Overview of ISO 9001:2015
ISO 9001 is split into 10 main sections – these mirror the standard layout for all management system standards.
Section 01
Section 1 (Scope) provides an introduction to the standard and what is designed to achieve.
Section 02
Section 2 makes reference to other documents that support the ISO 9001 standard (it refers to ISO 9000 within which are terms and definitions).
Section 03
Section 3 is where terms and definitions can be found. There are none as these are listed in a separate document (ISO 9000).
Section 04: Context of the organisation
Organisations are required to identify, monitor and review internal and external issues and understand the needs and expectations of interested parties. Understanding these issues will help the organisation to shape and develop the QMS so that it fits in to the wider world. Simply, the QMS itself does not sit in isolation.
The QMS scope sets its boundaries and what products and services it applies to and support. The scope of the QMS must be documented. Finally, this section reminds the organisation that the QMS is established, implemented, maintained and improved.
Section 5: Leadership
Top management are required to demonstrate both leadership and commitment. They must ensure that their organisation’s quality policy and objectives are consistent with their strategic direction and context and ensure that the QMS requirements re integral to business processes. Simply, top management (and nobody else) is accountable for the effectiveness of the QMS.
Customer and applicable statutory and regulatory requirements are identified. A quality policy is established, reviewed and communicated. Organisational roles, responsibilities and authorities are defined.
Section 6: Planning for the Quality Management System
Business risks and opportunities are determined, and action taken to reduce undesired effects and achieve continual improvement. This requires organisations to think about internal and external issues they face and relevant requirements of their interested parties. Quality objectives and plans are implemented. If you set objectives then you need to demonstrate what you are doing to achieve them. Changes are carried out in a controlled manner, adjustments to how you work and how you arrange the organisation should not affect your ability to deliver to customer. Sufficient resources are made available to effect the change.
Section 7: Support
Resources are in place to ensure the effective operation of the QMS. This includes suitable and sufficient personnel; these personnel are to be competent to undertake the tasks expected of them. Persons working under the control of an organisation are made aware of policy, relevance and importance of their work and how they can contribute towards achieving objectives. Necessary infrastructure is identified, provided and maintained as well as a suitable work environment. Monitoring and measuring resources (people and equipment) are fit for purpose. Organisational knowledge is capture and preserved. Internal and external communication methods are defined.
Documented information required by the standard and the organisational itself is identified and controlled.
Section 8: Operation
Processes are planned, implemented and controlled. These processes have to be planned and delivered in such a way as to meet requirements, and include customer interfaces, design and development, externally provided processes (control of vendors and sub-contractors), products and services, production/service provision (including identification, traceability, customer property and preservation, control of changes, release of products and services, post-delivery activities and control of nonconforming outputs).
Section 9: Performance Evaluation
The QMS performance and effectiveness is evaluated. What, how and when to measure is determined and analysed. (Key Performance Indicators). Data relating to customer perception of the organisation as well as the products and services provided is obtained and analysed. Internal audits are carried out. Management reviews are carried out by top management at planned intervals. The reviews consider opportunities for improvement and the status of risks and opportunities.
Section 10: Improvement
Organisations are required to actively seek out and implement improvements that will better enable the organisation to meet customer requirements and enhance customer satisfaction. Non-conformities (where you have failed to meet a requirement of ISO 9001 or your QMS) are identified, controlled and corrected. The potential for a similar non-conformity is established and prevented. Necessary correction and corrective actions are taken. Outputs from analysis of data, evaluations and the management review are used to identify areas of underperformance and any opportunities for improvement.
All your questions, answered.
This site has a list of frequently asked questions about ISO 9001 and other standards
Course Checklist
QCS have prepared a checklist tool that may be useful for you to establish what you already have in place and what your organisation might need to do if it wants to seek certification.
Go HERE to download a copy of our ISO 9001 checklist (registration on this website will be required).
