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ISO 13485:2016 Documentation
- All ISO 13485 documentation available here was created by the team of Lead Auditors and Consultants at Logix, who are specialists with a high degree of experience in Medical Devices Quality Management Systems.
- The Logix team responsible for our ISO 13485 documentation has many years of work experience with ISO certification around the world.
- The information contained in our documents is to-the-point and streamlined, presenting concentrated knowledge of ISO standards.
- Organizations ranging from Fortune 500 companies to small businesses have successfully integrated our materials within their systems.
- All necessary documents are included in our suite of products, including Manuals, Procedures, Forms, and Internal Audit Checklists.
- All clauses and requirements are covered in detail in our thorough ISO 13485 documentation.
- Our templates are applicable for Initial Certifications, System Upgrades, and any other applicable purposes of your organization, to make it compliant to scheme requirements as well as more effective and efficient.
- All our ISO 13485 documentation comes with detailed instructions on adapting it to the specific needs of your organization.
- All purchased Logix ISO 13485 scheme documents are available to download on demand.
Medical Devices Quality Management System Manual
$100 USD
Purchase Here The Medical Devices Quality Management System Manual is an all-encompassing guiding document outlining the steps your organization needs to take to meet all requirements under ISO 13485:2016. The manual is a vital document when it comes to external audits and serves as a useful resource for your organization’s personnel internally. Complete description of all components of the management system and references to documented procedures are present in each section of this detailed guide.
Medical Devices Quality Management System Procedures
$350 USD
Purchase Here All necessary procedures required by ISO 13485:2016 are included in the Medical Devices Quality Management System Procedures document, as well as supplementary procedures your organization can choose to put into practice. With a detailed set of procedures included here you will be able to make certain that all of the standard requirements are covered and adapted to the specific needs of your organization as necessary.
Medical Devices Quality Management System Forms
$200 USD
Purchase Here This is an all-encompassing set of forms carefully designed to be able to fit the requirements of various organization types with minor adjustments. The Medical Devices Quality Management System Forms cover all system processes of all sections of the ISO 13485:2016 standard.
ISO 13485 Internal Audit Checklist
$100 USD
Purchase Here The ISO 13485 Internal Audit Checklist is developed to be simple to use to aid in performing internal audits within your organization. The checklist specifies the data and documentation that needs to be delivered in the form of evidence for each clause and exhaustively summarizes all standard requirements.
Medical Devices Quality Management System Complete Package
$575 USD
Purchase Here The Medical Devices Quality Management System Complete Package is a complete collection of all ISO 13485 scheme documents necessary for any organization’s ISO 13485 management system. By applying these documents, your organization will have the ability to provide evidence of full compliance with all standard requirements. Contained within this package are the Manual, Procedures, Forms, and the ISO 13485 Internal Audit Checklist.
Documentation
ISO 13485 Documentation
