ISO9001:2008

The changes-
The obvious …..and
not so obvious

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 Intent of changes in 2008
• To bring the standard closer to Award models
• To bring more focus to processes (especially
outsourced processes) and to monitoring of
processes.
• To make internal audits more effective and
auditors more accountable.
• To make customer satisfaction data more
objective and data based.
• To closely link analysis to the implementation.

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 The direction of the change
Quality defined Quality defined as Quality defined
as Conformance Performance as Excellence

1987 version TS specification ISO 19011

1994 version 2000 version 2008 version

Mind set of Mind set of Emerging

Certification customers and Mind set of
bodies consultants TC176
Conflict No Conflict
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 Changes in standard
1. Introduction (0.1)
• The design and implementation of a QMS is influenced
by the environment and the risks associated with that
environment. (QMS is now related to external factors)
2008 Version 2000 Version of
Supplier capability standard

Statutory requir
Cheap manpower

QMS of a company
Manufacturing
cars

ements
Collaborator knowhow
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 2. Process Approach (0.2)
• 2000 version staqndard says IDENTIFY the
processes meaning LIST THEM.
• WHY should we list A B C and not E ? No answer

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 2. Process Approach (0.2)
• 2000 version standard says IDENTIFY the
processes meaning LIST THEM.
• WHY should we list A B C and not E ? No answer

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 2. Process Approach (0.2)
• Now, Organisation needs to determine those processes
which are producing desired outcome. (Derive the
processes from outcomes) Present
standard says to
determine

Customer
Satisfaction/
B Reliability/
Delivery time/
Defects/
Productivity
D
C
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 Interpretation of an expert
•

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 3. Scope includes other intended
Outputs in the processes(1.1)
• Scope of QMS should include product delivered to
customer and also any intended product from the
Intended
product realisation processes. Outputs
Project Plans
Test plans product
Test cases
Tools

Products delivered
QMS to
customer

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 3. Scope includes other intended
Outputs in the processes(1.1)
• This means clause no 7.3, 7.4,7.5,7.6. and 8.2.1,8.2.3
8.2.4 and 8.3are applicable for intended outputs..
Intended
Outputs
Project Plans
Test plans product
Test cases
Tools

Products delivered
QMS to
customer

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 4. Outsourced processes (4.1)
• Which are the processes which are
outsourced and which are needed by
QMS? (Responsibility lies with the
company)
• Control of the process by considering -
– What is the potential impact of the processes
on the product requirements?
– What are the controls and are they shared?
– Existing control through Purchasing

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 TC 176 Interpretation –No
exclusion on outsourced process

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 Purchasing and outsourcing
• Purchasing is buying • Outsourcing is buying
a product a capability.
• Specification is given • Specification is for a
for the product. complete service.
• Inspection at the entry • Inspection difficult.
possible.
• Multiple vendors • Multiple vendors not
possible. possible.
• Rejection/Rework • Rejection/Rework
easy difficult
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 5. Processes for measurement ,
analysis and improvement (4.1)
• Processes in QMS include
– Processes for management activities
– Processes for provision of resources
– Processes for Product realisation
– And now ………
– Processes for Measurement, analysis and
improvement.

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 6. Control of records (4.2.4)
• Records should be controlled.
– We need to Identify the originator
– We need to have a list of people to whom the
records are distributed.
– We need to have a date when it was sent.
– We need to have a check on unauthorised
corrections/copying of records or records
getting lost.

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7.Everyone affects product (6.2.1)
• Conformity to product requirements can be
affected indirectly by anyone performing any
task within the QMS.
• Every one within the QMS needs to have
– Responsibility to carryout any task assigned.
– Competence to carryout the task.
– Communication to know the customer requirements.

Process Person Outcomes

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 8. Training should end in
achievement of competence (6.2.2)
• Provide training or other actions to
achieve the necessary competence.
– Training plan should be triggered by needed
level of competence.
– Training effectiveness should be indicated not
by feedback of participant but by an exit
test/project to demonstrate the level of
competence.

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 9. Work environment (6.4)
- clarity on conditions
• The standard Area Environmental
condition to be
Requirement

montiored
requires the
Painting Temp 28 - 36deg
organisation to Air Quality
monitor Lighting 250 lux
environmental Humidity
Forge shop Sound 70 db
conditions like
Lighting 200 lux
noise, lighting, Temp 35 deg
temperature, Foundry Temp 38 deg
shop
humidity etc Dust level
Noise 80 db
Lighting 200 lux

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 10. Product requirements during
the delivery and post-delivery in life
cycle (7.2.1)
• A note added to detail the post delivery activities which extend to
recycling and final disposal.

Product Product in use Disposal or

in warranty with customer recycling

Contractual Maintenance
Supplementary services
services (as services
(EXPECTATION OF THE
a part of the ( separate offer
NEW STANDRD) HOW
order/offer) like AMS)
WILL WE ADDRESS????
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 11. Design review, verification and
validation are distinctly
differentiated (7.3.1)

• While planning design and development

activities, reviews and verifications during
the design phase and the validation of the
product are to be kept in mind as distinct.
• If combined, there needs to be a valid
reason for it.

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 12. Design outputs (7.3.3)
• Design outputs need to include
instructions for preservation of product to
maintain conformity to requirements till the
product is at customer place.

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13. Validation of processes (7.5.2)
• We need to validate ANY process where
the resulting output of a process cannot be
verified AND AS A CONSEQUENCE THE
DEFICIENCIES WILL BECOME
APPARENT AFTER DELIVERY.
– This means that we need to monitor field
failures and work back to determine which
output was not verified and hence which
process needs validation/revalidation.
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 14.Customer property includes
personal data (7.5.4)
• Not applicable to the manufacturing
organisations.
• Applicable to service organisations.

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15.Preservation in order to maintain
conformity (7.5.5)
• Conformity to requirements obviously is
required to be demonstrated at customer’s
place and hence the objective of
preservation is to maintain conformity till
customer starts experiencing the product.

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 16.Test Software (7.6)
• Configuration management and
verification is required for any software
used for testing of the product. (or any
intended product other than that which is
delivered to customer)

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 17. Customer satisfaction backed
up by data (8.2.1)
• The standard balances perception with
data and relies on warranty failures, dealer
feedback, product quality data, user
surveys, lost business analysis etc.

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 18.New approach to Internal audit
(8.2.2)
• ISO19011 was released in 2002 but not
much attention was paid. Now it is
officially included in ISO9001.
• .Principles of auditing
– Auditor competence
– Evaluation of competences
– Audit reports need to have corrections and
corrective actions

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 19.Non conforming product (8.3)
• Dealing with non conforming product now
includes the analysis of potential effects of
non conformity after the use has started.

– FMEA for every non conformity not corrected

/correctable could be a requirement.

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 20. Analysis is linked to other
clauses (8.4)
• Analysis of
– Customer satisfaction linked to 8.2.1
– conformity to product requirements linked to
8.2.4
– processes and products linked to 8.2.3 and
8.2.4
– suppliers linked to 7.4

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