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Product Design ISO 9001
ISO 9001 Monograph
Release Date: 09/20/2005
This article deals with the interpretation and application of product design req
uirements in ISO 9001:2000. Complicated task because design processes differ gre
atly among themselves in terms of product design, although they all follow a pat
tern common conceptual-which deals with ISO 9001 -. WHAT IS DESIGN? ISO 9000:200
0 Standard which contains the vocabulary of ISO 9000, defines design (and develo
pment): A set of processes that transforms requirements into specified character
istics or in the specification of a product, process or system. Losing a little
rigor, design is to create or define how it should be something that satisfies o
ur requirements. This is to create something that does not exist or do not know
it exists. We know which function to fulfill "the something" but not how it shou
ld be, we need to design it. Examples of Design: Industrial à MBITOEJEMPLO, produc
t design company detergents generalistaUna want to improve one of its star produ
cts, we want to get the same cleaning power by reducing the current volume% of c
omponent X. Industrial design as the clienteUna company dedicated to the manufac
ture of crane is commissioned by a client to install one on the ship you have ju
st purchased. Mobility, maximum load, and other features should be fulfilled. Pr
oduction and Service, a product design company dedicated to medidaUna manufactur
e and installation of control panels for machine control, is commissioned to ins
tall one to control three presses. Service, a product design medidaUna advertisi
ng company receives an order from a client to carry out an advertising campaign
to launch a new product to market. Training, product design academy generalistaL
a X wishes to incorporate a new course on geriatric assistant to the curriculum.
As we see in these examples, by design there is a need, we know what we want. B
ut we do not have the complete solution must be sought.
COMPREHENSIVE DESIGN CONCEPT Design includes not only the field of products mark
eted by the organization, but also the processes (such as product realization),
and the entire
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Management System. Notwithstanding the requirements of ISO 9001:2000 only focus
on the design of products (a material product, service, etc), and not these "oth
er designs." The Standard refers to this issue stating that, on a voluntary basi
s, the organization may consider applying the requirements for product design in
the design of the product realization processes. For example, ISO 16949:2002, I
SO 9001, automotive-, contains specific requirements for the design of manufactu
ring processes. That is, one thing to know which product manufacture (the produc
t is designed), and quite another to define how it will manufacture and quality
control (designing the manufacturing process). From now on all arguments are goi
ng to refer to the PRODUCT DESIGN as ISO 9001:2000 does not contain requirements
for the management of "other design processes."
DESIGN PROCESS OF A PRODUCT - STANDARD CONCEPTUAL Conceptually, the design proce
ss of a product can be assimilated to the following schedule:
ENTRY ELEMENTS OF PLAINTIFF IN DESIGN knows what he wants and communicates it by
specifying all the functions that the product must meet. The applicant may be t
he organization itself, the customer, or any other foreign entity. The Standard
requires the organization to identify and
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record what the functionality you require. On the other hand, in the design proc
ess there are other entries in the standard groups: legal and regulatory aspects
associated with the new product to be measured and recorded to verify that the
product meets those requirements. Information from previous designs. It is likel
y that the organization is supported by results of other designs. The supporting
documentation used (reports, plans, test results, ...) should be determined and
recorded, providing control and traceability to the design process. Any other r
equirement. The PLAINTIFF IN DESIGN may not know all the drawbacks or the variab
ility of what request, the organization itself, as it is skilled in the art. The
refore you should determine any prerequisite and take note of it (register).€Th
e input of the design process are the conjunction of the PLAINTIFF and requestin
g information from the three previous points. In general, the Standard requires
the organization to determine and record all input items.
PLANNING DESIGN Within the plan that the organization to carry out the design of
a product, the first thing to do is determine the input items. The uncertainty
in these efforts is a lack of quality. Have a clear procedure for the determinat
ion and collection of input elements can be of great help. First of all, two con
siderations: Consideration # 1: The design process can range from simple and mon
otonous, so complex and different, but they all must meet the requirements of pa
ragraph 7.3 of the Standard. They are usually simple and monotonous process plan
t design (HVAC, electrical, computer networks, etc. ..), and minor modifications
and mature designs. On more complex and different processes to NASA or the ESA
are good examples where the quality is also a vital factor. Consideration No. 2:
In the design of products may participate one or more persons. If only one pers
on involved, their personal discipline is important because often tend to do a "
throne unintelligible" of the job. The information relevant to the processes sho
uld be documented, and not heads of people. In the model ISO 9001:2000, this inf
ormation indicates requesting registration. The requirements demanded by ISO 900
1:2000 for design planning are the minimum necessary to require all planning: To
determine the stages in the design to be carried out. It is recommended to spec
ify the time intervals for their implementation. Determine the controls at each
stage (verification, review, or validation). Later addressing this issue in deta
il. Identify the responsibilities associated with the above activities (who does
that).
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Planning means thinking before how we are going to do. If the design is of the "
simple and monotonous, it is likely that planning will always have the same patt
ern, which is not necessary to think more the same, but the plan may already be
written in a procedure, remaining to be determined the date of completion (calcu
late the theoretical time to invest and the time) and other variables that could
change design layout. The management skills needed for planning and design cont
rol is equivalent to the management of a project. Often tends to underestimate t
he difficulty of implementing soft technologies (management), and underestimate
its benefits. But it is an incorrect assessment. THERE IS A HUGE DIFFERENCE IN Q
UALITY BETWEEN A well-managed project, and another poorly organized or opaque to
the organization in this sense, the standard affects this idea stating that "th
e organization must manage the interfaces between the different groups involved
in the design." In a design process, apart from the technical department or R &
D, may also participate in designing procurement staff (in the development of ne
w products with suppliers), Production (testing prototypes or production feasibi
lity analysis), Commercial (determining the input items and reviewing your progr
ess, etc.). Later-in-Design Outcomes will see that these departments are themsel
ves clients of the design. In the implementation of planned activities, derive s
ome results "should be updated, as appropriate, as the design progresses." This
last sentence quoted is the last requirement of ISO 9001:2000 for design plannin
g. For reasons of transparency, control, and traceability, it is clear that a pr
oject must be properly managed on file with the results obtained so far and furt
her actions to take.
RESULTS OF DESIGN The design result is the fruit of the process, the hen's egg:
WHAT YOU CAN ASK TO PEOPLE WHO HAVE ACHIEVED THE EGG OF THE CHICKEN?. That is th
e egg that needed to be told that chickens lay that egg Caring for the chickens
and feed them. How to know that eggs are incorrect. How to raise chickens withou
t the risk of infection. ... According to ISO 9001:2000, and logic, the result o
f the design should provide more than the new product because it is likely that
this product: it is required to make (or run as a service), require new material
s to suppliers (or recruit new services), must sell (product launch or delivery
to the customer), quality controls required (if fulfills the requirements)€be u
sed by people (any instructions, including those required for safe use)
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Literally, on the results the organization design must: Meet the requirements of
the input items. Provide appropriate information for purchasing, production and
service provision. Contain or refer to product acceptance criteria. Specify the
product characteristics that are essential for safe and proper use. QUALITY CON
TROL IN THE DESIGN planning requirements, the Standard and refers to the require
ment that quality controls that are relevant. Later, back on them again to reite
rate that the planning done for the design should incorporate the following cont
rols: Review: Review the design, or part thereof, are those activities that are
normally made at a meeting of all or part of responsible for the design. We revi
ew the results and project progress, assessing (as the standard) the ability of
the results obtained to meet the entry requirements (the requirements of the inp
ut elements of design), and identify and remedy any problems. The results of the
examinations should be recorded. The most common is to record these results in
meeting minutes or in a format that we designed specifically to control the desi
gn. Verification: the verification can be equated to any activity performed to v
erify that a variable of the design meets the requirements. A check is, for exam
ple, measuring the electric power consumed by a prototype (or part thereof), or
check the look of a piece developed with the supplier is free of defects specifi
ed. Not surprisingly, the results of verifications should be recorded. For examp
le, if a part of the design is a computer program, the right thing would be to d
efine the tests to be performed, and then record the results. This allows, for e
xample, refer to tests carried out later if the program has errors during use (w
e see what we fail to identify the tests to be performed, and thus learn from mi
stakes, because we can identify). Validation: to validate the design means, in p
lain words, test the product designed to verify that it works as expected. Valid
ation is a control that has a wider scope than the investigation, we do not meas
ure a variable, but functionally tested throughout the product or part of it. Va
lidation verifies compliance functionalities PLAINTIFF IN DESIGN, and other feat
ures that are part of the input items. Not all design products can be tested phy
sically, or at least not before delivery to the customer. This occurs in cases s
uch as: The design of a large civil works (eg, a suspension bridge.) A product a
s part of a large facility (eg a control panel to control a powerful engine, as
the company that designed the table does not have similar engines to test table)
.
The validation results must also be registered. In certain activities is common
to get a record operating under the customer. CHANGES IN DESIGN As design comple
xity increases, more commonly occurring situations or
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results that require rethinking lines of work, change the design variables done
so far, and even review the entry requirements. This happens "in the best famili
es", it is normal to happen, and does not penalize this Standard does not fall t
o assess the success of professionals (in case they could doubt, if the judgment
s are excessive, the efficiency in determining the initial conditions or the qua
lity of planning done). What I need is the record of the changes made and to rev
iew the new situation created, including the implementation of quality audits. A
ll this must be well documented (enough to rebuild the most important story of t
he design).
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