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Home
FAST TRACK
Agents
About Us
ISO9001 - Quality
ISO14001 - Environmental
OHSAS 18001 - H&S
ISO27001 - Information Security
Other Standards
Auditing
Frequently Asked Questions
ISO 9001 - Clause 7 Explained
Note: many of the sub-clauses of section 7 do not require that you have procedu
res, unlike their equivalents in previous versions of the standard. Some of them
require that you conduct certain activities or else keep records of certain act
ivities, but only a few of them require that you follow defined procedures.
Where you do not use procedures, there is an expectation that you train your sta
ff, so that they know what to do. A detailed explanation of what is required is
given in our CD.
Also, you can exclude sections of clause 7 if they are not relevant to your oper
ations. However, you must provide a robust justification for doing so.
Clause
Control of:
Meaning
7 Product Realization

The changes to the 2008 version of Clause 7, compared to ISO9001:2000 are mainly
minor changes for clarification purposes.
The net effect is that there is no change in the actual requirements, except whe
re noted below.
The ISO committee actually removed a number of potentially useful notes that had
been included in the earlier drafts of the standard. Shame, really.
7.1 Planning of Product Realization You must:
determine the quality objectives and requirements for your products,
ensure that you adequately plan all of the processes and sub-processes needed to
provide your products/services,
plan the required inspection/testing activities,
identify what records must be kept, to prove that the product has been properly
produced
7.2 Customer-related Processes
7.2.1 Determination of Requirements Related to the Product You must find ou
t what your Customer requires from you, with regard to the actual product or ser
vice that you supply and also any obligations that arise from it (such as legal
requirements, warranties, and support, etc)
A new note has been added to this Clause, for clarification purposes.
7.2.2 Review of Requirements Related to the Product You must ensure that cus
tomer requirements are defined. If they are not defined in writing, you must ide
ntify how you confirm what it is that you thought the Customer wanted. You must
ensure you have the resources to supply what has been ordered before you accept
the order.
You must define how changes in requirements are recorded how the information is
circulated around the relevant sections of your organisation.
7.2.3 Customer Communication You must identify how the Customer contacts your
organisation, especially for product information, feedback including complaints
, enquiries and orders, including amendments, etc.
7.3 Design and Development You must plan and control all aspects of your de
sign/development work.
Note: Even though you may not consider that you "design" anything, you may do!
For example, within a Service-sector organisation, you will probably "design" th
e service that you supply on a Customer-by-Customer basis.
However, you should note that "design" only refers to the products or services t
hat you supply to your customers. It does NOT include the design of software or
equipment that you use in-house, for example.
7.3.1 Design Planning You must ensure that you identify the various design / d
evelopment processes and the related review stages.
Also identify all relevant responsibilities
7.3.2 Design Inputs You must identify what the design inputs are (i.e. what
information do you need in order to design or develop your product or service?)
Your inputs should include any relevant functional requirements, standards, lega
l requirements (e.g. mandatory safety requirements, packaging disposal/recycling
requirements, CE marking requirements, etc).
Where it is relevant, you should consider similar previous designs and learn fro
m them.
A new note has been added to this Clause, for clarification purposes.
7.3.3 Design Outputs You must specify the design outputs (e.g. plans, drawing
s, schematics, etc) in such a way that they can be checked to ensure that they m
eet the design requirements. They must be suitable for use by the organisation t
hat receives them.
For example, your manufacturing department may require a Bill Of Materials, a "g
old" sample, and a full set of engineering drawings, etc. Your design plans shou
ld state what is required, after you have discussed and agreed this with the rec
ipient (whether an external Customer or an internal department).
A new note has been added to this Clause, for clarification purposes.
7.3.4 Design Review You must review the progress of the design activities at
appropriate stages. These can include theoretical calculation checks, Beta test
ing, etc.
You must identify and record any problems and propose follow-up actions. Your pl
ans should identify what these stages are and when they occur.
You must keep records of these reviews.
7.3.5 Design Verification You must verify your designs to ensure that the
design meets the design input requirements.
Your plans should state how and when you plan to do this.
7.3.6 Design Validation You must ensure that the product or service work
s correctly in practice.
In some cases, validation may include reviews of Customer feedback after release
of the product. This may lead to subsequent design changes, or changes in futur
e products.
Your plans should state how you plan to do this.
7.3.7 Design Changes You must ensure that any changes are reviewed and record
ed.
You must consider the effect that the changes may have on any sections of the de
sign work already completed or under way.
7.4 Purchasing
7.4.1 Purchasing Control You must ensure that you select suitable supplie
rs, and tell them clearly what it is that you want from them, so that you receiv
e the things you wanted.
7.4.2 Purchasing Information Your purchase orders (or letters of contract, et
c) must clearly state what it is that you want (clever stuff, huh?). These must
be reviewed for adequacy before they are sent to the Vendor
7.4.3 Verification of Purchased Product
This section is concerned with how you verify that the Vendor has supplied the c
orrect items to you (in the 1994 version of the standard, this was usually condu
cted at "Receiving Inspection", or sometimes after the item was installed in ano
ther assembly ("In-process Inspection").
The second part of this section of the standard is relevant only if you intend t
o inspect goods at your Vendor's premises before the goods are released (whether
to you or directly to your Customer) .
In this case, you should specify when they will be checked ("within 10 days of n
otification by the Vendor", "following installation of sub-assembly 31", etc) an
d how they will be released ("not to be released until in receipt of our written
release instruction", etc). This must be specified in the purchasing documents
(this can be included on the purchase order that you send to the Vendor, or incl
uded in a "Terms & Conditions" document or "Contract of Supply", etc).
7.5 Production & Service Provision
7.5.1 Control of Production & Service Provision
This section is concerned with the process of producing your goods or services.
You should consider how you control these processes, including:
information which specifies the characteristics of the product (so that inspecti
ons and functional tests can be properly conducted)
provision of work instructions (or SOPs, Method Statements, etc). This can be by
written instructions, drawings, photographs, samples, etc.
provision of suitable equipment and appropriate maintenance of the equipment
availability and use of suitable monitoring and measuring devices
provision of procedures for release, delivery and (if applicable) post-delivery
activities (e.g. installation, commissioning, servicing, etc).
7.5.2 Validation of Processes for Production & Service Provision This cau
se is probably the most misunderstood. Additional notes were to have been added
in the 208 version of ISO9001 to clarify what is meant by it. The ISO committee
had seemed to have taken on board some of the examples provided on this site fo
r many years, such as welding, heat treatment and call centres, etc. But at the
last moment, they dropped the notes. I wouldn't have pressed any claims for cop
yright, chaps!
This section is concerned with processes which produce items that cannot be test
ed directly.
Example: In specialist welding operations, where the the weld itself cannot be c
hecked without destroying it. In this case, the way to ensure that the work has
been properly conducted is to only use properly trained and qualified welders, w
ith highly-specified materials and equipment.
The resulting welds cannot be internally inspected, so all of the correct condit
ions must be ensured.
Also, some of the welder's work may be selected for random tests. These are prob
ably destroyed during the testing process, so a certain extra number are always
produced, for testing purposes.
Other methods (e.g. for testing of crimped electrical connectors) might include
destructive testing of first and last-off items or a sample destructive testing,
etc.
In this case, you must:
define how you review, approve and revalidate your production/service processes,
define how you approve and revalidate equipment and personnel involved in these
activities,
use "specific methods and procedures" to control the processes.
You must also define:
which methods or procedures must be followed when producing or servicing the pro
duct/service,
what qualifications/experience are required for people involved in the processes
what records must be kept
7.5.3 Identification and Traceability
Where appropriate and to the extent necessary, you must ensure that materials an
d goods are identified, so as to prevent accidental mix-ups. Labelling is a typi
cal method. Other methods include signs on the wall with a picture of the items.
Metal rods can have coloured paint put the end. However, if the differences are
immediately obvious, there may be no need to label goods. Do not overdo it!
Similarly, in some industries it may be necessary to be able to trace exactly wh
ich materials from which supplier were used in which goods. This may also extend
to knowing which operators were involved. The aerospace industry is a good exam
ple of this sort of level of traceability.
In the software industry, configuration management fulfils this requirement.
7.5.4 Customer Property
If you receive goods from your Customer which you then build into the items that
you supply back to the Customer, then this clause of the standard applies to yo
u. Also, if your activities involve items belonging to the Customer (e.g. if you
service household electronic items, etc), you must take care of them, etc.
In that case, you must record the goods upon receipt, and check that they are su
itable for use. If any problems are discovered, or it is damaged or lost whilst
under your control, you must report this back to the Customer.
Customer data can be included under this heading (e.g. you provide an analytical
service and you analyse the data, or you are an architect and you receive plans
, property deeds, etc from the Customer. Also, if you receive confidential infor
mation from your Customer, etc).
7.5.5 Preservation of Product
You must have procedures in place which ensure that all materials, subassemblies
and finished goods, etc are stored and handled so as to prevent them from damag
e or deterioration.
However, this is not just limited to your stores or warehouse. It includes all a
reas where materials are handled, processed or moved. (The clause might have bee
n more illuminating if had been entitled "Materials Handling"!)
Also included in this section are the steps that you take to ensure that goods a
re not damaged following your final inspection. If it is your responsibility to
deliver goods to your Client (that is, they do not arrange for the collection of
the goods), then you must also choose you method of carriage appropriately. (If
you use a carrier/courier, then they should be included in your supplier select
ion methods.
7.6 Control of Monitoring & Measuring Devices You must identify what m
easurements need to be made, and what equipment must be used.
Where measuring equipment is used to inspect or set up the goods that you manufa
cture, you must ensure that they are accurate enough for the purpose. You should
have then regularly checked (calibrated). You must be able to prove that the eq
uipment is calibrated, so keep records of it!
If you find that the equipment is faulty, you must consider the effect of that f
ault on the measurements taken using the equipment since the last time you knew
it was OK. This may mean that you have to recall goods (e.g. if a braking system
on a motor vehicle could have been adversely affected), or it may mean that no
action is required (e.g. if the inaccuracy is not enough to cause any adverse co
nsequences). Either way, you must formally consider the matter and record the co
nsideration and the decision.
All pages are © Centre for ISO9000 Ltd 1994 - 2009
This page was last on Oct 04, 2009

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