ISO 9001:2008
Product = Goods and/or Services!
For the history of ISO 9001, visit my website http://iso9001implementationdocuments.info
Published by International Organization for Standardization, Geneva
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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
improvementCopyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info [email protected]
Overview of the Clauses 1-81. Scope – purpose, generic, exclusions2. Normative references - ISO 9000:20053. Terms and definitions – product includes service4. Quality management system – Process approach,
documentation requirements5. Management responsibility - commitment, customer
focus, quality policy, planning, authorities, review.6. Resource management – human resources,
infrastructure, work environment7. 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 action.Copyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia]
www.iso9001implementationdocuments.info [email protected]
What is it?
It’s not about you!It’s 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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Clause 4 Quality Management System
4.2 Documentation requirements
4.1 General requirements [Process approach]
General – Quality Policy, Objectives, Quality
Manual, procedures, documents, records
Quality Manual
Control of records
Control of documents
Determine what processes?
Provide resources to processes
Sequence & interactions of processes
Measure & analyze processes
Control methods for processes
Improve processesCopyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info [email protected]
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 you’ve got your facts right!
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Why customers don’t buy from you?
They don’t want what you’re selling! They don’t have the money!
They don’t 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.Copyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info [email protected]
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 & post-
deliveryCopyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info [email protected]
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 to use.Copyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info [email protected]
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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Measurement, analysis & Improvement
What to measure?
Customer satisfaction QMS Processes Product conformity
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Measurement, analysis & Improvement
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 deliveryCopyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info [email protected]
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 taken
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Preventive action
Actions to eliminate the causes of a potential nonconformity to prevent occurrence
A procedure must be established to Determine the potential 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 taken
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Continual Improvement 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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Continual Improvement
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 processCopyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info [email protected]
Apply the Process ApproachStep 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.Copyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info [email protected]
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 processCopyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info [email protected]
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, user-friendly, has amenities, etc.
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Management Responsibility
Who’s 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 Providing required resources
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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
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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 QMSCopyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info [email protected]
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 businessCopyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info [email protected]
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.Copyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info [email protected]
ISO 9001:2008 Summary 1
Establish a Quality 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 Sales and marketing Product design and
development Purchasing & supplier
management Production / Services
Product monitoring and measurement
Monitoring equipment management
Measurement of customer satisfaction
Internal audit Product nonconformity
[defective products] Measure your performance
[objectives, KPI, trends] Analyze your performance
data Improve your performance Corrective actions Preventive actions
Manage your QMS processes
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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 haven’t established your QMS yet, then the first thing to do is …
GAP ANALYSIS Benefits:
You will understand the requirements of 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 what documentation is complete
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More info?
More info about these process and documentation in my Quality Manual
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