Many companies are aware of the existence of ISO 9001 and may understand that it’s desirable but do not fully understand how it’s obtained. Alternatively, they may feel that the benefits of obtaining ISO 9001 are outweighed by the effort required to secure it. Or they might feel that ISO 9001 isn’t for them.
In most cases, these views are mistaken. While the process of obtaining ISO 9001 can be challenging, the rewards are considerable.
What is ISO 9001, how difficult is it to obtain and what steps do companies need to take in order to obtain it?
What is ISO 9001 and why is it important?
ISO 9001 is an international standard for quality management systems (QMS). It was developed by the International Organisation for Standardization (ISO), and it provides a framework for businesses and organisations to ensure that their products and services meet customer expectations and regulatory requirements. The standard outlines a set of principles for quality management, including a strong customer focus, a process-based approach, and continual improvement.
It provides organisations with a structured approach to quality management, which can help to improve their overall efficiency and effectiveness. By implementing a QMS based on ISO 9001, an organisation can ensure that all aspects of its operations are aligned with its quality objectives and that it has a clear process in place for identifying and addressing potential quality issues.
By obtaining ISO 9001, companies can increase customer and stakeholder confidence, demonstrating that an organisation has been audited and certified to meet high-quality standards. As well as helping companies compete in a highly competitive environment, winning new business and building customer loyalty, it can also help organisations comply with relevant regulatory requirements.
Is it hard to get an ISO 9001 certification?
Obtaining ISO 9001 can be a challenging process, particularly for larger and more complex organisations. Much will also depend on the effectiveness and relevance of its existing quality management practices. In general, larger organisations with more complex operations and supply chains may face more challenges in implementing a QMS that meets the requirements of ISO 9001.
However, it’s important to remember that most challenges can be overcome. With a methodical approach and the right support from a partnership organisation such as Candy Management, you can implement a QMS that meets the requirements of ISO 9001.
How to get ISO 9001 certification
If you’re looking to gain ISO 9001 certification for your organisation there are a number of steps that you will need to follow.
- Check your readiness
Before you begin you will need to take a realistic look at how prepared your organisation already is to achieve ISO 9001. This will usually include conducting a gap analysis to determine the current level of your organisation’s quality management practices, and assessing if it is ready to implement a QMS based on ISO 9001. This can either be an internal self-assessment process or an external assessment by outside consultants.
This gap analysis can help you to identify areas of your existing quality management practices that need to be improved or developed in order to meet the requirements of the standard. It can also help you to prioritise areas for improvement and to allocate resources effectively, ensuring that you have the support and resources you need to implement a successful QMS.
- Develop a quality management system
Developing a QMS that meets the requirements of ISO 9001 requires careful planning and preparation. It also requires a thorough understanding of the requirements of the standard and the specific needs of your organisation.
To develop a QMS, you should start by reviewing the requirements of ISO 9001 and determining which elements of the standard are relevant to your organization. This will help you to tailor your QMS to your specific needs and to ensure that it meets the requirements of the standard.
As well as creating policies, procedures and processes for quality management, it’s also important to identify the roles and responsibilities of personnel involved in quality management.
Policies and procedures may include document control, management review, internal audits and non-compliance management. Some of the roles involved in quality management may include management representatives, internal auditors as well as those personnel involved in the implementation and future maintenance of the QMS.
It’s also crucial to ensure that your QMS is well-documented, including all policies, procedures, processes, and records. This will help to ensure that your QMS is easily understood and followed by personnel and that it can be audited effectively by a third-party auditor.
- Implement the QMS
Once your QMS has been developed, the next step is to ensure its smooth and effective implementation. This will involve rolling out the QMS across your organisation and providing the necessary training and support to employees as required.
The process will usually begin with a clear communications strategy. Employees should be involved in the process, with the purpose and benefits of the QMS strategy being clearly explained. All employees should be trained and knowledgeable about the QMS as well as their roles and responsibilities within the system.
Then you can make any necessary changes to existing systems and processes, as well as introducing new ones, to ensure that your QMS meets the requirements of ISO 9001. This may involve updating or creating policies, procedures, and processes for quality management, and training personnel on how to follow the new procedures.
Once the new QMS has been implemented, it’s important to continually monitor and evaluate its effectiveness to ensure that it’s having the required impact. This can involve conducting internal audits, monitoring noncompliance, and looking at how continuous improvements can be made.
This is the most critical step of the ISO 9001 process and requires careful planning, communication and support throughout.
- Document the QMS
Documenting the QMS provides a clear and comprehensive understanding of the policies, procedures and processes that have been developed and implemented for quality management. It should also set out the roles and responsibilities of the different personnel involved in quality management.
Documentation will usually include a number of elements:
- Quality Manual: This is a high-level document that provides a broad overview of the QMS, its policies, procedures, and processes.
- Work Instructions: These are detailed documents that set out guidance on how specific tasks should be performed to support the QMS. An example of this would be how to conduct an internal audit..
- Records: This is documentation that provides evidence of how the QMS has been implemented. It will also include evidence of its effectiveness such as internal audit reports and management review minutes.
QMS documentation should be clear, easy to understand and well-organised. It should be accessible and easy to locate when required. It should also be updated regularly to reflect any changes in the QMS. The documentation will need to be reviewed regularly to ensure that it remains accurate and up to date.
- Conduct an Internal Audit
An internal audit is a systematic review of your organisation’s QMS to ensure that it is not only working effectively but is also in compliance with the requirements of ISO 9001. The internal audit should provide valuable data with information on the performance and effectiveness of the QMS. It should also highlight areas where improvements can be made. The QMS should cover every aspect of the QMS, including policies, procedures and records.
Internal auditors will usually be appointed who have a thorough understanding of the QMS, and how it meets the requirements of ISO 9001. The auditors should be experienced in the principles of internal auditing and should follow a structured auditing process. This will include planning, preparation, execution and reporting. The internal audit process should be used as a means to provide continuous improvement in your QMS.
- Embed continual improvement
Continual improvement is a key aspect of ISO 9001. Obtaining certification isn’t a static, one-off event, but needs to be revisited and updated. The aim of this is to embed continual improvement to increase customer satisfaction by meeting their requirements and exceeding their expectations. It should also look to continually improve the overall performance and competitiveness of the organisation.
Achieving continual improvement requires a systematic approach and will usually include a range of measures. Internal audits will form a key part of this, ensuring that the QMS is working effectively.
Performance data, such as customer feedback and internal audits, should be regularly reviewed to identify any areas for improvement. Any areas where the organisation is no longer meeting ISO 9001 requirements should be addressed as a matter of urgency.
Employees should be included in the continual improvement process, encouraging them to identify areas that need attention and to make suggestions for improvement. The QMS should also be regularly reviewed with senior management to assess its overall performance so far.
- Seek Certification
The final step is to seek ISO 9001 certification. The certification process will involve an assessment of the QMS by a third-party certification body. The assessment will include a review of the QMS documentation, as well as an on-site assessment of the implementation and effectiveness of the QMS.
Firstly, you will need to choose a certification body that is accredited to perform ISO 9001 certifications. It should be one that has established a reputation for performing fair and impartial assessments. You will then need to prepare for the assessment by ensuring that the QMS documentation is complete, accurate, and up-to-date and that the QMS is being properly implemented.
You can then submit your application for certification to the chosen certification body. This should include a copy of the QMS documentation along with any other relevant information. The certification body will then conduct an on-site assessment of the QMS. This will include a review of the QMS documentation, an interview with key personnel and an observation of the QMS processes in action. After this has taken place, the certification body will make its decision. This might include recommendations for improvement or requirements for corrective actions.
- Maintain Certification
After successfully receiving certification there’s no time to sit on your laurels. To maintain certification, your organisation will need to regularly demonstrate its ongoing commitment to quality and compliance with the requirements of ISO 9001. This might include conducting internal audits, analyzing data, implementing corrective and preventive actions, and involving employees in the improvement process.
The QMS should be regularly reviewed with senior management to evaluate its overall performance and effectiveness, and to identify opportunities for improvement. The performance of the QMS should be monitored to ensure that key processes are working effectively and meeting the needs and expectations of customers.
Action should be taken to address any failings uncovered by internal audits, performance data and management reviews. It’s also important that all QMS documentation remains up-to-date and accurately reflects the current status of the QMS.
Your organisation should also regularly seek recertification by the certification body to demonstrate ongoing compliance with the requirements of ISO 9001.
Achieve and maintain ISO 9001 certification with Candy Management
At Candy Management Consultants, we’ve amassed an experienced team of expert ISO 9001 consultants – each with at least ten years of experience in the ISO and health and safety industries.
Thanks to this wealth of knowledge and experience, we can guide you through the process to help you achieve your ISO 9001 certification with ease. We take the headaches out of achieving ISO 9001.
To discuss your ISO requirements or new management system with our knowledgeable team, please don’t hesitate to get in touch by either calling us on 01614707929 or sending us your enquiry via email at firstname.lastname@example.org.
Alternatively, if now isn’t a good time, you can always request a call back at a time and date that’s right for you by filling out our online contact form with your contact details and enquiry.