8QUALITY MANAGEMENT PRINCIPLES Customer focusLeadershipInvolvement of peopleProcess approachSystem approach to managementContinual improvementFactual approach to decision makingMutually beneficial supplier relationships
9ISO 9000 is about QUALITY Quality is: defined by customer needs defined in terms of fitness for purposeachieved through continuous improvementmanaged through prevention not detection‘getting it right at the first time’measurable
10ISO stands forI nternationalO rganization forS tandardization
11Self-manageable P-D-C-A Plan what you doDo what you planned & record what you didCheck the resultsAct on the difference
23ISO 9000 - 20 Elements 4.1 Management Responsibility 4.2 Quality System4.3 Contract Review4.4 Design Control4.5 Document & Data Control4.6 Purchasing
24ISO 9000 - 20 Elements 4.7 Control of Customer Supplied Product 4.8 Product Identification and Traceability4.9 Process Control4.10 Inspection and Test Status4.11 Control of Inspection, Measuring and Test Equipment.
25ISO 9000 - 20 Elements 4.12 Inspection and Test Status 4.13 Control of Nonconforming Product4.14 Corrective & Preventive Action4.15 Handling , Storage, Packaging, Preservation and Delivery4.16 Control of Quality Records4.17 Quality Audits
26ISO 9000 - 20 Elements 4.18 Training 4.19 Servicing 4.20 Statistical Techniques26
27Stages Setting up Steering Committee Design of Management System Training all StaffSetting up documentation systemImplementationMonitoring & Evaluation27
28Stages Internal Audit & Pre-assessment audit Certification Audit RegistrationMaintenance of the systemInternal Q AuditSurveillance Visit28
29Self-manageable Plan what you do Do what you planned Record what you didCheck the resultsAct on the difference
30Standardized Clearly listed requirements / guidelines World-wide acceptanceThe standard was revised in 1994 to make it applicable to all kinds of organisationsThere will be another revision in 2000 to catch up with the latest requirement of quality
31Systematic Inter-relationship of elements Comprehensive Team work Elements are tightly corelated. The 20 elements conserve as a comprehensive checklist for managment
32Customer-oriented Needs defined by customer Stress on customer satisfactionEnhancement of quality cultureIt stressed the satisfaction of your customers
33Objectively assessed Internal audit (Self-assessment) Audit by 3rd partyThe management system governsRegular self-evaluation is a must & a 3rd party’s assessment & effectiveness to maintain the certification status
34Clearly Documented Data and record control Document process Every item, no matter it is a procedure, a product or a responsibility, must be identifiable and traceable in black and white. The organisation is governed by a system not by a single person.
35Human resources planning and control in ISO 9001 QMS
365.1 Management commitment Top management shall provide evidence of its commitment to the development and improvement of the quality management system by:d) Ensuring the availability of necessary resources
375.5.2 Responsibility and authority Functions and their interrelations within the organization, including responsibilities and authorities, shall be defined and communicated in order to facilitate effective quality management.
385.5.4 Internal communication The organization shall ensure communication between its various levels and functions regarding the processes of the quality management system and their effectiveness.
396.1 Provision of resources The organization shall determine and provide, in a timely manner, the resources neededTo implement and improve the processes of the quality management system, andTo address customer satisfaction.
406.2.1 Assignment of personnel Personnel who are assigned responsibilities defined in the quality management system shall be competent on the basis of applicable education, training, skills and experience.
416.2.2 Training, awareness and competency The organization shall:Identify competency needs for personnel performing activities affecting quality;Provide training to satisfy these needs;Evaluate the effectiveness of the training provided;
426.2.2 Training, awareness and competency d) Ensure that its employees are aware of he relevance and importance of their activities and how they contribute to the achievement of the quality objective;e) Maintain appropriate records of education, experience, training and qualifications.
437.4.1 Purchasing controlThe organization shall control its purchasing processes to ensure purchased product conforms to requirements.The type and extent of control shall be dependent upon the effect of subsequent realization processes and their output.
447.4.1 Purchasing controlThe organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements.Criteria for selection on periodic evaluation shall be defined.The result of evaluations and follow-up actions shall be recorded
457.4.2 Purchasing information Purchasing documents shall contain information describing the product to be purchased, including where appropriate:- personnel