Certification - Quality Management System
Quality Management System
What is ISO 9001?
ISO 9001 Quality Management System (QMS) is internationally recognised as the world’s leading quality management standard and has been implemented by over a million organisations worldwide. ISO 9001 if implemented to its full potential becomes an invaluable asset to your organisation.
The purpose of the standard is to assist companies in meeting statutory and regulatory requirements relating to their product while achieving excellence in their customer service and delivery. The standard can be used throughout an organisation to improve the performance or within a particular site, plant or department. An ISO 9001 certification can be achieved by any business of any size, in any given sector, which is looking to increase and enhance business productivity and performance.
The ISO 9001 contains eight key principles of quality management which is not auditable but do form the fundamental characteristics of quality management which includes:
- Customer focus and customer satisfaction
- Involvement of people
- Process approach
- A systematic approach to management
- Continual improvement
- Factual approach to decision making
- Mutually beneficial supplier relationship
- Benefits of ISO 9001
- Current version of the ISO 9001
Benefits of ISO 9001
- Become more cost efficient and profitable
- Increased credibility and competitiveness
- Lower costs and shorter cycle times through effective use of resources
- Enhanced customer satisfaction and improved customer loyalty leading to repeat business
- Increased revenue and market share obtained through flexible and fast responses to market opportunities
- Integration and alignment of internal processes which will lead to increased productivity and results
- Consistency in the delivery of your product or service
- Improved communication, planning and administration processes
Current version of the ISO 9001
The current version of the Quality Management System Is the ISO 9001:2015 which was published on September 2015. The ISO 9001 structure is split into ten sections. The first three are introductory, with the last seven containing the requirements for the quality management system. The seven main sections are as follows:
Section 4: Context of the organization – This section talks about requirements for understanding your organization in order to implement an QMS. It includes the requirements for identifying internal and external issues, identifying interested parties and their expectations, defining the scope of the QMS and identifying the processes required for the QMS.
Section 5: Leadership – The leadership requirements cover the need for top management to be instrumental in the implementation of the QMS. Top management needs to demonstrate commitment to the QMS by ensuring customer focus, defining and communicating the quality policy and assigning roles and responsibilities throughout the organization.
Section 6: Planning – Top management must also plan for the ongoing function of the QMS. Risks and opportunities of the QMS in the organization need to be assessed, and quality objectives for improvement need to be identified and plans made to accomplish these objectives.
Section 7: Support – The support section deals with management of all resources for the QMS, covering the necessity to control all resources, including human resources, buildings and infrastructure, the working environment, monitoring and measurement resources and organizational knowledge. The section also includes requirements around competence, awareness, communication and controlling documented information (the documents and records required for your processes).
Section 8: Operation – The operation requirements deal with all aspects of the planning and creation of the product or service. This section includes requirements on planning, product requirements review, design, controlling external providers, creating and releasing the product or service and controlling nonconforming process outputs.
Section 9: Performance evaluation – This section includes the requirements needed to make sure that you can monitor whether your QMS is functioning well. It includes monitoring and measuring your processes, assessing customer satisfaction, internal audits, and ongoing management review of the QMS.
Section 10: Improvement – This last section includes the requirements needed to make your QMS better over time. This includes the need to assess process nonconformity and taking corrective actions for processes.
These sections are based on a Plan-Do-Check-Act cycle, which uses these elements to implement change within the processes of the organization in order to drive and maintain improvements within the processes.