8.3.2.3 Development of products with embedded software - request for clarification

morteza

Trusted Information Resource
Hi all,

In clause 8.3.2.3 IATF 16949 states:

Using prioritization based on risk and potential impact to the customer, the organization shall retain documented information of a software development capability self-assessment.

My questions are:

1- Is “potential impact to the customer” anything else rather than “risk”? I think that potential impact to the customer = risk to the customer.

2- Suppose that risk and potential impact are two different things. Does this requirement ask the organization to determine the retention time of self-assessment records based on risk and potential impact to the customer? I.e. such as following table:
table 2.JPG

thanks all
 

John Broomfield

Leader
Super Moderator
Hi all,

In clause 8.3.2.3 IATF 16949 states:

Using prioritization based on risk and potential impact to the customer, the organization shall retain documented information of a software development capability self-assessment.

My questions are:

1- Is “potential impact to the customer” anything else rather than “risk”? I think that potential impact to the customer = risk to the customer.

2- Suppose that risk and potential impact are two different things. Does this requirement ask the organization to determine the retention time of self-assessment records based on risk and potential impact to the customer? I.e. such as following table:
View attachment 25266
thanks all

morteza,

Potential impact on the customer may be a working definition of negative risk (being as we also take positive risks).

Also see ISO 31000 on both types of risk.

The potential impact is considered when assessing risk along with probability of occurrence (and, possibily, probably of detection).

Your table shows that records associated with higher negative risks are kept longer than other records. At one time record keeping was so expensive that this table may have been useful. But is keeping electronically accessible archives that expensive these days?

Finally, risk and potential impact are not really two different things - the latter is part of the former.

John
 
Thread starter Similar threads Forum Replies Date
R Role of QA during Design and Development of Products and Processes Design and Development of Products and Processes 4
A 8.6 Release of products and services, 8.3 Design and development - evidence required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A Design and development of products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Y ISO 9001 Cl. 8.3 - Design and Development of Products and Services not applicable ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
T ISO 9001:2015 - 8.3 Design and Development of Products and Services (Repair Company) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
M Question about ISO 9001:2015 8.5.3 - Design and Development of Products and Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Understanding ISO9001:2015 - 8.3: Design and Development of Products and Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
G ISO 9001:2015 8.3 Design and development of products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P Development and Approval of New Products - Procedure Length and Detail Document Control Systems, Procedures, Forms and Templates 1
J TL9000 Common Measurements - Design and Development for Telecommunication Products TL 9000 Telecommunications Standard and QuEST 5
C D&D (Design and Development) Requirement for Semi-Finished Products Design and Development of Products and Processes 4
S Product Development Program - Design, develop, approve and manufacture new products Design and Development of Products and Processes 6
D Risk assessment & Product development - All products - Medical device or not? ISO 13485:2016 - Medical Device Quality Management Systems 20
R Design & Development - We sell products that we design and products we don't design Design and Development of Products and Processes 1
T Design and Development training AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
G What is Design&Development and what is product in a Research company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
P Supplier Development Process description Process Maps, Process Mapping and Turtle Diagrams 1
S Design and Development document ISO 13485:2016 - Medical Device Quality Management Systems 2
D Quality Gates for software development Software Quality Assurance 2
Bev D Development Process: FMEA, Critical Characteristics, Spec Setting and Controls Misc. Quality Assurance and Business Systems Related Topics 0
S Is design and development clause 8.3 applicable for laboratory ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Paul Simpson Quality management system software development - looking for candidate organizations Quality Assurance and Compliance Software Tools and Solutions 2
C MD Design and development procedure ISO 13485:2016 - Medical Device Quality Management Systems 1
K Exclusion of 8.3 Design and Development for Design Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Recognised/reputable courses for ISO 13485 Section 7.3 (Design & Development)? ISO 13485:2016 - Medical Device Quality Management Systems 1
J Design/Development. Oil and Gas Industry Standards and Regulations 6
O Regarding design and development requirements for a medical device EU Medical Device Regulations 6
rob3027 ISO 13485 justification for design and development exclusion for medical packaging ISO 13485:2016 - Medical Device Quality Management Systems 18
armani 7.1.5 and design and development of product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K Can I make an exclusion of Design and Development in ISO 13485:2016 if my product is not regulated ISO 13485:2016 - Medical Device Quality Management Systems 12
Robinson A Management Development and Leadership Skills General Information Resources 4
M How to apply IEC 62304 Problem Resolution Process for bugs discovered prior to release i.e. during initial development? IEC 62304 - Medical Device Software Life Cycle Processes 2
qualprod 8.3 for software development. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S ISO13485:2016 7.3.9 design and development change ISO 13485:2016 - Medical Device Quality Management Systems 3
S Design & Development records for Medical Devices Packaging and Labelling ISO 13485:2016 - Medical Device Quality Management Systems 9
F IEC 62304 agile development EU Medical Device Regulations 1
S Searching for TOYOTA Floor Management Development System (FMDS) board Customer and Company Specific Requirements 3
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
H Independence between the development and testing IEC 62304 - Medical Device Software Life Cycle Processes 6
E Design and Development file Procedure ISO 13485:2016 - Medical Device Quality Management Systems 1
J Are complaints applicable to development of medical devices? Customer Complaints 2
P Training department ideas and development for automotive supplier Training - Internal, External, Online and Distance Learning 6
N Example for design and development planning,input,output,review,verification,validation and transfer Misc. Quality Assurance and Business Systems Related Topics 5
Felony Melony Project Milestone Plan-Development to Mass Production APQP and PPAP 2
Sidney Vianna What ISO Standard (under the TC 176) supports the UN Sustainable Development Goal #10? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 11
A Design and development procedure for API Spec Q2 Oil and Gas Industry Standards and Regulations 10
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 14
D Using Laboratory Notebooks in R&D and Design and Development ISO 13485:2016 - Medical Device Quality Management Systems 3
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 6
M Clinical Development Plan - Advice Requested EU Medical Device Regulations 11

Similar threads

Top Bottom