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Implementation of ISO 13485 in the factory (medical device quality management system)

ISO 13485:2016

Medical devices — Quality management systems — Requirements for regulatory purposes

What is ISO 13485?

ISO 13485 is an international standard developed as a template for medical device manufacturers to meet regulatory requirements. It includes specific requirements for medical devices and excludes some requirements of ISO 9001 that are not applicable. This standard applies to organizations that design, develop, and manufacture medical devices.

Regulators, including the Medical Devices Agency (MDA), and the Ministry of Health, have adopted this standard with the following objectives.

Harmonizing the quality of the required system

Reduce the conflict between different standards

Facilitating license applications for medical device manufacturers

The Medical Devices Authority (MDA) referred to ISO 13485 in the implementation of the Medical Devices Act 2012 (Act 737).

Benefits of implementing ISO 13485

Benefits of the ISO 13485 Quality Management System (QMS) for medical devices:

Facilitating the export of medical devices.

Increasing the likelihood of manufacturing safe and effective medical devices.

Assure the authorities that you are a medical equipment manufacturer with a quality management system based on internationally accepted standards.

Safety and quality are non-negotiable in the medical equipment industry. That’s why we developed ISO 13485.

Regulatory requirements are becoming increasingly stringent at all stages of the product life cycle, including service and delivery. Increasingly, industry organizations are expected to demonstrate their quality management processes and ensure best practices in everything they do. This internationally agreed standard defines the requirements of a quality management system specific to the medical equipment industry.

Which organizations have adopted ISO 13485?

ISO 13485 is designed for use by organizations involved in the design, manufacture, installation, and service of medical equipment and related services. It can also be used by internal and external parties, such as certification bodies, to assist them in auditing and auditing processes.

ISO 13485:2016 is now applicable to organizations engaged in:

Maintenance and distribution of medicines

Equipment installation of medical equipment

Service of medical equipment

Decommissioning and final disposal of medical equipment

Design and development of medical equipment

Providing related activities (e.g., support)

In addition, the International Standard applies to external suppliers or parties who provide products or services (such as raw materials, devices, sterilization services, and calibration and maintenance services) to such organizations.

The ISO 13485 Quality Management System (QMS) for medical devices is recognized and supported.

Is ISO 13485 mandatory?

In answer to this question, every organization must meet the legal and regulatory requirements in the area where it intends to produce and sell services and goods

For medical equipment companies that wish to produce and sell in Europe (obtaining a sales license in the European Union CE), it is necessary to obtain ISO 13485 because they must meet the requirements of the European Union Medical Device Regulation and one of these requirements is obtaining ISO 13485.

You also need to have a quality management system (QMS) in place to comply with the EU MDR. ISO 13485:2016 is the only standard that is listed in the list of harmonized standards of the European Union for medical equipment; therefore, companies must obtain this standard. Therefore, for production and sale (obtaining a sales license in the European Union CE), it is necessary to obtain ISO 13485. Using ISO 13485 requirements to create your quality management system; You have a world-class system to meet the needs of medical device customers and regulators. ISO 13485 extends beyond the minimum to meet legal requirements and provides a complete system that helps you improve your quality processes.

What is the purpose of ISO 13485?

Acceptance of ISO 13485 provides a practical basis for manufacturers to comply with the EU Medical Device Directive (MDD), the EU Medical Device Regulation (MDR), and other regulations, as well as demonstrate a commitment to the safety and quality of medical devices.
By starting the establishment of the quality management system and identifying the customer’s requirements for the QMS, you should start developing documents such as the quality policy, quality objectives, and quality system. Together, these define the overall scope of the quality management system implementation. Along with these things, you should create mandatory and necessary processes and procedures for your organization to properly create and provide your product or service.

A survey of ISO 13485-certified companies shows that we see a growing trend in the number of companies that have implemented the ISO 13485 quality management system.

Requirements and structure of ISO 13485

ISO 13485:2016 specifies the requirements for a quality management system for manufacturing ISO medical devices and related services that consistently meet customer and applicable regulatory requirements. The requirements of ISO 13485:2016 apply to organizations regardless of size and type, except where expressly stated. Wherever requirements are specified for medical equipment, the requirements apply equally to related services provided by the organization.

The structure of ISO 13485 is divided into eight parts. The first three parts are preliminary and the last five parts contain mandatory requirements for the quality management system. The five main sections are as follows:

Clause 4- Quality management system (intersection)

Clause 4 addresses two very significant aspects of a quality management system: general requirements and documentation requirements.

General Requirements In the assessment of any ISO standard, several system requirements are the driving force for establishing and implementing a quality management system. The specific requirements of ISO 13485 include the following:

* Comply with the standard.

* Prepare the documents.

*Remember what is asked of you.

Have written implementation instructions and ensure the effectiveness of the system you implement.

*Consider risk factors in all activities.

* Minimize identified risks and aim to avoid accidents.

*Determine how things are done to produce a medical device and adhere to those processes.

*Determine ways to track your activities and keep records to show all ongoing activities.

* Comply with legal requirements.

*Even when you outsource work, make sure you retain responsibility for that work.

*Ensure that every system involved in your production processes is working as planned and does not negatively impact your processes.

Documentation Requirements: Most quality systems require one key component, the quality manual.

Beyond the quality system, an organization must establish a commitment to ensure an environment and culture that is consistent with prioritizing quality in all activities. A policy or an objective statement can be used to obtain this commitment. This standard contains very specific requirements for both procedures and records that must be followed:

The creation of a medical device must be accompanied by a file that includes product specifications and guidance on the intended use (technical file).

Planning for Program document control and control of records.


Clause 5- Management responsibility (highway)

Management must demonstrate its commitment by demonstrating that it can be held accountable for internal operations. Management must ensure that their focus does not deviate from the needs of the end user and that all rules are followed in the production process. Management has the absolute responsibility of supporting the quality policy, verifying its alignment with the laws of the country of operation, and communicating the mission to employees. They are responsible for planning, delegating, and communicating effectively. They are also responsible for periodic reviews of operations and improvements in the organization known as management reviews.


Clause 6- Resource management (road)

Top management is responsible for ensuring that the quality management system complies with ISO 13485 and meets the requirements of local regulations.

As a requirement of ISO 13485, top management must ensure that sufficient resources are available for the organization to carry out its work. Supplying resources can refer to personnel, infrastructure, consumables, equipment, succession planning, and risk aversion. Management’s commitment is vital to the success of the organization in producing medical equipment and is required by clause 6.


Clause 7 – Realization of the product (overpass)

When realizing a product, an organization must plan for the journey from conceptualization to implementation. This can include establishing a process for documenting how ideas originate, validating concepts, and designing and developing products. It can also include how to verify and validate to meet the requirements of ISO 13485, Clause 7.

The key is to follow the process from planning to inputs, outputs to review, onward to approval, followed by approval through validation. Communicating ideas, controlling design, documenting any required changes, and maintaining all processed files are critical to product realization. Defining and tracking resources, maintaining critical information associated with each product, and determining how to verify these products should be documented in a procedure.

Overseeing each part of the process includes maintaining cleanliness, monitoring installments, performing necessary services, and meeting specific medical device requirements. Effective monitoring and maintenance of equipment as well as ensuring that identification requirements for the device itself are met are also components of product realization. Finally, monitoring product effectiveness for traceability, customer asset management, and ensuring product retention will help achieve ISO 13485 compliance.


Clause 8 – Measurement, analysis, and improvement (bridge)

Now that your product is manufactured and released for public use, you have the responsibility to make sure people get what they want. So, how do you do it? It’s simple: you’re looking for feedback. According to paragraph 8, the development of a method to effectively monitor and measure the success of the product should include the following:

* Handling complaints

* Reporting events to regulatory authorities

* Conducting internal assessments through audits

* Internal product evaluation and improvement process

* Identifying and controlling products that do not meet original design requirements (non-conforming products).

* Analyzing the data produced and continuously improving

These parts are based on a Plan-Do-Check-Act cycle that uses these elements to implement changes in the organization’s processes to drive and sustain improvements in the processes.