Documentation Requirements for Quick ISO 13485 Certification
The international standards organization (ISO) established ISO 13485 as the global standard for medical device quality management systems. How do you manage your QMS? If you’re like the majority of the medical device business, your QMS is probably a mishmash of paper-based processes and general-purpose tools kept together by a group of individuals within your company–typically document control. It is significant since the last edition, released 13 years earlier in 2003, was long delayed. ISO 13485 is primarily a bridge standard. This bridge, in other words, expressly explains and defines contemporary QMS expectations for medical device firms. Before to the fully specified and documented modifications in the standard, many of the best practices recommended and carried out were haphazard and appeared to be based on auditor assessments.
Benefits of ISO 13485
- Increased Reputation of the Company
- Making Decisions Based on Evidence
- Continuous Improvement
- Increased customer Satisfaction
- Increased Employee Participation
Documentation Requirements for ISO 13485
The goal of the documentation in the QMS is to ensure that important processes, where all employees must execute the same thing consistently, are understood and reproducible. To make this work, it is best to keep these processes as simple as possible and express them in the simplest manner possible. In today’s piece, we’ll look at the documentation requirements for ISO 13485:2016, which will assist manufacturers get organized as they move to the most recent standard version.
The concept of document work can sometimes cause anxiety within a firm. Documentation is sometimes regarded as unduly cumbersome and, in many cases, unneeded, with little added value. Most businesses impose significant burdens and hurdles in terms of documentation. And it doesn’t have to be this way. Aside from the records mandated by your jurisdiction, ISO requires you to document aspects such as:
- Quality Policy and Objectives: You’ll need written declarations that indicate not only your commitment to quality but also the specific objectives that will assist you achieve those goals.
- Quality Manual: Your quality manual should cover the scope of your QMS as well as references to specified quality procedures.
- Describe the scope of your QMS. Include any excluded clauses or non-applications that are justified.
- List or refer to the QMS procedures.
- Describe the interactions of QMS processes.
- Outline the structure of the QMS documentation.
- Medical Devices File: The medical devices file concludes
- Product description, including intended usage and warnings.
- Labeling and usage instructions.
- Product specifications.
- Specifications and processes for manufacture, inspection, labeling, packing, transportation, handling, and delivery.
- Specifications for measuring and monitoring.
- Specifications and installation methods (if applicable).
- Product service procedures
- Procedures and Records for Quality Assurance: These must encompass all processes, including documentation and record control procedures. Records are proof that definite processes should be followed.
ISO 13485 was first published in 1996 and latest applicable version released in 2016. It outlines the requirements for a comprehensive quality management system for the design and manufacture of medical equipment. To gain ISO 13485 Certification, you must develop a Quality Management System and prepare ISO 13485 Documentation that clearly outlines the implemented system, in which organizations give information through digital platforms like e-mail and other methods.
List of SOPs
- Measurement of Temperature and Humidity
- Validation of Autoclave
- Microbial Monitoring of Production Area
- Temperature Monitoring of Sterility Room and Microbiology Laboratory
- Temperature & Humidity Monitoring
- Clean Room Condition Monitoring