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ISO stand for “International Organization for Standardization”. ISO is a Non-
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.
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?
Over the last 20 years, there are 8 Quality Management Principles being developed to represent the key factors to achieve the ISO 9001 quality 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’s requirements can be grouped into 5 main clause:
Section 4 -
Section 5 -
Section 6 -
Section 7 -
Section 8 -
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 Improvement |
| 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 ISO 9001 |
| Applying The Principle of Involvement of People In ISO 9001 |
| Applying The Principle of Factual Approach To Decision Making In ISO 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 Measurement, Analysis and Improvement |
| 4.1 General Requirements |
| 4.2 Documentation Requirements |
| 4.2.1 General |
| 4.2.2 Quality Manual |
| 4.2.3 Control of Documents |
| 4.2.4 Control of Records |
| 5.1 Management Commitment |
| 5.2 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 Communication |
| 5.6.1 General |
| 5.6.2 Review Input |
| 5.6.3 Review Output |
| 6.1 Provision of Resource |
| 6.2 Human Resource |
| 6.3 Infrastructure |
| 6.4 Work Environment |
| 6.2.1 General |
| 6.2.2 Competence, Training and Awareness |
| 7.1 Planning of Product Realization |
| 7.2 Customer Related Processes |
| 7.3 Design And Development |
| 7.4 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 |
| 7.4.1 Purchasing Process |
| 7.4.2 Purchasing Information |
| 7.4.3 Verification of Purchased Product |
| 8.1 General |
| 8.2 Monitoring and Measurement |
| 8.3 Control of Nonconforming Product |
| 8.4 Analysis of Data |
| 8.5 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 Action |
| PDCA |
| 7 QC Tools |