UNDERSTANDING - ISO 9000 QUALITY

MANAGEMENT SYSTEM

WHAT IS ISO ?

• International Organisation for Standardisation

• Established in 1946 @Geneva, Switzerland

• It is an association of National Standard Bodies of more than 150 countries

• Primary objective is coordination & unification of international standards.

• It employs system of technical committees, sub committees & working groups to develop international standards.

Why ISO ?

• It controls quality. • It saves money. • Customers expect it. • And competitors use it.

Benefits from (ISO-9001) Quality Management

System• 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.• It shows clarity of responsibility and

authority.• It increases consistent quality.• According to this better and defined

system.

Documents to be Prepared

• Quality Policy Manual• Quality System Procedures (QSPs)• Work Instructions (WIs)• Records / Formats / Forms

ISO Document Levels

Quality Manual

Procedures

Work Instructions

Other Documentation Records

LEVEL 1 – defines approach & responsibility

LEVEL 2 – defines Who, What & When

LEVEL 3 – Answers how

LEVEL 4 – Promotes Evidences

QUALITY POLICY MANUAL

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

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

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

Quality System Procedures (QSPs)

• Second level documentation defines who should perform specific tasks, when the task should be done and where the documentation will be made.

• It collectively defines the organisation’s operations from receiving an enquiry to delivering a completed product / service.

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

Work Instructions (WIs)• 3rd Level Documentation defines how

individual work processes (Ex: machining, welding..etc) are carried out within a company.

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

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

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

Records / Formats / Forms

• These are the evidence of activity having been performed in compliance with quality system procedure.

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

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

1.Scope

1.1. GeneralThe Standard specifies requirements

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

1.2 ApplicationAll requriements of this standard are

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

2.Normative Reference

ISO 9000:2000 – Quality Management Systems –

Fundamentals & Vocabulary

3.Terms and Definitions

The term “Organisation” replaces the term supplier used in ISO 9001:1994 and refers to

the unit to which the international standard applies.

4.Quality management system.

4.1General RequirementsThe organisation shall a) Identify the processes needed for QMS and their

application.b) Determine the sequence & interaction of these

processesc) Determine criteria & methods needed to ensure

the operation & 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 processes.4.2 Documentation Requirements.

All four level documents as explained earlier.

5.Management Responsibility

5.1 Management CommitmentTop 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 Objectives.

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

5.3 Quality PolicyTop Management shall establish, communicate, review the continuing suitability of the Quality Policy

5.4 PlanningTop 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 Policy.

5.Management Responsibility5.5 Responsibility, Authority & Communication

Top 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 includesa) Ensuring that processes needed for QMS are established, implemented & maintained.b) 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 organisation

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

6.Resource Management 6.1 Provision of resources

The organisation shall determine and provide the resources needed to implement & maintain the QMS and continually improve its effectiveness.

6.2 Human resourcesPersonnel performing work affecting product

quality shall be competent on the basis of appropirate education, training, skill and experience

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

6.4 Work Environment – work space, ventilation ..etc

7.Management Responsibility

7.1 Planning of Product RealisationA document specifying the processes of QMS and

the resources to be applied to a specific product referred as quality plan

7.2 Customer– related ProcessRequirements 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 Purchasing7.5 Production & service provision7.6 Control of monitoring and measuring devices

8.Measurement, Analysis & Improvement

8.1 GeneralThe organisation shall plan &

Implement the applicable methods, including statistical techniques and continually improve the effectiveness of the QMS.

8.2 Monitoring & Measurement8.2.1 Customer Satisfaction8.2.2Internal 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 customer.

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

8.5 Improvement – The Organisation shall continually improve 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 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)

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

Benefits on implementing QMS as per ISO standards

“Users” experience clearly indicates the several significant improvements in the following areas :

• Improved employee involvement (Avg gain 100%)• Improved House Keeping (Avg.gain 140%)• Improved 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 U