45318591-ISO-9001-PPT

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

Copyright 2010 @ Ismail ML, Nuri Consulting & Services [Malaysia] www.iso9001implementationdocuments.info [email protected]

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!


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?


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!


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 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


Sequence & Interactions


What processes?

Sales & Marketing

Determination of customers requirements,

Including applicable legal requirements.

Review of customers requirements Make sure you’ve got your facts right!


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?


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


Then what?

Only then can plan to meet your customers’ requirements

Only can you strive to enhance their satisfaction!

But how?


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


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


Identification and Traceability

Throughout the various manufacturing stages, identify product status in terms of conformity

Control and record unique identification system


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


Preservation of product

Preserve raw, in-process and finished products in terms of

Identification Handling Packaging Storage Protection


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



What to measure?

Customer satisfaction QMS Processes Product conformity



How to measure?

Customer satisfaction survey/questionnaires

Internal audit [QMS] Objectives & Key Performance Indicators

[processes] Monitoring & Measurement Equipments


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


Continual Improvement

Why analyze these data? To identify opportunities for

improvement of the QMS

How do you introduce improvements? Corrective actions and preventive

actions


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


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


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?


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.


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


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.


Management Responsibility

Who’s job is it to ensure that your QMS is effective in achieving its desired objectives?

MANAGEMENT!


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


Customer Focus

Management must be focused towards enhancing customer satisfaction

They can do this by ensuring that Customer requirements are determined

and met


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


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


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.


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


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.


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


More info?

More info about these process and documentation in my Quality Manual
