ISO 9001 is an international standard focusing on Quality Management Systems (QMS). A quality management system is a collection of procedures, requirements and processes guiding an organisation’s operation to attain the intended objectives. Before embarking on a journey to acquire the ISO 9001 standard, you must understand the mandatory practices you need to follow. In this article, we will discuss the six mandatory procedures for ISO 9001.
Six mandatory Procedures for ISO 9001
Control of documents: Maintaining efficient communication for your business operations to run seamlessly is necessary. The ISO 9001 standard requires organisations to properly control the documents so that the delivery of information, products and services can be appropriately monitored. This procedure ensures that everyone within the organisation has access to the most recent and accurate instructions while maintaining proper records of operations. you can get more information on ISO 9001 documentation Landing.
While implementing document control, there are certain aspects you need to consider, such as location, distribution, document security and document validation. The standard requires you to specify where you intend to store your documents. It could be familiar servers, cabinets, databases, or a web-based system. However, this specific location needs to be mentioned.
- Similarly, you need to define who should distribute the documents to the relevant party under the distribution section. Furthermore, document security implies keeping your documents safe from theft, fire or data breaches. Lastly, you need to have a clear plan for determining the validity of your documents, and the validation procedure should be mentioned in your records.
- Control of records: The ISO 9001 standard requires organisations to establish a documented procedure to control the retrieval, disposition, protection, retention, storage and identification of records. The primary goal of documenting these procedures is to enhance accessibility to data while showing compliance with the standard.
- Internal audit: The purpose of the ISO 9001 internal audit procedure is to evaluate the effectiveness and efficiency of an organisation’s QMS. The internal audit will measure how you implement and run your QMS to identify and mitigate any risks that may affect your internal and international standards compliance. Regular internal audits demonstrate the organisation’s performance by checking the effectiveness of internal controls in areas like financial reporting, accounting and administration. you can get more information about internal auddit on iso 9001 internal audit.
- Control of nonconforming products: Your QMS should highlight procedures to appropriately identify and correct nonconforming products or outputs that are inferior in quality. These nonconforming products should be identified internally with the help of internal audits. Alternatively, organisations can choose to control their nonconforming products externally by acquiring feedback from customers or other stakeholders. The control of nonconforming output procedures aims to reduce the delivery or consumption of services or products that fail to match up to the specified quality requirements.
- Corrective actions: This involves defining a problem, determining its root cause, containing it and developing appropriate actions to prevent these issues from re-occurring. Corrective actions aim to improve the overall performance of your business by eliminating all unpleasant activities in daily business operations.
- Preventive actions: This procedure aims to eliminate all the potential causes of non-conformities. Preventive action procedures involve recommending suitable actions to prevent specific risks from developing, thereby reducing the recurrence of issues. Clause 8.53 of the ISO 9001 standard requires organisations to document the proposed preventive measures.
ISO 9001 requirements
In addition to these six mandatory procedures, the ISO 9001 standard requires your organisation to address seven key areas, known as clauses, to achieve continual improvement in your QMS. These include:
- Context of the organisation: The standard requires organisations to include the scope of their QMS and the process mapping along with its characterisation. Identifying the organisation’s context helps establish the boundaries of the QMS, thereby enhancing its applicability and functionality.
- Leadership and commitment: The standard outlines the requirements concerning top management, where the management is responsible for developing a quality policy that sets the direction and alignment of the QMS. Additionally, the quality policy should be created to promote customer focus all over the organisation.
- Planning for the QMS: The standard presents the requirements for determining and working with risks and opportunities and provides recommendations for setting processes that align with the quality policy.
- Support and resource management: Appropriate allocation of resources must be done to support the proper functioning of the QMS processes.
- Operational planning and control: Organisations must outline requirements that deal with quality control and nonconformities related to products or services.
- Performance evaluation: The organisations must outline requirements for assessing customer satisfaction, internal audit, monitoring analysis and evaluation of process performance.
- Improvement actions: Organisations must outline their commitment to continual improvement of their QMS through implementing corrective actions that would continually review and improve the functionality of their processes.
Conclusion
The six mandatory procedures in ISO 9001 are control of documents, control of records, internal audits, corrective actions, preventive actions and control of nonconforming products. ISO 9001 requirements include specifying the organisation’s context, outlining the leadership commitment, planning for the QMS, providing support and resource management, conducting operational planning, performance evaluation and committing to improvement actions.
Users Comments
Get a
Quote