ISO 9001:2015 Quality Management System Consultancy

ISO 9001:2015 Implementation stages:

• Stage 1: Opening Meeting and Introduction to Project ISO 9001:2015
  

The opening meeting is considered as the first preparation for the employees and their introduction to the project and its benefits and steps, explain the benefits and importance of complying with ISO 9001 requirements to obtain ISO 9001 certification and the expected positive results for the company and the employees themselves to break down the barriers of fear of change.

• • • Stage 2: Gap analysis GAP Analysis

Using check list and interviews with employees, all of operations and management staff, On-site visit is conducted to the client’s premises to make an assessment to the current working procedures in order to assess the current state of operations and determine their compatibility with the requirements of the standard Specification of ISO 9001:2015 and to identify the applicable technical specifications, regulations and legislation, and to define the gap between the current situation and the situation hoped to be reached in accordance with the requirements of ISO 9001.

• Stage 3: Training and rehabilitation of human resources

Through the implementation of a series of training programs over the duration of the project with the aim of spreading awareness and knowledge to qualify project team with the needed skills and knowledge necessary to understand the requirements of the Quality Management System (ISO 9001), And the requirements for the preparation of quality management system documents and understanding of basic concepts of ISO 9001 standard such as “PDCA Cycle, The context of the organization, Interested parties, Risk-based thinking, Documented information, Corrective actions…. Etc., In addition to qualifying a group of the organization’s cadres to be internal auditors

• Stage 4: Documentation – documents required to establish a quality management system ISO 9001:2015

During this stage, based on the results of the gap analysis stage and after reviewing the organization’s working systems, The consultant will start the work on the creation of the required documents, Including quality manual, procedures and forms, ISO 9001 documents include the following procedures, but not limited to:

1. 1. Quality Guide ISO 9001:2015
   2. Procedure of control of documented information (documents – records)
   3. Procedure of context of the organization
   4. Risk management procedure
   5. Procedure of objectives
   6. Procedure of changes management
   7. Procedure of planning for the delivery of a product or service
   8. Procedure of product or service provision
   9. Procedure of internal and external communications
   10. Procedure of Training and human resources
   11. Procedure of purchasing and external service providers
   12. Procedure of identification and traceability
   13. Procedure of Storage
   14. Procedure of Maintenance
   15. Procedure of Monitoring and measurement
   16. Procedure of Calibration
   17. Procedure of special processes
   18. Procedure of customer property
   19. Procedure of Control of non-conforming services
   20. Procedure of Corrective and preventive actions and improvement
   21. Procedure of internal audit
   22. Procedure of management review
   23. Any other procedure required for the project in accordance with ISO 9001 requirements

• Stage 5: implementation of the documented system and record keeping as evidence of the application

After completing the preparation of the ISO 9001:2015, The most important stage begins in the project, Which is the implementation of the new procedures, the using of all forms attached to this procedures and the preservation of those records as evidence of the implementation, In addition to monitoring the implementation process to ensure the optimal use of documents and achieving the desired goal in the presence of a strong quality management system.

• Stage 6: Internal Audit
  

At that stage, the role of internal audit is verifying previous stages is and to confirm that it has been done well, It also ensures the continuity of the efficiency of the quality system and the commitment of all employees to the roles and tasks assigned to them, The internal audit plan is prepared by the consultant, An internal audit of the whole entire system will be carried out by the internal audit team under the supervision and assistance of the consultant, This stage is preceded by the implementation of the Internal Auditor course for the Quality Management System (ISO 9001:2015)

• Stage 7: conducting of the Management Review Committee Meeting Management Review Meeting

The management review meeting is conducted as one of the most important requirements of the International Standard ISO 9001 to ensure the support of top management in the implementation of the quality management system and demonstrate its commitment towards it, In addition to reviewing the overall performance of the company and providing the required resources, The company’s management is assisted in processing the preparation of meeting inputs, Manage it, record decisions and recommendations and follow up of their implementation.

• Stage 8: ISO 9001:2015 certification ISO 9001 by Certification body ISO 9001 Certification

Once the consultant has acknowledged the readiness of the project to obtain the ISO 9001 certificate, requesting of the external audit to be carried out by one of the internationally accredited certification body, which are recognized for their experience, competence and good reputation in the field of certification, By carrying out a field review and reviewing all documents and records and then recommending the granting of iso 9001 after ensuring that all requirements stipulated in the Quality Management System (ISO 9001:2015) specification are met and met.

ISO 9001:2015 Clauses

• Clause 4 Context of the Organization
• Clause 5 Leadership
• Clause 6 Planning
• clause 7 Support
• Clause 8 Operation
• Clause 9 Performance evaluation
• Clause 10 Improvement

Guidelines for effectively applying quality management system:

1. Full commitment by senior management and commitment to provide the necessary resources and resources
2. The formation of a team of employees of the company includes different disciplines and be responsible for the application of ISO 9001
3. Identify the responsibilities and powers of the team members and choose a team leader
4. Use a specialist consultant to guide the company in the iso 9001 application process if necessary
5. Full and accurate understanding of the requirements of the quality management system in accordance with ISO 9001:2015
6. Provide some necessary courses for the team to raise awareness of the requirements and concepts of the quality management system
7. Building and preparing quality system procedures and be paper procedures or through the company’s electronic system
8. Risk analysis, opportunities and objectives, quality policy and quality guide
9. Applying the documented system and obliging all employees of the company
10. Qualifying a group of employees of the company to be internal auditors and implement ing internal audit on the entire documented system and implementing the meeting of the management review committee
11. Call donor and external certification audit

Entities and sectors interested in applying ISO 9001:2015

1. All companies, institutions and bodies of different activity and size
2. Companies and industrial, commercial, service and agricultural institutions
3. Educational institutions, universities, institutes and schools
4. Health institutions, hospitals, medical centres and blood banks
5. Financial institutions, items, insurance companies and information security
6. Contracting companies, construction and infrastructure
7. Any company, entity, body or institution that provides services or products