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ISO 13485

Quality Management System

  • Overview
  • Course Outline
  • Trainer

Course Description

Awareness & Internal Auditing techniques are among the most critical tools for compliance in highly regulated industries.

  • This course aims to provide participants with the required knowledge and skills to plan & perform an internal audit based on the requirements of ISO 9001: 2015 Quality Management Systems (QMS) and ISO 19011:2018 guidelines for auditing management system.
  • ISO 9001: 2015 QMS is the latest version of an international standard designed for the organizations.
  • This training course is designed to guide you through the principles, requirements and practices of the ISO 9001 international standard and learn how to contribute to the continuous improvement of the management system. It helps in the management of Quality related documents such as CAR or non-conformance reporting, customer complaints and audit trails.This training course is designed to guide you through the principles, requirements and practices of the ISO 9001 international standard and learn how to contribute to the continuous improvement of the management system. It helps in the management of Quality related documents such as CAR or non-conformance reporting, customer complaints and audit trails.
  • A Quality Management System (QMS) is a set of coordinated activities required to produce the desired quality of products. This quality should be in conformance with specification standards that meet customer requirements in the most effective and efficient manner.
  • Quality Management‘ is the act of overseeing all activities and tasks that need to be performed to achieve a desired level of excellence. This includes implementing quality planning, assurance, control and improvement.

Course Objectives:

  • Describe the Quality management system requirements of ISO 9001
  • Describe the model of risk-based approach of ISO 9001
  • Describe the role of internal audit in the maintenance and improvement of management systems
  • Plan, conduct and report an internal audit of part of a QMS in accordance with ISO 19011:2018
  • The purpose of the training ensures a comprehensive transfer of knowledge and understanding of internal audit process based on ISO 9001:2015 requirements and ISO 19011:2018 guidelines for auditing management system.

Benefits of Implementing ISO 9001:2015:

  • Once implemented, quality management systems have the power to affect all aspects of company’s performance. However, the design and implementation of a QMS will bring two overarching benefits:
  • Meeting the organization’s requirements, which ensures that the company complies with industry regulations and provisions of services and products in the most cost-effective way.
  • Meeting customer’s needs, which will help to build trust in your company, in turn engaging even more customers, sales, and profits.
  • Other advantages include preventing errors, reducing costs, helping to communicate a willingness to produce consistent results, improving your company’s offerings, and ensuring all processes are completely controlled and defined
  • Increased customer satisfaction

Who should attend:

  • This course is designed for professionals who are involved in any aspect of management system but have limited experience, as well as those involved in any aspect of system evaluation. This includes internal audit of all departments to evaluate the effectiveness of the implemented management system.
  • This course is also suitable for those involved in the planning, implementing or supervising of an ISO 9001:2015 Quality management system, as well as internal auditors who are required to perform internal audits for their company’s ISO 9001: 2015 system. They may be management representatives, production managers, QA executives etc.

Organization Benefits:

  • When an organization has fully documented QMS, it meets two important requirements
  • Customer Requirement : It gives the customer confidence in the ability of an organization to deliver the desired output and provide consistent product or service.
  • Organization’s Requirement: It gives senior management the confidence that service can be provided at an optimum cost with efficient use of available resources.

Other than meeting customer and organization requirements, QMS will also help to:
  • Set goals for employees
  • Build motivation within the company
  • Establish a strong vision for the employees
  • Set standards for employees
  • Fight resistance towards change within the organization
  • Improve process control
  • Reduce wastage
  • Increase market share
  • Facilitate training 

S

Ahmed Sultan

Certification Manager & Lead Auditor

With more than a decade of expertise in advancing compliance and excellence, Mr. Ahmed ensures the continuous enhancement of quality, safety, environmental, and risk management standards.

Auditing Excellence

Mr. Ahmed conducted hundreds of third-party audits for ISO 9001, ISO 14001, ISO 45001, ISO 41001 systems, along with food safety audits for ISO 22000, FSSC 22000, and Global G.A.P.

Sustainable & Manufacturing Insights

Mr Ahmed promote sustainability with FSC COC audits and gap assessments according to national food safety guidelines. With over 15 years in manufacturing strengthened product quality and safety through rigorous internal audits, validations, and supplier evaluations.

Consulting and Educator

Mr. Ahmed has successfully led gap assessment, system implementations and tailored enhancements across diverse sectors, earning a distinguished reputation for his expertise in quality management and food safety.

With years of experience in teaching and mentoring, he has empowered professionals with his knowledge and guidance.

Holding an MSc in Quality Management and a B.Sc. in Agriculture, complemented by international certifications, he brings a strong foundation and strategic insight to his work

Key Roles & Expertise

• Certification Manager at TUV Limited

• Certified BRCGS Lead Auditor & Food Safety Specialist

• Former Lead Auditor at TUV Austria

• Former QA Deputy Manager at SEDICO Pharmaceutical

• Former production Specialist at MUVCO