Sample Pages and Description
   
Evidence Product Checklist for the standard
   
IEC 62304:20
15 
  
Medical device software

 Software life cycle processes

including Amendment 1

    
 
  

*IEC 62304 Edition 1.0 2015:06 – IEC 62304:2006/AMD1:2015
__________________________________________________
   
Available in MS .docx format or PDF format
                
NOTE:
The purchase of a checklist includes 4 hours of consulting about its use and application with requirements of the standard.
Introduction to Amendment 1 
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, and with a strong reference for using ISO 14971 processes.
3. Minor revisions to approximately 40% of the standard.
This checklist addresses the amendment and the base standard.
   
   
Introduction to the checklist
The process of defining what is necessary for compliance with a standard for software life cycle processes such as “IEC 62304:2015” is often confusing and laborious because the directions contained in the guidelines are unclear or ambiguous.  The checklist aids in determining what is actually “recommended” by the document in the way of physical evidence of compliance. This checklist is constructed around a classification scheme of physical evidence comprised of procedures, plans, records, documents, audits, and reviews.  There must be an accompanying record of some type when an audit or review has been accomplished. This record would define the findings of the review or audit and any corrective action to be  taken. For the sake of brevity this checklist does not call out a separate record for each review or audit.  All procedures should be reviewed but the checklist does not call out a review for each procedure, unless the standard calls out the procedure review. In this checklist “manuals, reports, scripts and specifications” are included in the document category. 
  
 
IEC 62304:2015 – Medical device software – Software life cycle processes checklist 
This checklist was prepared by analyzing each clause of the document for the keywords that signify a:
  • Procedure
  • Plan
  • Record
  • Document (including Lists, Manuals, Reports, Scripts and Specifications)
  • Audit
  • Review  
This checklist specifies evidence that is unique.  After reviewing the completed document, the second review was conducted from a common sense “reasonable person” approach.  If a document or other piece of evidence appeared to be recommended, but was not called out in the document, then it is added with an asterisk (*) after its notation in the checklist.  The information was transferred into checklist tables, based on the type of product or evidence.    
   
  
Using the checklist
When a company is planning to use IEC 62394:2015 Medicak Device Software Lifecycle Processes Standard, the company should review the evidence checklist. If the company's present process does not address an IEC 62394:2015 product, then this question should be asked: Is the evidence product required for the type of business of the company ? If in the view of the company the evidence is not required, the rationale should be documented and inserted in the checklist and quality manual. This rationale should pass "the reasonable person rule". If the evidence is required, planes should be prepared to address the missing item(s).
  
Detail Steps
An organization should compare the proposed output of their organization against the checklist.  In doing this, they will find one of five conditions that exist for each item listed in the checklist.  The following five conditions and the actions required by these conditions are listed in the table below. This table applies for section 2 through 8 
   
Condition Action Required
         
1 The title of the documented evidence specified by the checklist (document, plan, etc) agrees with the title of the evidence being planned by the organization.     
   

Record in checklist that the organization is compliant. This note (Yes) would go in  column with the heading “Availability”.

   
2 The title of the documented evidence specified by the checklist (document, etc) disagrees with the title of the evidence planned by the organization but the content is the same. 
  

Record in the checklist the evidence title  the organization uses and record that the organization is compliant, would go in column with the heading “Availability”.  The note would say  “The title of the documented evidence specified by the checklist (document, etc.) disagrees with the title of the evidence planned by the organization but the content is the same”.     

   
3 The title of the documented evidence specified by the checklist (document, etc) is combined with another piece of evidence. 
   
Record in the checklist the title of the evidence (document, etc) in which this information is contained. This note (The title of the documented evidence specified by the checklist (document, etc.) is combined with another piece of evidence.) would go in column with the heading "Availability".

   
4 The title of the documented evidence specified by the checklist (document, etc) is not planned by the organization because it is not required.

   
Record in the checklist that the evidence is not required and the rationale for this decision. This note  (The title of the documented evidence specified by the checklist (document, etc.) is not planned by the organization because it is not required) would go in the column with the heading "(NOT Required/Rationale)". 
 
   
5 5. The title of the documented evidence called out by the checklist (document, etc) is not planned by the organization and should be planned by it.

   

Record in the checklist when this evidence will be planned and reference a plan for accomplishing the task. (The title of the documented evidence called out by the checklist (document, etc.) is not planned by the organization and should be planned by it. This note would go in column with the heading (Comments).

 
     

Record in the checklist the title of the evidence (document, etc) in which this information is contained. This note (The title of the documented evidence specified by the checklist (document, etc.) disagrees with the title of the evidence planned by the organization but the content is the same.  

Components of the Checklist 
This checklist is composed of 9 sections:
  • Section 1: Introduction to amendment 1 and the checklist
  • Section 2: Composites of all recommended and suggested “IEC 62304:2015 -
    Medical device software – Software life cycle processes” evidence products   
  • Section 3-8: Individual checklists for each evidence type.
  • Section94: "About the Author"
Product Support 
Questions concerning this checklist, its use and compliance with requirements will be addressed free of charge for 60 days from time of purchase, up to a maximum of 4 hours consultation time.
      
   

Samples of the Checklist
     

Section 2 
IEC 62304:2015 Evidence Products Checklist by Clause

   
IEC 62304:2015 Clause Number,
Name and Software Safety
 Classifications
Procedures
Plans
Records
Documents
Audits and Reviews
4 General requirements
4.1 Quality management system 
Class A, B, C
SO 13485 Requirements or Equivalent for Procedures

 

ISO 13485 Requirements or Equivalent for Plans

 

ISO 13485 Requirements or Equivalent for Records

 

ISO 13485 Requirements or Equivalent for Documents

 

ISO 13485 Requirements or Equivalent for Audits
ISO 13485 Requirements or Equivalent for Reviews
4.2 Risk Management System 
Class A, B, C
ISO 14971 Requirements  for  Procedures

 

ISO 14971 Requirements  or Equivalent for Plans

 

ISO 14971 Requirements  for Records

 

ISO 14971 Requirements  for Documents

 

ISO 14971 Requirements  or Equivalent for Audits*
ISO 14971 Requirements  for Reviews*
* Suggested item     

Section 2 
IEC 62304:2015 Evidence Product Checklist by Clause

IEC 62304:2015 Clause Number, 
Name and Software Safety 
Classifications
Procedures
Plans
Records
Documents
Audits and Reviews
4.3 Software Safety Classifications 
Class A, B, C

Assignment of Software 
Safety Class Procedure
Risk Management File Document Procedure*
Software Safety Class Document Procedure*
 
 
Software Safety Class Document Records*
 
Risk Management File Document
Software Safety Class Documenr
 
Management File Document Review*
Software Safety Class Document Review*
Software Safety Class Records Review*
 
4.4 Legacy Software
4.4.1  General
* Suggested item     
       

change to Section 2  
IEC 62304:2015 Evidence Product Checklist by Clause

  
IEC 62304:2015 Clause Number, 
Name and Software Safety 
Classifications
Procedures
Plans
Records
Documents
Audits and Reviews
4.4.2 Risk Management Activities  Class A, B, C
Assessing Any Feedback on the Use of Legacy Software Procedure*
Performing Risk Management Activity Associated with the Continued Use of Legacy Software Procedure*
 
 
 
 
 
4.4.3 Legacy Software Gap analysis
Class A, B, C
Gap Analysis of Legacy Software Versus Using Other Available Software Procedure*

 

 
Software System Test (Associated with Gap Analysis) Records
 

 

 

4.4.4 Gap closure activities
Class A, B, C
Closure of All Gap Activities Plan Procedure*

 

 
 
 
Closure of All Gap Activities Plan Review*

 

* Suggested item     

Section 2
IEC 62304:2015 Evidence Product Checklist by Clause

IEC 62304:2015 Clause Number
 Name and Software Safety Classifications
Procedures
Plans
Records
Documents
Audits and Reviews
4.4.5 Rationale for use of Legacy Software
Class A, B, C
Legacy
Software Documentation Procedure*

       


Rational for the Continued Use of Legacy Software Record
Legacy Software Documentation

 

Legacy Software Documentation Review

 

5 Software development process
5.1 Software development planning

5.1.1 Sotftware development plan  Class A, B, C

Software Development Plan Procedure*
System Development Plan Procedure*

       

  
Software Development Plan
System Development Plan*
Software Development Plan Review*
System 
Development Plan Review*
5.1.2 Software development plan updated 
Class A, B, C  
 
 
Software Development Plan Update Records
 
 
Software Plan Update Records Review*
 
* Suggested item  
  

Section 2
IEC 62304:2015 Evidence Product Checklist by Clause

IEC 62304:2015 Clause Number, 
Name and Software Safety Classifications
Procedures
Plans
Records
Documents
AUDITS and REVIEWS
5.1.3 Software development plan reference to system design and development
Class A, B, C
Design and Development Validation Procedure
Software and System Development Coordination Procedure
System Requirements Document Procedure*

 

 

System Requirements Document

 

System Requirements Document Review*

 

5.1.4  Software development standards, methods and tools planning
Class C
Software Development Standards
Methods and Tools Plan Procedure*
Software Development Standards, Methods and Tools Plan

 

 

 

Software Development Standards, Methods and Tools Plan Review*

5.1.5 Software integration and integration testing planning
Class B, C

Software Integration (including SOUP) Plan Procedure*
Software Integration Test Plan Procedure*

 

Software Integration (including SOUP) Plan
Software Integration Test Plan
 

 

 

Software Integration Standards, Methods and Tools Plan Review*
Software Integration Test Plan Review*
* Suggested item