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Documented procedures required by ISO 9001


Introduction 

ISO 9001 is a globally recognized standard for quality management systems (QMS) that helps organizations ensure the consistent delivery of high-quality products and services. To achieve ISO 9001 certification, an organization must adhere to a set of mandatory procedures that form the foundation of its quality management system. These procedures are essential for meeting the requirements of ISO 9001 and demonstrating a commitment to continual improvement. In this article, we will explore the key mandatory procedures that organizations need to establish and maintain to attain ISO 9001 certification. 

1. Document Control Procedure 

Effective document control is crucial for maintaining the integrity of the quality management system. This procedure outlines how documents, including policies, procedures, and records, are created, approved, updated, and archived. It ensures that employees have access to the most current and relevant information necessary for their roles. Please take a look at an example of the Document Control Procedure sample

2. Control of Records Procedure 

ISO 9001 requires organizations to maintain records to demonstrate compliance with the standard's requirements. The Control of Records Procedure defines how records are identified, stored, protected, retained, and disposed of. This procedure ensures that records are available for audit purposes and that they are preserved for the required retention periods. 

3. Management Review Procedure 

Top management is responsible for overseeing the QMS and ensuring its effectiveness. The Management Review Procedure outlines how management reviews are conducted at planned intervals. These reviews assess the QMS's performance, suitability, adequacy, and opportunities for improvement.

4. Internal Audit Procedure

Internal audits are a critical part of maintaining and improving a QMS. The Internal Audit Procedure outlines how internal audits are planned, conducted, and reported. Auditors, typically from within the organization, assess processes and procedures to identify non-conformities and areas for improvement.

5. Corrective and Preventive Action (CAPA) Procedure

The CAPA Procedure defines how an organization addresses non-conformities, corrective actions to eliminate their causes, and preventive actions to prevent recurrence. It ensures that issues are addressed promptly, root causes are identified, and preventive measures are put in place. 

6. Control of Nonconforming Products or Services Procedure 

This procedure outlines how an organization deals with nonconforming products or services to prevent their unintended use or delivery. It includes the identification, segregation, evaluation, and disposition of nonconforming items, helping to maintain the quality of delivered products and services. Please take a look at an example of the  Control of Nonconforming Products or Services Procedure

7. Training and Competence Procedure 

To ensure that employees are qualified to perform their roles effectively, organizations need to establish a Training and Competence Procedure. This procedure identifies training needs, defines training plans, and monitors employee competence to ensure they have the skills and knowledge required for their positions. Please take a look at an example of the Training and Competence procedure.

8. Supplier Evaluation and Control Procedure 

To maintain the quality of purchased products and services, organizations must establish a Supplier Evaluation and Control Procedure. This procedure outlines how suppliers are selected, evaluated, and monitored to ensure they meet the organization's quality requirements. Please take a look at an example of the Supplier Evaluation and Control Procedure

9. Customer Complaint Handling Procedure

Customer satisfaction is a key element of ISO 9001. The Customer Complaint Handling Procedure details how customer complaints are received, documented, investigated, resolved, and analyzed. It helps organizations identify areas for improvement and enhance customer satisfaction. Please take a look at an example of the Customer Complaint Handling Procedure

10. Risk Management Procedure

While not explicitly mandated in ISO 9001, many organizations include a Risk Management Procedure to identify, assess, and mitigate risks that could affect the achievement of quality objectives. This proactive approach aligns with the principles of ISO 9001 and helps prevent issues before they occur. Please take a look at an example of the Risk Management Procedure

Conclusion

ISO 9001 certification requires organizations to establish and maintain a set of mandatory procedures that ensure the effective implementation and continual improvement of their quality management systems. These procedures cover key aspects such as document control, record management, internal audits, corrective and preventive actions, and more. By adhering to these procedures, organizations can enhance their quality processes, meet customer expectations, and demonstrate a commitment to delivering high-quality products and services.

Reading Sources:
  • ISO 9001:2015 Standard: This is the primary source to understand the ISO 9001 requirements. You can access and purchase this standard from the ISO website or ISO certification bodies.
  • "ISO 9001 for Small Businesses" by Ray Tricker: This book provides a practical guide on how to implement ISO 9001 in small and medium-sized businesses.
  • "ISO 9001:2015 Handbook for Small and Medium-Sized Businesses" by Robert W. Peach: This book is specifically aimed at small and medium-sized organizations and offers a step-by-step guide to complying with ISO 9001.
  • "The ISO 9001:2015 Implementation Handbook" by Milton P. Dentch: This book reviews how to implement ISO 9001:2015 within organizations and includes numerous case examples.
  • "Internal Auditing to ISO 9001:2015" by Fred Dobb: This is a useful guide to understanding and conducting internal audits in accordance with the ISO 9001 standard.
  • "ISO 9001:2015 in Plain English" by Craig Cochran: This book provides easily understandable explanations of the ISO 9001:2015 requirements without excessive technical jargon.
  • "ISO 9001:2015 for Small Enterprises – What to do?" by Lars Albinsson: This guide offers insights into how small businesses can comply with ISO 9001:2015 with limited resources.
  • "ISO 9001:2015 Explained" by Charles Cianfrani: This book helps you understand the ISO 9001:2015 requirements with clear examples and explanations.
  • "ISO 9001:2015 Internal Audits Made Easy" by Ann W. Phillips: This book focuses on how to efficiently conduct internal audits in line with ISO 9001:2015.
  • "ISO 9001:2015 for Small Businesses" by Robert D. Brown: This book provides a specific guide for small organizations looking to comply with ISO 9001:2015.
  • "ISO 9000 Quality Systems Handbook" by David Hoyle: This is a comprehensive reference on quality management systems, including ISO 9001.
  • Your Organization's Documentation: In addition to the above sources, make sure to refer to your organization's internal documentation, including the mandatory procedures you've created in accordance with ISO 9001.
Please check the availability of these books at your local bookstore or library. By reading these sources, you will be able to develop a better understanding of ISO 9001 and how to implement it within your organization.

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