ISO 13485 for medical devices Quality management system – Pittsburgh

ISO 13485 certification in pittsburgh
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The ISO 13485 certification in Pittsburgh refers to specific Quality Management System requirements for medical device manufacturers by the world organization for Standardization (ISO). The aim of ISO 13485 is to form the standard of medical devices more consistent across manufacturing facilities. It applies to manufacturers of medical devices and related services, also as any organization involved within the lifecycle of medical device development.

Every organization that obtains the ISO 13485 certification abides by approved methods during all stages of the medical device manufacturing lifecycle: design, development, manufacturing, distribution, storage, and installation. This will be a large order to fill, which is strictly why possessing the ISO 13485 certification is such a powerful mark of quality. Without a certification like ISO 13485, there would be no proof that a corporation knows or abides by accepted industry quality standards

Certifications are especially important within the medical field, because the quality and performance of a tool could literally mean life or death. An ISO 13485 certification in pittsburgh greatly increases the chances that end products are going to be of the very best quality when purchasing custom medical devices.

Manufacturing plants must continue with the foremost recent ISO certifications to stick to the newest industry expectations. As of today, Organizations must fulfill the subsequent requirements to get ISO 13485:2016 certification – the newest available:

  • Documentation requirements. Organizations that wish to get the certification must fulfill documentation requirements, including having a top quality Manual, Required Procedures, Required Forms and Records, Control of Documents, and Control of Forms.
  • Management requirements. Managers in QMS must fulfill certain requirements for ISO 13485 certification. These requirements address Management Responsibility, Quality Policy and Objectives, Customer Focus, Customer Satisfaction, and Management Review.
  • Production requirements. Medical device production must fulfill strict requirements in terms of designing, customer relations, design, purchasing, supply chain, process control, traceability, and customer property.
  • Monitoring requirements. A corporation must show that its QMS has testing, measurement, analysis, and monitoring processes in place to constantly improve medical device manufacturing. Process monitoring should serve the aim of ensuring customer satisfaction, complying with standards, and preventing defects.

These standards apply to all or any manufacturers of medical devices no matter their size and sort (except where the standards explicitly state otherwise). Establishments need to demonstrate an ongoing commitment to quality to renew their ISO 13485 certifications year by year. As long as an organization’s QMS fulfills all the demanding requirements of ISO 13485 it can achieve certification

Some of the advantages of getting ISO 13485:2016 Certified are:

Improved Brand Recognition and Credibility

With ISO 13485 certification in Pittsburgh for Medical Devices QMS implemented in your organization, you’ll reflect trustworthiness for your clients and customers to try to do business with you. Strong ISO 13485 QMS software makes an excellent marketing tool since it’s become a requirement for medical devices suppliers to showcase compliance in many countries. This permits you to draw in more opportunities.

Improved Decision-Making

An important principle of quality management under ISO 13485 certification in Pittsburgh is that it focuses on evidence when it involves decision-making. Once you will use the information and facts to form informed decisions, you’re likely to align them together with your business objectives. What your instinct tells you’ll not always be right; it can put you in serious business troubles sometimes. The added bonus here is an insight into your business health as you’ll track every improvement done and their results.

Better Processes

ISO 13485 specifies organizations to use a process approach that creates it easier for you to spot new opportunities to enhance. You’ll easily identify and eliminate the causes that would cause rework and waste. You’ll also reduce the probabilities of errors within the process while fostering the greater efficiency within the organization and increase cost-savings.

Increased Customer Satisfaction

The ISO 13485 standard relies on certain quality management principles. One important principle highlights customer satisfaction. You would like to realize this principle by evaluating the requirements and expectations of the purchasers and striving to satisfy them because today customers are more specific about their demands. Also, keeping customers satisfied will bring them back, and you’ll be ready to sell your services to new customers. This is often an immediate implication for increased revenue.

Employee Engagement

When you will seek help from the workers to enhance their own processes – they’re going to not only provide the simplest insights, but also are going to be happier and more involved. The more number of employees will understand their roles to deliver quality product and services; the more are going to be their engagement. This directly implies for improved productivity.

As you recognize, the medical device manufacturing vertical is much regulated industry. The ISO 13485 quality management system for medical devices industry must meet regulatory requirements which mandate the manufacturers to style and develop medical devices that are safe and fit their intended use. ISO 13485 standards were designed to help medical device manufacturers to develop and implement quality management systems that meet and exceed regulatory requirements. ISO 13485 springs from the ISO 9000 family of standards set forth by world organization for Standardization (ISO).

Why seek certification to ISO 13485?

Globally recognized ISO 13485 certification in pittsburgh shows commitment to quality medical products and a positive willingness to figure towards improving efficiency. Moreover, it addresses the extra safety and regulatory specific to the medical industry. This is often to enhance the company’s image within the international market and make customer, stakeholders and employees to trust upon the corporate.

Furthermore, it eliminates the necessity of multiple certifications. The certification reduces waste, create creditability, strengthen market access and develop trust factor. It satisfies the rigors of an independent external audit and this quality concern specifies your medical devices industry.

How to get ISO 13485:2016 certification in Pittsburgh – Consultants in Pittsburgh?

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