Introduction
Maintaining high-quality standards is crucial in the constantly changing world of business. For companies like Hymid, adhering to globally recognized standards such as ISO 9001 and ISO 13485 is the key to upholding our commitment to excellence, consistency, and continuous improvement. Recently, we underwent two recertification audits conducted by Raymond Welsh, from SGS Auditors, resulting in the re-awarding of ISO 9001 and ISO 13485 certifications. Raymond has not been to our site before, so it was good to have our QMS assessed by someone new to our business.
What is ISO 9001 & ISO 13485?
ISO 9001 is an international standard for quality management systems. ISO 13485 is a more comprehensive management system specifically for the manufacturing of medical devices. These standards provide a structured framework for process optimization, leading to improved efficiency and productivity. By establishing clear procedures and guidelines, companies can reduce errors, minimize waste, and consistently meet or exceed requirements. Additionally, ISO 9001 and ISO 13485 promote a culture of continuous improvement, driving innovation and enhancing competitiveness in the market. Customer relations also benefit from these standards, as they create a strong foundation of trust and satisfaction. ISO 9001 and ISO 13485 prioritize a customer-centric approach, ensuring that their needs and expectations are not just met, but exceeded.
Furthermore, for the medical device sector, ISO 13485's focus on safety and regulatory compliance provides assurance to customers that the products they rely on meet the highest quality and safety standards. This contributes to patient safety and overall public health.
The Audit Process
SGS's audit process is a meticulously planned and comprehensive endeavour that spans multiple days. Hymid’s process ensures a thorough evaluation by providing auditors with a detailed checklist or plan that outlines the specific areas of the business being scrutinized.
For Hymid's ISO 9001 and ISO 13485 recertification audits, we took on the challenge of assessing a wide range of our company's operations.The process begins with auditors conducting interviews with process owners from different departments. These interviews allow the auditor to gauge the implementation of established procedures, supporting processes, and relevant documentation. This is to ensure that the company not only adheres to protocol but also actively works in alignment with it.
Another crucial aspect of the process is the presentation of documented records that provide a historical overview of actions taken to achieve desired outcomes within each process.The audit depends on substantiating claims and assertions with documented evidence. Auditors carefully select samples of these records to trace the path of a purchase order, work order, or part number within Hymid's processes. This thorough tracing ensures that our operations align with established procedures and guidelines.
The importance of these records in demonstrating accountability, transparency, and adherence to standards cannot be emphasized enough.Our main objective through the audit is to confirm that the business follows essential management principles.
This includes customer-centric strategies, strong leadership, engaged employees, adherence to processes, continuous improvement, and making evidence-based decisions. Additionally, the audit evaluates the company's ability to consistently meet various requirements, whether they are driven by customers or regulatory bodies.
Conclusion
An audit is more than just a validation process; it's a chance for self-reflection and development. During an audit, areas of excellence are recognized, but it also uncovers nonconformities and reveals opportunities for improvement. Implementing a strong improvement strategy brings numerous advantages, including saving time and costs for both the company and its customers, as well as mitigating unforeseen risks. We understand that we can boost our overall performance by embracing the lessons learned from the audits. This ensures we stay agile, responsive, and adaptable in a competitive market. If you’re seeking a trusted partner for your plastic injection moulding needs, look no further than Hymid! Call us today on ☎️ 01803 615380 or email us at ✉️ hello@hymid.co.uk – our specialist staff are standing by to help!
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