5 Focus Areas of the ISO 13485 Medical Devices Quality Standard

 


Are you looking forward to getting the ISO 13485 standard for your medical device business? Well, to obtain compliance with the standard, you need to learn about its key requirements which are an impressive addition to the general standard, ISO 9001. The requirements of the ISO 13485 standard emphasize the quality and safety of the devices that are manufactured, assembled, distributed, sold, and serviced by a company. Having the standard certification implies that your medical device company has a dedicated management system in place that helps to assure the quality, safety, and consistency of your medical devices.

So, to prepare your medical device business for the certification, you need to learn the key areas it focuses on. We will go over those below.

5 Key Areas of Focus for the ISO 13485 Standard for Medical Device Quality Management

QMS Requirements

The standard first emphasizes the requirements for establishing, operating, and maintaining the Quality Management System (QMS).  It provides the general QMS requirements like ISO 9001 which include determination of processes of the QMS, documentation of the QMS, application of risk-based thinking, and adoption of process approach.

Management Responsibility

The standard then outlines the importance of the management team of your business in the implementation of QMS as well as maintaining it later. This section of the requirements thus emphasizes communicating the quality policy to the employees, training the staff to help them understand the ISO 13485 standard’s requirements, ensuring that the quality objectives are achieved, conducting reviews and audits periodically, and ensuring adequate resources are available for maintaining the QMS.

Resources Requirements

A section of the requirements also emphasizes the resources required to establish and maintain the QMS. It also implies the human resources, technical competency, or training required to maintain the effectiveness of the QMS. It also includes the provisions required overall to meet all the regulatory requirements of medical device industry and legislation as well as the customer requirements. Overall, the resource requirements outlined in the standard include need for human resources, tools or technical equipment, infrastructure, and appropriate work environment.

Product Realization

This is a specific requirement underlined by the standard, which emphasizes the planning stage of the products so that their quality and safety is well assured from the beginning. The requirement states that you need to determine the product realization efforts of your business. To plan the product realization efforts, you need to be more specific in including the quality requirements of your devices, processes for developing the devices and what documentation are necessary for them, company infrastructure and work environment needed, employee qualification and types of training required. Lastly, it should also include all the processes for verification, measurement, monitoring, examining, storage, packaging, and distribution of the products.

Measuring and Improving the QMS

Lastly, just like any other ISO standard, this medical device standard too specifies the need for businesses to periodically measure, evaluate, and make necessary changes to improve the processes of the QMS. This would result in continuous improvement of the quality of the end products. In the pursuit of continual improvement of the products, your business will be able to ensure the product conformity and maintain the effectiveness of the QMS.

 

Key Takeaway

To obtain the ISO 13485 standard, you need to streamline your processes and establish a QMS that interacts with your processes and meets the quality objectives and product conformity needs. The involvement of the management team or executives is crucial to make the QMS effective and compliant with the standard’s requirements. Keeping these facts in mind, all these five key areas are made the focus for medical device businesses that need to achieve the ISO 13485 certification.


Contact Details:

Business Name: Compliancehelp Consulting, LLC

Email Id: info@quality-assurance.com

Phone No: 877 238 5855


Also Read: What are the Benefits of Quality Certifications for Manufacturing Businesses?

Comments

Post a Comment

Popular posts from this blog

Overview of ISO 13485 Certification: Who Needs It and Why

Image
 ISO 13485 is the designated standard for quality management of medical devices. A Quality Management System (QMS) is the most indispensable management system needed in every business to help meet their customers’ needs continuously. In other words, it helps in maintaining a business’s position or competitiveness in the market. Since the medical device industry must focus specifically on maintaining the quality and reliability of products for patients’ safety, the ISO 13485 certification is instrumental for their QMS. Here is why businesses in the medical device industry should be conscious of the certification and why it is important.  What is the ISO 13485 Certification? ISO 13485 was clearly designed to assist manufacturers or businesses in the medical device industry with a powerful QMS. To achieve this certification, they need to standardize their processes and adopt effective quality management practices. It ensures that there is consistency in all the phases of producti...
Read more

Does the ISO 9001 Certification Augment Cost Effective Initiatives?

Image
The ISO 9001 certification is a widely adopted standard for quality management systems. The reason is the stringent protocols it offers and its comprehensive approach to quality assurance. A company’s long-term strategies must incorporate quality control measures as service quality is a key factor for brand establishment and brand loyalty along with other than promotional campaigns and marketing. The common question is whether accreditation helps with a company’s fundamental tactics for cost management or not. Small and medium-size companies that want to sustain their market pressure and competition based on their quality often raise this question. Their primary goals are to stabilize their profit margin, increase the number of loyal customers, and market expansion. The ISO 9001 is a single solution to a dozen such concerns. It has a robust structure that consists of a plethora of business requirements and one of them is cost management. The following blog will outline the ISO 9001’s ...
Read more

Bridging the Gaps in Your Quality Management Procedures

Image
If your business is striving to prosper and acquire more customers by providing quality products or services, then get your approach to quality management adherent with ISO 9001 standard. It is the international standard for the quality management system (QMS) achieved by millions of businesses worldwide. It specifies the regulations or guidelines for quality management that organizations need to adopt for ensuring quality and reliability of their products or services. But how to get your quality management approach compliant with ISO 9001 regulations? Well, bridging the gaps in your QMS to achieve ISO 9001 compliance is a systematic process. To figure out the steps involved in the gap analysis, you need support from a quality assurance services company . You can also do it yourself with a fully competent team having proper understanding of the regulations and practices specified by ISO 9001. While bridging the gaps in your quality management framework can h quality assurance services ...
Read more