ISO 9001:2008 Awareness Presentation

Suitable for all kinds of interested audiences

Empty your cup and enjoy the presentation

Facts about ISO 9001

1. ISO 9001 is being implemented in 175 countries around the world

2. Over 1.2 million certificates issued worldwide

3. ISO has 163 member countries

What is ISO 9001?

• It’s a quality management system that can be adopted by any kind of organization

• The system is focused towards the meeting of customer requirements and enhancing of customer satisfaction

Keywords: 1. Quality2. Management system3. Customer requirements4. Customer satisfaction

What is ISO 9001?

• This system has 4 components or elements and they are applied within your business management:a) Management responsibilityb) Resource managementc) Product realizationd) Measurement, analysis and improvement

• Before we explore these elements, why is ISO 9001 necessary for your organization?

Why do we need ISO 9001?

• To be effective in whatever we do, we need a system of doing things to be consistent. Just like craftsmen, managers need a good management tool to get the job done.

• There are too many activities in any organization. Easy to lose track of things and focus. Easy to get distracted. Managers need a good system to keep things in order.

• Systemizing of activities is a natural phenomenon. We do it all the time – privately, publicly or commercially

Why do we need ISO 9001?

• A business faces great risks – big investments, customer expectations, jobs, credibility, etc. The business owner must do all he can to ensure success, or he/she will fail.

• Every major economy in the world adopts it! Governments give recognition to it. Because it works.

Global Issuance of ISO 9001 Certificates

No of ISO 9001 certificates0

200,000

400,000

600,000

800,000

1,000,000

1,200,000

2000200120022003200420052006200720082009

ISO Survey 2010ISO 9001 Certificates issued by region

You already have a system of doing things too!

• But is it effective? If you keep doing what you always do, you will always get the same result.

• ISO 9001 is an option, a good one. It requires your organization to document your business processes (QMS), monitor, measure, analyze and improve it.

• Business owners and top management need to make a strategic decision on whether to implement the ISO 9001 QMS.

Biggest benefit• The ISO 9001:2008 Standard

provides managers with a tool that is designed to continually improve their business performance.

• ISO 9001 requires you to:– Plan what you want to do,– Follow that plan,– Monitor, measure and

analyze your execution of the plan, and

– Improve the plan.

Planning is the key

P D C A

• A well-designed and well-implemented quality management system can and should eliminate

• Ineffectiveness• Inefficiencies• Problems• Errors• Inconsistencies• Malicious practices• Uncertainties• Bad culture

What is ISO 9001?

• ISO = International Organization for Standardization

• isos = Greek = equal• 9001 = unique ID

number• 2008 = Year it was

published

Formation 23 February 1947 Type NGO Purpose Int’l standardization HQ Geneva Membership 63 countries Website www.iso.org No. of stds over 18,000

ISO 9000 Familya) ISO 9001:2008 Quality Management Systems –

Requirementsb) ISO 9000:2005 Fundamentals and vocabularyc) ISO 19011:2011 Guidelines for auditing management

systemsd) ISO 9004:2009 Managing for the sustained success of an

organization — A quality management approach

• The term “ISO 9000” is frequently used to refer to the ISO 9001 standard

• Only ISO 9001 is auditable. The rest serves as references only.

ISO 9001 History It all started when the US Military were getting sub-par products from their suppliers. Then it caught

on.

YEAR STANDARDS TITLE

1959 MIL-Q-9858 QUALITY PROGRAM REQUIREMENTS

1969 AQAP NATO ALLIED QUALITY ASSURANCE PUBLICATIONS

1974 BS 5179 GUIDELINES FOR QUALITY ASSURANCE

1979 BS 5750 SPECIFICATION FOR DESIGN DEVELOPMENT, PRODUCTION, INSTALLATION AND SERVICING

1987 ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing

ISO 9002:1987 Model for quality assurance in production, installation, and servicing

ISO 9003:1987 Model for quality assurance in final inspection and test

1994 ISO 9001:1994 QUALITY SYSTEMS – MODEL FOR QUALITY ASSURANCE

2000 ISO 9001:2000 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS

2008 ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS- REQUIREMENTS

What is ISO 9001:2008 Quality Management Systems - Requirements?

• Quality = degree to which customer requirements have been met

• Management = coordinated activities to direct and control an organization

• System = set of interrelated or interacting elements• Quality management system = a system to direct and

control an organization with regard to quality• Requirements = a set of management parameters your

QMS

More about quality• How do you know requirements have been met?

– Review = confirm that requirements are accurate– Verify = measure accuracy of output against requirements– Validate = Get feedback from customer/end-user

• Nonconformance = failure to fulfill requirements• Nonconformance = error• All forms of nonconformances require corrections and

corrective action to prevent recurrences• Correction = Elimination of error• Corrective action = Elimination of the root causes of the

error (Ask WHY 5 times)

Root cause analysis

Root cause Effect 1 Effect 2 Effect 3 Direct cause Nonconformity

1. Why did the nonconformity occur?2. Why did the direct cause occur?3. Why did effect 3 occur?4. Why did effect 2 occur?5. Why did effect 1 occur?

8 Quality Management PrinciplesThe ISO 9001 Standard is based on these principles

1. Customer focus2. Leadership3. Involvement of people4. Process approach5. System approach to

management6. Continual improvement7. Factual approach to decision

making8. Mutually beneficial supplier

relationships

System approach

• Quality must be managed by a system to be effective• This system is done for you, as represented by the

ISO 9001:2008 standard• Recall: A system is a set of interrelated or interacting

elements• System approach is described in Clause 4.1• The description of Clause 4.1 matches the PDCA

approach to process management - Plan, Do, Check, Act

System and process approach

• Quality must be managed by a system• The system must be managed using the

process approach because the system is made up of processes

• These processes are linked to each other• A process has inputs , resources, activities,

outputs and customers. Manage them all.

ISO Lingo

• Product = Any output- physical product or services• Output = product• Product = result of a process• Process = a set of inter-relating activities focused

towards producing the output• Input = requirements

input process output

Process approach

input Your process output

Can be applied to any other process that you

manage

Process approach• Every process require specific inputs, resources, activities,

outputs and customers• What you can do now is:

– Define and document the inputs– Define and document the kinds of resources that your process

use– Define and document the activities and their interactions– Define and document the responsibilities– Define and document the outputs

• You can name this document as Department Control Plan• Then execute this plan, and monitor, measure, analyze

and improve its performance (KPI)• Thus, Plan – Do - Check – Act (Edward Demmings)

Anatomy of a process

Process

Inputs

Activities

Outputs

Resources

Every process has an owner

Process management

ISO 9001:2008 ELEMENTS

input Your QMS output

ISO 9001:2008 Structure

• 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

Your QMS

Quality management

system

General requirements

Documentation requirements

Resource management

Product realization

Measurement, analysis and

improvement

Clause 1 Scope• Your organization should consider to adopt the

ISO 9001 standard if it – needs to demonstrate its ability to consistently

provide product that meets customer and applicable statutory and regulatory requirements, and

– aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

• In this International Standard, the term “product” only applies to a) product intended for, or required by, a customer,b) any intended output resulting from the product

realization processes.• All requirements of this International Standard

are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Clause 1.2 Application• Where any

requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

• Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within Clause 7.

• And such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

Clause 2 Normative references

• This document is indispensable in the application of the ISO 9001 standard:– ISO 9000 – Fundamentals and vocabulary

Clause 3 Terms and definitions

• Wherever the term “product” occurs, it can also mean “service”.

4.1 QMS General Requirements

1. Determine the QMS processes2. Determine the sequence and interactions 3. Determine the methods of operations and control4. Provide resources to ensure effective operations

(Clause 6)5. Monitor, measure and analyze processes (Clause

8.2 to 8.4)6. Improve the effectiveness of the processes

(Clause 8.5)

QMS processes are in the circle

Clause 4.2 Documentation requirementsa) Quality Policyb) Quality Manual – to describe

the systemc) Quality Objectives Register –

to document your quality objectives

d) Control of Documents Procedure

e) Control of Records Proceduref) Internal Audit Procedure

Note: Templates are available.

g) Control of Nonconforming Product

h) Corrective Action Procedure

i) Preventive Action Procedure

j) Quality Plank) Control plansl) Other documents, as

necessarym) Records (to show evidence

of work performed in all QMS processes)

Control of documentsCreate

documentGet

approvalRegister

documentDistribute document

Review document

Amend document

Get re-approval

Update register

Identify external

documents

Register external

documents

Check for updates

Update register

Dispose obsolete document

Stamp obsolete document if retained

Clause 4.2.4 Control of records

• Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled.

• Process owners must identify, classify and maintain all process records in good and secure conditions throughout retention period.

• Records shall remain legible, readily identifiable and retrievable.

Good records management

• Enables you toa) conduct business in an orderly, efficient and

accountable manner b) support and document decision making c) provide continuity in the event of a disaster d) meet legislative and regulatory requirements e) protect the interests of customers, employees

and stakeholders

Types of records to maintain• Go through the ISO 9001 standard or your Quality Manual

• Identify the following phrases where they appear: “Records …… shall be maintained (see 4.2.4)”

• Most of the records requirements are readily available, such as product planning records, product design records, purchasing records, production records, monitoring records, analysis records, employee performance appraisal and training records, job descriptions, organization chart, infra maintenance records, contract/sales records, marketing records, customer complaints records, etc.

• Records pertaining to the mandatory SOP’s and quality objectives shall be created.

Clause 5 Management Responsibility

• Top management must a) Be committed to the QMSb) Be customer focusedc) Establish a quality policyd) Plan for the QMS in terms of establishing quality

objectives and management of changee) Assign responsibility, authority and provide

suitable communication channelsf) Review the QMS performance

What to do• Read the ISO 9001:2008 Standard • Establish a Quality Policy• Appoint a Management Representative (from mgt rank)• Establish a QMS Committee • Establish your Quality Manual• Establish the 6 mandatory procedures (Clause 4.2)• Establish your Quality Plan• Establish your Department/Process Control Plans• Establish and document your quality objectives• Establish your KPI’s and start collecting data• Implement all the procedures

Key Performance Indicators• Ask this question when

determining KPI’s:• As the CEO/Manager of

this organization, what data will instantly give me the ability to assess overall performance at any given point of time?

• Then list all them down and select your desired KPI’s.

Balanced scorecard

Financials

Processes

Customers

Human capital

• Can be used to benchmark performance based on input requirements (customer wants 100 units per month, so give them 100 units per month)

• Can be used to improve KPI performance levels – decision must be based on past performance data and existing capacity to be realistic

• You can use existing performance levels to establish your quality objectives

• Use quality objectives to improve on productivity levels, decrease errors, improve speed, reduce costs, reduce complaints, etc.

Quality objectives

Employee responsibility• Know the Quality Policy• Aware of the relevance and importance

of their activities and how they contribute to the achievement of the quality objectives

• Comply with the requirements of the QMS, as stated in the Quality Manual, procedures, Quality Plan, etc.

• Provide feedbacks or ideas about the QMS

• Report any nonconformities

Clause 6 Resource management

• Clause 6.1 Provision of resources• The organization shall determine and provide

the resources neededa) to implement and maintain the quality

management system and continually improve its effectiveness, and

b) to enhance customer satisfaction by meeting customer requirements.

Types of resources

• Determine , provide and manage the following:a) Clause 6.2 Competent human resources

(competency assessment, training needs analysis)b) Clause 6.3 Suitable and well-maintained

infrastructures (maintenance of buildings, hardware, software, transportation, utilities)

c) Clause 6.4 Suitable and well-maintained work environment (5S program)

d) Consider including financial management in your QMS to ensure product conformity

• Clause 6.2.1 • Personnel performing work affecting

conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience.

Establish Job Description

Hire employee

Appraise performance

Identify training needs

Conduct training

Assess effectiveness

of training

PLAN DO CHECK ACT

• Create a survey form which contains these columns: 1. Employee’s name2. Job position3. List of routine activities4. List of non-routine activities5. Key performance indicators6. Skills required7. Competency assessment per skill (use score ratings)8. Recommendation for training

• Employees fill in columns 1 to 4• Manager fills in columns 5 to 8• Benefits: Manager can identify work

redundancies, activity gaps, competency gaps, need for training and maybe the need to re-engineer the work processes

• Output: ?

Sometimes, work activities are not defined. So there’s a lot of confusion

Defining staff duties and responsibilities and analyzing training needs to ensure competence is essential

5S Program for work environment management

SEIRI SEITON SEISO SEIKETSU SHITSUKE

SORT SET IN ORDER SHINE STANDARDIZE SUSTAIN

Product realization processesClause 7 Product realization

7.1 Planning

7.2 Determination of custom

er requirem

ents

7.3 Design & developm

ent

7.4 Purchasing

7.5 Production/Service provision

7.6 Control of monitoring and

measuring equipm

ent

Clause 7.1 Planning of product realization• The organization shall plan and develop the processes

needed for product realization, in terms ofa) quality objectives and requirements for the productb) the need to establish processes and documents,c) providing resources specific to the productd) required verification, validation, monitoring,

measurement, inspection and test activities specific to the product and the criteria for product acceptance

e) records needed to provide evidence that the realization processes and resulting product meet requirements

Clause 7.1 Create a Quality Plan• With the following contents:

a) Assigned responsibilities (who’s doing what)b) Quality objectives (productivity/quality targets)c) Customer requirements/Product characteristics, features, etc.d) References to procedures to control production/creation,

storage, release, delivery, etc.e) Required resources- HR, materials, equipment, etc.f) Required verification, validation, monitoring, measurement,

inspection and test activities specific to the product and the criteria for product acceptance

g) Types of records needed to provide evidence that the realization processes and resulting product meet requirements

What’s a Plan?

PLAN

Duties and responsibilities

KPI & Quality

objectives

Flow of activities

Quality control

activities

Output description

Required physical

resources

Description of activities

SOP’s and records

Clause 7.2

Customer related process

Determination of customer

requirements

Review of customer requirements

Customer communication

Design & development

Planning

Input

Output

Review

Verify

Validate

Control of changes

Clause 7.3 Create a Design Plan

• This clause can be excluded from your QMS if you don’t design the your products

Design & development• Review • activity undertaken to

determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives

• Verification confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

• Validation• confirmation, through the

provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled

Design & development• Review • activity undertaken to

determine the suitability, adequacy and effectiveness of the subject matter to achieve established objectives

• Verification confirmation, through the provision of objective evidence, that specified requirements have been fulfilled

• Validation• confirmation, through the

provision of objective evidence, that the requirements for a specific intended use or application have been fulfilled

PURCHASING

Purchasing process

Purchasing information

Verification of purchased product

Clause 7.4

• Keep records of your purchase orders, suppliers’ quotations & delivery orders and inspection forms for purchased products. Monitor, measure and analyze their performance (only those who supply materials/equipment/services used within the product creation process

Determine purchase

requirementsIssue RFQ Evaluate

quotesIssue PO Inspect DO

Assess supplier’s

performance

PLAN DO CHECK ACT

Production & service provision

Control of production and service provision

Validation of processes for production and service

provision

Identification and traceability

Customer property

Preservation of product

Clause 7.5 - Create a Production/Service

Plan

Clause 7.6 Control of monitoring and measuring equipment

• The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.

• Calibrate the monitoring and measuring equipment at suitable intervals.

• Verify the monitoring and measuring equipment at suitable intervals.

• Segregate those equipment which are not calibrated yet or not used within the process. Tag or cage them.

• This clause can be excluded from your QMS if you don’t use such equipment in your product creation process.

Product realization process controlsa) Quality Plan – to document how you intend

to meet your customers’ requirementsb) Customer & Legal Requirementsc) Customer complaints handling procedured) Design Plane) Purchasing Proceduref) Production/Service Plang) Monitoring & Measuring Equipment Plan

(can be included in Production/Service Plan)

Clause 8 Measurement, analysis and improvement

• The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed

a) to demonstrate conformity to product requirements,b) to ensure conformity of the quality management system, andc) to continually improve the effectiveness of the quality

management system. • This shall include determination of applicable methods,

including statistical techniques, and the extent of their use.

Why monitor and measure?

• If you cannot measure it, you cannot improve it. Lord Kelvin

• Measurements provide you with a baseline to improve upon.

What do you measure?

1. Customer satisfaction (Survey, returns rate, complaints, lost business, etc)

2. Process conformance and effectiveness (internal audit)

3. Process performance (Key Performance Indicators and quality objectives)

4. Product characteristics (QC inspection before release to customer) where nonconforming products must be controlled

Clause 8.3 Control of nonconforming productsWhere applicable, the organization shall deal with nonconforming product by one or more of the following ways: a) by taking action to eliminate the detected nonconformity;b) by authorizing its use, release or acceptance under

concession by a relevant authority and, where applicable, by the customer;

c) by taking action to preclude its original intended use or application;

d) by taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.

Internal audit process

• Purpose is to verify whether your QMS

a) Conforms to your Quality Plan,b) Conforms to ISO 9001 requirements,c) Conforms to your QMS requirements, andd) is effectively implemented and maintained.

Establish annual audit

schedule

Distribute Audit Plan

Perform audit

Report findings

Follow-up actions

Audit defined• Audit is a systematic and documented process for

gathering audit evidence and evaluating it against the audit criteria to determine whether it has been fulfilled

• Audit criteria is a set of policies, procedures or requirements

• Audit evidence is records, statements of fact or other information which are relevant to the audit criteria and verifiable

• Audit conclusion is the outcome of an audit provided by the audit team after consideration of the audit objectives and all audit findings

• What to ask?• What records to inspect?• What activities to observe?

1. Remember your purpose is to verify conformance and effectiveness against a specific requirement.

2. That requirement may come from the ISO 9001 Standard, your Quality Manual, SOP, etc.

3. So the answer depends on what audit criteria you want to verify

4. Remember, your job as an auditor is to look for the audit evidence, that’s all

5. So use the ISO 9001 Audit Checklist and start auditing.

Audit methodology

a) Interviewing the auditeeb) Inspection of documents

and records, etc.c) Observation of ongoing

activities

What do you analyze?

• Analyze what you measured:a) Customer satisfaction levelsb) Internal audit resultsc) Product QC inspection resultsd) KPI resultse) Suppliers’ performance.

How do you analyze?• Line Chart/Trend Chart/Control Chart - used to detect trends and unusual

activities within the data set,• Pareto Chart Analysis - used to analyze the different components that make

up the data value in a descending order, complete with the cumulative percentage line superimposed on it,

• SWOT Analysis - used to analyze process strengths, weaknesses, opportunities and threats based on the characteristics of the data set - whether internal or external,

• Arithmetic average or mean - used to identify the average performance value of the process,

• Median - used to identify the actual middle value of the data set,• Mode - used to identify the most frequent value occurring within the data set,• Range - used to identify the difference between the lowest and highest values

,• Standard deviation – used to identify the SD from the mean• Cause and Effect Analysis - used to analyze the causes and effects of a given

data set, • Risk Analysis - used to identify potential risks given the data set

0

2

4

6

8

10

12Errors What caused

this spike?

Trend chartUse it to identify potential problems

Pareto Principle20% of the causes contributes to 80% of the effects

• Identify and classify all problems

• Calculate cumulative occurrences up to 80%

• Focus on solving those problems

• Continually improve the management of those causes

• Analyze your sales figures and identify the contributors

• Focus your efforts on customers who contribute 80% of those sales

• Focus your efforts on the sales personnel who are managing those customers

Joseph M. Juran suggested the principle and named it after Italian economist Vilfredo Pareto, who observed in 1906 that 80% of the land in Italy was owned by 20% of the population; he developed the principle by observing that 20% of the pea pods in his garden contained 80% of the peas.

What to improve?

• The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

• All nonconformities require corrective actions• All potential nonconformities require preventive

actions.

Corrective action process

Detect nonconformity

Report nonconformity

Review nonconformity against criteria

Issue CARPerform root cause analysis

Evaluate need for corrective

action

Implement corrective

action

Record the results of

actions taken

Verify effectiveness of

actions taken

Preventive action processDetect

potential nonconformity

Report potential

nonconformity

Review against criteria

Issue PARPerform root cause analysis

Evaluate need for preventive

action

Implement preventive

action

Record the results of

actions taken

Verify effectiveness of

actions taken

Risk analysisPerforming a risk analysis on your business processes can help you detect potential nonconformities

• Describe the risk• Describe the potential effects• Quantify likelihood of occurrence

(consider frequency)• Quantify severity of consequence

(consider harm or damage)• Assign risk rating (likelihood x

severity)• Risk rating > 4 shall be controlled

(ALARP = as low as reasonably practicable)

Score ratings1 = very low2 = low3 – moderate4 = high5 = very high

Root cause analysis

Root cause Effect Effect Direct cause Nonconformity

causes effect

Sources of direct causes:1. Human error,2. Material defect,3. Equipment malfunction,4. Ineffective methods of operation or control, or5. Flawed management policies.

Nonconformities

• Don’t fear them because

–We detect and report them because we don’t want them to recur–We report and record them because we

want to document the improvements made to the QMS

ISO 9001 Certification

• Performed by independent Certification Body, such as SIRIM QAS, BVQI, LRQA, SGS

• Client gets a renewable 3-year certificate• Phase 1 audit = Adequacy audit =

Documentation audit• Phase 2 audit = Conformance audit = Physical

audit of personnel, records and processes

ISO 9001 Certification

• First year = Certification audit• 2nd year = Surveillance audit• 3rd year = Surveillance audit and/or re-

certification audit• If after 3 months, nonconformities were not

corrected (via the corrective action procedure) by the client, the ISO 9001 certificate will be revoked by the CB.

• Decide if ISO 9001 is for you• Purchase the standard online• Purchase a Quality Manual

template• Appoint a Management

Representative• Appoint a QMS Committee• Read the ISO 9001 Standard and

the Quality Manual• Plan your QMS by customizing

the Quality Manual• Plan and implement every clause

within the Quality Manual

Plan of action

Hope you benefited from that presentation