ISO 9001 Design Process Flow Chart

D

dave-o

#1
Hi all. I'm attempting to verify the completeness of a design control procedure and identify the resulting documentation with regards to the requirements of ISO 9001.

I'm a little more familiar with medical device design requirements, and I'm trying to follow the least burdensome approach by not including anything that's not necessary, while also not ignoring anything that would provide obvious advantages to manufacturing, safety, and support.
Care to take a look and see if I'm obviously missing anything, or including too much? Or if I'm absolutely mental?

Also I realize some of the abbreviations may be cryptic.

Key
DHF - Design History File
DMR - Device Master Record
D+D Plan - Design & Development Plan
FMEA - Failure mode and effects analysis form
I/O - Input / Output
DRF - Design Review Form
DTP - Design Transfer Plan
PM - Preventative Maintenance

I'm whiteboarding right now, so please excuse the non-digitized nature of this image. Thanks in advance!
 

Attachments

Elsmar Forum Sponsor

kgott

Quite Involved in Discussions
#2
It appears to me that you have the design review functions going and at the right places so it looks to me that it complies with design requirements of ISO 9001.

As a general point, you might like to take your pic to those people who work in the process and get their feedback on it. They will tell you if its OK or what changes need to be made. More importantly, take it to the person who is accountable for the outcomes of the process. They are the ones who have to answer for outcomes and ensure that any corrections or corrective actions that are later identified, are implemented.

It makes it a whole lot harder for them if the procedure does not accurately reflect the way things are actually done.
 

Alpine

Involved In Discussions
#3
I agree with Kgott, when I started at my current company I had to revise our Design procedure and key to that process was the consultation with the R&D team and the R&D Manager. That way the process they carry out is captured and key requirements in the ISO standard are identified and understood by the team. At the end of the day it they who have to live it and will be the ones audited to it.
 

John Broomfield

Staff member
Super Moderator
#4
Hi all. I'm attempting to verify the completeness of a design control procedure and identify the resulting documentation with regards to the requirements of ISO 9001.

I'm a little more familiar with medical device design requirements, and I'm trying to follow the least burdensome approach by not including anything that's not necessary, while also not ignoring anything that would provide obvious advantages to manufacturing, safety, and support.
Care to take a look and see if I'm obviously missing anything, or including too much? Or if I'm absolutely mental?

Also I realize some of the abbreviations may be cryptic.

Key
DHF - Design History File
DMR - Device Master Record
D+D Plan - Design & Development Plan
FMEA - Failure mode and effects analysis form
I/O - Input / Output
DRF - Design Review Form
DTP - Design Transfer Plan
PM - Preventative Maintenance

I'm whiteboarding right now, so please excuse the non-digitized nature of this image. Thanks in advance!
Dave,

I could not see design inputs to conceptual design.

John
 
D

dave-o

#5
Agreed, good input on making this a collaborative effort. I will certainly be involving other team members, but as it turns out, I'm the R&D team and primarily responsible for the end to end process in this scenario. We're a small company = fun & challenging.
 
D

dave-o

#6
Dave,

I could not see design inputs to conceptual design.

John
Thanks John - I have to admit, the concept phase is a little vague for me. Do you suggest creating design inputs for a concept and performing verification before moving to the design phase? Keep in mind that I'm asking out of ignorance, and not challenging your suggestion.
 

yodon

Staff member
Super Moderator
#7
Several things jump out at me. First, DHFs and such are terms from the medical device world (exclusively, I think). The concepts are solid but as others have pointed out, acceptance comes from within so be sensitive to the company's terminology, culture, etc.

The title of the post is design process yet the bulk of the flow is on V&V and production. Maybe that's your intent? Otherwise, you may want to flesh out the design 'phase' a bit more. Where do all your requirements come from? How are they accepted and resolved (conflicts, incompleteness, inconsistency, etc.)? How do the requirements get translated into the next level of decomposition? Do you have separate functional areas contributing to the design (electrical, mechanical, software)? How is the design allocated to the functional area; i.e., what is the system architecture / how is it defined? How is it the design (per functional area) and system architecture stay in sync as the design evolves? How do functional areas communicate between each other to ensure the design is cohesive?

Maybe that level of detail is not what you're after but since you specifically said "design process" I thought I'd throw it out.
 

John Broomfield

Staff member
Super Moderator
#8
Thanks John - I have to admit, the concept phase is a little vague for me. Do you suggest creating design inputs for a concept and performing verification before moving to the design phase? Keep in mind that I'm asking out of ignorance, and not challenging your suggestion.
Dave,

Conceptual design comes up with ideas for solving the customer's problem. Therefore, the nature of the problem has to be an input as does any constraints.

John
 
Last edited:
D

dave-o

#9
Several things jump out at me. First, DHFs and such are terms from the medical device world (exclusively, I think). The concepts are solid but as others have pointed out, acceptance comes from within so be sensitive to the company's terminology, culture, etc.

The title of the post is design process yet the bulk of the flow is on V&V and production. Maybe that's your intent? Otherwise, you may want to flesh out the design 'phase' a bit more. Where do all your requirements come from? How are they accepted and resolved (conflicts, incompleteness, inconsistency, etc.)? How do the requirements get translated into the next level of decomposition? Do you have separate functional areas contributing to the design (electrical, mechanical, software)? How is the design allocated to the functional area; i.e., what is the system architecture / how is it defined? How is it the design (per functional area) and system architecture stay in sync as the design evolves? How do functional areas communicate between each other to ensure the design is cohesive?

Maybe that level of detail is not what you're after but since you specifically said "design process" I thought I'd throw it out.
Thanks for your input! We've had some discussions on whether or not to carry over the additional concepts required for medical, and determined that since many of us are familiar with them anyway and they meet the documentation requirements for ISO 9001 (in excess, perhaps, but better safe than sorry).

I appreciate the level of detail regarding the actual design process. The specific design control procedure that I'm adopting is laid out according to my whiteboard drawing - that is, when you look at what's done in each phase and the expected outputs, the drawing illustrates what you generate. I'm with you, it seems a little lacking on the actual 'design' phase. I suppose it's left vague on purpose, with the steps you're describing left up to the project lead on a project-by-project basis, but I wouldn't mind having that cemented a little more. I'd love to see an example of a working system, though this product line doesn't have the complexity of, say, an implantable device. This is more of an automated backup appliance, and will be comprised primarily of off-the-shelf components with a minimum of assembly and configuration. The main need is to define requirements and generate specifications for the primary supplier to adhere to, and then ensure that requirements are met and specifications satisfy intent - hence the focus on V&V.

What I'm running into is that these appliances have already been designed and manufactured, and the primary reason for establishing design controls at this point is to begin adhering to ISO standards moving forward. Because of this, I don't have a lot of initial design records, but need to create procedures to be followed and forms to be populated for new designs and design changes. I'm also trying to keep things simple for two reasons: small design team and ease of adoption.
 

John Broomfield

Staff member
Super Moderator
#10
Hi all. I'm attempting to verify the completeness of a design control procedure and identify the resulting documentation with regards to the requirements of ISO 9001.

I'm a little more familiar with medical device design requirements, and I'm trying to follow the least burdensome approach by not including anything that's not necessary, while also not ignoring anything that would provide obvious advantages to manufacturing, safety, and support.
Care to take a look and see if I'm obviously missing anything, or including too much? Or if I'm absolutely mental?

Also I realize some of the abbreviations may be cryptic.

Key
DHF - Design History File
DMR - Device Master Record
D+D Plan - Design & Development Plan
FMEA - Failure mode and effects analysis form
I/O - Input / Output
DRF - Design Review Form
DTP - Design Transfer Plan
PM - Preventative Maintenance

I'm whiteboarding right now, so please excuse the non-digitized nature of this image. Thanks in advance!
Dave,

Instead of white-boarding the perfect design process with us, why not work with your process owner and the process team to analyze your current design process?

Capture how customer needs are translated into product specifications via planning, assigning responsibilities, gathering inputs, reviewing inputs, conceptual design, reviewing concepts to choose the one most likely to satisfy customer needs with your contraints (another input), detailed design with reviews at the 30, 70, 100% stages, verification per the plan and then validation per the plan to authorize production.

You may also apply this design process to the design of production, delivery, use and maintenance of the product.

You may find it already conforms to the requirements of ISO 9001, with or without a few tweaks.

Best regards,

John
 
Thread starter Similar threads Forum Replies Date
S Documenting Design Verification Test Results (ISO 9001) Design and Development of Products and Processes 1
A Design process goal for ISO 9001 Manufacturing and Related Processes 23
S ISO 9001 Clause 8.3 Design for an education services provider ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
S ISO 9001 Clause 8.3 - Design & Development for training course center ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S ISO 9001:2015 & ISO 14001:2015 - I need a format for Design & Development planning ISO 14001:2015 Specific Discussions 2
A ISO 9001:2015 - How to apply 7.1.5 to an organization performing only design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Development separated from design? ISO 9001 cl. 8.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K ISO 9001 2015 Exclusions - Product Design is purchased. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C ISO 9001 2015 Documentation for Engineering and Design ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
P Design and Development Clause ISO 9001:2015 Exclusion for Medical Services Design and Development of Products and Processes 3
G ISO 9001:2015 8.3 Design and Development (in Civil Engineering) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
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
J ISO 9001:2015 8.3.2 f) - Interfaces between Persons in Design & Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
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
4 Adding a new Company - ISO 9001 Design Exclusion Design and Development of Products and Processes 1
C Optic Patchcord Cables - Does 8.3 (Design) Apply Here? ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R Understanding a few points on ISO 9001's Design and Development Planning ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C ISO 9001:2015 - Non Applicable Design and Development (Power Plant Operator) Design and Development of Products and Processes 2
pammesue ISO 9001:2008 Design and Development Process & Forms examples wanted Design and Development of Products and Processes 3
L Auditing Design and Development in ISO 9001 (Internal Audit) Internal Auditing 1
M "Partial Design" Designation and Applicable ISO 9001:2015 Exemptions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
Q ISO 9001:2015 - Design of Process vs. Design of Service Service Industry Specific Topics 4
T ISO 9001 - Design Validation Record exemption ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
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
J ISO 9001:2015 - Clause 8.3 - Design in the Custom Manufacturing industry ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
N Dual ISO 9001 (Manufacturing) and ISO 13485 (Design Control) for same product line ISO 13485:2016 - Medical Device Quality Management Systems 3
I ISO 9001 Scope - Exclusion of Design in an engineered solutions company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
Q ISO 9001:2008 requirement for Design Organization Approval prior to "Repair" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
K ISO 9001 Section 7.3 Design and Development Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
H ISO 9001 Document Control Requirements - Design and Development Department Checklists Document Control Systems, Procedures, Forms and Templates 3
A Quality Manual Statements - ISO 9001:2008 Design and Development Exclusions Design and Development of Products and Processes 6
D Consultancy company - ISO 9001 Implementation and Design Exclusion ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
smryan Satisfying the ISO 9001:2008 7.3.5 Design & Development Verification requirement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
I Interior Design Company Design Procedure Example wanted (ISO 9001:2008) Design and Development of Products and Processes 3
E ISO 9001 vs ISO 13485 or both? A QMS for a Design and Development Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Y Clarification on ISO 9001 - Exclusion of Design and Development, Clause 7.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A ISO 9001 Clauses 7.5.1 and 7.5.2 - Exclusion for Design Activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C How to do a procedure for ISO 9001 2008 7.3 Design and Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Design & Development in Updating Machines and Equipment - ISO 9001 Help Design and Development of Products and Processes 4
L ISO 9001 Clause 7.3.2 Design & Development Input - Adequacy, Complete, Unambiguous ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T Does the Layout Design of a PCB fall under clause 7.3 in ISO 9001 Design and Development of Products and Processes 7
B Design and Development Exclusion - ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
D ISO 9001 Clause 7.3 - Design & Development - Requirements help wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
M ISO 9001 Certified Education Company - Defining the Product & Design and Development ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
S Advisory Services - Design and Development requirements per clause 7.3 of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B Question about Design Exclusions - Clause 7.3 of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
W ISO 9001:2008 Clause 7.3 Design and Development Exclusions Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Guidance on ISO 9001 Clause 7.3 Design and Development Exclusions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D Design & Development Input Records Requirements - ISO 9001 Clause 7.3.2 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Similar threads


















































Top Bottom