Getting ISO 13485 Certified in Teterboro, New Jersey (NJ)
ISO 13485 is an international quality management standard that is widely used in the medical device industry. It is an effective solution for meeting the requirements of the quality management system in the medical device industry. You have to start by identifying customer requirements for quality management support.
It entails developing the necessary documentation such as quality manual, quality objectives, quality policy. These, together, define the overall implementation and scope of the quality management system. To add to this, you have to create additional and mandatory procedures and processes that are essential to create and deliver your products and services properly. Companies that implement the ISO 13485 have a track record of maintaining a positive trend in the global economy.
The latest version of ISO 13485 was published in March 2016. The additions to this standard include better alignment of development and design requirements for several organizations, improved facility requirements, clarifying training responsibilities, clarifying management responsibilities, focus on risk, more emphasis on supplier control, additional complaint handling, traceability procedures requirements, and enhancing product cleanliness requirements. The ISO 13485 is aligned to the previous versions of ISO 9001. However, ISO 13485 does not align with the current version of ISO 9001.
ISO 13485 Requirements
ISO 13485 specifies the guidelines for a QMS for the medical device industry and the related services that meet regulatory and customer requirements consistently. ISO 13485 requirements are applicable to organizations of all types and sizes. Whenever there is a requirement that applies to medical devices, the standard will apply to the associated services that the organization supplies.
The structure of ISO 13485 has eight main sections. The first three form the introductory part while the last five contain the mandatory requirements for the QMS. The five main sections include quality management system, management responsibility, resource management, product realization, and measurement, analysis, and improvement. IQC The ISO Pros will help you to implement all these standards in the best way possible.
ISO 13485 is not a mandatory requirement. You can create a quality management system that suits the needs of your organization as long as the QMS processes meet the regulatory and legal requirements for the medical device industry. However, we have so many companies that use this requirement in implementing their QMS. When you use the ISO 13485 guidelines to create your quality management system, you will have a world-class system in meeting the needs of legislators and customers for your medical devices. The ISO 13485 gives you a higher than the bare minimum for meeting the legal requirements. It provides a complete system that is devoted to assisting you to better your quality processes.
There are some steps that your organization should perform to guarantee the successful implementation of the ISO 13485 standards. These include internal audits, management reviews, and taking corrective actions. The certification process is also divided into two. The first stage is the documentation review and the second stage is the main audit. If you have any problem with the implementation of any of these processes, all you need to do is consult IQC The ISO Pros. Our company has the potential to help you implement this standard in the best way possible.
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