
How to ensure the awareness of personnel.
Auditing awareness during a QMS audit.
Defining what, when, with whom, how to communicate and who is responsible for the communication process in an organization.
The requirements for documented information as part of the quality management system according to ISO 9001:2015.
Maintain and retain documented information.
Controls for the documented information.
Auditing the quality management system documentation.
Plan, implement and control the processes necessary for the provision of products and services.
About ensuring clear and efficient communication with customers.
Auditing customer communication.
About how to identify customer requirements with regards to products and services.
Auditng the process to determine customer requirements.
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.
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.
Specific audit documents - plans, checklists, nonconformity forms.
Opening and closing meetings.
Methods to collect information during a management system audit.
What is a nonconformity.
How should nonconformities be reported.
Major and minor nonconformities and opportunities for improvement.
What should the management system audit report include.
Cristian is an experienced auditor, consultant and trainer who has been working in conformity evaluation for more than 15 years,
Passionate about standards and how their use can help organizations improve, Cristian has been involved in more than 500 audits in different European countries as well as numerous consulting projects on different standards.
A certified auditor and risk assessor, Cristian held top management positions in a major certification body and today he is the managing director of RIGCERT.