Quality management should be a key priority for any organisation, regardless of the type of services or products they provide. This is why many organisations implement a Quality Management System (QMS).
This is designed to help businesses consistently deliver products and services that meet customer and regulatory requirements while driving continual improvement.
An ISO 9001-certified QMS helps your organisation achieve and maintain high-quality levels using a systematic, data-driven process approach. So, how can you check your QMS is compliant? Explore our ISO 9001 checklist below to find out more about the route to ISO 9001 certification in 10 simple steps.
Understanding the Core Principles of ISO 9001
ISO 9001 is a global standard for Quality Management Systems. It outlines the best way to establish and maintain a QMS, covering the following:
- Leadership
- Customer focus
- Employee engagement
- Process approaches
- Data-based decision-making
- Continual improvement
The standard provides a framework that organisations can use to improve their processes and deliver consistent quality. Becoming ISO 9001 compliant includes establishing a culture of continual improvement and effectively documenting processes. These can require a high level of detail and commitment required from all levels of an organisation. Making sure your QMS is ISO 9001-compliant may seem daunting, but our ISO 9001 checklist makes the process more manageable. It aims to explain the standard’s requirements in manageable steps.
Not sure where to begin? Take our ISO 9001 Readiness Quiz to assess your organisation’s preparedness and explore your next steps toward certification.
ISO 9001 Checklist – 10 Steps to Compliance
1. Understand the requirements
Begin your certification journey by studying the ISO 9001 standard to grasp its principles and criteria. It may help to read the official ISO 9001:2015 document to understand the standard’s key clauses and terminology.
2. Get senior management support
Securing commitment from senior management is crucial to the success of a QMS, as they provide the necessary resources and authority to drive the process. Their buy-in also highlights the importance of quality management to the rest of the organisation, reinforcing the focus on continual improvement.
3. Build an implementation team
You will need to choose someone to take charge of ISO 9001 implementation. In a very small business, this may be handled by just one or two individuals such as the business owner or a key employee who takes on multiple roles. Larger, more complex businesses may require a dedicated team drawn from different departments and with different skill sets for a comprehensive approach to quality management. Clearly defining roles and responsibilities is crucial for accountability and regular meetings can help coordination efforts during the implementation process.
4. Conduct a gap analysis
Assess your existing QMS to identify any gaps between your existing processes and the requirements of ISO 9001. This may involve reviewing documentation, evaluating procedures and interviewing key personnel. The goal should be to pinpoint areas that need improvement so that they can be adjusted to meet the required standards. A comprehensive gap analysis can provide a clear starting point for making necessary changes, helping you to prioritise actions and effectively allocate resources.
5. Develop an implementation plan
If the gap analysis reveals areas of non-compliance and opportunities for improvement, create a detailed plan outlining the steps necessary to achieve ISO 9001 certification. This plan should include defined objectives, timelines and the resources required for each phase. It should also include milestones to track progress and identify potential challenges. Consider using project management tools to organise tasks and monitor deadlines. A well-structured plan serves as a roadmap, guiding your organisation through the implementation process while ensuring efficient resource allocation and timely execution.
6. Develop and document processes
Maintaining records at every step is a core aspect of many ISO standards, including ISO 9001. Documentation should clearly explain each process. It can serve as an essential reference to guide employees in maintaining standards and achieving continual improvement.
7. Implement processes
Roll out the documented changes across your QMS, checking that all employees understand and adhere to the established processes. You also need to anticipate and prevent any operational challenges that might occur and address them if they happen. Monitoring the implementation is essential for managing the QMS’s compliance and effectiveness. Without it, you could waste time, money and resources, and could struggle to proactively manage risk. A successful implementation involves quality management practices becoming fully integrated into daily operations.
8. Train your employees
Your employees are the ones on the front line when it comes to maintaining quality standards. Train staff according to their role in the QMS, helping everyone to understand how their actions impact overall quality. Consider various training methods, such as workshops, e-learning and hands-on practice. Well-informed, engaged employees could be more likely to embrace the QMS, contributing to its success and sustainability.
9. Conduct internal audits
Conduct internal audits to evaluate the effectiveness of the QMS and identify any nonconformities or areas for improvement. Use your audit findings to implement corrective actions, keeping your QMS tightly aligned with ISO 9001 requirements and encouraging continual improvement.
10. Find the right certification body
An accredited certification body will conduct the external audit of your QMS as part of the certification process. You will need to prepare for the audit by reviewing documentation, addressing potential nonconformities, and ensuring all processes are compliant. The external audit verifies your adherence to ISO 9001 standards and must be passed in order to become successfully certified. A successful certification demonstrates that your organisation is committed to quality management and can help to give your business a competitive edge. Not all certification bodies are the same, so you may need to do some research before finding the right one for your unique business needs. ISO recommends selecting an accredited certification body, such as UKAS (United Kingdom Accreditation Service). Read more about choosing a certification assessment body.
Prepare for Your Certification Audit
When it comes to your certification audit, preparation is essential. You may want to do the following:
- Review the required documentation: Make sure all your documents are up-to-date, complete and accurately reflect your QMS.
- Undergo a final internal audit or gap analysis: Check that you have identified any oversights or weaknesses in your QMS.
- Address any last-minute issues: Resolve any issues or nonconformities to maintain compliance before your certification audit.
- Brief employees: All staff should know what to expect during the audit, including their roles in providing evidence and answers.
- Collect evidence: Collate all records that showcase the effective implementation and operation of your QMS.
- Contact your certification body: Confirm the audit dates and check that you are prepared for any specific requirements or expectations your external auditor might have.
An auditor from your certification body will perform the Stage 1 audit, which is the first step in certifying your organisation for ISO 9001. They will identify any gaps in your current Quality Management System that you must address and fix before you can continue your certification journey. After these are addressed and your auditor is satisfied, the in-depth Stage 2 assessment can begin. Once that is successfully completed, your organisation will be awarded its ISO 9001 certification. Read about the many benefits of ISO 9001 certification.
Get Your Free ISO 9001 Checklist
Download our free ISO 9001 checklist to get started.
Why You Should Choose British Assessment Bureau
UKAS is the only Government-endorsed body for ISO certification in the United Kingdom, and as a UKAS-accredited certification body, British Assessment Bureau offers the highest standards of reliability and credibility. We pride ourselves on providing a quality experience to businesses seeking ISO certification. Don’t just take our word for it – our “Exceptional” service status on Feefo, based on independent reviews, speaks for itself. Get started on your ISO 9001 certification journey – get a quote today or contact our team to discuss your needs.
