ISO 9001 is not just a standard; it’s a game-changer for quality management systems. By achieving certification, your healthtech can reap a multitude of benefits, including streamlined processes, heightened customer satisfaction, and an unrivaled reputation. Uncover the true potential of ISO 9001 and witness your business thrive like never before.
ISO 9001 certification provides health technology companies with a competitive edge when doing business with the NHS. It assures the NHS of your unwavering commitment to quality, compliance with regulations, and your ability to meet the specific needs of the health and care sector.
In this way, ISO 9001 acts as a guiding light for health tech businesses, ensuring they meet customer and NHS expectations for compliance. It does this by establishing a framework for maintaining consistent and efficient processes, while also encouraging continuous improvement.
ISO 9001 is a globally recognised standard for quality management systems (QMS). It involves a systematic approach to ensure that an organisation consistently provides products and services that meet customer requirements and comply with applicable regulations.
To achieve ISO 9001 certification, an organisation must demonstrate its ability to effectively implement and maintain a QMS that meets the requirements of the internationally recognised standard. This involves 7 key steps:
Understanding and interpreting the ISO 9001 standard: Defining ISO 9001 in the context of the product or service to understand how it applies to the business operations.
Developing the Quality Management System (QMS): Establishing and documenting quality policies, objectives, and processes to address the requirements of ISO 9001. This includes defining responsibilities, documenting procedures, and implementing controls to ensure quality.
Implementing the Quality Management System: The organisation needs to put its QMS into practice and ensure that it is effectively implemented across all relevant functions and levels of the organisation.
Conducting internal audits: Regularly auditing the QMS to verify compliance with ISO 9001 requirements. Internal audits help identify areas for improvement and ensure the effectiveness of the system.
Management review: A periodic review of the QMS to evaluate its performance, identify opportunities for improvement, and make necessary changes.
External audit: An accredited certification body, independent of the organisation, conducts an external audit to assess compliance with ISO 9001. The certification body evaluates the QMS documentation, processes, and evidence to determine if it meets the requirements of the standard.
Corrective actions and improvements: Where non-conformities or areas for improvement are identified, corrective actions are taken to address them. Continual improvement is a key principle of ISO 9001 and organisations are encouraged to constantly strive for better performance and customer satisfaction.
Book a free, no obligation discovery call with one of our ISO standards experts to learn more about how your business could benefit from ISO certification.
Our team of dedicated in-house experts are ready to guide you on your ISO 9001 certification journey. By collaborating through shared project boards, we’ll deliver efficient implementations with minimum disruption to your business operations. And, because we customise Information Security Management Systems (ISMS) or Quality/Risk Management Systems, you can rest assured your policies and procedures will be tailored to your unique needs.
If you’re ready to embark on a transformative journey to unlock the full potential of ISO 9001 certification, contact us below to get started.
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What are the key benefits of ISO 9001 certification when doing business with the NHS?
ISO 9001 certification provides several benefits for health technology companies that want to do business with the NHS in the UK:
