ISO 9001 Quality Management System (QMS)

ISO 9001 is structured into ten clauses, which are known collectively as Annex SL.

It focuses on four crucial areas:

1. Leadership accountability: Refers to the areas of the Quality Management System (QMS) that require leadership’s active participation and responsibility. It highlights the importance of leadership in developing, supporting and constantly improving the QMS.
2. Optimal resource allocation: Deals with properly allocating resources such as staff, infrastructure and facilities. It emphasises how these resources need to be managed to successfully set up and continuously improve the QMS.
3. Operational excellence: Offers guidance on how your organisation can consistently provide high-quality products or services. It covers all steps from initial planning to final execution, making sure customer needs and legal requirements are fulfilled.
4. System evaluation and improvement: Highlights how to evaluate the performance of your QMS to encourage continuous improvements. It requires using data to check how well your processes are working and to make informed decisions for improvements.

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ISO 9001 certification can benefit your business in various ways, including increased sales, improved consistency, efficiency and productivity.

We also asked our customers how achieving ISO 9001 certification had helped them and found that:

• 76% improved internal processes and efficiency
• 62% qualified for or won new business
• 24% could tender for more new business
• 13% retained contracts with existing clients

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To become certified, you must demonstrate that your Quality Management System (QMS) is established and meets the necessary standards. This proof is essential for certification. We’ll supply the tools and recommendations that help you to do this.

Check out our ISO 9001 checklist to ensure you have all the necessary documentation for certification.

Read our free guide on how to get ISO 9001 certification and our guide to ISO 9001 requirements.

Preparing for your certification doesn’t have to be overwhelming or time-consuming. Start by familiarising yourself with the requirements of the 9001:2015 standard – this will give you an idea of what needs to be done in preparation. When preparing for certification, there are a few steps you should consider:

1. Define the scope of your QMS: Understand which processes, departments and locations will be included in your Quality Management System.
2. Assign roles and responsibilities: Form a team of employees who will oversee the implementation of ISO 9001. Assign clear roles and responsibilities to streamline the process.
3. Conduct a gap analysis: Identify the areas that are already in compliance with the ISO standard and those that require improvements.
4. Implement a document control system: All your processes and procedures adhering to the standard need to be documented. Implement a system to manage and control this documentation to ensure consistency and traceability.
5. Employee training: Ensure your employees understand the requirements of ISO 9001 and are adequately trained to carry out their roles within the QMS.
6. Corrective actions: Any non-conformities with the standards should be addressed promptly and effectively.

Taking these steps will move your organisation closer to achieving ISO 9001 certification, but remember, it’s not a one-off event. Think of it as a stepping stone towards continual improvement. The QMS should be reviewed regularly for increased efficiency and effectiveness.

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ISO 9001 lays the groundwork for a Quality Management System (QMS) that assists businesses in meeting the requirements of their customers and regulatory bodies. This standard champions the use of a process-oriented approach to deliver consistent improvement.

What are the ultimate goals of ISO 9001?

• Boost customer satisfaction
• Ramp up operational efficiency
• Guarantee the steady delivery of top-notch products or services

Securing an ISO 9001 certification doesn’t have to be a daunting task.

Here’s a simplified step-by-step guideline:

1. Understand the standard: Familiarise yourself with the ISO 9001:2015 standard. The standard sets out the requirements for a Quality Management System, which focuses on customer satisfaction, consistency and continual improvement.
2. Perform a gap analysis: Conduct a gap analysis to identify where your current process aligns with the standard and where changes may be needed.
3. Plan your approach: Develop a plan detailing how your organisation will meet requirements. When designing your Quality Management System (QMS), be sure to consider your organisation’s goals, challenges and customer needs.
4. Implement your QMS: Put your plan into action. This involves developing and implementing new processes, procedures and policies as required by the standard.
5. Train your team: Ensure all staff understand the QMS, their role within it and the importance of the ISO 9001 standard. Effective training is key to a successful implementation process.
6. Conduct internal audits: Carry out regular internal audits to check your QMS is working as planned and meeting the ISO 9001 requirements.
7. Management review: Host a management review meeting to examine the suitability, adequacy and effectiveness of your QMS, ensuring it aligns with your strategic direction.
8. Certification audit: Invite a certification body for the two-stage external audit process, such as Amtivo. The initial audit checks your preparedness for the final audit, which verifies conformity to the standard. Be sure to choose a UKAS-accredited certification body at this stage.
9. Achieve certification: If your organisation meets the requirements, the certification body will issue ISO 9001 certification that is valid for three years.
10. Continuous improvement: Maintain and continually strive to improve your QMS to ensure ongoing compliance with the ISO standard. Regular surveillance audits will be conducted by the certification body over the three-year period.

The path to certification may take some time and resources, but the benefits of improved quality management can greatly outweigh the investment.

A certified company is an organisation that has met the requirements outlined in the standard and successfully implemented a Quality Management System (QMS) that focuses on continual improvement, customer satisfaction and the delivery of consistent, high-quality products or services.

The certification is issued following a thorough audit of the company’s processes and procedures. It validates that the company is committed to maintaining high standards of quality in its operations.