Introduction to ISO 9001:2000 Copyright, 2002 © Jerzy R. Nawrocki Quality Management Lecture 15 Quality Management Lecture 15

J. Nawrocki, ISO 9001 The History of Quality Standards 1920’s: Munitions Standard, UK 1950’s: US Navy Polaris submarine programme, Admiral Hymen Rickover, 18 root causes of quality problems 1979: British Standards Institution, BS 5750 series on quality systems, 20 quality factors 1987: ISO 9000 set of standards ‘Quality Management Systems’ 1994: ISO 9000: : ISO 9001:2000 a significant refinement 2001: PN-EN ISO 9001

J. Nawrocki, ISO 9001 ISO 9000:2000 series ISO 9000:2000 Quality Management Systems – Fundamentals and vocabulary (superseding ISO :1994) ISO 9001:2000 Quality Management Systems – Requirements (superseding ISO 9001:1994, ISO 9002:1994, ISO 9003:1994) ISO 9004:2000 Quality Management Systems – Guidelines for performance improvements (superseding ISO :1994, ISO :1994)

J. Nawrocki, ISO 9001 QualityQuality The degree to which a set of inherent characteristcs fulfils requirements

J. Nawrocki, ISO 9001 Quality Management System Management system: system to establish policy and objectives and to achieve those objectives Quality management system: management system to direct and control organization with regard to quality.

J. Nawrocki, ISO 9001 QMS Development & Implementation Determine the needs and expectations of customers Establish the quality policy and quality objectives Determine the processes and resposibilities Determine and provide the resources Establish methods to measure effectiveness of each process Apply these measures Determine means to preventing nonconformities Establish and apply a process of continual improvement of QMS

J. Nawrocki, ISO 9001 QMS Documents Quality manual – organisation’s QMS Quality plans – QMS applied to a specific project Specification – description of requirements Guidelines – recommendations or suggestions Documented procedures, work instructions – description of process and activities Records – provide evidence of activities performed and results achieved

J. Nawrocki, ISO 9001 Plan of the lecture McCall’s quality factors Operating environment Metaphor of the system System’s functionality Standard traced-from relation

J. Nawrocki, ISO 9001 SummarySummary CMMI: A software specific quality management standard CMMI: Measurement and Analysis ISO 9001: A general quality management standard

J. Nawrocki, ISO 9001 Further readings PN-EN ISO 9001: Systemy zarządzania jakością – wymagania, PKN, wrzesień 

J. Nawrocki, ISO 9001 HomeworkHomework Prepare a document template for SDS requirements

J. Nawrocki, ISO 9001 Quality assessment 1. What is your general impression? (1 - 6) 2. Was it too slow or too fast? 3. What important did you learn during the lecture? 4. What to improve and how?