ISO 9001:2008 is an international standard that gives requirements for an organization’s Quality Management System (QMS). It is part of a family of standards published by the International Organisation for Standardisation (ISO) often referred to collectively as the “ISO 9000 series”. The ISO 9000 series consist of three standards these are:
- ISO 9000: 2005: Fundamentals and vocabulary
- ISO 9001: 2008: Quality Management System requirement
- ISO 9004: 2000: Guidelines for performance improvement
The objective of ISO 9001:2008 is to provide a set of requirements that, if they are effectively implemented, will provide you with confidence that your supplier can consistently provide goods and services that meet your needs and expectations of your customers and comply with statutory and regulatory requirements applicable to your products or services. Management system refers to what the organization does to manage its processes or activities in order that the products or services that it produces meet the objectives it has set itself, such as; satisfying the customer’s quality requirements, complying to applicable regulations, and any other requirements you determine to be necessary.
REQUIREMENTS OF ISO 9001
The requirements cover a wide range of topics, include top management commitment to quality, customer focus, adequacy of resources, employee competence, process management (for production, service delivery and relevant administrative and support processes), quality planning, product design, review of incoming orders, purchasing, monitoring and measurement of processes and products, calibration of measuring equipment, processes to resolve customer complaints, corrective/preventive actions and a requirement to drive continual improvement of the QMS. Last but not least, there is a requirement to monitor customer perceptions about the quality of the goods and services you provide.
The key to a successful ISO 9001 QMS is having documented procedures that are implemented and maintained in such a way that customer requirements are appropriately determined and properly satisfied or even exceeded successfully. In addition, the QMS must include appropriate monitoring and review to ensure effective functioning of the QMS and to identify and implement corrective measures in a timely manner for continual improvement.
ISO9001 standards include the need for sites to document and communicate to all relevant stakeholders within the organisation a Quality Policy, Quality Objectives and the Quality Manual. In addition, procedures must be established for ongoing review of the QMS activities. Programs must then be set in place to implement these activities. Internal Audits of the QMS must be conducted periodically to ensure that non-conformances to the system are identified and addressed. In addition, the management review process must ensure top management involvement in the assessment of the QMS, and as necessary, addressing the need for changes.
The Quality Management System (QMS) manual is the central document that describes the interaction of the core elements of the system, and provides a third-party auditor with the key information necessary to understand the QMS in-place at the company. Consistent with the quality management principles of ISO 9001, the Quality Policy and the Procedures, including legal & other requirements, shape the program by influencing the selection of specific measurable quality goals, objectives, & targets. Specific programs and/or projects must then be developed to achieve these goals, objectives, & targets. The checking & corrective action elements of the system help ensure continual improvement by addressing root causes on non-conformance’s. The ongoing management review of the QMS and its elements helps to ensure continuing suitability, adequacy, & effectiveness of the program.
BENEFITS OF ISO 9001
- Be more efficient and profitable
- Produce products and services that consistently meet customer requirements
- Achieve customer satisfaction
- Maintain market share
- Improve communication and morale in the organization
- Reduce costs and liabilities
- Increase confidence in the production system.