Design Review: Does ISO9001 demand it?

[DamianCastillo]

Does anyone know if ISO9001 states that a "Design Review" is something that must happen in order to be compliant?

"Too many people walk around like Clark Kent, because they don't realize they can Fly like Superman"
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[gchampoux]

I'm operating from memory, but I believe the answer is no.

All that ISO 9000/9001 requires is that all your of your policies and
procedures are documented and that the parties responsible for such are
documented as well.
The goal is simple: If something goes wrong, you know who to blame.

Gerry

WILLIAMS INTERNATIONAL A COMPANY WITH A VISION

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[DamianCastillo]

I am getting conflicting responses, but there is one response that copied the statement directly from the ISO 9001 Documentation.

Here is what I got on it.

=====================================================================================

ISO 9001 Section 7.3.4 Design and Development Review says: Ai suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1):

· To evaluate the ability of the results of design and development to meet requirements.
· To identify any problems and propose necessary actions.

Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).

========================================================================================

I understand that ISO9001 is "Say what you do, Do what you say" but I believe that certain requirements are still mandatory in order to get certification. You can handle the requirements in many different ways as long as you do it, but some are still requirements to insure Quality.

I could be wrong, but It's what I remember. I am looking for a correct answer here and so far the above text is stating that it must be done.

[ptc-810450]

The design review does not have to be onerous. Presumably your drawings
get reviewed for completeness, this can be your design review. As can a
final meeting before handing over the design to a client (that probably
also happens anyway). Your quality system just needs to specify where the
review will be (don't get too carried away with details because then you
will need to comply with every detail you have written down) and then you
have to make sure that you review all drawings or have a review meeting
with the every client (and document the outcomes - such as meeting
minutes). It is best to document what you already do as a matter of common
sense instead of invent some complicated system.
--
Mark von Huben




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[DamianCastillo]

I appreciate all the feedback from everyone. It seems that ISO9001 can be a confusing topic on many fronts.

Let me ask it this way.

What are your feelings about Design Reviews for Revision Changes?

I believe many Companies perform a Design Review for a new product, but should the Design Review be conducted for all revision changes?

A Revision Change means that the Form, Fit or Function of the product has been affected.

Your comments are always appreciated.

"Too many people walk around like Clark Kent, because they don't realize they can Fly like Superman"

[jflores-3]

Damian,

It's all a mater of whether or not you have design controls in place and
a paper trial to prove it. Some times a revision change requires a
design review. Depends on what the revision is, what is the impact of
the form, fit or function of the product? But most of the time at least
at companies that I've worked for, a design review happens during a
phase change of the product life cycle (development phase to design
phase to production phase). Typically your daily drawing revisions are
only subjected to a review of a lesser scope known as a peer review or
supervisory review or technical review. We call ours peer reviews; they
are not intended to be comprehensive, definitive and multidisciplinary.
Basically a peer review verifies that your design output (revised
drawing) meets the original design input (user needs) and does not
introduce any new risks nor has impacted any existing risk. These risks
are typically documented in requirements documents such as a hazards
analysis or failure mode and effects analysis.



Our peer reviews as a minimum only require the responsible engineer, a
quality assurance engineer and if user labeling is involved a regulatory
affairs representative is also required. Although not required by our
procedures, typically I try to include a representative from any
department that will be affected by the change, which usually means
purchasing dept, manufacturing dept and sometimes service dept is
invited to attend the peer review. I find it easier to get the change
order approvals if all affected parties have a say or at lest know is or
is not changing.





Thank you, Jim Flores

Mech. designer/CAD admin.

Clinical Care Systems

Philips Healthcare

2271 Cosmos Court

Carlsbad, CA. 92011

-

Phone: (760) 918-7329

Fax: (760) 918-0169

www.philips.com/healthcare

[DamianCastillo]

We currently do a Desing Review for New product development and a major revision change. B to C for example.

I see it as a beneficial step, but is it something ISO9001 requires me to do?

"Too many people walk around like Clark Kent, because they don't realize they can Fly like Superman"

[ptc-1151073]

You may have an answer already.
We are currently going through ISO certification. What everyone has said about doing what you say and saying what you do, and paper trails seems correct.
There is one thing that is missing though. We are required to validate and verify designs. The Design Review is our way of doing this.
The design review is used to verify the design and prototypes are used to validate the design. I do not believe that a design review is mandatory, but some sort of verification is.
The design review just appears to be the most common adaptation of this process. Once a product is in production, our ECN system replaces this.

My understanding is that anytime a revision (using your definition) is made it must be verified and validated.

Casey Stahl
Designcraft, Inc.
650 Telser Road
Lake Zurich, IL 60047
P - 847-719-2500 extension 308
F - 847-719-2501
e - <u>casey@designcraft.com</u>
w - <u>www.designcraft.com</u>