ISO 9001:2015 is the world’s best known and most implement quality management system (QMS). Organisations implement ISO standards to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. ISO 9001:2015 belongs to the International Standards Organisation family. It is one of thousands of standards aimed to standardise and identify quality organisations across the globe. ISO 9001:2015 is one of the most sought after and identified standards in the ISO 9000 series. Not to mention, it is the only standard in the series to which organisations can certify.
ISO9001 has the aim of enhancing customer satisfaction through the effective application of the system. This includes processes for improvement, and the assurance of conformity to both customer requirements and all applicable statutory/regulatory requirements.
All the requirements of the international standard are generic and are intended to be applicable to any organisation. This is regardless of its type or size, or the products and services it provides.
In a QMS, documentation is a core requirement for the overall success of the management system. The size and scope of the organisation will determine the level of documentation required, but it can consist of different types of documents, such as:
- Quality policy
- Quality objectives
- Procedures and instructions
- Risk register
- Strategic plan
The purpose and the benefits of the QMS documentation are multiple, including:
- Providing a clear framework of the operations in an organisation
- Allowing consistency of processes and better understanding of the QMS
- Providing evidence for achievement of objectives and goals
When designing QMS documentation, you should focus on efficiency and create processes and documents that are applicable in your organisation.