C P CHANDRASEKARAN QUALITY MANAGEMENT CONSULTANT PUNE INDIA
LIST OF CHANGES IN ISO 9001:2008 AND LIKELY IMPACT ON QMS 270609
No Clause Change done Likely Impact on QMS
No/Title
1 0.1 General The design and implementation of the QMS is
influenced by organizational environment,
change in that and the risks associated with
that environment.
2 0.1 General Statutory requirements and regulatory
requirements mentioned together.
3 0.2 Process Organisation needs to determine the
Approach processes (not just identify).
The processes have been recognised as
producing outcomes (not just outputs)
4 1.1 Scope- Note The product includes any intended
General. output from product realisation process
5 4.1 General Note has been added to define the Outsourced
Requirement processes:
s An outsourced process is a process that the
organisation needs in its QMS and which the
organisation chooses to have performed by an
external agency.
6 4.1 Quality The type and extent of control on outsourced
management processes shall be defined within the QMS.
system Ensuring control over outsourced process
General does not absolve the organization of its
Requirement responsibility of conformity to all customer,
s statutory and regulatory requirements. The
type and extent of control to be applied to
outsourced process can be influenced by
factors such as a) Potential impact of
outsourced process on the organization and its
capability to provide a product that conforms
to requirements. b) the degree to which the
control for process is shared c) the capability
of achieving the necessary control through 7.4
7 4.1 Quality The process covered under QMS include the
management processes for management activities like
system planning , provision of resources, product
General realization and measurement analysis and
requirements improvement.
8 4.2.3 Editorial clarification:
Document A single document may address a requirement
control for 2 procedures or a requirement for a
Dec 5th 2008 © C P Chandrasekaran Pune India 2008 Mail cpchandrasekaran@gmail.com
Revised on 25th June 2009 Rev marked by (R1)
Though not auditable, one needs to know
whether the QMS as it is designed
addresses the organizational environment
which includes the supply chain, product
features, ability to cope up with customer
demands etc. Risks could be product
liability or penalties and loss of export
orders.
Now legal requirements mean statutory
requirements (passed as a law in
parliament) and regulatory requirements
( issued by the enforcing authorities as
rules)
These changes are in the direction of
award models and reflect the current
thinking that the process design and
deployment is to be taken more rigorously.
This marks a departure from the earlier
standard.
Earlier product is what is supplied to
customer. Now any intended output (like
tooling or a test fixture or a packaging) is
also a product. This elevates the
importance to be given to such outputs in
QMS.
With this definition, you may have a)
infrastructure maintenance b) logistics c)
commissioning d) Tools manufacture e) IT
and all these will get included, if not
already done. Refer to scope once again
for clarity.
Outsourced process needs to have an
assessment of its impact on product and
mechanisms need to be in place for
controlling the process. If any system is
there already under 7.4 please link it here.
The controls may be shared so that you are
always in the know of things.
You need to have a process for analysis
and improvement. This needs to be under
QMS.
This is not likely to impact on existing
QMS but it provides support in case you
have got say two procedures for 8.3.
 C P CHANDRASEKARAN QUALITY MANAGEMENT CONSULTANT PUNE INDIA

procedure can be met with by two documents.

9 4.2.4 Control Records shall be controlled We need to know the date on which the
of Records records were created by whom and if they
were distributed to whom and when. Lot
of work for you if you are MR.
10 6.2.1 Human Note has been added as follows: Conformity This brings all people in QMS at same
Resource to product requirements can be affected level whether a designer or an accountant
directly or indirectly by personnel or a storekeeper all can affect product. So,
performing any task within QMS. the resources need to be planned with his
in mind.
11 6.2.2 The training should be provided to achieve This places direct responsibility to
Competence the necessary competence (earlier demonstrate that the required competences
Training and requirement was to satisfy competence needs) have been achieved after training.
awareness
12 6.3 Information system has been added in IT planning, providing latest software and
infrastructure supporting services. hardware and maintaining these now will
be included in QMS.
13 6.4 Work It has been elaborated as follows: Work One has to collect data on all these and
Environment environment relates to those conditions under show that these are monitored. It is getting
which work is performed including physical closer to OHSAS 18001 now.
environmental and other factors (such as
noise, temperature, humidity, lighting and
weather)
14 7.1 product In planning for manufacture of product or 2000 version did speak about
Realisation delivery of service, now organization needs to measurement in 8.1 but now it gets
R plan not only for verification and validation reinforced because the organization needs
1 but measurement of product quality as well. to plan some measurements specific to
This measurement could be a part of product or service to assure that it
acceptance criteria. conforms to all requirements.
Inspection/verification alone may not
suffice. The move is towards a
Quantitative decision on quality.
15 7.2.1 Post delivery activities include, for example, The entire product life cycle is given in
Requirement actions under warranty provisions, contractual one sentence and very clearly. This needs
s related to obligations such as maintenance services and to be reviewed for adequacy in the QMS.
product supplementary services such as recycling or
final disposal.
16 7.3.1 Design Note : Design and development review, Designers have been weak on this clause
and verification and validation have distinct because of overlap between review and
Development purposes. They can be conducted and verification. This note brings out the
Planning recorded separately or in any combination as intent of the standard clearly.
suitable for the product and the organization.
17 7.3.3. Design Note: Information for production and service Packing and Packaging specification
and provision can include details of preservation needs to be included as a design output.
Development of product. Output linked to 7.5.3. Also refer scope
outputs (Companies with TS certification may
have already done it.)
18 7.5.2 The organization shall validate ANY process This hits the nail on its head as every one
Validation of for production and service provision where wants to take a short cut on validation of
processes the resulting output cannot be verified by process. Let the fresh thinking be done
subsequent monitoring and measurement now about validation and any non
AND AS A CONSEQUENCE inspectable activity should be validated.
DEFICIENCIES BECOME APPARENT
only after the product or service has been
delivered.
19 7.5.4 Customer property includes personal data. It is more for service organizations like
Customer banks/educational institutions etc..
property
20 7.5.5 The sentence on preservation says now ” in The conformity to requirements is to be

Dec 5th 2008 © C P Chandrasekaran Pune India 2008 Mail cpchandrasekaran@gmail.com

Revised on 25th June 2009 Rev marked by (R1)
 C P CHANDRASEKARAN QUALITY MANAGEMENT CONSULTANT PUNE INDIA

preservation order to maintain the conformity to validated at customer’s place and so

of product requirements.” preservation needs to be validated by
getting customer feedback
21 7.6 Control Note : Confirmation of the ability of the For the computer software in QMS
of computer software to satisfy the intended organization needs to maintain
monitoring application would typically include its configuration management and periodic
and verification and configuration management test results of its performance. New
measuring to maintain its suitability for use. releases need to be monitored till the
equipment acceptance is obtained.
22 8.2.1 Monitoring customer perception can include There are now more avenues to obtain the
Customer obtaining input from sources such as on information on customer perception
perception customer satisfaction surveys, customer data and some like warranty claims are actually
on delivered product quality, user opinion data and not perceptions.
surveys, lost business analysis ,compliments,
warranty claims dealer reports.etc
23 8.2.2 Internal Reference to ISO 19011 given. ISO 19011 was released in 2002 and was
audit treated with disdain by auditors, trainers
and MRs apparently because the ISO 9001
still was referring to ISO 10011. This
hopefully will change now. However, it
will call for more efforts on the part of
auditors to conform to ISO 19011.
24 8.2.2 Internal Management will ensure CORRECTIONS We may need to differentiate in the Audit
Audit and CORRECTIVE ACTIONS ……. report which corrections are to be done
immediately and what corrective actions
will be required to close the findings.
25 8.2.3 When determining methods for monitoring of This will call for categorization of
Monitoring processes, it is advisable that the organization processes as core, and others so that the
and consider the type and extent of monitoring monitoring can be decided. Critical
measurement and measurement appropriate to each of its process
of processes processes in relation to their impact on the More measures higher frequency and less
conformity to product requirements and on leeway. Less critical less measures and
the effectiveness of QMS. lower frequency.
26 8.3 Control A para d is added to the list of ways to deal This in a way was there already but it is
of non with the non conforming product : emphasized now as one of the ways of
conforming d) by taking action appropriate to the effects dealing with the non conforming product..
product or potential effects of the non conformity The word Potential effects indicates the
when non conforming product is detected need for a risk analysis and without a
after delivery or use has started. FMEA it may not be possible to comply
with this requirement.
27 8.4 analysis Reference to the sections are added against Analysis is very well linked to other
of data the para a to d. to give linkages within the clauses and hence QMS should provide
standard. the linkage practically.
1. cust sat against 8.2.1
2.conformity to product requirements 8.2.4
3. processes and products 8.2.3 and 8.2.4
4 suppliers 7.4
28 8.5.2 and Reviews have been specifically mentioned as This is to emphasise the need for
8.5.3 reviews of effectiveness of reviewing the effectiveness rather than the
Corrective corrective/preventive actions as the case may actions themselves.
action and be.
Preventive
action

General:
1. wherever the word “Product Quality Requirements” was used now it is replaced by “Product requirements”.
2. Many sentences in passive voice have been changed to active voice.

Dec 5th 2008 © C P Chandrasekaran Pune India 2008 Mail cpchandrasekaran@gmail.com

Revised on 25th June 2009 Rev marked by (R1)