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ISO Requirements
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ISO Requirements Home :: ISO 8 Principles :: ISO9001 Requirements
:: ISO 9001 Training :: ISO 9001 Implementation ISO 9001 Auditing ::ISO Quality Tools
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PROFESSIONAL FREE ISO 9001 TRAINING CENTER Home ISO 9001 8 Principles ISO 9001 RequirementsISO 9001 Training
ISO 9001 ImplementationISO 9001 Audit
ISO Quality Tools
Site Map Contact Us ISO stand for “International Organization for Standardization”. ISO is a Non-profit Organization and established in 23th Feb 1947. The head office is based in Geneva, Switzerland, total over 170 member countries in the world.WHAT IS ISO?
ISO 9001 is a Quality Management System (QMS) standard developed by the International Organization for Standardization (ISO) that is recognized by its 170 odd member countries worldwide.WHAT IS ISO 9001?
ISO 9001 REVISION
The first version of Quality Management System is established back to year 1979, it call BS 5750:1979 during the time. Here is the journey of Quality Management System:* BS 5750:1979
* ISO 9000:1987
* ISO 9000:1994
* ISO 9000:2000
* ISO 9000:2008 (latest version) ISO 9001 helps you to run your business more efficiently and effectively as well as to achieve customer satisfaction by meet your customers requirements. ISO 9001 also helps to control company in more systematic way and ensure continual improvement through the corrective and preventive actions. For further understanding in ISO 9001, you are required to understand the ISO 9000 standard series, * ISO 9000:005 Quality Management Systems: Fundaments and Vocabulary * ISO 9001:2008 Quality Management Systems: Requirements * ISO 9004:2009 Managing for the sustained success of an organisation * ISO 19011:2002 Guidelines for Quality and/or Environemental Management systems auditing. Only ISO 9001 Quality Management Sysems: Requirements can be used in auditing process, others are all for reference and improvement. Certificate Body (CB) are all base on the ISO 9001 Quality Management Systems: Requirements to audit and certify company. ISO 9001 FAMILY SERIES THE BENEFITS OF IMPLEMENT ISO 9001 ISO 9001 able to apply to all types of organizations does not matter on organization’s size or business nature (product or service oriented organization), ISO 9001 help organizations to achieve standards of quality that are recognized and respected globally. Advantages of implementing ISO 9001 system are: * Increase organization reorganization * Increase customer satisfaction * Improve staff knowledge and competency * Improve organization effectiveness and efficiency * Reduce reject and waste * Improve productivity HOW TO OBTAIN ISO 9001? ISO 9001 8 QUALITY MANAGEMENT PRINCIPLES Over the last 20 years, there are 8 Quality Management Principles being developed to represent the key factors to achieve the ISO 9001quality system :
* Leadership
* Customer Focus
* Process Approach
* System Approach to Management * Involvement of People * Factual Approach to Decision Making * Continual Improvement * Mutually Beneficial Supplier Relationship ISO 9001 REQUIREMENTS OVERVIEW ISO 9001’s requirements can be grouped into 5 main clause: Section 4 - Quality Management System Section 5 - Management Responsibility Section 6 - Resource Management Section 7 - Product Realization Section 8 - Measurement, Analysis and Improvement ISO Certificate Body able to provide certification to an organization which able to fulfill the ISO 9001 requirements, the certification process would be adhered the PDCA concept:Leadership
Customer Focus
Process Approach
System Approach To Management Involvement of People Factual Approach To Decision Making Continual Imrpovement Mutually Beneficial Supplier Relationships Applying Principle of Leadership In ISO 9001 Applying The Principle of Customer Focus In ISO 9001 Applying The Principle of Process Approach In ISO 9001 Applying the Principle of System Approach To Management In ISO9001
Applying The Principle of Involvement of People In ISO 9001 Applying The Principle of Factual Approach To Decision Making InISO 9001
Applying The Principle of Continual Improvement In ISO 9001 Applying the Principles of Mutually Beneficial Supplier Relationships In ISO 9001 Section 4 Quality Management System Section 5 Management Responsibility Section 6 Resource Management Section 7 Product Realization Section 8 Monitoring, Analysis and Improvement 4.1 General Requirements 4.2 Documentation Requirements4.2.1 General
4.2.2 Quality Manual 4.2.3 Control of Documents 4.2.4 Control of Records 5.1 Management Commitment5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility, Authority and Communication 5.6 Management Review 5.4.1 Quality Objective 5.4.2 Quality Management System Planning 5.5.1 Responsibility and Authority 5.5.2 Management Representative 5.5.3 Internal Communication5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
6.1 Provision of Resource6.2 Human Resource
6.3 Infrastructure
6.4 Work Environment6.2.1 General
6.2.2 Competence, Training and Awareness 7.1 Planning of Product Realization 7.2 Customer Related Processes 7.3 Design And Development7.4 Purchasing
7.5 Production and Serivce Provision 7.6 Control of Monitoring and Measuring Equipment 7.2.1 Determination of Requirements Related To the Product 7.2.2 Review of Requirements Related To The Product 7.2.3 Customer Communication 7.3.1 Design And Development Planning 7.3.2 Design And Development Inputs 7.3.3 Design And Development Outputs 7.3.4 Design And Development Review 7.3.5 Design And Development Verification 7.3.6 Design And Development Validation 7.3.7 Control of Design and Development Changes 7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.4.3 Verification of Purchased Product 7.5.1 Control of Production and Service Provision 7.5.2 Validation of Processes for Production and Service Provision 7.5.3 Identification and Traceability 7.5.4 Customer Property 7.5.5 Preservation of Product8.1 General
8.2 Monitoring and Measurement 8.3 Control of Nonconforming Product 8.4 Analysis of Data8.5 Improvement
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 8.5.1 Continual Improvement 8.5.2 Corrective Action 8.5.3 Preventive ActionDetails
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