What are the 6 mandatory procedures for ISO 9001?

ISO 9001 is an international standard that mainly focuses on Quality Management Systems. A Quality Management System is a set of processes, requirements, and procedures guiding an organisation’s operations to attain the intended objectives. Before embarking on a journey to adopt ISO 9001 procedures, it’s essential to understand, what the mandatory procedures for ISO 9001:2015 are. Here are six ISO 9001 mandatory procedures to implement:

1. Control of Documents

It’s essential to maintain efficient communication for a seamless business operation. ISO 9001 requires organisations to establish proper control of documents including the use of procedure templates, to meet documentation requirements and monitor the delivery of information, products, and services. The procedure ensures that everyone in the organisation has access to the most accurate and recent instructions and maintains proper records.

Some of the document control aspects to consider include:

• Location – This is where you intend to store your documents. It could be a local database system, cabinets, common servers, or a web-based system.
• Distribution – You need to define who should distribute the documents to the relevant parties.
• Document security – It’s essential to ensure your documents are safe from elements like data breaches, fire, or theft.
• Document validation – You need to have a clear plan on how to determine the validity of documents.

2. Control of Records

IS0 9001 requires organisations to establish a documented information procedure to control the identification, storage, retention, protection, disposition, and retrieval of records, including records of design. The primary purpose of documenting the procedure is to show compliance and enhance the accessibility of data to improve business operations.

3. Internal Audit

The importance of the ISO 9001 internal audit procedure is to evaluate the effectiveness and efficiency of an organisation’s Quality Management System, including aspects like design and development control, management review and monitoring customer satisfaction. For example, the audit will check how you implement and run your Quality Management System.

An internal audit also helps identify and mitigate the risks that may affect your internal and international standards compliance. It also demonstrates the organisation’s performance by checking the effectiveness of internal controls in areas like administration, accounting, and financial reporting.

4. Control of Non-Conforming Products

Your quality management system should involve procedures to identify and correct non-conforming or poor-quality outputs. The non-conforming products can be identified internally through internal audits or externally by customers or other stakeholders. The control of non-conforming output procedure aims to eliminate the delivery or consumption of products or services that fail to match up to the specified quality requirements.

5. Corrective Action

A corrective action involves defining a problem, determining its cause, containing it, and developing appropriate actions to prevent the issue from occurring again. The procedure aims to improve the overall performance of your business by eliminating unpleasant activities in the daily business operations and achieving your quality objectives.

6. Preventive Action

Preventive action is a procedure that aims at getting rid of all potential causes of non-conformity, ensuring the quality of your organisation’s products and services. The procedure involves recommending suitable actions to prevent specific risks and thus reducing the risks from recurring. Clause 8.53 of ISO 9001:2015 requires organisations to document the proposed preventive measures.