ISO 9001 Obvious and Not So Obvious Changes

8/14/2019 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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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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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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Documents

ISO 9001 Obvious and Not So Obvious Changes