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28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 …
Process Interaction Chart - Graphical representation of top level ...
2002年9月27日 · Process Interaction To show the interaction of processes I completed somewhat of a process flow chart in visio which follows our internal processes from Marketing, Contract …
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., …
Quality Plan at a small Medical Device Company - Is the quality …
2017年10月29日 · Normally the QP is an independent item, one of the top-level documents of the QMS. From the FDA’s QSIT (inspection guidance): Much of what is required to be part of the …
Definition - Functional and Allocation Baselines - MIL-STD-973 …
2008年12月12日 · requirements that are allocated from those of a system or higher level configuration item; interface requirements with interfacing configuration items; and the …
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 …