iso 9001 obvious and not so obvious changes
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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 moreobjective and data based.
To closely link analysis to the implementation.
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The direction of the change
EmergingMind set of
TC176
Mind set ofcustomers and
consultants
Mind set ofCertification
bodies
ISO 19011
2008 version
TS specification
2000 version
1987 version
1994 version
Quality definedas Excellence
Quality defined asPerformance
Quality definedas Conformance
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)
QMS of a company
Manufacturing
cars
Supplier capability
Statutory
require
ments
Ch
eapm
anpower
Collaborator knowhow
2000 Version ofstandard
2008 Version
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2. Process Approach (0.2)
2000 version staqndard says IDENTIFY theprocesses meaning LIST THEM.
WHY should we list A B C and not E ? No answer
B
C
A
D
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2. Process Approach (0.2)
2000 version standard says IDENTIFY theprocesses meaning LIST THEM.
WHY should we list A B C and not E ? No answer
B
C
A
D
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2. Process Approach (0.2)
Now, Organisation needs to determine those processeswhich are producing desired outcome. (Derive theprocesses from outcomes)
B
C
A
D
Customer
Satisfaction/
Reliability/
Delivery time/
Defects/
Productivity
Present
standard says to
determine
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Interpretation of an expert
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3. Scope includes otherintended
Outputs in the processes(1.1) Scope of QMS should include product delivered to
customer and also any intended product from the
product realisation processes.
QMS
Products delivered
to
customer
productProject PlansTest plans
Test cases
Tools
Intended
Outputs
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3. Scope includes otherintended
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..
QMS
Products delivered
to
customer
productProject PlansTest plans
Test cases
Tools
Intended
Outputs
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4. Outsourced processes (4.1)
Which are the processes which areoutsourced and which are needed byQMS? (Responsibility lies with the
company) Control of the process by considering -
What is the potential impact of the processeson 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 buyinga product
Specification is given
for the product. Inspection at the entrypossible.
Multiple vendors
possible. Rejection/Rework
easy
Outsourcing is buyinga capability.
Specification is for a
complete service. Inspection difficult.
Multiple vendors not
possible. Rejection/Rework
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 recordsgetting 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.
PersonProcess 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 ofcompetence.
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9. Work environment (6.4)
- clarity on conditions
The standard
requires the
organisation to
monitorenvironmental
conditions like
noise, lighting,
temperature,humidity etc
38 deg
80 db
200 lux
Temp
Dust level
Noise
Lighting
Foundry
shop
70 db
200 lux
35 deg
Sound
Lighting
Temp
Forge shop
28 - 36deg
250 lux
Temp
Air Quality
LightingHumidity
Painting
RequirementEnvironmental
condition to be
montiored
Area
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11 Design re ie erification and
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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 duringthe design phase and the validation of the
product are to be kept in mind as distinct.
If combined, there needs to be a validreason for it.
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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 BECOMEAPPARENT AFTER DELIVERY.
This means that we need to monitor field
failures and work back to determine whichoutput was not verified and hence which
process needs validation/revalidation.
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15.Preservation in order to maintain
conformity (7.5.5)
Conformity to requirements obviously is
required to be demonstrated at customers
place and hence the objective of
preservation is to maintain conformity tillcustomer 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 isdelivered 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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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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