ISO 7101 Overview HCQMS

About Course

The overview trainings introduce ISO, a review of the elements of the applicable standard(s), and the necessary steps to becoming certified.

Benefit of the ISO 7101 HCQMS Overview Course

The ISO 7101 QMS Overview Course provides a comprehensive introduction to the foundational elements of the ISO 7101 standard, equipping your team with the knowledge to implement and sustain a robust Quality Management System effectively. This course is designed to elevate your company from ad hoc practices to a systematic and integrated approach to quality management, ensuring that all processes align with international standards. Participants will gain a deep understanding of the ISO 7101 requirements, from documentation and process management to operational and performance metrics, empowering them to confidently contribute to the organization’s quality goals.

Why This Course is Essential:

This course is essential because it lays the foundation for your entire quality management strategy, ensuring that all team members are aligned and informed. Understanding the ISO 7101 standard is not just about compliance—it’s about driving continuous improvement, increasing operational efficiency, and fostering a culture of quality throughout the organization. By equipping your team with this critical knowledge, you ensure that everyone is prepared to support the company’s goals, contribute to successful certification, and ultimately, enhance customer satisfaction. This training is a vital step towards building a strong, sustainable QMS that can adapt to evolving market demands and regulatory requirements.

Training Objectives

Who should attend

Course Curriculum

Intro to the Course

About the Course

22:00
Intro to course

22:00

Project Mgmt of Implementation
ISO 7101 training highlights the advantages of ISO standards for businesses and government, focusing on sustainable development and operational efficiency. With over 60 years of experience and 18,000 collaboratively developed standards, ISO enhances performance, customer satisfaction, and global trade. The training emphasizes the importance of a quality management system (QMS) for regulatory compliance, detailing the seven principles of ISO standards and the steps for ISO 7101 registration, including documentation, internal audits, and mandatory employee training. Management reviews and group interviews are crucial for aligning procedures with ISO standards and ensuring successful implementation and certification.

Process Management Approach
Explore the third video in the ISO 7101 series, focusing on ISO 9001 process management in healthcare. Learn about the importance of customer focus, leadership roles in implementing Quality Management Systems (QMS), and the significance of user feedback for continuous improvement. Discover how to identify and map processes, allocate resources effectively, and establish key performance indicators (KPIs) to enhance patient outcomes. The video also emphasizes risk management, strategic direction, and the PDCA for healthcare PDSA ~study cycle for ongoing success in healthcare organizations.

The Standard Outline
ISO 7101 training focuses on enhancing healthcare quality management systems by building on the principles of ISO 9001. It emphasizes patient-centered care, ethics, and safety, with a specific focus on organizational context, stakeholder expectations, and leadership roles. Key terms are redefined for the healthcare sector, and organizations are guided to understand internal and external issues, including climate change. The training will also cover the importance of defining the scope of the quality management system, integrating stakeholder needs, and ensuring effective documentation and continuous improvement.

Leadership
Explore the key highlights of ISO 7101 training, emphasizing leadership commitment and the integration of a new "access to care" standard in healthcare. Learn about the transition from management to leadership, the importance of defining mission and values, and establishing quality governance structures. Discover how effective communication, risk-based thinking, and accountability enhance user experience while aligning with UN sustainability goals for universal healthcare coverage.

Risk and Opportunities
ISO7101 introduces a new healthcare quality management standard that emphasizes proactive risk identification and management, moving away from traditional preventive actions. The standard is structured into three planning sections, highlighting the importance of understanding organizational stakeholders to identify risks effectively. It integrates risk management with corrective action programs, fostering a risk culture supported by top management and continuous workforce education. Key methodologies like FMEA are recommended for assessing risks, which should be documented, monitored, and regularly reviewed to enhance patient safety and quality. A structured approach to risk management is essential, involving the identification, analysis, and prioritization of risks, while ensuring accountability across departments.

Quality Objectives and Resource Management
An overview of ISO 7101 training highlights the importance of establishing quality objectives early in project management, emphasizing the need for simplicity and alignment with the quality policy. Objectives should adhere to SMART criteria and incorporate user experience assessments, while considering socioeconomic and cultural factors. The training also covers the necessity of document control, electronic record-keeping, and cybersecurity measures, alongside the importance of regular audits and auditor training. Future sessions will delve into HR processes within a Quality Management System (QMS).

Operations
Explore the essential components of ISO 7101 training, emphasizing operational aspects crucial for healthcare facilities management. Key topics include effective planning, control, and service design, alongside the importance of managing outsourced services and maintaining quality through approved suppliers. The training covers preventive maintenance, safety compliance, and waste management, highlighting environmental responsibility in line with ISO 14001 standards. Additionally, learn about the management of patient belongings and the upcoming discussion on emerging technologies in healthcare.

Measurement and Analysis
Explore the essentials of ISO 7101 training, focusing on measurement, analysis, and follow-up activities. Key topics include monitoring performance, conducting internal audits, and the critical role of management reviews in quality management systems. Learn how to evaluate supplier performance, align Key Performance Indicators with health standards, and ensure compliance through effective audit programs. The training emphasizes the importance of auditor qualifications and the need for timely corrective actions based on audit findings, all while highlighting the significance of data analysis in management reviews.

Management Review, Continual Improvement and Corrective Action Program
The final overview of the standard 7101 training emphasizes the importance of understanding key sections of the standard and internal procedures for management and implementers. Participants will complete a quiz and receive a certificate, with a focus on measurement analysis and management reviews to evaluate QMS performance. Regular management reviews, including data discussions and action items, are essential for assessing progress and identifying improvement opportunities. The training also covers audit preparation, the significance of honest communication with auditors, and the necessity of continuous improvement through corrective action programs. Feedback is encouraged to enhance future training sessions.

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