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[Audio] Greetings, Learner! Welcome.. SINCE 1909 Mitta.

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[Audio] This is ISO 9001:2015 Quality Management System Awareness Training – the first learning module of QMS..

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[Audio] In this module, we will discuss the ISO 9001:2015 Quality Management Systems – Requirements of the international standard and everything that we need to know about the ISO 9001:2015 Certification Process that the organization is currently involved with. This module aims to provide you with helpful learning insights so let's get right into it..

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[Audio] To encourage active participation throughout this two-part awareness training, we will have a workshop to be participated by all attendees and will be conducted simultaneously with the discussion..

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[Audio] The workshop will be a revalida and instructions of which are as follows..

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[Audio] Let us officially begin the training with the first part – the ISO 9001:2015 Quality Management System – Requirements..

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[Audio] By the end of part one, you are expected to recognize the benefits of ISO 9001:2015 in an organization and to understand the requirements of this international standard and how these requirements are being integrated and applied in Chong Hua Hospital's very own management system..

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[Audio] ISO or International Organization for Standardization is an independent, non-governmental international organization with a membership of 167 national standards bodies and a Central Secretariat in Geneva, Switzerland. The word "ISO" is derived from the Greek 'isos', meaning equal. It brings together experts to share knowledge and develop International Standards that provide solutions to global challenges. At present, there are over 24,000 International Standards available..

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[Audio] Of these International Standards, the ISO 9001:2015 is one of the most popular ISO standards. It specifies requirements for a quality management system or QMS. In addition, this standard defines how an organization can meet the requirements for products and services, promotes continual improvement, and is suitable for organizations of all types, sizes and sectors..

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[Audio] The International Standard is based on the 7 quality management principles described in ISO 9000. Through Customer Focus, the primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations. Through Leadership, leaders at all level establish unity of purpose and direction and create conditions in which people are engaged in achieving the quality objectives of the organization. In the Engagement of People, it is essential for the organization that all people are competent, empowered and engaged in delivering value. By adapting Process Approach, consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system. With ongoing focus on Improvement, success of an organization is better achieved. Evidence-Based Decision Making is when decisions based on the analysis and evaluation of data and information are more likely to produce desired results. Finally with Relationship Management, organizations manage their relationships with interested parties including suppliers to sustain success..

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[Audio] ISO 9001:2015 Standard helps ensure that customers get consistent, good-quality products and services, which in turn brings many benefits. In the perspective of the organization, it will: Provide solution to problem areas Improve quality of processes Ensures compliance Getting certified in ISO 9001:2015 gives prestige to the organization In the perspective of the customer, it will: Increase degree of customer satisfaction Give assurance that products and services are of quality Enhance dependability of customers on the company products and services Ensure compliance with ISO and government requirements as these entities also serve as customers to the organization As employees, we will: Be motivated through improved communication and readily available information Be able to increase our work productivity and efficiency Reduce conflict which will result to enhanced teamwork.

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[Audio] ISO 9001:2015 adapts the Annex SL framework for all ISO management system standards. It follows the High-Level Structure (HLS) which specifies the following 10 standard clauses: Scope Normative references Terms and definitions Context of the organization Leadership Planning Support Operation Performance evaluation Improvement The High-Level Structure ensures that all management system standards contain identical clause titles, identical text and common terms and definitions. This allows the organization to integrate ISO 9001:2015 with other standards such as ISO 14001, ISO 27001 and ISO 45001. For any management system standard including ISO 9001:2015, the only clauses that contains auditable requirements are 7 which starts from Clause 4 all the way to Clause 10..

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[Audio] ISO 9001:2015 Standard employs the process approach, which incorporates the Plan-Do-Check-Act (PDCA) cycle and risk-based thinking. Using the same approach, the structure of this international standard is represented in a PDCA cycle. In the PLAN stage, the organization shall: establish the objectives of the management system and its processes, and the resources needed to deliver results in accordance with customers' requirements and the organization's policies identify and address risks and opportunities In the DO stage, the organization shall implement what was planned. In the CHECK stage, the organization shall: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities report the results In the ACT stage, the organization shall take actions to improve performance, as necessary. All throughout the PDCA cycle, there should be leadership. With this, leaders at all levels shall establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization's quality objectives. In summary: The input of the process consists of customer requirements and will be transformed by the process through the PDCA Cycle where Clauses 4, 5 and 6 is under PLAN, Clauses 7 and 8 is DO, Clause 9 is CHECK while Clause 10 is ACT. This will produce results of the QMS, quality products and services which in turn bring about customer satisfaction..

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[Audio] By incorporating the same PDCA Cycle and risk-based thinking into Chong Hua Hospital's own quality management system, the QMS Process Map has been established. This outlines the processes that the organization deemed to be necessary in the delivery of quality service – this is the quality management system of Chong Hua Hospital. It consists of 28 processes grouped into four: the Management Responsibility Process, which consists of the Planning and Objectives Process, QMS Review Process, Regulatory Management Process and Internal and External Communication Process, will receive requirements from customer and other relevant interested parties then from these requirements, provide policies and directives as well as initiate continual improvement to the Service Realization Process. the Service Realization Process, which consists of the Medication Management process, Nutrition Care Process, Social Support Process, Infection Control Process, Emergency Process, Outpatient and Diagnostic Process, Direct to Room Process, Patient Care Process, Discharge Process and Billing Process, will receive resources from the Resource Management Process and provide process data to the Performance Evaluation Process. the Resource Management Process, which consists of the Medical Staff Management Process, Recruitment Process, Training Program Management Process, Supplies and Inventory Management Process, Procurement Process, IT Management Process, Preventive Maintenance and Calibration Process, Document Control Process and Records Control Process, will received directive on the needed resources from the Management Responsibility Process and provide such resources to the Service Realization Process and process data to the Performance Evaluation Process. the Performance Evaluation Process, which consists of the System Audit Program Management Process, Change Management Process, Incident Reporting and Management Process, Risk Management Process and Customer Feedback and Satisfaction Process, will receive process data from the Service Realization Process and Resource Management Process including feedback/complaints from customer and interested parties and from this, provide performance data to all processes for continual improvement..

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[Audio] Taking into consideration the QMS of the organization, let us understand the ISO 9001:2015 Standard by defining the corresponding process in the QMS Process Map that complies with the requirements of the standard..

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[Audio] Mandatory requirements of the standard begins with Clause 4 – Context of the organization. Clause 4 contains the following subclauses:.

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[Audio] 4.1 Understanding the organization and its context. This is the requirement of the standard which is being complied by the QMS Process on Planning and Objectives. The intent of this subclause is to understand the external and internal issues. The organization should be aware that external and internal issues can change, and therefore, should be monitored and reviewed. An organization might conduct reviews of its context at planned intervals and through activities such as management review. Examples of external issues : 1) economic factors such as money exchange rates, economic situation, inflation forecast, credit availability; 2) social factors such as local unemployment rates, safety perception, education levels, public holidays and working days; 3) political factors such as political stability, public investments, local infrastructure, international trade agreements; 4) technological factors such as new sector technology, materials and equipment, patent expirations, professional code of ethics; 5) market factors such as competition, including the organization's market share, similar products or services, market leader trends, customer growth trends, market stability, supply chain relationships; 6) statutory and regulatory factors which affect the work environment such as trade union regulations and regulations related to an industry Examples of internal issues : 1) overall performance of the organization; 2) resource factors, such as infrastructure, environment for the operation of the processes, organizational knowledge; 3) human aspects such as competence of persons, organizational behaviour and culture, relationships with unions; 4) operational factors such as process or production and service provision capabilities, performance of the quality management system, monitoring customer satisfaction; 5) factors in the governance of the organization, such as rules and procedures for decision making or organizational structure. At the strategic level, tools such as Strengths, Weaknesses, Opportunities and Threats analysis (SWOT) and Political, Economic, Social, Technological, Legal, Environmental analysis (PESTLE) can be used..