ISO 9001 is the most widely used standard in the world. It forms the foundation for defining a system of processes required to achieve customer satisfaction which is the fundamental reason of existence for all organizations.
ISO 9001:2015 will be the fifth edition of the Quality Management System (QMS) standard and deemed to be the most significant change since year 2000. The process approach model introduced in year 2000 has been replaced with the high level structure based on Annex SL, Appendix 2 of the ISO/IEC Directives, Part 1, Consolidated ISO Supplement-Procedures Specific to ISO.
Evolution of the standard is a continual improvement progression taking into consideration the current and future needs of the standard users. This has resulted in more explicit requirements in risk-based thinking, more user-friendly requirements, more flexibility in documentation and a performance based system meeting the needs of interested parties. With the changes introduced into the standard, organizations should realize more beneficial outcome of using the ISO 9001 in line with current business strategies.
Understanding the ISO 9001:2015 Standard 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 internal and external issue, needs and expectation of the interested parties, outlining the risk and opportunities and take necessary action to achieve the intended outcome of the organization.
This training course will be presented with detailed explanation of the requirements for ease of understanding and practical activities to document and apply the system. It is useful for users of the previous standard as well as new users with first time exposure to the quality management system.
This programme aims to provide delegates with the following knowledge:
- An interpretation of the new requirements
- An understanding of the rationale and the foundation of the new standard
- Actions required to establish, implement and achieve a successful certfication
- Step-by-step application guide and “know-how” to setup a Quality Management System that conforms to the ISO 9001:2015 Standard.
Upon completion of the training, delegates will :-
- Have a good overview of the development and evolution of the ISO 9001 standard
- Have a good understanding of the requirements
- Have a good knowledge on the practical approach to apply the standard from development, implementation to maintaining a successful certification
Day 1 Interpretation of ISO 9001:2015 Requirements
- The ISO 9001 Evolution
- An overview of the evolution of ISO 9001 standard and rationale for the changes to the latest revision
- Understanding the New Structure, Terminology and Concepts
- The high level structure of Annex SL; changes in terminology; context of the organization; risk-based approach; scope and applicability; documented information; organizational knowledge; control of externally provided products and services.
- The Foundation of the Standard
- The quality management principles; the PDCA cycle and process approach
- Clause 4: Context of the Organization
- Understanding the organization and its context; needs and expectations of interested parties; scope of the system; processes of the quality management system
- Clause 5: Leadership
- Leadership and commitment; quality policy; organizational roles, responsibilities and authorities
- Clause 6: Planning
- Actions to address risks and opportunities; quality objectives and planning to achieve them; planning of changes
- Clause 7: Support
- Resources; competence; awareness; communication; documented information
- Clause 8: Operation
- Operational planning and control; Requirements for products & services; design and development; control of externally provided processes, products and services; production and service provision; release of products and services; control of nonconforming outputs
- Clause 9: Performance Evaluation
- Monitoring, measurement, analysis and evaluation; internal audit; management review
- Clause 10: Improvement
- Nonconformity and corrective action; continual improvement
Day 2 Application of ISO 9001:2015 Requirements
- Introduction to the Route of Certification
- Delegates are provided with an overview of the certifcation process.
- Setting up the Quality Management System Milestone
- Action plan and the timescale are discussed.
- Management Commitment and the Quality Policy
- To define the boundary and discuss the commitment required from management
- Overview of QMS Strategic Planning
- To briefly provide an overview of the organizational context, scope, compliance obligations, business process map, risk & opportunities, quality objectives
- Introduction to Process Approah and Process Control
- To understand application of processes approach within the quality management system
- Establishing Documented Information
- To understand the documentation structure, document type and how to develop them
- Application and Implementation of Quality Management System
- Actions to apply and implement the system successfully
- Reviewing the Quality Management System Progress
- This section explains how the status of implementation can be monitored.
- Preparing and Performing Internal Audit
- An overview of the audit process is provided in this section.
- Preparing and Performing Management Review
- The key points of Management Review are covered.
This programme is designed for ALL functions and levels of an organization who need to gain understanding of the requirements in the standard, including those from organizations that are currently certified or yet to be certified.
This programme is particularly useful to those managing the quality management system, 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