Things that must know about the ISO 13485 standard

Posted by Charles Wilson on May 10th, 2022

ISO 13485 standard is specifically established for the manufacture of medical devices, ISO 13485’s main objective is to help enable consistent medical device regulatory requirements in the industry. It contains a comprehensive list of necessities meant to guide organizations that belong to the medicinal supply chain by referencing specific requirements for the manufacture, installation, and servicing of supplies. Its applicability is extended by the fact that it is useful to organizations that operate in any stage of the industry, with special attention to organizations that service medical device manufacturers.

Despite it being based upon ISO 9001, ISO 13485 shifts its attention from continual improvement to meeting regulatory requirements and risk management. The system makes its parallel with the requirements to match those of the FDA and other foreign regulators, which offers the framework to increase upon additional regulatory as well as customer requirements.

Why ISO 13485 standard is important?

The necessities of ISO 13485 are flexible and sufficient to apply to any organization of any size any type. These organizations could be tangled in the design, production, distribution, servicing, or even external suppliers. ISO 13485 starts specific requirements for organizations to follow through on to confirm that they can meet customer and regulatory requirements. Because of its adaptability and range within the market, ISO 13485 has become a staple necessity for organizations in the market, especially competitive ones.

How to become ISO 13485 certified?

The progression of becoming certified in ISO 13485 involves developing a management system based on the standards’ guidelines customized to the organization and then hiring a recognized third party to conduct regular audits. The prime objective of the management system development process must revolve around the product policy and quality manual; these set the base for the implementation of the system. Starts with management support and identifying the customer requirements for the management system, initially the documentation needs to start with defining the quality policy, objectives, and manual which will work to determine the scope and extent of implementation of the management system.

Additional processes and procedures – including mandatory ones, need to be created to ensure efficient delivery of products and services. For this, must consult the list of mandatory ISO 13485:2016 documents required. Once all of this is accomplished, the management system will need to be operational for a period to collect the necessary records and documentation required for audits and system reviews to become certified. So, here are the five important elements of the ISO 13485 standard.

1. Quality Management System (QMS)

In the QMS section, let’s discuss the general quality management system requirements, as well as the documentation needed to implement and maintain an effective quality management system. According to ISO, organizations need to:

• Regulate the processes the quality management system necessitates and what\'s needed to apply these procedures throughout the organization, considering the several roles involved,
• Apply a risk-based approach to the control of the appropriate processes needed for the quality management system, and
• Determine the sequence and interaction of these processes.

2. Management responsibility

This section outlines the unique roles and responsibilities of management as it pertains to quality management system execution and maintenance. Management should provide evidence of its commitment to the growth and maintenance of the quality management system and its efficiency. To do that:

• Communicate the importance of meeting regulatory necessities
• Found a high-value quality policy
• Confirm that quality objectives are established
• Conduct management reviews
• Confirm the availability of quality management system resources

3. Resource management

At this stage, planning the proper resource management to implement the quality management system and maintaining system effectiveness. Its requirements are needed to meet major regulatory and customer requirements.

Resources in this section include:

• The facility of resources
• Human resources
• Infrastructure
• Work environment
• Contamination control

4. Product realization

In a hurry to get products into development as soon as possible, many organizations often overlook the planning phase. The requirements need to match to plan that realization effort.

More specifically, it states that it should:

• Start the quality requirements for the products
• Define the required procedure and what necessary documentation will be needed for those processes
• Outline the company structure that will need to be created and what the work environment should be like
• Define employee qualification and ISO 13485 auditor training requirements
• Start the actions for verification, validation, measurement, monitoring, handling, inspection, storage, distribution, and traceability
• Lastly, it’s important to organize all that information in such a way that it can be effortlessly accessed and understood.

5. Measurement, analysis, improvement

According to ISO standards, every organization should plan and implement the monitoring, measurement, analysis, and improvement processes correlated to the quality management system and products.

In this pursuit, organizations need to:

• Authenticate conformity of the product
• Ensure the proper quality management system
• Keep the productivity of the quality management system

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