DOCUMENTING & AUDIT OF QUALITY MANAGEMENT SYSTEMS

Transcription

1 DOCUMENTING & AUDIT OF QUALITY MANAGEMENT SYSTEMS Lecture 4: QMSs - basic principles and concepts according to ISO 9000 family of standards Zofia Krokosz-Krynke, Ph.D., MBA zofia.krokosz-krynke@pwr.edu.pl Wroclaw University of Technology, Building B4 Room 521

2 8 Principles of Quality Management Principle 1 Customer focus Organizations depend on their customers and therefor should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations Principle 2 Leadership Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization objectives. Principle 3 Involvement of people People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization benefit. Principle 4 Process approach A desired result is achieved more efficiently when activities and related resources are managed as a process. 45

3 8 Principles of Quality Management, cont. Principle 5 System approachto management Identifying, understanding, and managing interrelated processes as a system contributes to the organization effectiveness and efficiency in achieving its objectives. Principle 6 Continual improvement Continual improvement of the organization overall performance should be a permanent objective of the organization Principle 7 Factualapproachto decision making Effective decisions are based on the analysis of data and information. Principle 8 Mutually beneficial supplier relationship An organization and its suppliers are independent and a mutually beneficial relationship enhances the ability of both to create value. 46

4 8 Principles of Quality Management, cont. theprinciplesarea transpositionof TQM philosophyto theiso 9000 family of standards allowsmanagersto managean organizationina systematicand clear way benefits: visible improvements in the functioning of the organization, focus on value creation, profit growth, incraesed financial stability of the organization,.. ISO 9000, ISO 9001, ISO 9004, and ISO theirbase, requirements and guidelines for improvement of the QMS are grunded on the principles 47

5 The 8 Quality Management Principles reflection in ISO 9001:2000 requirements QUALITY MANAGEMENT PRINCIPLES (QMPs) THE 8 QMPS REFLECTION IN ISO 9001:2008 REQUIREMENTS, OBSERVED IN THE SELECTED CLAUSE clause 4 clause 5 clause 6 clause 7 clause 8 Quality management system 1 Customer focus 4.1; Leadership Management Resource resopinsibility management 5.1; 5.2; 5.3; 5.5.2; ; 5.2; 5.4; Involvement of people 5.5.1; Process approach 4.1; System approach to management 4.1; ; 5.4.2; 5.5.1; Product realization Measurement, analysis and improvement ; ; 7.3; 7.5.1; 7.5.2; 7.5.3; 7.5.5; ; 8.2.3; 8.5.2; ; 6.3; ; Continual improvement 4.1; ; 5.4; Factual approach to decision making Mutually beneficial supplier relationships 5.4; 5.5.2; ; 7.3.4; 7.3.5; 7.3.6; 7.3.7; 7.4.1; 7.4.3; 7.5.2; ; ; 8.2; 8.3; 8.4; 8.5.2; source: B.Sujak-Cyrul Quality Management Systems, Wroclaw

6 PDCA, PDCA cycle, Deming s wheel Establish objectives and make plans Correct and improve the plans and/or practice Plan Act Do Check Implement the plans Monitor and measure results ISO 9001 (ISO 9000 family ISO acceptspdca cycleas theoperatingprincipleof management system standards PDCA cyclecanbe applied to allprocesses source: B.Sujak-Cyrul Quality Management Systems, Wroclaw

7 Model of a process-based quality management system PROCEDURE ( specified way to carry out an activity or a process canbe documentedornot, depends on the ISO 9001 requirements) EFFECTIVENESS OF A PROCESS extent to which planned activitiesarerealizedand planned results achieved INPUT includes data and resources PROCESS ( set of interrelated activities which transforms intups into outputs POSSIBILITIES TO MONITOR AND MEASURE, when needed (before, during and after the process) OUTPUT PRODUCT also service ( resultof process.. ) EFFICIENCY OF A PROCESS relationship between resultachievedand resources used source: on the base of B.Sujak-Cyrul Quality Management Systems, Wroclaw PKN, 2001; ISO 9000:2000; ISO 9000:

8 Model of a process-based quality management system presented in ISO 9001:2000 and ISO 9001:2001 with notes referring to 5 major clauses of ISO 9001 and PDCA cycle Continual Improvement of the Quality Management System (c.4) CUSTOMERS Plan Resource Management Resposibility (c.5) Management (c.6) (c.8) Measurement Analysisand Improvement Act Satisfaction Requirements Input Do Product Realization (c.7) Check Output Product CUSTOMERS Value-adding activities Information flow source: B.Sujak-Cyrul Quality Management Systems, Wroclaw

9 Model of a process-based quality management system presented in ISO 9001:2000 and ISO 9001:2001 with ISO s suggestions referring to application of other guidelines /supporting standards CUSTOMERS Requirements Continual Improvement of the Quality Management System Plan ISO ISO Input Value-adding activities Resource Management ISO ISO ISO Do Product Realization ISO ISO Management Resposibility Measurement, Analysisand Improvement Check Output ISO ISO ISO ISO Act Product ISO ISO ISO ISO Information flow Satisfaction CUSTOMERS source: B.Sujak-Cyrul Quality Management Systems, Wroclaw

10 Basic terminological concepts term quality requirement characteristic customer satisfaction term definition (acc. ISO 9000:2005) degree to which a set of inherent characteristics fulfill requirements need or expectation that is stated, generally implied or obligatory distinguishing feature customer's perception of the degree to which the customer's requirements have been fulfilled remarks such a definition allows you to talk about the poor, good, or excellent quality there are different classes of characteristics: physical, sensory, behavioral, temporal, ergonomic, functional; may be qualitative or quantitative the complaint lodged by the client clearly indicates a lack of satisfaction; however lack of complaints does not necessarily mean a hogh level of satisfaction process set of interrelated or interacting activities which (for details see : B.Sujak-CyrulQuality Management transform inputs into outputs Systems, Wroclaw 2011, p27) product result of process as above procedure specified way to carry out an activity or a process as above as above non-fulfillment of a requirement nonconformity defect quality management system quality assurances non-fulfillment of a requirement related to an intended or specified use management system to direct and control an organization with the regard to quality part of quality management focused on providing confidence that quality requirements will be fulfilled as above as above as above source: B.Sujak-Cyrul Quality Management Systems, Wroclaw