ISO 9001 ISO 9001 ISO 9001

What is the quality management system (ISO 9001)?

The ISO 9001 standard is called a quality management system standard, which means that this standard seeks to create a system that manages quality throughout the organization. The purpose of the text of the 9001 standard is that the organization that implements and implements this standard commits to produce a product that has consistent quality. One of the things that is very important in ISO 9001 is system thinking and process approach. This standard sees the organization in the form of a system and with a process-oriented view of the organization, it tries to create a favorable relationship between the units of the organization so that in addition to improving the organization’s communication and the quality of these communication, it is possible to provide better products and services to the customer. did

Audience of the Quality Management System (ISO 9001) course:

1- Managers and experts of quality assurance and quality management

2- Industrial, mechanical and safety engineering students

3- Enthusiasts and students of safety, health and environment (HSE) fields

Title of the Quality Management System (ISO 9001) course:

1- Scope of application

This international standard determines the requirements of a quality management system. All the requirements of this international standard are general and are intended to be applicable to all organizations regardless of the type, size and product they offer.

2- Mandatory references

There are no mandatory references. This clause is intended to maintain consistency in clause numbering among other ISO management systems standards.

3- Definitions and terms

• Requirement: The need or expectation that is expressed is generally or common or mandatory.
• Monitoring: Determining the status of a system, a process or an activity.
• Competency: Ability to use knowledge and skills to achieve desired results.
• Effectiveness: The degree of realization of the planned activities and the achievement of the planned results.
• Policy: the objectives and orientation of the organization that is formally expressed by senior management.
• Organization: a person or a group of people who have their duties, responsibilities, powers and relationships to achieve their goals.
• Management system: It is a set of related and interactive elements of an organization to create policies, goals and processes to achieve those goals.

4- The organization’s environment in the quality management system

• Understanding the organization and its environment: the organization must determine the internal and external issues that are related to its existential objectives and strategic direction, and that affect the organization’s ability to achieve the expected results from the quality management system, as well as the organization He should monitor and review this information.
• Understanding the needs and expectations of the interested parties: Due to the potential impact of the interested parties on the ability of the organization, the following should be determined by the organization:

• Stakeholders related to the quality management system
• The requirements of these interested parties that are related to the quality management system.
• Determining the application scope of the quality management system: the organization must determine the boundaries and applicability of the quality management system to implement its application scope. When one of the requirements of this International Standard is applicable in the designated scope of application, it shall be used by the organization.
• Quality management system and its processes: The organization must create, implement and maintain the quality management system including the required processes and their interactions in accordance with the requirements of this international standard and continuously improve it.

5- Leadership and commitment in the quality management system

Senior management must demonstrate leadership and commitment to the quality management system by:

• Increasing awareness of the process approach
• Accountability for the effectiveness of the quality management system
• Ensuring the availability of resources required by the quality management system
• Conveying the importance of quality management effectiveness and compliance with quality management system requirements
• Conveying the importance of the effectiveness of quality management and compliance with the requirements of the quality management system
• Ensuring that the quality policy is communicated, understood and applied in the organization.

6- Planning for the quality management system

At the time of planning for the quality management system, the organization must determine the following:

• Evaluating the effectiveness of measures
• Achieving continuous improvement
• Prevent or reduce unwanted effects
• Actions related to risks and opportunities
• Integration and implementation of measures in quality management system processes

7- Support in the quality management system

The organization’s support should include the following:

• Capabilities and limitations of available internal resources
• Needs to be met from external suppliers.

8- Operations in the quality management system

The organization must control the planned changes and review the consequences of unwanted changes, and if necessary, reduce any unwanted changes. This planning and control of the organization’s operations must include the following:

• Determine requirements for products and services
• Implementation of process control in accordance with criteria
• Establish criteria for processes and for acceptance of products and services
• Determine the resources required to achieve compliance with product and service requirements
• Maintain documented information to the extent necessary to ensure that processes are as planned

9- Performance evaluation in the quality management system

• Monitoring, measurement, analysis and evaluation:

The organization must determine the following:

• Monitoring and measurement time
• Process performance evaluation
• Demonstrate successful implementation of planning
• Items needed for monitoring and measurement
• Time to monitor and analyze the results obtained
• Ensuring the compliance and effectiveness of the quality management system

Customer satisfaction should include the following:

• Methods of receiving and using information
• Registering and recording customer views and opinions
• Monitoring the customer’s perception of the fulfillment of requirements

• External audit:

The organization must conduct internal audits at planned intervals, and the management system’s information supply must be in line with the requirements and be effectively implemented and maintained.

• Management Review:

Management review should take into account the following:

• Customer satisfaction
• Internal audits
• Monitoring and measurement results
• Nonconformities and corrective action

10- Improvement in the quality management system

The organization must determine and select improvement opportunities and take necessary measures to meet customer needs and increase customer satisfaction. The improvement function in the quality management system can be implemented reactively, incrementally, stepwise, creatively, or reorganized and includes:

• Improving the results of the quality management system
• Process improvement to avoid non-conformities
• Improving products and services to meet known and anticipated requirements