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Understanding, Documenting & Implementing an ISO 9001: 2008 Quality Management System

ISO 9001:2008 is the fourth edition of the Quality Management System (QMS) standard that was published by the International Organization for Standardization (ISO) on 15 November 2008. This quality management system standard  is recognized and adopted by its 150 odd member countries world wide. The standard is written in a generic, adaptable and non-prescriptive manner, thus making it suitable for all organizations eg manufacturing, services, governmental, as well as non-govermental agencies.

Understanding the ISO 9001:2008 standards is vital to ensure there is correct interpretation and application to one’s organization. Careful planning and execution is required to ensure that the QMS established addresses the needs of the organization and is able to yield results that enhance operational effectiveness  and customer satisfaction.

This programme aims provide delegates with:
• An understanding of the concepts and requirements of ISO 9001:2008
• The techniques of documentation that is in conformance to the ISO 9001 standard
• Effective implementation “know-how” on how to set-up and maintain the quality management system

Course Content  
Day 1: Understanding An ISO 9001:2008 QMS
• The Overview of ISO 9000 Family of Standards
The overview of ISO9000 family of standards and 8 quality management principles are discussed.
• Understanding the Business Process
The roles of business process in developing an effective quality management system are explained.
• ISO 9001:2008 Quality Management System requirements
This section looks into :
- The rationale of the QMS
- The process approach and process-based model of the QMS
• ISO 9001:2008 Quality Management System
The general requirements of the QMS, and the types and structure of the documents involved are explained.
• ISO 9001:2008 Management Responsibility
The roles and responsibilities of the organization’s top management, and their related areas in the QMS are highlighted.
• ISO 9001:2008 Resource Management
The requirements related to human competency, infrastructure and work environment are explained.
• ISO 9001:2008 Product Realization
This section explains the requirements related to :
- Planning of Product Realization
- Communication with the customers and order processing
- Product design & development
- Purchasing and sub-contracting activities
- Manufacturing activities / service provision
- Product identification, traceability and preservation
- Control of customer property
- Control of equipment used in monitoring and testing
• ISO 9001:2008 Measurement, Analysis and Improvement
This section highlights the requirements related to :
- Monitoring and improvement of QMS processes
- Customer satisfaction
- Internal audits
- Product and process inspection
- Nonconforming products
- Data analysis
- Corrective Action and Preventive Action

Day 2: Documenting & Implementing An ISO 9001:2008 QMS
• Setting up the Quality Management System Milestone
Management commitment and the timescale are discussed.
• Quality Management System Documentation
• Developing the Quality Manual
• Documenting Procedures
• Developing Work Instruction and Support Documentation
• Developing the Quality Plan
The above sections look into the structure and the development of the various types of ISO 9001 related documents.
• Implementing the Quality Management System
Some useful tips are provided to kick-off the system implementation.
• Reviewing the Quality Management System Progress
This section explains how the status of implementation can be monitored.
• Preparation and Performing Internal Audit
An overview of the audit process is provided in this section.
• Preparation and Performing Management Review
The key points of Management Review are covered.
• Introduction to the Route of Certification to ISO 9001:2008
Delegates are provided with an overview of the certifcation process and the audits involved.
• Beyond ISO 9001:2008 Certification
The concept of continual improvement is highlighted in this section.

Upon completion of the training, delegates will :-
• Have an overview of the development, evolution and objectives of the standard
• Have a good understanding of the standard requirements and its application to their respective organisations
• Be able to prepare the standard documentation ie. quality manual, procedures and supporting documents
• Have the basic knowledge to establish and implement the quality management system in their organizations
• Understand the certification process

For Whom 
Suitable for ALL functions and levels who have no prior knowledge of the standards and are responsible for the development, implementation and/or maintenance of the quality management systems.  A MUST for the Quality Management Representatives (QMRs), process owners and Internal Auditors.

All Neville Clarke tutors are full time consultants, auditors and trainers. The tutor assigned is a professional who has years of experience working with organisations to help them set-up and successfully maintain their quality management system. They are able to share their experiences, provide practical advice and solutions, and share common pitfalls faced by real-life organisations in their quest towards ISO 9001 certification.

This is a two-day course running from 9.00 am to 5.00 pm.

HRDF scheme 
This programme is claimable under SBL scheme

Other Related Courses 
Delegates who have attended this programme, will find the following courses informative and useful to enhance the implementation of the ISO 9001 QMS in their organizations :
QMS04 :  ISO 9001 Process Based Internal Auditing
IMS10 : Effective Implementation of Document Control System
IMS03 : Management Representative Skills
QMS12 : Measuring & Improving Customer Satisfaction



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