Achieving ISO 9001 certification is a major milestone for businesses committed to managing themselves properly and effectively.
It often sounds complex, but in reality ISO 9001 really requires you to do nothing more than create a “book of best practice” specifically tailored to the needs of your business and your own objectives and targets.
ISO 9001 helps you set out your objectives, targets, aims and ambitions and then develop processes and practices that result in better profits, streamlined operations and, as a result, increased customer satisfaction. It also demonstrates compliance with international standards often necessary for winning more work via PQQ’s and tenders.
While the process may seem complex, this checklist breaks the journey down into clear, manageable steps for applicable to any UK business or organisation.
- Understand ISO 9001 Requirements
Before you begin, it’s important to fully understand what ISO 9001 involves. This international standard provides a framework for a Quality Management System (QMS), ensuring consistent delivery of products and services. Start by purchasing the official ISO 9001:2015 document from BSI (British Standards Institution) or the ISO website or get our layman’s version by downloading “how to implement management systems that improve sales and bolster margins”.
Take time to thoroughly understand the seven quality management principles, which include customer focus, leadership, and continuous improvement. By reviewing these principles against your current operations, you’ll naturally identify gaps that need addressing and create a smoother path for implementation.
Many organisations find it valuable to arrange training sessions for key team members, ensuring everyone grasps essential concepts like risk-based thinking and the process approach. This early investment in understanding helps build a system that genuinely adds value rather than simply “ticking a box” and meeting minimum requirements.
- Secure Leadership Commitment
The success of your ISO 9001 implementation relies heavily on genuine commitment from senior management, who must then drive the process and demonstrate their dedication to maintaining and implementing quality standards set against your own business goals and targets. When presenting to leadership, focus on tangible benefits such as improved efficiency, reduced errors, and increased customer satisfaction.
Appointing a dedicated Quality Management Champion can provide crucial oversight of the certification process while helping to build a culture of continuous improvement. This commitment should naturally extend beyond resource allocation – leadership needs to actively participate in management reviews, set meaningful business and quality objectives, and consistently communicate the importance of quality management throughout the organisation.
You might also consider establishing a steering committee to maintain oversight and ensure the implementation and development of management system remains a priority across all departments.
- Define Your Quality Management System (QMS)
We’d suggest you never want the ISO system tail wagging the business dog, so, we’d recommend starting with the most significant business goals and make the quality goals sub-servient to those.
The next step would be to create a clear Quality Policy that meaningfully reflects your commitment to meeting your own objectives and targets and your customer requirements whilst maintaining high quality standards.
The process of mapping out key business workflows helps everyone understand their role in maintaining quality standards while also revealing opportunities for improvement. Work closely with staff who perform these processes daily, as their practical insights will prove invaluable for creating effective procedures that work in real-world conditions.
Document your QMS scope clearly, defining which products, services, and locations it covers, while identifying how different processes interact and influence each other.
- Conduct a Gap Analysis
A thorough assessment of your current practices against ISO 9001 requirements naturally reveals where to focus your implementation efforts. By creating a detailed checklist covering the standard requirements means that you can systematically evaluate existing processes, procedures, and documentation against these.
This evaluation leads to a comprehensive action plan where gaps are prioritised based on their impact on your business objectives and the quality of products and services you deliver. As you assign responsibilities and deadlines for addressing each gap, regular review points help monitor progress and ensure continuous advancement toward your certification goal.
- Develop Required Documentation
Proper process documentation is a fundamental part of ISO 9001 certification. You will need to create and maintain records that demonstrate compliance with your internally defined “best practice” and the standard. Documenting key business processes and procedures ensures consistency across departments.
Key Documents for ISO 9001 Compliance
- A document detailing your objectives and targets
- A Quality Policy
- Process Maps
- Work Instructions
- Risk Register
- Internal Audit Reports
- Records of Customer Feedback
All of which would sit in a “system” designed to help you control, manage and update documents along with defining document retention periods and the relevant responsibility for document disposal.
- Implement the Quality Management System (QMS)
Rolling out your QMS (your book of best practice) should happen systematically, beginning with comprehensive training that helps your people understand key processes and their responsibilities within the system. Starting with pilot areas often provides valuable learning opportunities before expanding the initiative across the whole organisation.
As implementation progresses, encourage open feedback from staff and be prepared to make adjustments based on real-world experience. Regular communication about progress helps maintain momentum while acknowledging that cultural change takes time and helps teams adapt more naturally to new ways of working.
- Conduct Internal Audits
At Statius we’d suggest that standard focused audit processes are often concentrated more on the efficiency of a process. We think this is a mistake. We’d say focus on effectiveness first and only then only focus on efficiency.
Either way, the internal audits are a vehicle to help assess the effectiveness of your QMS and identify areas for improvement before the official certification audit. Assign or hire trained internal auditors to conduct impartial reviews. Document audit findings, implement corrective actions where necessary, and address any non-conformities before moving on to the next stage.
Internal audits should be conducted at least annually, but more frequent audits may be beneficial depending on business complexity and any associated risks.
- Undertake the Management Review
Regular reviews of the system serve as vital checkpoint for evaluating the effectiveness of the QMS. This can be a meeting in its own right but can also be a “process” itself, making the review “a process” would involve looking at existing meetings and establishing where management review requirements overlap.
Management review would typically encompass a review of:
- Objectives and targets
- Key performance indicators and process performance
- Risk and opportunities
- Customer feedback
- Supplier performance
- Problems and errors (non-conformance)
- Audit results and
- Opportunities for improvement.
These reviews provide perfect opportunities to adjust the business (and quality) objectives and resource allocation while considering emerging strategic and operational risks and opportunities. Well-documented reviews demonstrate ongoing leadership commitment while ensuring your system continues supporting your key business objectives.
- Select a UKAS-Accredited Certification Body
Choosing the right certification body is crucial. In the UK, businesses should work with a UKAS (United Kingdom Accreditation Service)-accredited certification body to ensure credibility. Research different options, compare service details and pricing.
The certification body you select will become a long-term partner in your management system journey, so ensure their audit team brings relevant expertise and their auditing style aligns with your organisational culture.
However, UKAS demand that all UKAS accredited certification bodies do provide a FREE (given you have no open major no-conformances) transfer process.
- Undergo the External Certification Audit
The certification audit consists of two stages and any gaps identified need to be addressed before moving to the next stage or being awarded of the ISO certificate:
- Stage 1 essentially involves a “desk-top” review of your QMS documentation to check compliance with ISO 9001 requirements
- Stage 2 is the on-site assessment during which the auditors will visit your business, interview employees, observe processes, and review records to ensure you are properly applying your “book of best practice”.
- Address Non-Conformities (If Any)
At each of the above stages a report detailing any non-conformities or recommendations for improvement is presented which is essentially a trigger for helping you to continually improve.
If issues have been raised you’ll need to develop a corrective action plan, implement the necessary changes, and submit evidence of compliance to the certification body
- Receive ISO 9001 Certification
Once all issues are resolved, your certificate will be despatched ready for you to celebrate and promote your achievement to the outside world.
The certificate demonstrates your commitment to your quality management system and to the continuous improvement process. You can now display the certification proudly, use it in marketing materials, and inform stakeholders of your sterling achievement.
- Maintain Certification Through Continuous Improvement
Maintaining certification requires an ongoing commitment to quality principles through regular internal audits, management reviews, and continuous monitoring of customer feedback and process performance.
Prepare systematically for annual surveillance audits while staying informed about evolving ISO 9001 requirements. By fostering a culture of continuous improvement, your QMS will remain effective and continue adding value to your organisation well into the future.
Need Expert Help?
Navigating ISO 9001 certification can be complex, but you don’t have to do it alone. At ISO Consultants, we specialise in helping UK businesses achieve and maintain ISO 9001 certification with expert guidance and tailored support. Get in touch today to see how we can streamline your journey to certification.
