The ISO 9001:2015 standard is globally recognised for Quality Management Systems (QMS). It helps organisations streamline their processes, improve operational efficiency and maintain a culture of continual improvement. This standard focuses on customer needs and satisfaction.
Achieving certification can boost credibility, increase client trust and open the way for better market access. It can be a crucial tool for any business that wishes to improve the quality of its products and services and provide a more competitive offering.
Read on to discover the common mistakes or challenges made by organisations implementing a QMS in line with the ISO 9001 standard – and read our tips on how to avoid them.
Common Mistakes in Implementing the ISO 9001 Standard
1. Lack of top management commitment
Leadership involvement is crucial when implementing a QMS that complies with ISO 9001. Senior management is vital in aligning quality management with business goals and setting the tone for a quality-focused culture. Without direction from organisation leaders, your Quality Management System (QMS) could lack clear objectives.
Senior management is also responsible for allocating the resources your business needs and empowering all employees to participate in continual improvement so that they feel engaged and positive about your organisation’s quality initiatives.
Try these tips to secure management engagement for the certification process:
- Talk to senior management: Explain how ISO 9001 can align with your overall business goals and explain the benefits of achieving certification, such as reducing costs and achieving higher customer satisfaction.
- Encourage early buy-in: Involve leaders before the start of the process so they feel prepared and empowered.
- Provide information: Provide clear details about the typical roles and responsibilities of leaders within a QMS, and allow time for management to fully understand their long-term role in the implementation process.
- Share data and relevant case studies: Demonstrate the benefits of ISO 9001 for similar organisations – including improved reputation and operational efficiencies. Highlight how ISO 9001 has worked for other similar businesses.
Read our ISO 9001 case studies to learn how similar organisations achieved ISO 9001 certification.
2. Inadequate training and awareness
It is important to recognise the importance of training for employees, on the certification, at all levels, as a lack of awareness can derail implementation efforts.
Understanding the principles and objectives of ISO 9001 is also crucial for fostering a quality-focused culture with buy-in from the entire organisation and less resistance to change. ISO 9001 Training also equips employees to follow processes correctly, reducing the risk of errors.
When all employees fully understand their roles in a QMS, they are more likely to feel confident and carry out their responsibilities competently. Knowing how their contribution impacts the organisation can mean they are more likely to feel engaged in implementation and continual improvement.
Try these tips for training and skill development when implementing ISO 9001:
- Choose relevant training methods that best suit your employees: Depending on your needs, you might decide on training courses, online workshops or in-person sessions. You might try various methods depending on knowledge gaps within your organisation.
- Implement regular training: Conduct training regularly so that your employees are kept updated on any changes to your QMS or the ISO 9001standard. If there is any news, you can find our updates on our ISO 9001 Revision page.
- Encourage ongoing participation and skill development: Think about offering a mentor or buddy system and refresher sessions for employees. This can also help you maintain an environment of continual improvement as people learn new skills.
- Ask for feedback: Employee input can be crucial for continual development and improvement. Regular feedback sessions or surveys could help you assess how effective your training is and what could be done differently, if necessary.
Discover our ISO 9001 training courses.
3. Poor documentation and record-keeping
Maintaining accurate and comprehensive documentation across different departments can be challenging for any business.
However, good documentation and record keeping are fundamental to the ISO 9001 standard certification process as it demonstrates your organisation’s commitment to maintaining a robust QMS. Without standardised documentation, it may not be possible to demonstrate that processes are performed consistently.
A lack of well-kept records will mean that your organisation is unable to provide the data needed to monitor performance and identify areas for improvement so corrective actions can be implemented.
Keeping your records organised and up to date means that your organisation will be ready for internal and external audits, which can make the certification process smoother.
Try these ideas for creating and maintaining essential documents when implementing your QMS:
- Set a standardised documentation guide: Write guidelines for creating clear and relevant documentation. This can help auditors quickly understand and verify processes. Consider using templates and formats to maintain uniformity across departments.
- Implement a process for updates and versions: Create a clear system for all employees to manage their documentation efficiently and avoid multiple or old versions of the same document.
- Keep documents secure but accessible: Documents should be stored securely but also need to be easily available to relevant employees and auditors. Reduce the risk of unauthorised access to documents or the chances of incorrect data with systems in place to prevent this from happening.
- Conduct regular reviews and updates: Check that your documents reflect your current practices and comply with the relevant ISO 9001:2015 standard requirements. This will be crucial for passing the Stage 2 audit.
4. Overlooking the process approach
Becoming familiar with the ISO 9001 process approach is fundamental for successful certification.
The principle focuses on understanding, mapping and managing interrelated processes as a system. This can contribute to your organisation’s effectiveness in achieving its objectives.
If you overlook this process approach, you may be unable to understand how your organisation’s departments and processes work together or identify areas for improvement within your business. Without understanding these processes, producing products or services of consistently high quality could be challenging.
Try these tips for effectively mapping and improving business processes:
- Clearly define the processes within your organisation: This could include defining employee roles and responsibilities, your resources and operating procedures. This could help you avoid inconsistent outcomes.
- Implement process mapping: Consider how you could outline the steps and interactions between processes within your business. This might include developing process maps as visualisation tools to help identify inefficiencies.
- Encourage continual improvement: Regularly review processes and your KPIs (key performance indicators). As well as looking at your internal processes, think about regularly examining your customer feedback so that you can align your plans with their needs.
- Hold regular internal meetings or workshops: This could help teams understand the work of others and how their work influences the business. It can also encourage more cross-departmental interaction and collaboration.
5. Neglecting continual improvement
Fostering a culture of continual improvement is crucial when your organisation is implementing ISO 9001. Without this, you risk stagnating productivity and quality and may not meet customer needs and expectations.
A lack of continual improvement can also increase operational costs if inefficiencies are not identified and eliminated regularly. It may also be challenging to develop new ideas that can improve your organisation’s products and services.
Continual improvement is a core principle of ISO 9001. If you don’t integrate this into your QMS, you may not be compliant with your certification audit.
The Plan, Do, Check, Act cycle is a fundamental concept in this standard. It provides a structured and systematic approach to problem-solving and process improvement. The cycle incorporates regular checks and adjustments and helps organisations anticipate and mitigate potential risks. It relies heavily on evidence-based, data-driven decisions and encourages businesses to adapt to changes and new information.
Read more about the Plan, Do, Check, Act cycle and how to implement it.
Tips to encourage continual improvement in your organisation:
- Train employees on the Plan, Do, Check, Act cycle: Enable all staff to feel empowered by giving them training on the techniques they need to contribute towards continual improvement.
- Encourage employees to offer ideas: Enable employees to contribute via initiatives such as improvement teams or suggestion schemes.
- Develop KPIs and benchmark performance: Track your key performance indicators to measure performance and compare your processes and performance against industry standards. Use your data to identify areas that need improvement.
- Conduct regular audits and management reviews: These can help you assess how effective your processes are and check the efficiency of your QMS. Use your findings to decide on areas for improvement and track progress over time.
6. Insufficient internal audits
There’s no benefit to skipping internal audit or not scheduling enough of them. These audits are vital for helping organisations maintain the integrity of their QMS. Without audits, it may not be possible to sufficiently identify nonconformities, assess the effectiveness of processes and manage risks.
Internal audits involve employees, so they help to boost awareness and engagement with the QMS, which supports the certification process. Insights you can garner from your internal audits can help with data-driven decision-making. Crucially, they prepare your organisation for important external audits by addressing issues beforehand.
A lack of preparation, inadequate scope and objectives and poor documentation can lead to incomplete and inadequate audits, hindering the implementation of corrective actions and leaving gaps in performance assessment.
Try these tips for planning and executing thorough internal audits:
- Make comprehensive plans: Develop a detailed plan for your internal audit, including information about your resources, which areas will be audited and the timeline for the audit. The scope, objectives and criteria should be clearly defined.
- Choose the right auditor for your organisation: Whether you choose an internal auditor or use an external consultant, make sure you have picked the best fit for your organisation. This will depend on your internal skillset, training resources and budget.
- Analyse audit results comprehensively: Once you have the audit results, it’s important to analyse them thoroughly before creating a report on the findings. These should be shared with leadership teams and relevant employees to help them take the next steps.
- Conduct efficient follow-ups: Your organisation’s corrective and preventative actions should be based on your audit findings, so make sure you have a process in place to verify their effectiveness.
7. Resistance to change
Resistance to change can impede your organisation’s ISO 9001 implementation, particularly if it is not addressed. It can slow down the process, preventing your business from enjoying the benefits of ISO 9001. When employees or leaders resist change, it can lead to missed opportunities, as inefficiencies or areas for improvement can be overlooked.
Resistance can also lead to low morale and reduce employee motivation to contribute to the certification process.
These tips could help your organisation overcome any cultural and behavioural challenges:
- Open all communication channels: Set your organisation up for efficient communication between departments so that employees can address any reservations and find solutions for them.
- Foster a supportive environment: Encouraging feedback and collaboration can help your business foster a supportive culture in which all employees can feel a sense of ownership.
- Encourage leadership to visibly support the certification process: It can be beneficial to create a positive culture from the top down, so leaders should actively participate in initiatives and set an example for employees.
- Share internal success stories: Communicating the organisation’s wins can help demonstrate the beneficial impact of ISO 9001 throughout your organisation and foster a positive attitude towards process changes.
Proactive measures and continual learning are vital for successful ISO 9001 implementation.
British Assessment Bureau can help with a successful implementation – read our ultimate guide to ISO 9001 to discover more.
We have created an essential checklist that offers a comprehensive insight into what is needed to achieve certification in the ISO 9001:2015 standard.
Download our free ISO 9001 checklist to get started.
