Iso 9001

ISO 9001:2008
Pu b l sh e d b y I te rn a ti n a l O rg a n i ti n fo r i n o za o S ta n d a rd i ti n , G e n e va za o
Product = Goods and/or Services!

Fo r th e h i ry o f I O 9 0 0 1 , vi t m y sto S si w e b si te h ttp :// i 9 0 0 1 i p l m e n ta ti n d o cu m e n ts so m e o .info
Copyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info
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ISO 9001:2008 Standard

The standard has 8 clauses:

Clause 1 Scope Clause 2 Normative references Clause 3 Terms and definitions Clause 4 Quality management system Clause 5 Management responsibility Clause 6 Resource management Clause 7 Product realization Clause 8 Measurement, analysis and improvement
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Overview of the Clauses 1-8

1. Scope purpose, generic, exclusions 2. Normative references - ISO 9000:2005 3. Terms and definitions product includes service 4. Quality management system Process approach, documentation requirements 5. Management responsibility - commitment, customer focus, quality policy, planning, authorities, review. 6. Resource management human resources, infrastructure, work environment 7. Product realization customer requirements, design & development, purchasing, production, monitoring & measurements 8. Measurement, analysis & improvement customer satisfaction, internal audit, product & process conformity, continual improvement, corrective and preventive Copyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info
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What is it?
Its not about you! Its not about your company!

What is it about?

Your customers!
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Your Customers Is The Focal Point!

What they want? How they want it? Where they want it? When they want it? Why they want it?
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Truth will set you free!

Only then You are able to .. Let your customers know . Why they should . Buy [or continue to buy] from . YOU!
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When Your Customers Love You
You will experience .
Increased Market Share! Increase Profitability!
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Increased Market Share & Profitability

How do you achieve that?
By planning and implementing..

Effective and efficient
Internal business [organizational] processes!
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C l u se 4 Q u a l ty M a n a g e m e n t S yste m a i
4 . 1 G e n e ra l re q u i m e n ts [ Pro ce ss a p p ro 4 ch ]D o cu m e n ta ti n re q u i m e n ts re a .2 o re
D e te rm i e w h a t p ro ce sse s? n G e n e ra l Q u a l ty Po l cy , O b j cti s, Q u a l ty M a n u a l p ro ce d u re i i e ve i , S e q u e n ce & i te ra cti n s o f p ro ce sse s n o C o n tro l m e th o d s fo r p ro ce sse s Pro vi e re so u rce s to p ro ce sse s d M e a su re & a n a l yze p ro ce sse s I p ro ve p ro ce sse s m
Q u a l ty M a n u a l i C o n tro lo f d o cu m e n ts C o n tro lo f re co rd s
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Clause 4.1 What processes?

Processes related to:
Clause 5 Management responsibility Clause 6 Resource management Clause 7 Product realization Clause 8 Measurement, analysis &
improvement
Note: Including outsourced processes
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Sequence & Interactions
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What processes?
Sales & Marketing
Determination of customers requirements, Including applicable legal requirements.
Review of customers requirements Make sure youve got your facts right!
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Why customers dont buy from you?

They dont want what youre selling! They dont have the money! They dont believe they should buy from
you!
Why?????? Wrong positioning!! Wrong product!! No credibility? No integrity? Your sales & marketing people are sleeping on the job?
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What your Sales & Marketing should be doing?

Receiving and conveying the right &
complete information from and to the market Handling all customers needs Correcting all complaints Collect relevant info/data Analyze data Improve
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Then what?
Only then can plan to meet your
customers requirements Only can you strive to enhance their satisfaction!
But how?
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Design & Development

Inputs customer requirements
[functional, & legal]. Outputs production design plan, purchasing info Review outputs and inputs [check and recheck] Verify outputs against inputs [make sure you got it right] Validate the product design [test the prototype against a test market] Review, verify, validate & record all changes.
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Purchasing
Evaluate and select suppliers on their
ability Purchase requirements- What to buy? Inspect purchased product Re-evaluate suppliers based on performance Keep records
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Manufacture Your Product
Control [manage] the following: Information Materials Work instructions Manufacturing equipments Monitoring equipments Monitoring & measuring activities Product release, delivery & postdelivery
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Process validation
If resulting product cannot be
measured, the manufacturing process must be validated by way of:

Review and approval of processes Approval of equipment and qualified
personnel Use of specific methods and procedures Requirement for records Revalidation
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Identification and Traceability

Throughout the various
manufacturing stages, identify product status in terms of conformity Control and record unique identification system

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Customer property
Identify, verify, protect and safeguard
customer property, if any is used during design and/or production Report loss, damaged or unsuitable customer property to customers Maintain records
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Preservation of product
Preserve raw, in-process and finished
products in terms of
Identification Handling Packaging Storage Protection

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Control of monitoring & measuring equipments

Determine what and how to measure, and
what measuring equipment to use Equipments must be

Calibrated or verified [or both] at specified
intervals Adjusted and re-adjusted as necessary Identified in terms of its calibration status Be safeguarded from adjustment error Protected from damage/deterioration
If error is found on equipment, previous
calibrations records must be checked for validity and correct the equipment and affected products. Software settings must be confirmed prior
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Measurement, analysis & Improvement

Why measure and analyze? To demonstrate product conformity To ensure QMS conformity To continually improve the effectiveness of the QMS
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What to measure? Customer satisfaction QMS Processes Product conformity
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How to measure?
Customer satisfaction
survey/questionnaires Internal audit [QMS] Objectives & Key Performance Indicators [processes] Monitoring & Measurement Equipments

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Control of Nonconforming Product

This process applies to control defective
purchased and manufactured products Documented procedure for controlling nonconforming product is necessary. Nonconforming product must be dealt by way of:
Taking action to eliminate the
nonconformity Authorizing its use, release and acceptance under concession Precluding its original intended use Taking appropriate actions if nonconforming product is detected after delivery
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Analysis of Data
What to analyze? Data collected from the monitoring
and measuring activities.

Customer satisfaction Product conformity Process trends Suppliers performance
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Continual Improvement
Why analyze these data?
To identify opportunities for
improvement of the QMS
How do you introduce improvements?

Corrective actions and preventive
actions
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Corrective action
Actions to eliminate the causes of
nonconformities to prevent recurrence A procedure must be established to

Review the nonconformities Determine the causes Evaluate [plan] the course of actions
to be taken to prevent recurrence Implement the plan of actions to be taken Record of the results of actions taken Review the effectiveness of actions Copyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info
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Preventive action
Actions to eliminate the causes of a
potential nonconformity to prevent occurrence A procedure must be established to

nonconformities and their causes Evaluating [plan] the course of actions to be taken to prevent the potential occurrence Implement the plan of actions Record the results of actions taken Review the effectiveness of the actions Copyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info
Determine the potential
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Effectiveness of the QMS must be
continually improved through the use of

Quality Policy : increase commitment/passion
in everyone Objectives : keep raising performance targets Audit results : what can we improve? Analysis of data : can we do any better? Corrective actions : we will eliminate the problem altogether and make sure it never happens again Preventive actions : smarten up and anticipate the problems Management review : what does the QMS need in order to be better?
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In other words, the reason we do
anything is to improve the QMS . for as long as we do it. And to continually do this because we want to continually enhance customer satisfaction by delivering their needs.
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How do you build a QMS?

Determine the processes needed Determine the sequence and interactions of the
processes Determine control methods to ensure effectiveness of these processes* Determine and provide the required resources to these processes Monitor, measure and analyze these processes Implement these processes as per the plan Continually improve these processes
* Includes outsourced process
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Apply the Process Approach
Step 1: Identify your business processes and their sequence

Customers Sales R & D Purchasing Production Customers
Step 2: Break down each process to its activities according to their sequences and interaction

Sales activity 1 activity 2 activity 3 End.
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Process Approach
Step 3: Determine the inputs for each activity Step 4: Determine the required outputs Step 5: Determine the key performance area and objectives for each process
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Process Approach
Step 6: Monitor, measure and analyze the process performance Step 7: Improve the process
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Resource management
Provide necessary resources to
support your business processes

Human resources manage their
competence, training and QMS awareness Infrastructure determine and maintain your buildings, utilities, equipments, hardware, software Work environment ensure your work environment is conducive, safe, userfriendly, has amenities, etc.
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Management Responsibility
Whos job is it to ensure that your
QMS is effective in achieving its desired objectives?
MANAGEMENT!
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Management Commitment
Management must be committed
towards enhancing customer satisfaction They can do this by:
Consistently communicating the
important of meeting customer requirements Establishing the Quality Policy Making sure that measureable objectives are established at relevant functions and levels Reviewing the QMS at regular intervals
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Customer Focus
Management must be focused
towards enhancing customer satisfaction They can do this by ensuring that

Customer requirements are
determined and met
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Management Responsibility
Management must also ensure that
proper planning of the QMS is carried
out and ensure that its integrity is maintained if changes are introduced Responsibilities and authorities are defined
Appoint Management Representative and other necessary functional posts
Communication takes place regarding
the effectiveness of the QMS
Review Meetings at the process level

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Management Review
Management must meet regularly to
evaluate the performance of the QMS Inputs of review must include:

Results of audits Customer feedback Process performance Product conformity Status of preventive and corrective actions Follow-up actions from previous management reviews Changes that could affect the QMS Recommendations for improvement Copyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info

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Management Review
Outputs must include decisions
related to:
Improvement in the effectiveness of
the QMS and its processes Improvement of product related to customer requirements Resource needs.
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QMS Documentation
Quality Manual A document that specifies the QMS in
its entirety Quality Policy - A written statement of management commitment to meet customer requirements and enhancing customer satisfaction Objectives - Desired process performance targets Control of Documents Procedure for the management of documents used in the QMS Control of Records Procedure for management of implementation records Internal Audit Procedure for assessing implementation compliance to planned arrangement of the QMS Control of Nonconforming Product Procedure for the management of defective products Corrective Action Procedure for the management of any nonconformity within the QMS Preventive action Procedure for the management of any potential nonconformity within the QMS
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QMS Documentation
Other documents that you may require
include procedures, work instructions, plan, etc for

Sales & Marketing Design and Development Customer Complaints Warehousing Delivery Product Returns & Refunds Etc.
This depends on the nature of your

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QMS Records
Maintain records for your QMS Develop a procedure for records
identification, storage, protection, retrieval, retention and disposal. Make sure your records remain legible, identifiable and retrievable. Maintain a Records Register for each process or department. Make red labels with white titles.
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ISO 9001:2008 Summary 1
Manage your QMS processes

Policy Set your quality objectives Appoint your Management Representative Establish your QMS organization Establish communication channels Manage your human resources Manage your infrastructure Manage your work environment Copyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia]
Establish a Quality
a n d m e a su re m e n t M o n i ri g e q u i m e n t to n p m anagem ent M e a su re m e n t o f cu sto m e r sa ti cti n sfa o I te rn a la u d i n t Pro d u ct n o n co n fo rm i ty [ defective products ] M e a su re yo u r p e rfo rm a n ce [ objectives , KPI , tre n d s] A n a l yze yo u r p e rfo rm a n ce d a ta www.iso9001implementationdocuments.info
Pro d u ct m o n i ri g to n
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ISO 9001:2008 Summary 2

Document your QMS

Quality Manual Quality Policy Quality Objectives Mandatory Procedures

Control of documents Control of records Internal audit Control of nonconforming product Corrective action Preventive action
Include other documents that you need
such as procedures, work instructions, forms, formats, flowcharts, plans, etc.
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But first
If you havent established your QMS
yet, then the first thing to do is
GAP ANALYSIS
Benefits:
the ISO 9001:2008 standard in terms of what you need to do in order to be compliant to the standard You will know what processes are missing You will know what processes are incomplete You will know what documentation is missing You will know Services [Malaysia] www.iso9001implementationdocuments.info Copyright 2010 @ Ismail ML, Nuri Consulting & what documentation is
You will understand the requirements of
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More info?
More info about these process and
documentation in my Quality Manual
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ISO 9001:2008

Product = Goods and/or Services!

ISO 9001:2008 Standard

Overview of the Clauses 1-8

Your Customers Is The Focal Point!

Truth will set you free!

When Your Customers Love You

You will experience .

Increased Market Share! Increase Profitability!

Increased Market Share & Profitability

How do you achieve that?

By planning and implementing..

Effective and efficient

Internal business [organizational] processes!

Clause 4.1 What processes?

Note: Including outsourced processes

Sequence & Interactions

Sales & Marketing

Determination of customers requirements, Including applicable legal requirements.

Why customers dont buy from you?

What your Sales & Marketing should be doing?

customers requirements Only can you strive to enhance their satisfaction!

Design & Development

Manufacture Your Product

measured, the manufacturing process must be validated by way of:

Identification and Traceability

Identification Handling Packaging Storage Protection

Control of monitoring & measuring equipments

what measuring equipment to use Equipments must be

Calibrated or verified [or both] at specified

If error is found on equipment, previous

Measurement, analysis & Improvement

Measurement, analysis & Improvement

What to measure? Customer satisfaction QMS Processes Product conformity

Measurement, analysis & Improvement

Control of Nonconforming Product

and measuring activities.

improvement of the QMS

How do you introduce improvements?

nonconformities to prevent recurrence A procedure must be established to

potential nonconformity to prevent occurrence A procedure must be established to

continually improved through the use of

How do you build a QMS?

* Includes outsourced process

Apply the Process Approach

Step 1: Identify your business processes and their sequence

Customers Sales R & D Purchasing Production Customers

Sales activity 1 activity 2 activity 3 End.

support your business processes

QMS is effective in achieving its desired objectives?

towards enhancing customer satisfaction They can do this by:

Consistently communicating the

towards enhancing customer satisfaction They can do this by ensuring that

determined and met

the effectiveness of the QMS

Review Meetings at the process level

evaluate the performance of the QMS Inputs of review must include:

include procedures, work instructions, plan, etc for

This depends on the nature of your

ISO 9001:2008 Summary 1

Manage your QMS processes

ISO 9001:2008 Summary 2