Subject: Quality Management System Clause 4 - Context of the organization 03.03.2016.
Many are stubborn in pursuit of the path they have chosen, few in pursuit of the goal. Friedrich Nietzsche (German Philosopher, 1844-1900)
Quality Management System
Products and services in conformity to requirements! Quality? Time Costs
Objectives of a Quality Management System Examples Consistently meeting customer requirements & ensuring legal compliance Increasing customer satisfaction & fulfilling the owners awaiting Acting proactively Modelling capable processes Ability to demonstrate conformity
Benefits of Quality Management Systems Internal advantages Better process control Process improvement Improved product or service quality Increased productivity Increased legal certainty Simplified traceability of processes Easier initiation: employees Reduced costs Increased customer satisfaction Secured corporate knowhow Support for strategy deployment Strengthened competitiveness
Benefits of Quality Management Systems External advantages Access to new markets. Sectors expecting or explicitly requiring certification of the management system Increase in the market share. Improvement of customer satisfaction, product quality, delivery performance
ISO 9000 Family type (profit-making organizations, non-profit organizations, manufacturing companies, service providers etc.) and size (micro-enterprises, small and medium-sized enterprises and large companies) to implement a quality management system.
ISO 9000 Family
ISO 9000 Family
ISO 9000 Family The quality objectives supplement other objectives of the organization
Design of the quality management system It is determined by many influencing factors:
ISO 9000 Establishes the fundamentals of quality management. Defines the relevant terms for quality management. Important basis of quality management is formed by the 7 principles of quality management.
ISO 9000 The seven principles
ISO 9001 The organization shall ISO 9001 promotes the process approach and risk-based thinking! This should help to increase customer satisfaction by meeting the customer expectations.
Visualization of the process approach
Visualization of the structure of ISO 9001
ISO 9004 Sustained success of an organization is achieved by the organization s ability to meet the requirements (needs and expectations) of its customers and other interested parties in the long run.
Interested parties Needs and expectations Quality, price, delivery performance Profitability, increase of shareholder value, legal security, transparency Good working conditions, job security, recognition, payment Mutual benefits, continuity, fair treatment Compliance with legal and statutory requirements, ethical behavior (moral behavior), environmental protection
Quality management systems - Requirements
Contents Leadership Context of the organization Support Planning Operation Performance evaluation Improvement
CLAUSE 4 - Context of the organization Topics
Scope of the quality management system the relevant external and internal issues the requirements of relevant interested parties the products and services of the organization
Context of the organization Relevant to its purpose and strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
Context of the organization Legal Technological Competitive Market Cultural Social Economical
Context of the organization Values Culture Knowledge Performance of the organization
Context of the organization Customers Proprietors Employees Suppliers Banks Authorities Unions Partners Society
Quality management system and its processes The organization shall Determine the inputs required and the outputs expected from these processes. Determine the sequence and interaction of these processes. Determine and apply the criteria and methods needed to ensure the effective operation and control of these processes.
Quality management system and its processes The organization shall Determine the resources needed for these processes and ensure their availability. Assign the responsibilities and authorities for these processes. Address the identified risks and opportunities.
Quality management system and its processes The organization shall Evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results. Improve the processes and the quality management system. Maintain and retain documented information to support the operation of its processes.
Project Work - instructions Quality Manual Select group members Get a group number Choose the group leader Choose the example organization Follow instructions based on ISO 9001 Prepare prsentation for the exam Translate project template on Serbian lang. Pass the exam Prepare section by section Finalize Quality Manual
A Goal is a dream with a deadline. Napoleon Hill (American author, 1883-1970)