Now! The experts at SEPT have produced a checklist for the medial device Standard IEC 62304:2006 Medical Device Software Software Life Cycle Processes This checklist defines clearly the artifacts required by this standard. 
 This checklist was prepared by analyzing each clause of this document for the key words that signify a policy, procedure, plan, record, document, audit, or review. The Checklist provides an easy-to-use classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. The number required or suggested by this document is over 325 items. This checklist reflects these requirements for artifacts. Artifact # 
 Procedure 77 
 Plan 13 
 Record 77 
 Document ( Including List, Manuals, Reports, Scripts and Specifications) 42 
 Audit 3 
 Review Total 125 
 337 The Checklist clarifies what is required for compliance through a product evidence list that will assist any software organization in meeting the requirements of this standard. Every Checklist comes with 3 hours of free consultation. SEPT will answer any question concerning the standard or Checklist for 60 days after purchase. Use of the Checklist will save time and money, and may aid in meeting certain governmental requirements. A quality product at a reasonable price! This is an aid that will pay dividends.

Evidence Product Checklist For Standard IEC 62304:2006, Medical Device Software - Software Life Cycle Processes

Stan Magee CCP

Reference

Software Engineering Process Technology (SEPT)

Has your company updated its quality system?  Now a checklist for ISO 9001:2008 Standard Quality Management - Requirements The 2008 version of ISO 9001 has proved to be a landmark quality standard for the international community, but its still difficult to interpret what is required and what is suggested in many areas. The generic nature of a standard that applies to software, hardware, process materials and services makes it difficult to apply in any one situation. But, help is available with our new checklist.  As part of series of useful checklists, SEPT is pleased to announce the availability of a checklist for ISO 9001:2008. This is a must have for all quality managers and engineers involved in ISO 9001 certification, presenting all the required items that are necessary to demonstrate evidence of conformity to ISO 9001:2008. It includes many suggestions for items that are not specifically required by the standard but hinted at in the text. The checklist is particularly useful for anyone updating their quality management system to the newest version of the ISO 9001 standard as an easy way to show gaps in meeting the new requirements. For auditors, especially as part of pre-assessment of an organization to ISO 9001:2008 requirements, the checklist is an essential tool. The Checklist uses a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. This standard calls out or suggests over 200+ items of physical evidence. The Checklist clarifies what is required for compliance by providing an easy-to-use product evidence list that will assist any organization to meet the requirements of this important standard.  This checklist was prepared by analyzing each clause of this document for the key words that signify a policy, procedure, plan, record, document, audit, or review. The Checklist provides an easy-to-use classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews. The number required or suggested by this document is over. Artifact #  Policy and Procedure 65+  Plan 35+  Record 25+  Document ( Including Manuals, Reports, and Specifications) 20+  Audit  1  Review Total 65+  200+  Every Checklist comes with 3 hours of free consultation. SEPT will answer any question concerning the standard or Checklist for 60 days after purchase. Use of the Checklist will save time and money, and may aid in meeting certain governmental requirements. This is an aid that will pay dividends. A quality product at a reasonable price!

Checklist for ISO 9001-2008 Standard Quality Management - Requirements

Andy Coster

See the best price to sell, buy or rent books by the Software Engineering Process Technology (SEPT) publisher. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Books by Software Engineering Process Technology (SEPT)

See the best price to sell, buy or rent books by the Software Engineering Process Technology (SEPT) publisher. BookScouter helps to compare book prices from 25+ online bookstores and 30+ buyback vendors with a single search.

Evidence Product Checklist For Standard IEC 62304:2006, Medical Device Software - Software Life Cycle Processes

Checklist for ISO 9001-2008 Standard Quality Management - Requirements