ISO 13485:2016

Medical devices — Quality management systems

ISO 13485:2016 is an international standard that details the requirements of a quality management system for medical device companies, and it specifies the experiences necessary to ensure that these organizations are capable of providing products and services that consistently meet customer, regulatory and market needs. Medical device companies can greatly benefit from adhering to the ISO 13485 standard. It’s designed for organizations that plan on having their devices used by human beings. It’s important that all parties involved in its creation or sale are dedicated to securing the highest quality for the patients who will be using it.

Processes that are relevant to ISO 13485:2016 that are not performed by the organization but are relevant to quality must be assessed. Any problems or changes in these processes must be monitored, maintained, and controlled by the organization.

Requirements of ISO 13485:2016 are applicable to medical device companies no matter their size or type. If there is a requirement that applies to medical devices, the same requirements also apply to any associated service supplied by the organization. Specific requirements apply especially when it comes to validation activities, where the parts will be tested after certain stages of production and then need to be documented properly.

ISO 13485 is organized into the following eight sections

  • Scope- Describes The purpose and the Benefits of the Standard.
  • Normative References: Provides introductory information and confirms common nomenclature.
  • Terms and Definitions: Defines the terminology used throughout the standard.
  • Quality Management System– A medical device manufacturer’s quality management system includes general and documentation requirements that ensure the device meets all federal regulatory requirements. Quality manual must be written and should be followed by the organizations. The process of controlling documentation and records will help to ensure that the most current and correct versions of documents and records are available at all times and that access or distribution rights and/or any limitations or restrictions on access or distribution rights are observed.
  • Management Accountability: Recognizes upper management as accountable for supporting and providing resources for the QMS. Recognizes that upper management is responsible for setting and reviewing and assuring policy and that there are financial objectives associated with all measurable customer commitments.
  • Resource Management: Resource management is a broad term that essentially encompasses the identification and allocation of available resources. It also involves securing these resources, allocating people to take care of them, and monitoring their performance.
  • Product Realization: This includes everything that goes into manufacturing, from plastics to metals. Since the FDA requires that significant changes or alterations are documented for medical devices, Product Realization is an important section of the standard because it helps to understand how changes are concluded and ultimately introduced in the device’s designs.
  • Analysis, Feedback and Improvement: Provides feedback on incorporating effective QMS implementation strategies so as to sustain the effectiveness of the QMS.

 Benefits of ISO 13485:2016 Certification

  • Meaningful feedback on the effectiveness of the quality management system
  • Confidence in compliance with regulations
  • Identification of areas requiring attention
  • Detection of areas of non-compliance and risk
  • Reporting and certification that is valuable and recognized