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ISO 9001, the Standard for quality management systems (QMS) outlines the requirements organisations should follow to consistently deliver products and services that meet customer expectations and regulatory requirements. In this blog, we’ll explore the six mandatory procedures for ISO 9001:2015.
Mandatory procedures for ISO 9001:2015
1. Control of documents
The first of the ISO 9001 mandatory procedures is the control of documents. The aim of this procedure is to make sure that all the documents related to the QMS are managed properly, including creating, reviewing, updating and approving documents to make sure all the necessary information is available when needed. Documents no longer in use should be clearly marked to avoid them being used. The control of documents also covers the distribution and storage of these documents, making sure they are accessible to those who need them while protecting their confidentiality.
2. Control of records
The control of records is another crucial procedure for ISO 9001 compliance. Records provide evidence of the effective operation of the QMS and the quality of products or services. This procedure involves the identification, storage, protection, retrieval, retention, and disposal of records. By controlling records, businesses can make sure they have accurate and reliable data to highlight their compliance with the ISO 9001 mandatory procedures and requirements.
3. Internal audit
Internal audits are a key component of the ISO 9001:2015 Standard. This procedure involves regularly assessing the QMS to ensure that it meets the ISO 9001 requirements and it’s effectively implemented and maintained. An ISO 9001 audit helps organisations to identify areas for improvement, potential risks, and non-conformities so they can address issues before they escalate. The internal audit procedure should outline how audits are planned, conducted, reported, and followed up on.
4. Corrective action
The corrective action procedure is essential for addressing non-conformities in the QMS. Why? Because when a non-conformity is identified, the business needs to take action to correct it and prevent it from happening again. This involves getting to the bottom of the causes, and then implementing corrective actions and regularly reviewing their effectiveness. By doing this, organisations can completely eradicate the root problems and improve the quality of their products and services.
For more on this, take a look at our blog ‘What is Corrective Action’.
5. Preventative action
Preventative action focuses on identifying potential non-conformities before they happen and taking steps to stop them from happening again. This mandatory procedure for ISO 9001 involves analysing processes, identifying potential risks and implementing measures to mitigate those risks.
6. Control of non-conforming products
The final of the mandatory procedures for ISO 9001:2015 is the control of non-conforming products. Its aim is to make sure that products or services that don’t meet specified requirements are identified, controlled, and prevented from being delivered to customers. Businesses must determine how non-conforming products are handled, whether they are corrected, reworked, or disposed of. This procedure also includes documenting the non-conformity and any actions taken. Controlling non-conforming products is crucial for maintaining the purpose of the QMS and ensuring that customers receive products and services that meet their expectations.
Become ISO 9001 certified with Citation ISO Certification
Not yet certified? Take the certification journey with us and we’ll guide you all the way through the ISO 9001 certification process. You can create a QMS that works for your business, improving quality and efficiency in areas across your organisation. We’ll help you hit the ground running with ISO 9001 and make sure that you meet all of the six ISO 9001 mandatory procedures.
Don’t forget, our handy guide to ISO 9001 in the workplace is always available if you’d like some more information on the Standard. Contact us today to speak to a member of our team!
