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ISO 9001 Training

Understanding ISO 9001:2008 Requirements for Quality Management Systems


0.0 Foreword
The purpose of this ISO 9001 training e-Book document is to provide a clear and in-depth understanding of the intent and implication of each clause and sub-clause of the ISO 9001:2008 standard. While not intended to serve as an implementation guide, this document should provide sufficient insight for a quality practitioner to develop and implement an effective ISO 9001 based quality management system (QMS). This document can be used by: Beginners - to understand and apply ISO 9001 requirements. QMS managers - to develop a more effective QMS for their organization. QMS auditors - to conduct more effective QMS audits. Top management - to gain an understanding of ISO 9001 as a business tool. Consultants - to provide value-added service to their clients. The ISO 9001:2008 standard is shown in the beige box and below each section, clause or sub-clause of the standard, I provide "key points and tips" to help you better understand the specific concepts, principles and requirements. You will find important explanatory points and tips being repeated or further elaborated in different parts of the standard. Whenever I make reference to you or your QMS, I mean your organizations or facilitys quality management system. In going through the explanatory points and tips, I request that you read each paragraph carefully and sometimes twice to fully grasp the additional interpretation or insight it may convey. By doing so, you might be able to save much time, effort and money in understanding and implementing these requirements or help make your QMS more effective and get the most of this ISO 9001 training. 0.0 ISO 9001:2000 Standard - clause headings: 0. Introduction 1.Scope 2.Normative Reference 3.Terms and Definitions 4.Quality Management System 5.Management Responsibility 6.Resource Management 7.Product Realization 8.Measurement, Analysis and Improvement

ISO 9001 Training Key Explanation Points and Tips: The first four clauses (clause 0. Introduction to - clause 3. Terms and Definitions) do not provide any requirements for a QMS. They provide background information as to the purpose; concepts and principles used in the standard (e.g. process approach; PDCA); guidance on the QMS scope; reference to related documents; and key terms and definitions used. These clauses will all be explained in more detail as we go through each section. The remaining five clauses numbering 4 through 8 provide the control requirements that a QMS must implement. The following is a summary explanation of these 5 major clauses or elements of the ISO 9001:20000 standard. Each major clause has several sub-clauses. Collectively, these 5 clauses set out the requirements for your QMS. Clause 4 - Quality Management System - sets requirements to identify, plan, document, operate and control QMS processes and to continually improve QMS effectiveness. Clause 5 - Management Responsibility - sets requirements for top management to demonstrate its leadership and commitment to develop, implement and continually improve the QMS. Clause 6 - Resource Management - sets requirements to determine, provide and control the various resources needed to operate and manage QMS processes; to continually improve QMS effectiveness; and to enhance customer satisfaction by meeting customer requirements. Clause 7 - Product Realization - sets requirements to plan, operate and control the specific QMS processes thatdetermine, design, produce and deliver an organizations product and services. Clause 8-Measurement, Analysis and Improvement - sets requirements to plan, measure, analyze and improve processes that demonstrate product and QMS conformity and continually improve QMS effectiveness. The overall objective of your QMS must be to enhance customer satisfaction by meeting their requirements. This objective can be achieved by using the ISO 9001 requirements to control your QMS processes and by continually improving QMS effectiveness. To help you get the most out this e-Book, you might find it useful to follow key themes that the ISO 9001 standard has emphasized. These include:

All QMS processes must be planned, implemented, measured and improved ISO 9001 requirements focus on controlling QMS processes, not product. QMS controls must emphasize prevention of nonconformities rather than detection. QMS processes must be customer focused. Process personnel must be aware of and strive to meet internal and external customer requirements. You must continually improve the effectiveness of your QMS.

0.0 Foreward 0.1 Introduction 0.1.1 Quality Managment Principles 0.2 Process Approach 0.2 Types Of Business Processes 0.2 Process Characteristics 0.2 Process Plan - Do - Check - Act 0.3 Relationship With ISO 9004 0.4 Compatibility With Other Management Systems 1.1 ISO 9001 QMS Scope 1.2, - 3 QMS Application 4.1 QMS General Requirements 4.1 QMS General Requirements - Continued 4.2.1 Documentation Requirements 4.2.2 Quality Manual 4.2.3 Control of Documents 4.2.3 Control of Documents -Continued 4.2.4 Control of Records 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4.1 Quality Objectives 5.4.2 Quality Management System Planning 5.5.1 Responsibility and Authority 5.5.2 Management Representative 5.5.3 Internal Communication 5.6 Management Review 6.1 Provision of Resources 6.2 Human Resources 6.3-4 Infrastructure and Work Environment 7.1 Planning of Product Realization 7.1 Planning of Product Realization - 2 7.2 Customer-Related Processes 7.2 Customer-Related Processes - Cont'd

7.3.1 Design and Development Planning 7.3.2 Design and Development Inputs 7.3.3 Design and Development Outputs 7.3.5-7 Verification, Validation & Changes 7.4 Purchasing Process 7.4.2-3 Purchasing Information & Verification of Purchased Product 7.5.1 Control of Production and Service Provision 7.5.2 Production Process Validation 7.5.3 Identification and Traceability 7.5.4-5 Customer Property and Preservation of Product 7.6 Control of Monitoring and Measuring Equipment 7.6 Control of Monitoring and Measuring Equipment 2 8.1 Measurement, Analysis and Improvement - General 8.2.1 Customer Satisfaction 8.2.2 Internal Audit 8.2.3 Monitoring and Measurement of Processes 8.2.4 Monitoring and Measurement of Product 8.3 Control of Nonconforming Product 8.4 Analysis of Data 8.5.1 Continual Improvement 8.5.2 Corrective Action 8.5.3 Preventive Action

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