This article focuses on the key requirements which medical device manufacturers need to fulfill to attain an ISO 13485 certification, thereby emphasising how to improve their quality management system and gain higher customer trust.

Successful implementation of globally acknowledged certifications, like ISO 13485, requires you to undergo a series of provisions and protocols and is certainly not an easy job. From seeking management support to ascertaining the main customer requirements for QMS, you have to develop detailed documentation, including the quality objectives, quality policy, and quality manual. So, though the task is arduous, you can enjoy a wide range of benefits when it comes to attaining an ISO 13485 certification for your medical device manufacturing company.

Producing certified ISO 13485 medical devices would not only improve your organisation’s image and credibility but also nurture a culture of persistent improvement while promoting better employee management.

What is ISO 13485: An Introduction

ISO 13485 is the most widely accepted international standard that is followed by the medical device industry to strengthen their quality management practices. Issued by the International Organisation for Standardisation (ISO), it is considered to be a highly effective solution for medical device manufacturers to meet the requirements for a QMS. By attaining ISO 13485 certification, they will be able to address all the rules and regulations related to medical device production and demonstrate a commitment to maintaining the quality and safety of their devices.

Considering the importance of achieving ISO 13485 certification, an organisation needs to abide by a list of crucial requirements to achieve it. The ISO 13485 structure includes eight clauses, three of which are introductory. Therefore, you must focus on the last five mandatory requirements to get your business ISO 13485 certified.

Clause Four: Quality Management System

This requirement clause focuses on two significant aspects of a QMS, called General and Documentation requirements.

General Requirements: In the case of every ISO standard, there is a list of requirements that serve as the driving force for implementing and establishing a QMS. Some of these requirements include:

  Abiding by the standards.
  Documenting all the things that need to be documented.
  Maintaining all the things that need to be maintained.
  Keeping all the written procedures in proper sync and periodically evaluating the effectiveness of the implemented system.
  Identifying the risk factors of all business activities.
  Implementing necessary steps to mitigate the identified risks.
  Determining the process of generating medical devices and always abiding by the same.
  Finding out the effective ways to monitor all your activities, rectify process oversights and failures, and generate reports that ensure all the tasks are being completed properly.
  Finding out the legal requirements and taking the necessary steps to meet them.
•  Even when outsourcing work, you should maintain the responsibilities for such tasks.
•  All the system processes should be checked to ensure they function as they are intended to function and do not negatively affect the operations at any point in time.

Documentation Requirements: Quality systems require a key element, called a Quality Manual. Additionally, the organisation ensures that they will foster a culture and environment that will consider quality as the ultimate priority in all business activities. This must be documented with an objective statement or policy. Some of the documentation requirements of the ISO 13485 standard include:

A plan for maintaining records.
A plan for maintaining documents.
Medical device creation must be supported by a file emphasising the product specifications and supervision on purposeful use.

Clause Five: Management Responsibility

The senior management must exhibit their continual commitment towards quality sustenance and emphasise the fact that they can be held responsible for their organisational processes. They must confirm that their focus lies on the end-user needs and that all laws are being strictly followed during the manufacturing process. The management also has the chief responsibility to abide by the quality policy, ensure that it properly aligns with the national laws of the particular country of work, and convey the company’s mission clearly to the employees. They need to plan and delegate authority while ensuring clear communication. Furthermore, they are held accountable for conducting a periodic review of the improvements and operations of the organisation, which is termed as a ‘Management Review’.

Clause Six: Resource Management

The senior management must make sure that the QMS fully complies with the ISO 13485 standard and meets all the local regulatory requirements. They must confirm that all the necessary resources, including infrastructure, personnel, consumables, succession planning, equipment, and risk aversion are available to conduct the operational tasks. All these requirements can be extremely specific, such as monitoring the daily workflow and preventing contaminants. Though this managerial commitment may seem to be of minimal importance, but it is highly critical to determine the success of your medical device manufacturing organisation and it is a key criterion as per clause six.

Clause Seven: Product Realisation

An organisation must have a proper plan, from its conceptualisation to implementation, which can include the task of creating a process to document the initiation of thoughts, assessing the viability of concepts, design and development of products, and the validation of products to meet the requirements of ISO 13485’s clause seven.

The ideal solution will be to follow a streamlined process that includes planning, resource procurement, final outputs, review analysis, verification, and validation. Specifying and tracking all the supplies, maintaining all the crucial information related to the products, and ascertaining the ideal verification process of the products needs to be well documented within the procedure.

Overseeing all parts of the process will include monitoring the products, maintaining cleanliness, and checking whether all the ISO 13485 requirements are being met with the products.

Clause Eight: Measurement, Analysis and Improvement

Once your product has been produced and made ready for general use, you need to be assured that the customers are now able to find what they were looking for. This process is generally accomplished by seeking valuable feedback. As per clause eight, the procedure of effectively measuring and monitoring your product’s success should include:

    Managing complaints.
    Reporting events to the respective regulatory authorities.
    Conducting internal evaluation by auditing.
•    Continual internal product and process evaluation.
    Picking out the products and modifying them as they fail to meet the requirements for the original design.
Analysing the generated data to ensure future process improvements.

Though this entire process of meeting all the crucial requirements and attaining ISO 13485 certification can be complex, with the professional assistance of a consultancy firm, the task can be accomplished much easier. Once you start manufacturing ISO 13485 medical devices, it becomes much easier for you to not only raise the standards of your production process but also help you gain customer trust.

Author's Bio: 

Damon Anderson is associated with a highly distinguished ISO consultation firm and boasts an excellent track record in offering specialised solutions to become certified medical device manufacturers and produce ISO 13485 medical devices. He guides his clients through the various ISO 13485 requirements they need to meet while focusing on bringing an operational change to improve product quality.


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