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