What is ISO 13485 Manual and Its Requirements for Medical Device Manufactures

Quality is a degree to which a set of inherent characteristics fulfills requirements. The term quality is also defined as a totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs. Similarly, quality manual defines the scope of the quality management system, including details of and justification for any exclusion. ISO 13485 Quality Manual references the procedures detailing the actual means by which the system operates and demonstrates the interaction between the processes which make up the system. Changes to the Quality manual that effect conformity to ISO 13485 or Regulatory requirements are submitted to the Registrar used by Systems.

The Quality Management Systems described in ISO 13485 Manual is specific to non-sterile and non-implantable medical devices components. Quality manual provides reference to the procedures established for the Quality Management System and also shows the relationship between the procedures and the requirements of the Quality Management Standards.  Measurable quality objectives are established at the appropriate functions throughout the organization that are relevant in supporting the quality policy, meeting the requirements for products and processes, improving quality and performance, and maintaining and enhancing customer satisfaction.

The quality management system for medical device manufactures is carried out in order to meet the requirements given in the quality manual as well as the quality objectives, and that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. Including, those needed to meet requirements for the product, are established for relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the quality policy and include the planning of product realization to include the quality objectives and requirements for relevant the product.

ISO 13485 Audit Checklist and Its Requirements for Certification

Across the world, medical equipment manufactures and their suppliers are required to meet the highest quality assurance standards and regulations such as ISO 13485. Established by the International Organization for Standardization (ISO), ISO 13485 is the worldwide legal standard for organizations the design and manufacture medical products, equipment and parts. Compliance with this important standard is confirmed through a complex auditing and certification process. While meeting the many requirements contained in ISO 13485 is challenging, an ISO 13485 audit checklist can greatly simplify the process.

ISO 13485 Audit Checklist for organizations that need to assess and control of Quality Management Systems based on the international standard ISO 13485-2003 policy and procedure requirements. This audit checklist covers every standard requirement, and includes sample audits, mark sheet for the rating of the results. A team of experienced Manufacturing and Quality Engineers effort with input and suggestions with this set of audit checklist that is easy to use and time and error saving tool for every Medical Device Organization.

The audit checklist addresses all main and sub clauses and requirements of the ISO 13485 -2003 Standard. A simple rating system is included that enables the user to record compliance measurement based on the audit findings. The Set of ISO 13485 Audit Checklist and Guide contains Introduction Description how to apply and use the audit checklist, Short introduction into audit requirements, discerning minor verses major or critical nonconformities, and how to tally respective findings and rate the overall performance. The set of ISO 13485 Audit Checklist with questions addressing each requirement stated in the Standard contains all the documentation.

Medical manufacturer Device to plan and carry out regular internal audits, for this purpose ISO 13485 audit checklists is required, which is essentially a list of tasks that must be completed during implementation. The ISO 13485 audit is an integral part of the evaluation process for the internal audit plan. The format of this checklist encourages the auditor to objective evidence on the basis of the document: the processes of the organization, the characteristics of the process and the requirements of the audit standard. Typically, the lead auditor creates and manages the ISO 13485 audit checklist.