Importance of ISO 9001 Quality Management System
Implementation of the Quality Management System, commonly known as ISO 9001 (Quality Certification).
It is an international standard that specifies the requirements for an effective quality management system.
This certificate is issued by the International Organization for Standardization (ISO).
It is therefore considered one of the most important certificates in the field of quality management.
The ISO 9001 Quality Certification aims to help organizations improve their efficiency and achieve customer satisfaction.
This is done by providing a framework through which quality can be managed in an organized and continuous manner.
The ISO 9001 Quality Management System Certification is the strongest ally to improve the company’s ability to compete.
This is in order to be able to access markets in all regions of the world.
In addition, the quality certificate is the model that companies around the world rely on.
This is to implement their quality management systems.
The certificate adds greater value to the company’s ability to compete.
The quality management system is applied in all sectors, for example:
Automotive, aviation, health products, medical transportation, and information technology services.
Moreover, all factories in various fields and all companies with various activities…. etc.
In addition, maintaining quality certification standards is a basic requirement for the success of your company.
Learn more about the importance of ISO certificates
Implementing the ISO 9001 Quality Management System
After explaining the importance of the quality certificate, you must know how to apply it.
According to the international standard ISO 9001:2015, it consists of 10 items
The first three items are introductory items, which are:
The first item is the scope, the second item is references, and the third item is terms and definitions.
While the last seven contain the requirements of the quality management system.
The company can then be accredited on the basis of them and apply the 9001 quality certificate as it should be.
Towards implementing the ISO 9001 certificate Here is what the seven main items revolve around:
Clause 4: Organizational context
Understanding your organization in order to implement the quality management system.
The requirements include identifying internal and external issues, identifying stakeholders and their expectations.
In addition, defining the scope of the quality management system or defining your processes and how they interact.
Stakeholder expectations also include regulatory requirements.
The actions required in this clause are, for example:
- Establish the organizational context in which internal and external issues are identified (clauses 4.1 and 4.2).
- Identify stakeholders (clauses 4.1 and 4.2).
- Scope of the quality management system (clauses 4.3) This is mandatory.
Clause 5: Leadership
– This clause addresses the requirements of ISO 9001 for the quality management system.
The leadership requirements cover the need for senior management to be effective in implementing the quality management system.
Senior management therefore needs to demonstrate commitment to the quality management system.
This is done by ensuring customer focus, defining and communicating the quality policy.
In addition, assigning roles or responsibilities throughout the organization.
The actions required in this item are, for example:
- Quality policy (item 5-2) is mandatory.
- Job description procedure (item 5-3).
Clause 6: Planning
– Senior management must also plan the ongoing function of the quality management system.
In addition, the risks and opportunities of the quality management system in the organization must be assessed.
Then, quality objectives for improvement must be identified and plans must be made to achieve these objectives.
The actions required in this item are, for example:
- Risk and opportunity treatment procedure (item 6-1).
- Quality objectives (item 6-2) are mandatory.
Clause 7: Support
– The support Clause deals with the management of all resources related to the quality management system.
Thus, it covers all resources, for example:
Human resources, buildings, infrastructure, work environment, and monitoring and measurement resources.
In addition, the item includes requirements on competence, awareness, communication, and control of documented information.
The procedures required in this item are, for example:
- Resource calibration monitoring and measurement forms (item 7-1-5-1) are mandatory.
- Training, skills, experience or qualification records (item 7-2) are mandatory.
- Equipment and measuring instrument maintenance procedures (item 7-1-5).
- Procedure for competency, training and awareness (items 7-1-2, 7-2 and 7-3).
- Procedure for documentation and record control (item 7-5).
Clause 8: Operation
– Operational requirements deal with all aspects of planning and creating a product or service.
In addition, this item includes planning requirements, reviewing product requirements.
Then design, controlling external suppliers, and creating the product or service.
In addition, controlling non-conforming process outputs.
The procedures required in this item are, for example:
- Product or service requirements review records (item 8-2-3-2) are mandatory.
- Review of design and development outputs (item 8-3-2) Mandatory.
- Design and development input record (item 8-3-3) Mandatory.
- Design and development control records (item 8-3-4) Mandatory.
- Design and development output record (item 8-3-5) Mandatory.
- Design and development change records (item 8-3-6) Mandatory.
- Product characteristics to be produced and service provided (item 8-5-1) Mandatory.
- Customer property forms (item 8-5-3) Mandatory.
- Changes in production/service (8-5-6) Mandatory.
- Product or service conformity records to acceptance criteria (item 8-6) Mandatory.
- Non-conforming output record (item 8-7-2) Mandatory.
- Sales procedure (item 8-2).
- Design and development procedures (item 8-3).
- Production and service procedures (clause 8-5).
- Warehouse procedures (clause 8-5-4).
Clause 9: Performance Evaluation
– This clause includes the requirements to ensure that your quality management system is working well.
In addition, it includes monitoring and measuring your operations, assessing customer satisfaction, and internal auditing.
The actions required in this clause are, for example:
- Monitoring and measurement (clause 9-1-1) is mandatory.
- Internal audit program (clause 9-2) is mandatory.
- Internal audit results (clause 9-2) are mandatory.
- Management review results (clause 9-3) are mandatory.
- Procedure to ensure customer satisfaction (clause 9-1-2).
- Conduct internal audit (clause 9-2).
- Conduct management review (clause 9-3).
Clause 10: Improvement
– This last clause includes the requirements to improve your quality management system over time.
This includes the need to assess process non-conformities or take corrective action on processes.
Hence, the procedures required in this item are, for example:
- Results of corrective actions (item 10-1) are mandatory.
Important note:
This international standard applies to all institutions or companies, whether they produce or provide services.
In addition, all previous records and procedures apply to all activities.
However, some may be excluded depending on the nature of the activity so as not to affect the quality management system.
The most prominent aspects of ISO 9001:
- Customer focus: Meeting customer expectations or needs to ensure their satisfaction.
- Leadership: Effective leadership encourages commitment and motivates employees.
- People involvement: Benefiting from employees’ capabilities or enhancing their participation.
- Practical approach: Focusing on processes and improving them, and then achieving the specified goals.
- Continuous improvement: A constant commitment to improving all aspects of the business.
- Evidence-based decision-making: Relying on data or analysis in decision-making.
- Relationship management: Building strong and sustainable relationships with stakeholders, such as suppliers or customers.
Implementing the Quality Management System (QMS) ISO 9001
Here are the steps to implement the Quality Management System:
- Commitment and support from senior management:
- Identifying needs and expectations:
- Developing the necessary documentation
- Training employees
- Implementing the system
- Internal review
- Management review
- External audit and certification
- Continuous improvement
By implementing these steps systematically, the organization can achieve significant benefits.
Thus improving the efficiency and effectiveness of operations and increasing customer satisfaction.
How to obtain a Quality Management System Certificate
You can obtain a quality certificate from QRS, the leading company in the field of ISO certification services.