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Checklists for Software Engineering Standards

Introduction

The process of defining what is necessary for compliance with a standard is often confusing and laborious because the directions contained in the standards are sometimes unclear or ambiguous. To aid in determining what is actually “required” by the standard in the way of physical evidence of compliance, the experts at SEPT have produced checklists. These requirements checklist are prepared by experts to ensure that your organization understands the requirements of a standard and what is required for compliance. Requirements checklists reduce the confusion surrounding what is really required. The requirements checklists are constructed around a classification scheme of physical evidence comprised of policies, procedures, plans, records, documents, audits, and reviews. These checklists provide an easy-to-use product evidence list. Each checklist comes with 4* hours of consultation on how to apply the checklist to the particular standard.  Order information listed below. They are available in PDF or in a "Self-Extracting File Format" option (MS Word)..

New Free presentation on “Interpreting and using The new ISO 13485:2016 – Medical devices - Quality management systems- Requirements for regulatory purposes”
If you would like a free copy of this presentations send an E-mail to stanmagee@smartwire.net.

*Every Checklist comes with four hours of free consultation. SEPT will answer any question concerning the standard or checklist for 60 days after purchase.

BSIBSI

Checklist for - ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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ISO 13485:2016 Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes

Published By: Software Engineering Process Technology (SEPT)

Page Count: 176

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BSI BSI

Checklist for - ANSI/UL 1998-2004, Software in Programmable Components, Incorporates revision. 1 (Complete Document)

Revision / Edition:    Chg: REAF     Date: 01/00/03   Abbreviations Definitions

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ANSI/UL 1998-2004, Software in Programmable Components, Incorporates revision. 1

Published By: Software Engineering Process Technology (SEPT)

Page Count: 87

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BSIBSI

Checklist for - FDA, Electronic Records; Electronic Signatures; Final Rule-FDA 21CFR Part 11 (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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FDA, Electronic Records; Electronic Signatures; Final Rule-FDA 21CFR Part 11

Published By: Software Engineering Process Technology (SEPT)

Page Count: 31

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BSI BSI

Checklist for - FDA, Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices. (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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FDA, Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices. May 11,2005

Published By: Software Engineering Process Technology (SEPT)

Page Count: 84

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BSIBSI

Checklist for - 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 (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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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

Published By: Software Engineering Process Technology (SEPT)

Page Count: 22

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BSI BSI

Checklist for - FDA, General Principles of Software Validation Final Guidance for Industry and FDA staff. (Release date January 11, 2002), 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. (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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FDA, General Principles of Software Validation Final Guidance for Industry and FDA staff. (Release date January 11, 2002), 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.

Published By: Software Engineering Process Technology (SEPT)

Page Count: 120

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Checklist for - IEC 62304:2015 Medical device software - Software life cycle processes (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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IEC 62304:2015 Medical device software - Software life cycle processes

Published By: Software Engineering Process Technology (SEPT)

Page Count: 130

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BSIBSI

Checklist for - ISO 9001:2015, Quality Management Systems - Requirements. (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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ISO 9001:2015, Quality Management Systems - Requirements.

Published By: Software Engineering Process Technology (SEPT)

Page Count:178

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BSI BSI

Checklist for - ISO 9004:2009--Managing for the sustained success of an organization. (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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ISO 9004:2009--Managing for the sustained success of an organization.

Published By: Software Engineering Process Technology (SEPT)

Page Count: 71

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BSI BSI

Checklist for - ISO/IEC 12207:2008, Software Life Cycle Processes. (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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ISO/IEC 12207:2008, Software Life Cycle Processes.

Published By: Software Engineering Process Technology (SEPT)

Page Count: 223

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BSI BSI

Checklist for - ISO/IEC 15288:2008-Systems and software engineering-System life cycle processes. (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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ISO/IEC 15288:2008-Systems and software engineering-System life cycle processes.

Published By: Software Engineering Process Technology (SEPT)

Page Count: 203

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BSIBSI

Checklist for - ISO/IEC 12207:2008 and 15288:2008 - Cost saving if ordered as a kit. (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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ISO/IEC 12207:2008 and 15288:2008 . Cost saving if ordered as a kit.

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BSIBSI

Checklist for - ISO/IEC/IEEE 42010:2011 Systems and Software Engineering —Architecture Description- (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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ISO/IEC/IEEE 42010:2011 Systems and Software Engineering —Architecture Description-

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BSIBSI

Checklist for - ISO/IEC 20000-1:2011, Information technology - Service management - Part 1: Service management system requirements (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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ISO/IEC 20000-1:2011, Information technology - Service management - Part 1: Service management system requirements

Published By: Software Engineering Process Technology (SEPT)

Page Count: 124

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BSIBSI

Checklist for - ISO/IEC 27002:2005 Information technology -Security techniques -- Code of practice for information security management. (Including Technical Corrigendum 1.) (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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ISO/IEC 27002:2005 Information technology -Security techniques -- Code of practice for information security management. (Including Technical Corrigendum 1.)

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BSIBSI

Checklist for - ISO/IEC 90003:2014, Software Engineering. Guidelines for the application of ISO 9001:2008 to computer software. (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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ISO/IEC 90003:2014, Software Engineering. Guidelines for the application of ISO 9001:2008 to computer software.

Published By: Software Engineering Process Technology (SEPT)

Page Count: 115

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BSIBSI

Checklist for - ISO/IEC TR 90006 Checklist-This checklist for ISO/IEC TR 90006:2013 “Guidelines for the Application of ISO 9001:2008 to IT Service Management and its Integration with ISO/IEC 20000-1:2011. (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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ISO/IEC TR 90006 Checklist-This checklist is for ISO/IEC TR 90006:2013 “Guidelines for the Application of ISO 9001:2008 to IT Service Management and its Integration with ISO/IEC 20000-1:2011.

Published By: Software Engineering Process Technology (SEPT)

Page Count: 150

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BSI BSI

A Checklist for Assessing Software Suppliers Compliance With ISO/IEC 90003:2014. (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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The purpose of this document (Checklist) is to assist a company to determine if their “software” supplier(s) meet the requirements of Standard ISO/IEC 90003:2014 Software engineering: Guidelines for the application of ISO 9001:2008 to computer software.

Published By: Software Engineering Process Technology (SEPT)

Page Count: 35

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Software Quality Kit
BSIBSI

The SEPT quality kit contains 4 checklists and one template. This kit is for those companies that are trying to get certified to ISO 9001:2015 with emphasis on software.(Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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The SEPT quality kit contains 4 checklists and one template. This kit is for those companies that are trying to get certified to ISO 9001:2015 with emphasis 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 9001:2015
  • A Checklist for ISO/IEC 90003:2014
  • A Supplier Assessment Checklist
  • A Checklist for ISO Standard 9004:2009
  • Templates for Software Configuration Management Version 6.0

Published By: Software Engineering Process Technology (SEPT)

Page Count: 600+

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BSI BSI

Medical Device Standard Checklist Kit (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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Medical Device Standard Kit:

A kit of 8 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 ISO Standard 13485:2016
  • Checklist for IEC 62304:2015
  • Checklist for ISO 9001:2015
  • Checklist for ISO/IEC 90003:2014
  • 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.
  • Checklist for 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

Published By: Software Engineering Process Technology (SEPT)

Page Count: 1000+

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Software Process Templates

Introduction

SEPT templates will help a software engineer, without extensive knowledge of a software engineering process to prepare a plan or document that meets highly professional expectations. Templates are the key to producing software engineering documents that are clear and concisely represent the requirements of the process. International authorities working in their specific area of software process expertise authored these templates. The templates are neither theory nor academic exercises. They provide wording and recommendations based on experience and extensive knowledge in the workplace. Each template's illustrative text is designed for use by stripping underlined tutorial notation and adding requirements and guidance unique to your organization and operating environment. The text can also be modified for requirements and guidance to meet organizational needs, and unique environments. The templates are applicable to all types of software from information technology, commercial, scientific, and other non-business applications. Each template comes with four hours of free telephone or electronic consultation. SEPT will answer any questions concerning the Templates for 60 days after purchase. Order these great software engineering tools today!

BSI BSI

Templates and Plans for Software Configuration Management Documents - Version 6.0 (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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Templates and Plans for Software Configuration Management Documents-Version 6.0

Author: John M. Neorr

For a "FREE COPY" of A Power Point presentation on "The Six Most Common Problems With the Configuration Management (CM) Processes and a Plan To Overcome Them". E-mail: stanmagee@smartwire.net

Contains Templates for:

  • Software Configuration Management Policy
  • Software Configuration Management Strategy
  • Software Configuration Management Organization Charts
  • Software Configuration Management Plan
  • Software Configuration Management Process
  • Software Configuration Identification Procedure
  • Software Configuration Change Control Procedure
  • Software Configuration Status Accounting Procedure
  • Software Configuration Item Check-in and Check-out Procedure
  • Software Configuration Audits and Reviews Procedure
  • Subcontractor Software Configuration Control Procedure
  • External Interface Configuration Control Procedure
  • Software Product Release and Delivery Procedure

Our CM templates provide significant added value through 15 unique diagrams that accompany templates and plans text. These diagrams add clarity to the processes and provide excellent educational aids for both technical and management personnel

Meets the requirements of software CM artifacts for: ISO/IEC 12207:2008 Software Life Cycle Processes , ISO/IEC standard 15288:2008, System Life Cycle Processes, IEC 62304, Medical device software – Software life cycle processes and ANSI/EIA-649-B, Configuration Managements Standard.

Published By: Software Engineering Process Technology (SEPT)

Page Count: 110

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BSI BSI

Software Documentation Management Plan Template - Version 2.0 (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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Software Documentation Management Plan Template Version 2.0

Product # 55

Authors: Andy Coster & Stan Magee

Templates Contain: Managements Standard

  • Documentation Plan Objective
  • Documentation Management Policy
  • Documentation Assumptions, Constraints, Risks and Dependencies
  • Managed Plans, Documents and Records
  • Documentation Processes
  • Documentation Management Tools and Aids
  • Documentation Management Organization
  • Documentation Management Schedule
  • Document Management Budget

Meets the requirements of ISO/IEC 12207:2008

Published By: Software Engineering Process Technology (SEPT)

Page Count: 95

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BSI BSI

System Documentation Management Plan Template - Version 2.0(Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

Active, Most Current

System Documentation Management Plan Template

Version 2.0

Product # 59

Authors: Andy Coster & Stan Magee

Templates Contain:

  • Documentation Plan Objective
  • Documentation Management Policy
  • Documentation Assumptions, Constraints, Risks and Dependencies
  • Managed Plans, Documents and Records
  • Documentation Processes
  • Documentation Management Tools and Aids
  • Documentation Management Organization
  • Documentation Management Schedule
  • Document Management Budget

Meets the requirements of ISO/IEC 15288:2008

Published By: Software Engineering Process Technology (SEPT)

Page Count: 95

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BSI BSI

Software Maintenance Plan Template - Fourth Edition. (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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Software Maintenance Plan Template - Fourth Edition.

Author: Thomas M. Pigoski

Software Maintenance Plan Contains:

  • Scope and Purpose
  • Acronyms and Definitions
  • Application of the Plan
  • General Requirements
  • Maintenance Concept
  • Maintenance Activities
  • Resources
  • Maintenance Process
  • Training Requirements
  • Records and Reports
  • Sample Request Form

Meets the requirements of IEEE Std 14764: 2006 and ISO/IEC 12207:2008

Published By: Software Engineering Process Technology (SEPT)

Page Count: 39

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BSI BSI

Template Kit for Software Engineers (Complete Document)

Revision / Edition:    Chg: REAF     Date: 00/00/00   Abbreviations Definitions

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This kit contains the following Software Engineering Templates

  • Templates For Software Configuration Management Documents Deluxe Version 6.0
  • Software Documentation Management Plan Template - Version 2.0
  • System Documentation Management Plan Template - Version 2.0
  • Software Maintenance Plan Template - Fourth Edition

Published By: Software Engineering Process Technology (SEPT)

Page Count: 339

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