1. Leadership
ISO 9001 requires that senior leadership are supportive, committed, and engaged, without this, it is impossible to meet ISO 9001. According to clause 5, the leadership includes the following:
- Holding annual management reviews
- Establishing a quality policy, objectives and plans
- Creating and implementing a quality management system that meets the requirements of the standard and the organization
- Communicating the policies and objectives to stakeholders.
2. Planning
The second requirement is planning to find and mitigate potential risk factors. Therefore, according to clause 6, a company must -
- Recognize and document potential risk factors. List them according to their levels of severity and chances of occurrence.
- Plan accordingly to prevent the risks.
- Integrate plans for increasing the productivity
3. Organizational content
In the form of organizational content, a company must determine the following:
- Purpose and objectives of the system.
- The strategic direction of the organization
- The scope of the Quality Management System (QMS)
4. Provision of resources
As per clause 7, there should be adequate resources in form of:
- Effective and robust infrastructure.
- Productive working environment.
- Effective and competent personnel
5. Operation
Clause 8 covers the operations of a company and focusses on the responsibility of developing and delivering quality products / services. The operational structure should:
- Monitor and test systems to ensure that quality benchmarks are being met
- Set out the quality objectives and customer requirements
- Create documentation, specifications, and / or instructions and make the needed resources available for employees
6. Performance evaluation
Clause 9 of ISO 9001 requires frequent performance evaluations for analyzing collected data from production and management to ensure among other things:
- Customer satisfaction
- Supplier compliance
- Successful application of each aspect of the Quality management system
- Supporting continual improvement
7. Continual improvement
A goal of ISO 9001 is to continually improve. For that companies must:
- Identify in a timely manner which aspects of the system are not working as per the defined objectives and plan accordingly to improve them
- Make contingency plans as needed.