ISO 9001

 Definition of quality management system compliant with ISO 9001: 2015. 

The Quality Management System (QMS) is  ISO 9001: 2015, a set of policies, and processes, necessary for the development, implementation, and delivery (of products and/or services) to ensure that companies can meet. 

And defined as a procedure. Customer Request; QMS is used to implement the principles of continuous improvement of services and products. Introduction  ISO 9001 compliant quality management systems can be implemented in public or private institutions. 

 

Benefits of ISO 9001: 2015 and ISO certification. 

• A documented system involves using a system-based methodology rather than an individual-based methodology, so the system will continue to function regardless of individual development. 
• Help your organization manage all its functions and activities efficiently and orderly. 
• Improve the ability of organizations to identify environmental risks, understand their environment, and identify stakeholders and their needs. 
• Implementing ISO 9001: 2015 improves processes and procedures and enhances an organization's ability to maintain quality standards throughout the life cycle of a product or service, from equipment procurement and warehousing to delivery and after-sales service. 
• Optimize the value and performance of each process by reducing all unnecessary activities that are time-consuming, costly, and labor-intensive. 
• Improve the image of the company among customers and increase their trust in the company's products and services.  
• Make your company more competitive with your competitors and give them an edge. 
• Reduction of waste, errors, and deterioration of product and service quality. 
• Improve your organization's ability to identify errors early and take corrective action in a timely manner. 
• Make employees proud of their work and improve internal and external communication processes.  
• Increased market share, sales, sales, and operating profit. 
• Saver platform that improves the  export capacity of the facility and meets the legal requirements of the exporting country, such as: 

 Approach to the implementation of quality management system ISO9001: 2015.

 Phase 1: Kick-off event and introduction of ISO 9001: 2015 project.  

The kick-off event is an employee's initial preparation and knowledge of the project, its benefits and procedures for increasing the benefits and importance of meeting the requirements of ISO 9001 certification, and the positive results expected of the company and the employees themselves. Is considered to explain. A barrier to fear of change.  

Phase 2: Gap analysis.  

Using checklists and direct interviews with employees, managers, and supervisors, visit the company's headquarters and sites where products and services are provided to examine current work practices and assess the current situation to determine if it meets the requirements of ISO 9001:201. 

Identify technical specifications and regulations and legal and national legislation applicable to the organization's work, and understand the difference between the current situation and the expected situation according to the requirements of ISO 9001.

Phase 3: Staff training and qualifications.

 Necessary to organize a series of training programs during the project to raise awareness and to help project managers and related personnel understand the ISO9001 quality control system and quality control system documentation requirements and these important concepts. 

To acquire the skills and knowledge. " Organizational Context, Stakeholders, Risk-Based Thinking, Documented Information, Corrective Actions,

Phase 4: ISO 9001: 2015 Documents required to implement a quality management system.  

In this phase, after reviewing the organization's working system based on the results of the gap analysis, the consultant begins preparing the necessary documents such as quality manuals, procedures, and forms. 

The ISO 9001 system documentation includes, but is not limited to, the following steps: 

1. Quality manual ISO9001: 2015. 
2. Management and traceability of documented information (document registration).  
3. Steps in the context of your organization 
4. Risk management procedure. 
5. Definition of goals 
6. Change management procedures. 
7. Procedures for planning the delivery of a product or service.  
8. Instructions for providing a product or service. 
9. Internal and external communication management.  
10. Training and management of human resources. 
11. Purchasing and external service providers. 
12. Differentiation and traceability. 
13. Storage procedure. 
14. Maintenance procedures.
15.  Inspection and measurement procedures.  
16. Calibration and verification procedures for measuring instruments. 
17.  Performance of special operations.  
18. Inspection of customer's assets. Inspection of non-compliant services.  
19. Implementation of corrective, preventive, and recovery measures. 
20. Implementation of internal audit. 
21. Conducting management reviews. 
22. Other steps required for the project according to ISO 9001 requirements.

Phase 5: Implement a documented system and keep records as proof of implementation. 

When the documented ISO 9001: 2015 quality management system is ready, the most important phases of the project life cycle begin. 

This is to implement the updated procedure, use all attached forms and records as proof of implementation, and monitor the implementation process. 

Make sure your document is used optimally and fits your purpose, such as a sound quality management system. Stage 

Phase 6: Internal audit 

 In this phase, the role of the internal audit is to ensure that the above process was performed correctly. It also ensures that the quality system remains effective and that all employees and contractors fulfill their assigned roles and responsibilities.

 The internal audit plan is created by the consultant, and the internal audit of the entire system is carried out by the internal audit team. Prior to this, under the guidance and support of a consultant, he will complete a qualification course to become an internal auditor of the quality management system ISO 9001: 2015. Step 

Phase 7: Schedule a meeting with management. 

As one of the key requirements of the ISO 9001 international standard, the Management Review Council was established to ensure that top management supports and demonstrates its commitment to quality systems and oversees its implementation.

Phase  8: ISO 9001 certification 

 When the consultant determines that the project is ready for ISO 9001 certification, an external audit will be arranged by one of the internationally recognized certification bodies known for their experience, effectiveness, and reputation in the field of certification. It is recommended that the agency conduct an on-site visit, review all documents and records, ensure that all requirements of the ISO 9001: 2015 quality management system specification are met, and then grant ISO 9001 certification.

Requirements for ISO 9001: 2015 

 The  ISO 9001 standard requirements are a set of standard elements designed to support the implementation and implementation of quality management systems (QMS). All requirements must apply to all companies in all sectors, whether they are manufacturers or service companies.

 In other words, the requirements show the essential elements in the QMS, but not how to implement and achieve those requirements.  The  "ISO 9001: 2015 Requirements" article is divided into eight sections (so-called ISO 9001 articles), five of which include the requirements.

 QMS requirements: Overall Quality Management System Requirements 

(Article 4). ), Management responsibility 

(Article  5), Resource management

 (Article 6), Product implementation 

(Article 7),  Measurement, analysis, Improvement 

(Article 8).  All  ISO 9001 2015 articles and the elements of the previous five articles are mandatory, except for the product validation article, which the company can remove by excluding irrelevant parts. Sections 1-3 are considered optional, but include specific sections of the specification area and references to better understand the specification, terminology, and definitions. Section 

Four  Organizational Consistency 

•  Article 5 Governance 
•  Section 6 plan 
•  Support for Clause 7  
•   Implementation 
• Performance evaluation 
•  Improvement of clause 10  

 

Guide to effective implementation of Quality Management System 

1. Full commitment of top management and their commitment to providing the necessary resources and expertise. 
2. Creating a team of employees of companies with different disciplines responsible for implementing ISO 9001. 
3. Define the responsibilities and authorities of team members and select a team leader.  
4. If necessary, hire an experienced consultant to guide the company through the ISO 9001 implementation process. 
5. Fully and accurately understand the requirements of the ISO 9001: 2015 quality management system. 
6. It provides the team with the training needed to raise awareness of the requirements and concepts of the quality management system. 
7. Implementation and development of quality system procedures, both on paper and in the company's electronic system. 
8. Analyze risks, opportunities, and goals and develop quality policies and manuals. 
9. Documented system implementation and employee commitment of all companies. 
10. Certified a group of company employees as internal auditors, conducted a documented internal audit of the entire system, and established a management audit committee. 
11.  Involve donors and conduct external certification audits.

 Institutions and sectors affected by the implementation of ISO 9001: 2015.

1. All companies, institutions, and companies with different activities and scales. 
2. Industry, trade, services, agricultural companies, and institutions.  
3. Educational institutions, universities, colleges, research institutes, and schools.  
4. Medical institutions, hospitals, medical centers, and blood banks.  
5. Financial, merchandise, insurance, and information security agencies. 
6. Contractors, construction and infrastructure companies, and facilities.  
7. A company, organization, organization, or institution that provides services or products.