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Business Excellence Through QMS

Conformance to Performance

By

Arefin KhanDirector, QUICK ISO.com

(B.Sc. IT, MBA Marketing, Lead Auditor ISO 9001 series, ISO 14001, ISO 18001, ISO 27001,HACCP)E-mail: sales@quickiso.com, Web: www.quickiso.com

Contact : +91 9768374277

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WHAT IS THE ‘IOS’(1) International organisation for

standardisation: Formed in Geneva Switzerland300(+) countries are members800(+) new and revised standards issued

annually(2) Technical committee 176 – responsible for

Quality standard creation – members:• ANSI - American national Standards Institute• SCC –standards Council of Canada• BSI – British Standards Institute

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FOUNDATION DOCUMENTS

• MIL 9850• BSI 5750• CAN Z299• EN 29000• Universal ISO 9000 adopted (1987)• Revised: 1994 & 2000

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Other Standards

• New QMS- ISO 9001:2008• EMS- ISO 14001:2004• OHSAS- ISO 18001• FSMS-ISO 22000 : 2005• INFO SEC-ISO 27000• Social A/C- SA 8000

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Evolution of Quality System

• Inspection• Quality control• Quality Assurance• Quality Management system

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ISO Family of Standards :

ISO 9000 :- FUNDAMENTALS AND VOCABULARY

* ISO 9001 :- REQUIREMENTS* ISO 9004 :- GUIDELINES FOR PERFORMANCE

IIMPROVEMENT

* Consistent Pair

QUALITY SYSTEMS

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What is Quality?• Meeting specification?• Fitness for use?• Good – satisfactory?• Great – excellence?• Bad – liability?• Customer satisfaction?• Repeat business?• I know when I see it?• It is a state of mind, not an activity• It must be defined for each organization

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Scope of ISO 9001 : 2008(Requirements for a QMS)

• To demonstrate its ability to provide consistently product that meets customer and applicable regulatory requirements

• To address customers satisfaction through the effective application of the system, including processes for continual improvements and the prevention of non conformity

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P- D- C- A CYCLE

ACT

CHECK

PLAN

DO

TAKE APPROPRIATE ACTION

Checkeffects

Determine goal

Determine Method of Reaching goal

Education &training

Implementation

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Principles of Quality Management

• Customer focused organization• Leadership• Involvement of people• Process approach• System approach to management• Continual improvements • Factual approach to decision making• Mutually beneficial supplier relationships

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Process Definition

Process OutputsInput

A system of activities which uses resources to transform inputs into outputs.

Effectiveness of process:Ability to achieve desired result

Efficiency of process: Results achieved Vs resources used

Includes resources Product- result of process

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Training and competence ‘Competence focused approaches can provide the much needed

”glue” to assure that the frame work for quality is structurally sound’

• A system that provides clearly understandable and measurable standards for all personnel

• A gap in standards ( a deficit in knowledge, attitude, skills or habits) can indicate a training need

• When training has been provided, how do we know that it has done us any good?

• A system that provides clearly understandable and measurable standards for all personnel

• A gap in standards ( a deficit in knowledge, attitude, skills or habits) can indicate a training need

• When training has been provided, how do we know that it has done us any good?

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Benefit of the standard• Availability of competent and skilled employees• More time for top management to think about

organizational growth and development• Brings order and discipline into the organization • Working system is more effective and efficient.• Easy for top management to know performance of

organization any time.• Employees feel more comforts and ease in performing

task.• Satisfied internal and external customers.• Problems are prevented to occur. Customers are happy

with excellent product and services• Easy to face competition and challenge• More business oriented, less procedure oriented • Company wide involvements• Customer focus than product focus• Less emphasis on documentation

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4.1 General Requirements

• Identify the Processes• Determine sequence and interaction• Determine criteria and methods for effective

control• Ensure availability of resources and

information • Monitor, measure and analyze processes• Implement actions for continual improvement.

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4.2 Documentation Requirement

The QMS Documentation shall include :• Documented statements of Quality

Policy and Quality Objectives• A Quality Manual• Documented Procedures• Documents to ensure effective

planning, Operation and control.• Records.

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ISO 9001 - Requirements

5. Management Responsibility5.1 Management Commitment5.2 Customer Focus5.3 Quality Policy5.4 Planning5.5 Responsibility, Authority and Communication5.6 Management Review

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ISO 9001 - Requirement

6. Resource Management6.1 Provision of Resources6.2 Human Resources6.3 Infrastructure6.4 Work Environment

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Exclusions

Limited to clause 7 requirement only• Such exclusions do not effect the

organizations’ ability or responsibility to provide a service that fulfils members’ and applicable regulatory requirements.

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ISO 9001 – Requirements

7 Product Realization ( Permissible Exclusions)

7.1 Planning of Product Realization7.2 Customer Related Processes7.3 Design and Development7.4 Purchasing7.5 Production and Service Provision7.6 Control of Monitoring and Measuring

Devices

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ISO 9001 – Requirement

8. Measurement, Analysis and Improvement8.1 General8.2 Monitoring and measurement8.3 Control of non conforming product8.4 Analysis of data8.5 Improvement

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Quality policy & Quality Objectives

• Policy to include a commitment to meeting ISO 9001:2000 requirements

• Quality objective shall be measurable and consistent with quality policy

• Communicated and understood at appropriate levels in the organization

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Quality Objectives

• Establish to provide focus to direct the organization

• Objective determine the the intended result and lead the organization to utilize resources to realize the results

• Objectives need to be measurable and achievable

• Achievements:positive impact on product quality, System effectiveness, financial performance, satisfaction / confidence of stake holders

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Quality Management System

• “All activities of overall management function that determines the quality policy, quality objectives and responsibilities and implement them by means of such as quality planning, quality assurance and quality improvements within the quality system” or in short “ this is a management system to direct and control an organization with regard to quality”

The quality management system defines the quality environments within a business. Every business is different and so each QMS will be unique and different.

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System Monitoring

• Correction, corrective & preventive action

• Internal Audit• Management Review• Improvement

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Corrective action

• Process Approach• Identify root cause• Establish action necessary to

eliminate root cause• Establish risk / implications of

no action• Implement action• Monitor success

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Preventive action

• Taking steps to prevent the occurrence of problems

• What could go wrong?• Priorities action on the basis of risk

( both to the organization and members)

• Ensuring that the management system is suitable to fulfill the the current and future needs and expectation of the customer

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Internal Audit

• Systematic examination to determine compliance and effectiveness

• Compliance with ISO 9001: 2000• Planning to consider status and

importance• Suitably chosen and trained auditors

are a crucial resource within the management system

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Management Review

• A top management activity undertaken to ensure suitability adequacy, effectiveness and efficiency of the system to achieve established objective

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Management Review Input• Meeting or circulated report subscribed to / commented

up on by top management Review to encompass:

• Policy and objective review• Results of audits• Customer feed back• Resource needs• Improvement activities – system – product / service• Process performance• Changing circumstances• System changes• Action from previous reviews

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Improvements

• Improvements required where requirements (customer, legal, policy, and objectives) are not being met

• Improvement should be integral to and achieved through the quality system

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List of Mandatory Records Required

Sl.No. Clause No. Type of Record

1 5.6.1 Management Review

2 6.2.2 Human Resources

3 7.1 Service Realization

4 7.2.2 Customer Related Processes

5 7.3.2 Design & Development - input

6 7.3.4 Design & Development - review

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Continued.........

7 7.3.5 Design & Development - verification

8 7.3.6 Design & Development - validation

9 7.3.7 Design & Development –review of changes

10 7.4.1 Purchasing/Supplier Evaluation

11 7.5.1 Planning

12 7.5.2 Process Validation

13 7.5.3 Validation of Processes for Production and Service

Provision 7.5.2 14 7.5.4 Customer Property 7.5.4

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Continued.........

15 7.6 Control of Monitoring & Measuring Devices

16 8.2.2 Internal Audit

17 8.2.4 Monitoring & Measurement of Services

18 8.3 Control of Nonconforming Services

19 8.5.2 Corrective Action

20 8.5.3 Preventive Action

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Essential documents for ISO 9001:2008

• Quality Policy• Quality Objectives• Apex Quality Manual• Mandatory Procedures Control of documentsControl of recordsInternal AuditControl of Non conformityCorrective ActionPreventive Action

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Continued ......

• Functional Procedures as required by the Organization such as---

Policy, Audit Review & evaluation, Failure/Deviation Analysis,Approvals, Manpower

Planning & Training , Support & Coordination, PQM, Correlation Programmes, Information Sharing,Lab facilities,Budget, MIS etc.

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About Certification• New ISO 9001:2008 Certification valid for 3

years , Surveillance Audit will be held after 1 year,9 months or 6 months of certification Audit to ensure continued implementation & Continual improvements in the Organization.

Surveillance Audit Schedule

FrequencyNo. of Audit 1 Year 29 Months 36 Months 5

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Thank For Your Patience!For more details please logon to our site www.quickiso.comAnd write a comment in our blog www.blog.quickiso.com

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