ISO 13485 CERTIFICATION IN SINGAPORE, PENANG, MANILA- MEDICAL DEVICES QUALITY MANAGEMENT SYSTEM
DOCUMENTED INFORMATION STRUCTURE
One of the key requirements and essential steps for achieving ISO 13485 certification is identifying and maintaining documents and retaining records as evidence.
The purpose of ISO 13485 documentation is threefold:
- To provide a transparent framework for the organization’s operations,
- To provide process consistency and a stronger understanding of requirements of ISO 13485.
- Showing the evidence of the company’s achievement of its goals and objectives;
In order to determine the ISO 13485 documented information structure, the key focus is on efficiency, and on developing those processes and documents that are beneficial to a corporation and meeting regulatory requirements.
DOCUMENTED INFORMATION STRUCTURE OF ISO 13485
- QUALITY MANUAL
The Quality manual must meet the following criteria:
- Describe the scope. Include any clauses that are excluded or non-applications supported with justification.
- List or reference the procedures comprising the QMS.
- Describe the interactions of QMS processes.
- MEDICAL DEVICE FILE
A medical device file is required for every medical device type or device family.
The medical device file shall include:
- Description of the device, including intended use and guidelines to use.
- Product labelling and book of instructions.
- Specifications for the device.
- Specifications and procedures for manufacturing, inspection, labelling, packaging, storage, handling, and distribution.
- Specifications for measuring and monitoring.
- Specifications and procedures for product servicing and installation. (if applicable)
Following are the mandatory procedures required to fulfil ISO 13485 requirements:
- Control of documents
- Control of records
- Internal audit
- Control of non-conforming products
- Corrective and preventive actions
- Validation of computer software
- Customer specifications like manufacturing, inspection, packaging, and delivery
- Monitoring and measurement
- Servicing and installation (if applicable)
- Management review
- Work environment and contamination control
- Design and development
- Validation of sterilization and sterile barrier systems (if applicable)
- Identification and traceability
- Preservation of product
- Calibration or verification for measuring equipment
- Feedback and complaint handling
- Reporting to regulatory authorities
- Advisory notices, reworks, data analysis
Additionally, to the specified documents, there is a requirement for organizations to develop ISO 13485 documentation for any procedures that are likely to get non-conformances if they not considered.
Documented information retained as an evidence that a process is in place and fulfils the requirements.
For sure, planning the size and scope of your QMS documentation based on your organizational needs is an important activity for a functional and efficient Management System
Partner with us to ensure the right documented information structure is developed for your organization located in Singapore, Manila, Makati, Cavite, Yangon, Batam Islands, Penang by the best and the top certification agency 2020, 2021 – ISO 13485 certification, drop an email to [email protected]