A quality manual is a document that defines a company’s Quality Management System (QMS) and the policies and procedures in place to ensure that its products or services meet the needs of its customers. To make the quality manual comply with the ISO 9001 standard, the following steps can be taken:
Understanding the requirements of the ISO 9001 standard: The first step in creating an ISO 9001-compliant quality guide is to understand the requirements of the standard. This can be done by reading and studying the standard, attending training courses, or consulting experts.
Define the scope of your quality management system: The scope of your quality management system should be defined and documented in the quality manual. This includes the products or services covered by the QMS, which sites and processes are included, and any exclusions that exist.
Define and document your quality management system policies and procedures: The quality manual should include a detailed description of the policies and procedures that make up your quality management system. These policies and procedures must be designed to meet the requirements of the ISO 9001 standard.
Establish a documentation system: The quality manual should include a description of the documentation system in place. This should include a description of the types of documents used, procedures for document control, and procedures for maintaining and updating documents.
Include instructions for implementing and maintaining your quality management system: The quality manual should include instructions for implementing and maintaining your quality management system. This should include details on how to train staff, how to monitor and measure the effectiveness of the quality management system, and how to make continuous improvements.
Perform internal review and audit: Once the quality manual is complete, it must be reviewed and revised internally to ensure that it meets the requirements of the ISO 9001 standard and that it accurately describes your quality management system.
Continuous Improvement: Continuous improvement is a continuous process that should be part of the quality management system. The quality manual should include a process for identifying areas for improvement and implementing necessary changes.
By following these steps, you can create an ISO 9001-compliant quality manual that effectively communicates your company’s quality management system to customers, employees, and other stakeholders. Keep in mind that the Quality Manual must be a living document, and it must be reviewed and updated regularly to bring it in line with company processes and ISO 9001 requirements.
More about the quality guide and how to write it from the topics below
Components of the Quality Manual
Work procedures guide «quality guide» for a pharmaceutical company