Understanding ISO 13485 for Compliance and Quality

Many Global Regulatory bodies are including ISO 13485 into their requirements making the product suitable to the organization to help in aligning with the regulatory requirements with other elements of the standard.

Greater emphasis on risk-based approaches

The ISO 13485 standard does not have a high-level Annex SL structure. However, it requires risk-based approaches for quality and safety protection for the compliance of the standard. There is a greater emphasis on risk-based approaches as compared to the ISO 13485:2003.

Compliance with ISO 9001:2016 requires companies to demonstrate the entire organization's Quality Management System (QMS) processes.

Quality Management System (QMS)

The QMS consists of the fundamental set of sequences, interactions, and resources to do business with a medical device company.

The regulatory requirements vary from organization to organization addressing the specific regulatory requirement of the market.

Companies can demonstrate more specific requirements for validation of systems such as Enterprise Resource Planning (ERP), QMS, and Laboratory Information Management Systems (LIMS) in the development or maintenance of medical devices are in ISO 13485 Certification.

Documentation Requirements

Documentation of QMS processes, quality events, and workflows should be developed with great care to ensure the safety of the medical device. Documentation is about defining the processes that are being followed.

Documentation assists your staff through the manufacturing and support of medical devices and provides adequate training based on ISO 13485 Certification.

Quality Manual

The Quality Manual is a critical part of your ISO 13485 Certification. It helps to ensure the scope of the organization and documentation procedure.

Medical Device File

The requirements for the various elements of a medical device file are in Sub-clause 4.2of ISO 13485:2016.

• Keep demonstrating conformity supporting documents
• Include a description of each medical device
• Develop and maintain procedures for each medical device
• Develop and maintain specifications and procedures
• Document procedures for servicing

Document Control

In adherence to Section 4.2.4 (Control of documentation) of ISO 13485 Certification, the QMS should be maintained to ensure their usability, effectiveness, and adequacy for operation. Defined controls are used to track unintended changes in documents.

Control of records

Records should be controlled to provide proof that the required processes have been executed. It is vital to ensure the correct understanding of records and documents.

Management Responsibility

Even the best of control over records will fail if there is no complete support of the Executive management in maintaining product safety. By embracing true compliance of ISO 13485 Certification they should foster a culture of true quality across the organization. A small slip in their approach to true quality can make it extremely difficult in maintaining quality.

Resource Management

Section 6 of ISO 13485 standards identify the need to allocate qualified staff, infrastructure, processes, and work environment to ensure product safety to support business operations, and support services.

Product Realization

Product realization is a description to define customer needs, design, and development, purchase, production, and field assistance to develop quality and safe medical devices.

Many elements of the QMS and a variety of staff and resources help your product realization efforts to have the following in place:

• Established quality criteria
• Defined processes
• Appropriate infrastructure
• Trained staffs
• Established verification in line with the products and processes.
• Documented records providing evidence to product meet the required specifications

Measurement, Analysis, and Improvement

• Feedback is not just about customer complaints, the feedback is the process clearly defined to gather data from production and post-production activities.
• Assure that the product monitoring is being done
• More clarity about the monitoring a measurement of processes for companies to comply with during the implementation of a quality system.
• clarity about the nonconforming product before and after delivery to ensure that the instances are each handled appropriately.

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