Category Archives: SEPT

SEPT IEC 62304 Checklist

IEC 62304:2015, Medical Device Software – Software Life Cycle Processes

Published by: 2015-10-20 / 2015-10-20 / 127 pages
The checklist comes with 4 hours of free consultation, from experts that have firsthand knowledge of the underlying standard, to answer questions on the standards and checklists and is valid for 60 days after purchase of the product.

IEC released amendment 1 for IEC 62304 in June of 2015. The purpose of this revision was:

  • 1. Additional requirements to address software life cycle processes specific to legacy software
  • 2. Clarification of requirements and updates for Software Safety Classification to include a risk-based approach, focus on overall medical device risk analysis. With a strong reference for using ISO 14971 processes
  • 3. Minor revisions to over 40% of the standard.
  • 4. The standard has over 160 required and over 160 suggested policy, procedure, plan, record, document, audit, or review

This checklist addresses the amendment and the base standard

IEC 62304:2015, is often confusing and laborious. This is because directions contained in the standard can seem unclear or ambiguous. To aid in determining what is actually required by IEC 62304, the experts at SEPT have produced a checklist. This checklist was prepared by analyzing each clause in IEC 62304 for key words that signify a required policy, procedure, plan, record, document, audit, or review.

This revised standards has over 160 required artifacts and over180 suggested ones. Below is a table showing the required artifacts by type.

Required Artifacts

Procedures Plans Records Documents Audits Reviews TotalCell
25 12 69 46 1 10 163

The resulting checklist then provides an easy-to-use categorized list of physical evidence against which you can audit your work products to help insure conformance with IEC 62304.

To better understand this model a user of this product should understand SEPT definition of an auditor. An auditor can be your boss, an inside auditor or an outside auditor such as the European Union, FDA or a prime contractor for your product. The checklist will give the auditor and you a common reference point in the standard (Clause number) that becomes the index point for physical evidence. If a standard calls out physical evidence more than once , such as a “training plan” it is always index to the first clause that reference the training plan This method will allow you to organize you physical evidence in a systematic manner for presentation to the auditor. This simple checklist allows you to bring the document down to simple terms that a professional lay person can understand (policy, procedure, plans, records, documents, audits and reviews).

The checklist will allow the organization to divide the compliance activity into manageable work packages such as procedures, plans, documents etc.

The checklist is available in PDF or word format. The latter format allows you to tailor the document to your business case or the media that your organization wants to use the checklist in such as excel web page format or any other end product type in order to meet compliance with the standard in the most efficient way possible.
The checklist comes with 4 hours of free consultation, from experts that have firsthand knowledge of the underlying standard, to answer questions on the standards and checklists and is valid for 60 days after purchase of the product.

Ordering and availability

This publication is available both in printed and PDF edition.

SEPT Template Kit – Product 77

Template Kit for Software Engineers

Software Engineering Process Technology / 01-Apr-2012 /

New! Order the "Self-Extracting File Format" option to get this product in an editable Microsoft Word document!

SEPT is pleased to announce a kit of key software engineering templates.

Save 40% off the individual prices when ordering this collection of templates.

This kit contains the following Software Engineering Templates:

This kit comes with three hours of free consultation. SEPT will answer any question concerning the standards or checklists for 60 days after purchase.

Ordering and availability

This publication is available both in printed and PDF edition.

SEPT Product 78

Software Quality Kit

Software Engineering Process Technology / 01-Apr-2012 /

New! Order the "Self-Extracting File Format" option to get this product in a series of editable Microsoft Word documents!

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 to ensure conformance with ISO Standard 9001:2008 "Quality Management – Requirements 2008 Edition." This checklist defines over 200 items of physical evidence (policies, procedures, plans, records, documents, audits, and reviews) that are required or suggested as being required by the standard.
  • A Checklist for ISO/IEC 90003:2004
    A checklist to ensure conformance with guidelines for the application of ISO 9001:2000 to computer software.
  • A Supplier Assessment Checklist
    A checklist to use with your software suppliers to determine if they meet the requirements of Standard ISO/IEC 90003:2004
  • A Checklist for ISO Standard 9004:2009
    A checklist for ensuring conformance with ISO 9004:2009. "Managing For The Sustained Success Of An Organization – A Quality Management Approach."
  • Templates for Software Configuration Management
    This product provides a set of templates for implementing software configuration management conforming to ISO/IEC 15288 and 12207 standards.

Ordering and availability

This publication is available both in printed and PDF edition.

SEPT CM Template – Product 76

Templates for Software Configuration

Edition: 6.0
Software Engineering Process Technology / 01-Apr-2012 / 110 pages

New! Order the “Self-Extracting File Format” option to get this product in an editable Microsoft Word document!

New in Version 6.0! Templates have been updated to ensure consistency with the Software CM requirements of ANSI/EIA-649-B, Configuration Managements Standard.

Prior to the release of V6.0, the CM templates in this document were reviewed to ensure consistency with the Software CM requirements of ANSI/EIA-649-B, Configuration Managements Standard. As a result:

  • An appendix was added in V6.0 to provide an overview of the ANSI/EIA-649-B standard
  • Minor modifications were made to several of the templates to ensure compatibility with ANSI/EIA-649-B while still remaining compliant with ISO/IEC 12207:2008, ISO/IEC 15288:2008, and IEC 62304.
  • Traceability matrices were added to show how ISO/IEC 12207:2008 and Version 6.0 templates map to ANSI/EIA-649-B functions and principles.

Abstract:
This document contains a set of templates that enable engineers and managers to implement effective, standards-compliant software configuration management (CM). The templates conform to software CM requirements specified in standards ANSI/EIA-649-B, Configuration Managements Standard, ISO/IEC 12207:2008, Software life cycle processes, ISO/IEC 15288:2008, System life cycle processes, and IEC 62304, Medical Device Software – Software Life Cycle Processes. In addition to informative and adaptable text, these templates provide many illustrative diagrams that ease the implementation and communication of CM processes.

These templates provide generic descriptions and instructions that are compliant with the standards listed above and provide a structure within which you can include detailed project-specific information. Once tailored, the templates become a complete set of documents that allow implementation of software configuration management compliant with both widely-used standards and project-specific requirements.

Thirteen templates are provided. They are:

  • 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

Ordering and availability

This publication is available both in printed and PDF edition.