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ISO 9001 QMS LEAD AUDITER COURSE BASICS Prepared By . Nithin V Joseph

BASICS FOR ISO 9001 QMS LEAD AUDITOR COURSE

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Page 1: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

ISO 9001 QMS LEAD AUDITER COURSE BASICS

Prepared By .

Nithin V Joseph

Page 2: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

Deming cycle/shewart chart

Plan, Do, Check & Act

In 6sigma PDCA known as DMAIC

PDCA was made popular by Dr W. Edwards

Deming, who is considered by many to be the

father of modern quality control; however,

he always referred to it as the "Shewhart

cycle". Later in Deming's career, he modified

PDCA to "Plan, Do, Study, Act" (PDSA)

because he felt that "check" emphasized

inspection over analysis

Page 3: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

Establish the objectives and processes

necessary to deliver results in accordance

with the expected output (the target or

goals).

By establishing output expectations, the

completeness and accuracy of the spec is

also a part of the targeted improvement.

When possible start on a small scale to test

possible effects.

Page 4: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

Implement the plan.

execute the process.

make the product.

Collect data for charting and analysis in the

following "CHECK" and "ACT" steps.

Page 5: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

Study the actual results (measured and collected in "DO" above) and compare against the expected results (targets or goals from the "PLAN") to ascertain any differences

Look for deviation in implementation from the plan and also look for the appropriateness and completeness of the plan to enable the execution, i.e., “DO”

Charting data can make this much easier to see trends over several PDCA cycles and in order to convert the collected data into information. Information is what you need for the next step "ACT".

Page 6: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

Request corrective actions on significant differences between actual and planned results. Analyze the differences to determine their root causes.

Determine where to apply changes that will include improvement of the process or product.

When a pass through these four steps does not result in the need to improve, the scope to which PDCA is applied may be refined to plan and improve with more detail in the next iteration of the cycle, or attention needs to be placed in a different stage of the process.

Note: Some modern trainers now also refer to the "A" as "Adjust". This helps trainees to understand that the 4th step is more about adjusting/correcting the difference between the current state and the planned state instead of thinking that the "A" is all about action and implementation (which actually happens in the second ("D") stage).

Page 7: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

2. RELATIONSHIP B/W

QUALITY MANAGEMENT &

CUSTOMER

SATISFACTION

Page 8: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

2.1Customer Satisfaction

Customer satisfaction is a term frequently used in marketing.

It is a measure of how products and services supplied by a company meet or surpass customer expectation.

Customer satisfaction is defined as "the number of customers, or percentage of total customers, whose reported experience with a firm, its products, or its services (ratings) exceeds specified satisfaction goals.

Page 9: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

CUSTOMER SATISFACTION-

Why, How? Within organizations, customer

satisfaction ratings can have powerful effects. They focus employees on the importance of fulfilling customers' expectations. Furthermore, when these ratings dip, they warn of problems that can affect sales and profitability.

Therefore, it is essential for businesses to effectively manage customer satisfaction.

To be able do this, firms need reliable and representative measures of satisfaction.

Page 10: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

QUALITY MANAGEMENT

SYSTEM A collection of business processes

focused on achieving quality policy

and quality objectives to meet

customer requirements. It is

expressed as the organizational

structure, policies, procedures,

processes and resources needed to

implement quality management.

Page 11: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

Quality Management System

process

A QMS process is an element of an

organizational QMS.

The ISO9001:2000 standard requires

organizations

seeking compliance or certification to define the

processes which form the QMS and the

sequence and interaction of these processes.

Page 12: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

ISO 9000 & ISO 9001

ISO 9001 deals with the requirements thatorganizations wishing to meet the standardmust fulfil.

ISO 9000 family of quality managementsystems standards is designed to helporganizations ensure that they meet theneeds of customers and other stakeholderswhile meeting statutory and regulatoryrequirements related to a product. ISO 9000deals with the fundamentals of qualitymanagement systems, including the eightmanagement principles upon which the familyof standards is based

Page 13: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

Difference b/w ISO 9000 & ISO

9001 ISO 9000

ISO 9000 is a family ofstandards focused onquality management, puttogether through input from awide spectrum oforganisations and expertsboth in the public and privatesectors. The ISO 9000 suiteis intended to helporganisations, no matterwhat size or industry, tobecome better managed,more efficient and morecustomer-focused.

ISO 9000 is based aroundeight Quality ManagementPrinciples:

ISO 9001

ISO 9001 isthe only standard within theISO 9000 family that anorganisation can becomecertified against, because itis the standard thatdefines the requirementsof having a QualityManagement System.

Page 14: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

8 Quality Management

Principles

Page 15: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

8 Quality Management

Principles Customer focus

Leadership

Involvement of people

Process approach

System approach to management

Continual improvement

Factual approach to decision making

Mutually beneficial supplier

relationships

Page 16: BASICS  FOR ISO 9001 QMS LEAD AUDITOR COURSE

QUALITY MANAGEMENT

TERMS