ISO 13485 vs. ISO 9001: similarities and differences


Editor’s note: Halina compares ISO 9001 and ISO 13485 and explains how to understand which of these standards is right for your medical device manufacturing organization. If you want to know how to implement a quality management system (QMS) according to ISO 9001 or ISO 13485, you can use the ScienceSoft team to healthcare IT consulting.

The quality management system (QMS) covers the entire production cycle of a software or device. To understand the difference between ISO 9001 and ISO 13485, we compare these international standards.

ISO 9001: the essence

ISO 9001 is an international standard developed by the International Organization for Standardization (ISO) for the creation, implementation and maintenance of QMS and aimed at increasing customer satisfaction with the quality of products or services. Organizations can follow ISO 9001 regardless of industry. The standard was revised several times and the latest version did ISO 9001: 2015.

ISO 13485: the essence

ISO 13485 is the international quality management standard for medical devices. Its last revision took place in 2016. The requirements for ISO 13485: 2016 were developed taking into account the need to ensure the safety of all stages of the life cycle of a medical device: design, production, operation, disposal, etc.

Risk assessment

Both standards emphasize the importance of incorporating risk management into the design and production stages and developing a risk management strategy to minimize the potential negative consequences of risks.

Customer focus

Both ISO 13485 and ISO 9001 aim to ensure that customers are satisfied with the final product.

Quality improvement model

Although ISO 13485 and ISO 9001 do not have the same structure, both use a PDCA (Plan-Do-Check-Act) cycle, the model of continuous quality improvement that consists of a logical sequence of four repetitive steps for the continuous improvement of a product or service.

Employee competence

To comply with either of these two standards, the medical device manufacturing organization must ensure that its employees are competent to perform the work entrusted to them.

In general, ISO 9001 can be used for a variety of industries (e.g., manufacturing), but ISO 13485 applies. exclusively to medical devices and Software as a medical device (SaMD). There are also other notable differences:

Documentation control

ISO 13485, compared to ISO 9001, is more demanding in terms of documentation: it requires the inclusion of regulatory documents (detailed product specification, description of production processes, installation and maintenance processes) in the system documentation.

Make your SGC meet international standards

ScienceSoft’s healthcare IT team can research your quality management system and help make it compatible with relevant international standards.

Distribution of functions

ISO 9001 allows organizations to distribute quality control responsibilities without being tied to specific managers, while ISO 13485 states that a medical device manufacturer must designate a particular management employee to be responsible for the SGC.

Risk management

ISO 13485 focuses on the development of documentation for risk management and requires a medical device manufacturer to keep records of the risk management process during the production of medical devices. In addition, the standard requires medical device manufacturers to analyze consumer complaints and establish after-sales monitoring of product compliance with declared quality.

Quality requirements

For ISO 9001, customer satisfaction is the hallmark of a quality-oriented culture. ISO 13485 focuses on customer safety and, in addition to the quality-oriented culture, establishes specific safety requirements, for example, during production (such as sterility), assembly and packaging of each medical device, installation, inspection and service life of medical products. devices.

Resource management

Resources, according to both standards, are defined as the different equipment, buildings, staff, and computer resources needed to create high-quality products. In accordance with ISO 13485, the organization, which participates in the complete production cycle of medical devices, must document the requirements for the health and cleanliness of staff clothing, monitor the production environment and develop systems for the containment of contaminated products. .

If your company is engaged in the production and sale of medical devices internationally, it would be logical to opt for ISO 13485. If your company is not sure that your health software qualifies as SaMD and what certification is relevant in the your case, our healthcare computer they will be happy to offer a consultation on how to improve your GSC and make it compatible with applicable international standards.

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