UNDERSTANDING - ISO 9000 QUALITY MANAGEMENT SYSTEM

UNDERSTANDING ‐ ISO 9000UNDERSTANDING ‐ ISO 9000 QUALITY MANAGEMENT SYSTEMQ

Presented by Manikandan

WHAT IS ISO ?WHAT IS ISO ?

I t ti l O i ti f St d di ti• International Organisation for Standardisation• Established in 1946 @Geneva, Switzerland• It is an association of National Standard Bodies of more than 150 countriesP i bj i i di i & ifi i f• Primary objective is coordination & unification of international standards.It l t f t h i l itt b• It employs system of technical committees, sub committees & working groups to develop international standardsinternational standards.


Why ISO ?Why ISO ?

• It controls quality.

• It saves money.It saves money.

• Customers expect it.

• And competitors use it.


Benefits from (ISO‐9001) Quality Management System

i f i i i l k• It is a passport for entry in international market.• It increases the professional image of your organization.

• It increased customer confidence.• It improves quality cut in costs reducing to rejection control.rejection control.

• It shows clarity of responsibility and authority.• It increases consistent quality• It increases consistent quality.• According to this better and defined system.


Documents to be PreparedDocuments to be Prepared

• Quality Policy Manual

• Quality System Procedures (QSPs)Quality System Procedures (QSPs)

• Work Instructions (WIs)

• Records / Formats / Forms


ISO Document LevelsISO Document Levels

Quality Manual

LEVEL 1 – defines approach & responsibility

Manual

Procedures LEVEL 2 – defines Who, What & When

Work Instructions LEVEL 3 – Answers how

Other Documentation Records LEVEL 4 – Promotes Evidences


QUALITY POLICY MANUALQUALITY POLICY MANUAL

• First level documentation, defines “ what will be done and why”y

• The manual communicates the quality policy and objectives of an organisationand objectives of an organisation

• It is a living document because it reflects the current system being followed in the organisation.organisation.


Quality System Procedures (QSPs)Quality System Procedures (QSPs)

d l l d i d fi h• Second level documentation defines whoshould perform specific tasks, when the task should be done and where the documentation will be made.

• It collectively defines the organisation’soperations from receiving an enquiry to p g q ydelivering a completed product / service.

• These are confidential documents and need• These are confidential documents and need not be revealed to outsiders.


Work Instructions (WIs)Work Instructions (WIs)• 3rd Level Documentation defines how individual work processes (Ex: machining, welding..etc) are carried out within a company.p y

• It also specifies how the work should be done; who should undertake the work and what recordswho should undertake the work and what records are to be maintained.

• It may be in the form of drawings routing sheetIt may be in the form of drawings, routing sheet, photographs..etc

• It is advisable that it should be written by the• It is advisable that it should be written by the employee who performs the task.


Records / Formats / FormsRecords / Formats / Forms

• These are the evidence of activity having been performed in compliance with quality system p p q y yprocedure.

• These are used to provide traceability of• These are used to provide traceability of actions on specific product or batch of products.

• “IN GOD WE TRUST FROM ALL OTHERS WEIN GOD WE TRUST FROM ALL OTHERS WE REQUIRE OBJECTIVE EVIDENCE”


1.Scopep

1.1. General

The Standard specifies requirements for QMS where an organisation needs to demonstrate itswhere an organisation needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirementscustomer and applicable regulatory requirements.

1.2 Application

ll f h d d dAll requriements of this standard are generic and are intended to be applicable to all organisations

dl f d d d dregardless of type, size and product provided.


2.Normative Reference

ISO 9000:2000 – QualityISO 9000:2000 Quality Management Systems –

Fundamentals & VocabularyFundamentals & Vocabulary


3 Terms and Definitions3.Terms and Definitions

The term “Organisation” replaces the term supplier used in ISO 9001:1994 and refers to the unit to which the i i l d d liinternational standard applies.


4 Quality management system4.Quality management system.4 1General Requirements4.1General Requirements

The organisation shall

a) Identify the processes needed for QMS and their application.

b) Determine the sequence & interaction of these processes

c) Determine criteria & methods needed to ensure the operation & t l f th ff ti& control of these processes are effective.

d) Ensure availability of resources & information necessary to support the operation and monitoring processes.

e) Monitor, measure & analyse these processes.

f) Implement actions necessary to achieve planned results and continual improvement of these processescontinual improvement of these processes.

4.2 Documentation Requirements.

All four level documents as explained earlier.p


5 Management Responsibility5.Management Responsibility5.1Management Commitment

Top Management shall provide evidence of its commitment to the development & implementation of the QMS and continually improving its effectiveness by Establishing the Quality policy and Quality Objectiveseffectiveness by Establishing the Quality policy and Quality Objectives.

5.2Customer Focus

Top Management shall ensure that the customer requirements are determined and are met with the aim of enhancing customer satisfaction.

5.3Quality Policy

Top Management shall establish communicate review the continuingTop Management shall establish, communicate, review the continuing suitability of the Quality Policy

5.4Planning

Top Management shall ensure that Quality objectives including those needed to meet the requirement of the products are established and the same shall be measurable & consistent with the Quality Policysame shall be measurable & consistent with the Quality Policy.


5 Management Responsibility5.Management Responsibility5.5Responsibility, Authority & Communication

Top Management shall ensure that responsibilites and authorities are definedTop Management shall ensure that responsibilites and authorities are defined and communicated within the organisation. Top Management shall appoint a member of management who irrespective of other responsibilites shall have responsibility and authority that includesother responsibilites shall have responsibility and authority that includesa) Ensuring that processes needed for QMS are established, implemented & maintained.b) Reporting to top management on the performance of the QMS and anyb) Reporting to top management on the performance of the QMS and any need for improvementc) Ensuring the promotion of awareness of customer requirements throughout the organisationthe organisation

5.6Management ReviewTop Management shall review the organisation’s QMS at planned intervals to ensure its continuing suitability adequacy and effectivenessensure its continuing suitability, adequacy and effectiveness.


6.Resource Management g6.1 Provision of resources

The organisation shall determine and provide the resources needed to implement & maintain the QMS and contin all impro e its effecti enesscontinually improve its effectiveness.

6.2 Human resources

P l f i k ff ti d t lit h llPersonnel performing work affecting product quality shall be competent on the basis of appropirate education, training, skill and experienceskill and experience

6.3 Infrastructure – Buildings, transport, communication devices ..etc

6.4 Work Environment – work space, ventilation ..etc


7 Management Responsibility7.Management Responsibility

7.1 Planning of Product Realisation

A document specifying the processes of QMS and the resources to be applied to a specific product referred as quality planresources to be applied to a specific product referred as quality plan

7.2 Customer– related Process

Requirements specified by the customer for delivery and postRequirements specified by the customer for delivery and post delivery activities / requirements not stated by the customer but necessary for specified or intended use

7.3 Design & Development

7.4 Purchasing

d &7.5 Production & service provision

7.6 Control of monitoring and measuring devices


8.Measurement, Analysis & Improvement

8 1 G l8.1 GeneralThe organisation shall plan & Implement the li bl h d i l di i i l h iapplicable methods, including statistical techniques

and continually improve the effectiveness of the QMSQMS.

8.2 Monitoring & Measurement8 2 1 C S i f i8.2.1 Customer Satisfaction8.2.2 Internal Audit8.2.3 Monitoring & measurement of Processes8.2.4 Monitoring & measurement of Product


8.Measurement, Analysis & Improvement

8.3 Control of nonconforming product

(a) by taking action to eliminate the detected nonconformity

(b) by authorising its use, release or acceptance under concession by relevant authority and where applicable by the customercustomer.

8.4 Analysis of data – with data from customer satisfaction, conformity of product requirement suppliers etcconformity of product requirement, suppliers..etc

8.5 Improvement – The Organisation shall continually improve the effectiveness of the QMS through the use of theimprove the effectiveness of the QMS through the use of the quality policy, objectives, audit results, analysis of data, corrective and preventive actions


ISO 9000 family a reviewISO 9000 family a reviewISO 9001 – for QA in design, development, production, installation and servicing (Module H in ISO 9001 : 2000)

ISO 9002 – for QA in Production and installation (Module D in ISO 9001: 2000)( )

ISO 9003 – for QA in final inspection & test (Module E in ISO 9001:2000)E in ISO 9001:2000)

ISO 9004 – for Quality Management and system elements guidelines (Converted as QMS in ISOelements guidelines (Converted as QMS in ISO 9001:2000)


Benefits on implementing QMS as per ISO standards

“U ” i l l i di h l i ifi“Users” experience clearly indicates the several significant improvements in the following areas :

• Improved employee involvement (Avg gain 100%)Improved employee involvement (Avg gain 100%)• Improved House Keeping (Avg.gain 140%)• Improved Decision making based on facts & data (Avg.gainImproved Decision making based on facts & data (Avg.gain

95%)• Improved Customer Satisfaction (Gain 55%)• Improved safe working area (Gain 45%)• Reduced Customer Complaints (about 40%)• Reduced inspection efforts (about 45%)• Reduced Quality Cost (about 50%)


List of Changes in ISO 9001: 2008 & likely impact on QMS

• Refer the text matter attached 3 pages


ALL THE BEST

THANK UTHANK U


UNDERSTANDING - ISO 9000 QUALITY MANAGEMENT SYSTEM

Documents

Transcript of UNDERSTANDING - ISO 9000 QUALITY MANAGEMENT SYSTEM