ISO 7101: Requirements for quality management systems in healthcare organizations

The implementation of the system for improving the qualifications of employees in the organization’s quality management system in accordance with the requirements of ISO 9001:2015 and ISO 7101 is carried out by GOODZON CONSULT LLC on the basis of a license to carry out educational activities.

The content of the training sessions is determined by this training program developed and approved by the organization.

Persons with higher or secondary specialized education can take this additional training course.

The implementation of the advanced training program is carried out with a focus on new goals of enterprises of any industry in the field of development, implementation, operation and improvement of the quality management system.

The program is intended for managers and responsible specialists involved in the development, implementation and improvement of the quality management system. The standard labor intensity of the program is 7 hours (480 minutes.)

When developing the program, the educational activities of the participants in the training course include the following training sessions: lectures and practical classes, work with theoretical materials, training in regulatory documents, processes.

Persons who have successfully mastered the additional training program and passed the final certification are issued qualification documents. That is, a certificate of advanced training.

If this advanced training program is successfully implemented, other training programs can also be developed in accordance with this training program. The program has been developed taking into account the requirements of ISO 9001:2015 and ISO 7101.

Objective

The objective of the course is to develop the necessary knowledge, skills and abilities in the participants of the training program, allowing them to develop competencies in the development, implementation, operation and improvement of the management system.

Objectives of the training course:

– Informing the course participants about the standards ISO 9001:2015 and ISO 7101:2023;

– Study, explanation, monitoring and analysis of the application of the requirements of ISO 9001:2015 and ISO 7101:2023;

To consolidate the acquired knowledge, training sessions are conducted with the development of practical documents on quality management systems.

Expected learning outcomes

Upon completion of the program:

The participant of the training course should have the following knowledge:

* About the basic requirements of ISO 9001:2015 and ISO 7101:2023,

* About the basic concepts used in the standards;

* About integration possibilities;

* About the product life cycle;

• About planning and applying monitoring, measurement, analysis and improvement processes;
• And the advantages of ISO 9001 and ISO 7101:2023 standards for the enterprise.

Upon completion of the training course, the participant of the training course should know:

* The basic requirements of ISO 9001:2015 and ISO 7101:2023,

* The procedure for forming processes and approach to the process in managing activities in the QMS;

* Risk and opportunity assessment methods;

* General idea of the mechanism for implementing the process approach in the development, implementation and improvement of the effectiveness of the quality management system;

* the procedure for planning activities taking into account the context, stakeholder requirements, internal and external risks, changes, etc.;

* SWOT analysis rules;

* analysis of internal audit results and the possibility of applying its results;

* methods for monitoring documented information.

Upon completion of the training course, participants acquire the following knowledge:

* systematization of knowledge obtained during the training process;

* correct definition of the processes required for the enterprise quality management system, determination of the sequence and interaction of these processes, criteria and methods for assessing their effectiveness;

* apply the acquired knowledge in practice;

* determination of stakeholder requirements;

* identification and assessment of internal and external risks;

* implementation of statistical methods at various levels of enterprise management;

* conducting information monitoring;

* Use these methods of collecting and using data for continuous process improvement.

* Understanding the requirements of ISO 9001:2015 and ISO 7101:2023 standards and the ability to explain them to other employees of the enterprise.

TRAINING PROGRAM

ISO 9001:2015 and ISO 7101:2023

The training program consists of 8 hours and is designed for 1 day. The course will be presented to the participants of the training course in the form of a presentation.

5. Duration of the train:

8 hours

6. Trainer: Full name: Murtazaev Z.S. ______________________

Position: consultant of GOODZON CONSULT LLC

7. Conclusion:

The participants actively participated in this training, received the necessary theoretical and practical knowledge. ___________________

Position: consultant of GOODZON CONSULT LLC