The ISO 9001 Clause 2 Normative references specify the documents that are indispensable for the application of this document. It includes documents that provide the basis for the development of the quality management system requirements specified in ISO 9001.
The main normative references for ISO 9001 are:
- ISO 9000, Quality management systems – Fundamentals and vocabulary
- ISO 9004, Managing for the sustained success of an organization – A quality management approach.
In addition to the above, other documents may be used as normative references, as required. These could include:
- Documents that specify the requirements for products, services, or processes, if these requirements are to be met by the quality management system
- Recognized standards or documents that may supplement the requirements of ISO 9001
This standard refers to the following publications:
- ISO 9000:2015, Quality management systems – Fundamentals and vocabulary
- ISO 9001:2015, Quality management systems – Requirements
The publications listed above are mandatory in order to comply with this standard.
To meet the requirements of this standard, organizations need to implement and maintain a quality management system.
The quality management system needs to be designed and implemented in such a way that it considers the requirements of this standard.
The normative references listed in ISO 9001 Clause 2 are the documents that specify requirements to be used in the development of products and services. These requirements can be found in international, regional, or national standards.
To ensure that products and services meet customer and regulatory requirements, it is important to identify and control the specific requirements that apply to them. This is done by defining the requirements in a document and then referring to that document in the contract or agreement between the customer and supplier.
The requirements listed in the contract or agreement are then used to develop the product or service. This process is known as requirements traceability.
In order to ensure that the requirements are met, ISO 9001:2015 Clause 2 requires that the organization establish and maintain a list of normative references.
The ISO 9001 Clause 2 normative references are the requirements that must be met in order for a product or service to be compliant with the ISO 9001 standard.
These requirements are specified in the ISO 9001 standard and are divided into two parts:
- General requirements
- Requirements specific to the product or service being supplied.
The requirements specified in ISO 9001 Clause 2 are generic in nature and are applicable to all organizations regardless of size or type of business.