Design in ISO9001 - R U Confounded?

Marc

Fully vaccinated are you?
Leader
#1
A snippet from the ISO ListServe:

-----snippo-----

Subject: Re: Q: Design vs. R&D/..../Kottha/Deibler
Date: Thu, 22 Oct 1998 11:41:47 -0600
From: ISO Standards Discussion

From: Bill Deibler
Subject: Re: Q: Design vs. R&D/..../Kottha/Deibler

Listfolks,

I worked for a firm that is based in the UK and is now a part of the Fujitsu family, ICL (International Computers Ltd). By 1991, all manufacturing facilities in the UK were registered to 9001. We found it advantageous from a quality perspective to apply 4.4 Design Control, to the design of our manufacturing processes....it simply made us a better manufacturing organization.

At the time, ICL was Europe's largest computer manufacturer, and was well known for it's state-of-the-art manufacturing capabilities. Major players such as Sun Microsystems, were using ICL to manufacture their high-end workstations.

In contrast to what Jag has stated below, there are plenty of companies applying 4.4 Design Control to process design or service design.

BTW, I also was involved in implementations of 9001 that were company-wide. That is, 9001 was applied across the company. All organizations were included in the registration (including groups such as human resources, legal, accounting, MIS development, etc.)! BSi was offering a program called company-wide-registration which supported companies who wanted to apply 9001 to all internal organizations.

Now...I haven't had much time to follow this thread very much, but I haven't noticed whether the argument of R&D vs. Design has touched on the point I made on this list some years back...that the ISO vocabulary does not include the words Design or Production.

Is software development a purely design process or is it also a production process? Finding the answer to the question is even more muddled when considering the difference in the guidance offered in ISO 9000-3:1991 vs. ISO 9000-3:1997 which contradict each other. 9001's 4.9 Process control is mapped to the development process in 9000-3:1991, while 9000-3:1997 states that 4.9 applies to replication, delivery, and installation.

Another confounding fact, overlooked by the authors of 9000-3:1997 is that 9000-1:1994 states "The process of development, supply and maintenance for software is different from that of most other types of industrial products in that there is no distinct manufacturing phase. Software does not wear out and, consequently, quality activities during the design phase are of paramount importance to the final quality of the product". This statement is in line with the guidance given in 9000-3:1991.

This issue of undefined terms is referenced in Chapter 20 in Irwin Publishing's, ISO 9000 Handbook, 3rd Edition.

The thing is, 9001 4.4.2 adresses design and development planning. Software development methods often mix research/design/development together. Some of the latest methods for development embrace a build-a-little, test-a-little, incremental approach that embraces these often blurred phases.

This blurring of phases is not unique to software development, as hardware development organizations employ similar techniques.

Remember the D, in R&D stands for development, and ISO 9001 4.4 definitely applies to development.

....now research...the R in R&D....that's another topic for next time......

nuff said,
bill
--------------------------------------------------------------------
Bill Deibler
 
Elsmar Forum Sponsor
R

Roger Eastin

#2
This is another good snipit. I think that including process design under 4.4 is an interesting concept, although the "General" paragraph of 4.4 states that this applies to products. QS9K is especially good here because between APQP and the additional QS9K verbage in 4.9 forces a closer look at how processes are "designed". ISO9K would do well to emphasize the process more in its spec.
 

Marc

Fully vaccinated are you?
Leader
#3
Yeah - I guess I typically blurred the distinction due to automotive prejudice - process design is addressed through APQP and the related documents (Process Flow Diadram, PFMEA, Control Plan). I am well aware of ISO registration of colleges, service industries and such and just 'naturally' looked at design of their processes as applicable.
 
D

deibler

#4
The definition of product includes service(s). From ISO/DIS 9001:2000:

--> ...3.1 - product - result of a process
--> NOTE 1 There are four agreed generic product categories:
--> - hardware,
--> - software,
--> - services,
--> - processed materials.

[email protected]

[This message has been edited by Marc Smith (edited 21 January 2000).]
 

CarolX

Trusted Information Resource
#6
deibler said:
The definition of product includes service(s). From ISO/DIS 9001:2000:

--> ...3.1 - product - result of a process
--> NOTE 1 There are four agreed generic product categories:
--> - hardware,
--> - software,
--> - services,
--> - processed materials.

[This message has been edited by Marc Smith (edited 21 January 2000).]
Looking for some thoughts on this.....The generic product categories????

We are not a "service" company....we provide "hardware". I have seen arguments before about "servicing the customer" , i.e. your standard stuff, like follow up visits, calls, etc. falling under the "servicing" requirements of the standard. I have seen some discussions go so far as to throwing this into a "design" function.....

CarolX
 
Thread starter Similar threads Forum Replies Date
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
M Auditing ISO9001/AS9100 7.3 Design and Development Quality System Effectiveness Manufacturing and Related Processes 12
P ISO9001 Scope Exclusion Verification in a Design Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
O Is this considered Design and Development in ISO9001? Mushroom Farming ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A From ISO9001 to AS9100 Section 7.3 - Presentation to our Development and Design group AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
B ISO9001 with respect to Design and Development Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
ScottK What defines the need for the ISO9001 Design & Development process? Design and Development of Products and Processes 15
B When is a Design Review required? - ISO9001:2000 Clause 7.3 Design and Development of Products and Processes 7
A "Design" or "Design and Development" in and ISO9001:2000 system Design and Development of Products and Processes 8
B ISO9001 certification necessary for R&D? Design development facility Design and Development of Products and Processes 3
D Design and Development Measureables - ISO9001:2000 Clause 7.3 Design and Development of Products and Processes 5
I ISO9001 Clause 7.3 include Design and Development of Processes Design and Development of Products and Processes 9
B Validation of design for valve api 6d 25 edition ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
B Hi , everyone i need a procedure for validation of design prototype api 6d (valve manufacturing) Oil and Gas Industry Standards and Regulations 0
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)? Other ISO and International Standards and European Regulations 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
W Rights of Supplier in Design & Build WP Manufacturing and Related Processes 0
K ISO 13485 Design Requirement with respect to "component" manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 11
rob3027 ISO 13485 justification for design and development exclusion for medical packaging ISO 13485:2016 - Medical Device Quality Management Systems 18
K What constitutes design under 9001? Design and Development of Products and Processes 15
P Product Requirements Control during Design Changes Design and Development of Products and Processes 4
B Minitab factorial design regression equation center point term Manufacturing and Related Processes 1
J Design Input Verification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
P Self Certified Class 1 MDR 2017/745 Design Change CE Marking (Conformité Européene) / CB Scheme 2
N Design V&V courses Career and Occupation Discussions 11
B AS9100 Design Authority questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
K Process FMEA responsible For "Make to Design Parts" (Inhouse or Suppliers ?) FMEA and Control Plans 3
K CE design Certificate EU Medical Device Regulations 3
M ISO 13485 consultants and auditors with design oriented focus ISO 13485:2016 - Medical Device Quality Management Systems 7
T Design Transfer & use of "prototype" components in production devices. ISO 13485:2016 - Medical Device Quality Management Systems 10
Q What are Quality Requirements for Design? Quality Management System (QMS) Manuals 8
G Mfr. Process Validation BEFORE Design Transfer? Other Medical Device and Orthopedic Related Topics 1
B Use of Statistical Techniques in Design Verification Design and Development of Products and Processes 18
X Design stage overview (Product specification) EU Medical Device Regulations 3
gohyl Fixture Setup Design Manufacturing and Related Processes 3
D IS0 13485 - Design perspective to regulatory requirement. ISO 13485:2016 - Medical Device Quality Management Systems 3
T Software item classification and Detailed Design IEC 62304 - Medical Device Software Life Cycle Processes 4
armani 7.1.5 and design and development of product ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
Sidney Vianna ISO 9001 News ISO 9001 Design Specification to be developed - May 2022 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
C Design output vs acceptance criteria ISO 13485:2016 - Medical Device Quality Management Systems 8
M Design Control Procedure Medical Device and FDA Regulations and Standards News 4
lisap Design falling outside ISO scope Misc. Quality Assurance and Business Systems Related Topics 11
S Link Between Essential Performance Requirements and Essential Design Outputs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
G Calculating Ppk for Design Verification - Variable Sampling Design and Development of Products and Processes 15
G How many Design FMEAs do you have? FMEA and Control Plans 4
G Updating FMEAs after Design Updates FMEA and Control Plans 4
Stoic Details of Operational Qualification (OQ) test design for plastic extrusion processes, effect of material property noise, and GHTF/SG3/N99-10 US Medical Device Regulations 2
H R&D and Design procedures - can one procedure cover both activities Design and Development of Products and Processes 6

Similar threads

Top Bottom