Applying EN 62304 - Medical Device Software Architecture - Level …
2011年4月4日 · [ISO/IEC 90003:2004, definition 3.14, modified] NOTE Three terms identify the software decomposition. The top level is the SOFTWARE SYSTEM. The lowest level that is …
What is included in the Four Tiers of Documentation Pyramid?
2001年3月26日 · DON'T duplicate stuff just to have a tier xx document. If its a top level (professionals using it) don't do a work instruction if its not needed. Sometimes a self …
Definition - Document Levels - Definition of what Level 1, 2, 3 ...
2004年10月27日 · I like to think of the differences in the scope of each level of document. The Level 1 manual covers the entire organization, each Level 2 procedure tends to be owned by …
Management Review Meetings - Process Performance and …
2004年8月5日 · In an orderly fashion, the management team reviews each process under its domain - a process may be as all-encompassing as the entire supply chain process from …
PPAP Level 4 vs. PPAP Level 5 - What's the difference?
2005年8月24日 · Level 4 should include elements as specified by the customer; Level 5 is the same as Level 3, only the package is reviewed at the supplier's location. Have a look at the …
CS2 (Controlled Shipping Level II status) and TS 16949 Registration
2007年1月22日 · An organization seeking certification to ISO/TS 16949:2002 that is in Controlled Shipping Level II status has a major nonconformance to ISO/TS 16949:2002, clause 8.2.1.1., …
Definition - SOP (Standard Operating Procedure) vs. Work …
2006年6月6日 · I've seen 2 places with over 200 employees where the only procedures were the 6 required. Their next level was process materials (high level- mainly flowcharts), followed by …
Overhaul vs. Repair vs. Rework - FAA Definitions - The Elsmar Cove ...
2011年6月10日 · Here come more exceptions: REBUILDING is generally prohibited, since this is the domain of the manufacturer... unless the repair facility is an agent of the manufacturer …
What are the FAI requirements for an assembly? New to AS9102
2008年10月17日 · Next the FAIR is created based on customer requirements to do so in the contact with you. It is based on their, not your, drawing requirements. If their drawing only …
Difference between Fault Tree and Factor Tree Analysis
2009年2月2日 · The idea is that specific conditions must be present for an action to result in an undesireable effect, and that causes and effects form an infinite chain (e.g., 5 Why), where the …