Software Engineering Standards Requirements Checklists
(Includes 4* Hours of Consultation)
These requirements checklist are prepared by experts to ensure that your organization understands the requirements of a standard and is compliant. Available now in easy to use in PDF or in a "Self-Extracting File Format" option to get thischecklist in as an editable Microsoft Word document!
The requirements checklists are constructed around a classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, audits, and reviews. Requirements checklists reduce the confusion surrounding what is really required for compliance by providing an easy-to-use product evidence list that will assist any software organization in meeting the requirements of the standard. Each checklist comes with 4* hours of consultation on how to apply the checklist to the particular standard. Order information listed below.
| Checklists for |
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| ANSI/AAMI/ISO 13485:2003 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes1--Defines over 300+ required or suggested requirements of physical evidence. (policies, procedures, plans, records, documents, audits, and reviews) |
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| ANSI/UL 1998-2004, Software in Programmable Components, Incorporates revision. 1--Defines over 350+ required or suggested requirements of physical evidence. (policies, procedures, plans, records, documents, audits, and reviews) |
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| FDA, Electronic Records; Electronic Signatures; Final Rule-FDA 21CFR Part 11 -- Defines over 60+ required or suggested requirements of physical evidence. (policies, procedures, plans, records, documents, audits, and reviews) |
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| FDA, General Principles of Software Validation Final Guidance for Industry and FDA staff. (Release date January 11, 2002). -- Over 400 required or suggested requirements of physical evidence. (Policies, procedures, plans, records, documents, audits, and reviews) |
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| FDA, Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices. May 11,2005-- Over 120+ required or suggested requirements of physical evidence.(policies, procedures, plans, records, documents, audits, and reviews) |
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| FDA, Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices as amended by Guidance for Industry, FDA Reviewers and Compliance on Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software", January 14, 2005 Defines over 60+ required or suggested requirements of physical evidence. (policies, procedures, plans, records, documents, audits, and reviews) |
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| Evidence Product Checklist, For Standard IEC 60601-1 Ed. 3.0 b: 2005 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance,for Clause 14 Programmable Electrical Medical Systems (PEMS) Defines over 100+ required or suggested requirements of physical evidence. (procedures, plans, records, documents, audits, and reviews) |
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| IEC 60601-1-4 (Edition 1.1 2000-04) Medical Electrical Equipment Part 1: General Requirements for Safety. Part 4. Programmable Electrical Medical System. Defines over 500+ required or suggested requirements of physical evidence. (procedures, plans, records, documents, audits, and reviews) |
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| IEC 62304:2006 Medical device software - Software life cycle processes Defines over 300+ required or suggested requirements of physical evidence. (procedures, plans, records, documents, audits, and reviews) |
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| ISO 9001:2008, Quality Management Systems - Requirements. Even though the changes to ISO 9001:2008 were not extensive, has your company updated its quality system? Buy this checklist it defines over 200+ required or suggested requirements of physical evidence. (policies, procedures, plans, records, documents, audits, and reviews) |
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| ISO 9004:2009--Managing for the sustained success of an organization – A quality management approach. To support the use of ISO 9004:2009 this checklist is constructed around a classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, and reviews. There are over 250 suggested items of physical evidence |
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| ISO/IEC 12207:2008, Software Life Cycle Processes. - Defines over 800 required or suggested requirements of physical evidence. (policies, procedures, plans, records, documents, audits, and reviews) |
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| SEPT Evidence Product Checklist for ISO/IEC Standard 15288:2008-Systems and software engineering-System life cycle processes. This document defines over 800+ required or suggested requirements of physical evidence. (policies, procedures, plans, records, documents, audits, and reviews). |
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12207 and 15288 Checklist Set- For ISO/IEC Standard 12207:2008 and 15288:2008. A savings of 14% if purchased separately. |
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| (New)Standard ISO/IEC 20000-1:2011Checklist for ISO/IEC Standard 20000-1:2011, Information technology - Service management - Part 1: Service management system requirements Defines over 360+ required or suggested requirements of physical evidence. (policies, procedures, plans, records, documents, audits, and reviews) |
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| Standard ISO/IEC 27002:2005 Information technology -Security techniques -- Code of practice for information security management. (Including Technical Corrigendum 1.)
Defines over 450+ required or suggested requirements of physical evidence. (policies, procedures, plans, records, documents, audits, and reviews) |
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| ISO/IEC 90003:2004, Software Engineering. Guidelines for the application of ISO 9001:2000 to computer software. Defines over 550+ required or suggested requirements of physical evidence. (policies, procedures, plans, records, documents, audits, and reviews) |
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| SUPPLIER ASSESSMENT CHECKLIST, for Standard ISO/IEC 90003:2004 Software engineering: Guidelines for the application of ISO 9001:2000 to computer software. A checklist to use with your software suppliers to determine if they meet the requirements of Standard ISO/IEC 90003:2004. |
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(New)Software Quality Kit
The SEPT quality kit contains 4 checklists and one template. It is focused on those companies that are trying to get certified to ISO 9001:2008 with emphases on software. It will also allow a company to do assessments of their software suppliers. Because many software companies have problems with software configuration management, we have also included the SEPT product containing templates for implementing software configuration management conforming to ISO/IEC 12207 and 15288 standards.
The kit consists of the following SEPT products:
- A Checklist for ISO 9001:2008
- A Checklist for ISO/IEC 90003:2004
- A Supplier Assessment Checklist
- A Checklist for ISO Standard 9004:2009
- Templates for Software Configuration Management Version 6.0
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| Medical Device Standard Kit: SEPT is pleased to announce a kit of 10 key checklists for medical device firms. Save 50% or more off the individual prices when ordering this collection of medical device standards checklists!
This kit includes:
- Checklist for ANSI/AAMI/ISO Standard 13485:2003
- Checklist for ANSI/UL 1998:2004
- Checklist for FDA, General Principles of Software Validation (Release date January 11, 2002)
- Checklist for FDA, Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices:2005.
- Guidance for Industry, FDA Reviewers and Compliance on Off-the Shelf Software Use in Medical Devices as amended by
Guidance for Industry - Cyber security for Networked Medical Devices Containing Off-the Shelf (OTS) Software:2005
- IEC 60601-1 Edition 3.0 b Clause 14:2005
- Checklist for IEC 60601-1-4 (Edition 1.1 2000-04)
- Checklist for IEC 62304:2006
- Checklist for ISO 9001:2008
- Checklist for ISO/IEC 90003:2004
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Benefits of the Checklist
- Every Checklist comes with four hours of free consultation. SEPT will answer any question concerning the standard or checklist for 60 days after purchase.
- The Checklist clearly defines the standards' expectation for procedures, plans, records, documents, audits, and reviews.
- Use of the Checklist may aid in meeting certain governmental requirements.
- A quality product at a reasonable price.The 4 hours of consultation is conducted by telephone or e-mail for up to 60 days following checklist purchase date.*
Save time, save money, and increase compliance! Order now!
Many firms are posting these checklists to their Intranet for wider access to this important information. We have a 5 year license for $1800 for any checklist in word format. Contact SEPT at stanmagee@smartwire.net for details.
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