We were recently asked the following question: “I have a specific question about product requirements relating to standards that I’d like your input on: Which requirement syntax is preferred? #1 or #2 1) “The System shall allow user to silence or inactivate audible alarm indications per IEC 60601-1-8 section 6.8.1″ (this example allows the requirement […]
Tag: Standards
How to Refer to Other Documents within your Requirement Document
We were recently asked the following question from one of our clients concerning how to refer to other documents within your requirement document: “One of my co-workers stated that just by listing a document in Section 2.0 “Documents” made all the requirements in that document fully applicable, in toto, to the system. This seems dangerous, […]
Guidelines for Referring to Other Documents in Your Requirements Document
This post is a continuation of the previous post: “How to Refer to Other Documents within your Requirement Document” Standards and Regulations that apply to your project should have been identified by the project during scope definition as drivers and constraints. These documents can come from the government, industry, international standards organizations, your company, your […]