QMS ISO 9001 2008 Awareness Programme1

7/28/2019 QMS ISO 9001 2008 Awareness Programme1

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PTC Industries Limited

Presented on

13th July 2011



Quality

› Degree of expectations› Features

› Fulfil requirements

Management› Planning

› Organising

› Monitoring

System

› Standards

› Guidelines

› Facilities

Q

u a l i t y

M a n

a g e m

e n t

S

y s t e m



History Of ISO 9000 QMS Standards

In 1987, the Standard was produced in five parts:

ISO 9000 was a guide to the selection and use of theappropriate part of the ISO 9000 series of standards.

ISO 9004 was a guide to overall Quality Management andthe Quality System elements within the ISO 9000 series. It alsoprovided guidance in other areas, such as, marketing andquality costing.

ISO 9001 related to Quality System Requirements for design,development, production, installation, and servicing.

ISO 9002 related to Quality System Requirements for production, installation, and servicing, in other words, wherethe design is externally done or is static.

ISO 9003 specified the Quality System to be used for finalinspection and test.

The ISO 9000 series of standards were reissued in 1994 toinclude clarifications and again in 2000 to reflect a new

process approach and expand on the requirements andguidance.



ISO 9000:2005 QMS – Fundamentals and vocabulary

ISO 9001:2008 QMS – Requirements (Certification)

ISO 9004:2009 QMS – Guidelines for performanceimprovement

ISO19011:2002 QMS – Guidelines on Quality & environmental

auditing

Initially published in 1987 & was produced by ISO technical

Committee (TC176).

First revision done in 1994.

Second major revision done in Dec 2000.

Third technical revision done in Nov 2008 (Continued).





Establish the objectives and processes necessary to deliver results

in accordance with customer requirements and theorganization’s policies

Implement the processes

Monitor and measure processes and

product against policies , objectives and requirements

for the product and report the results

Take actions to continually improve

the process performance

“Plan”

“Check”

“Act”

“Do”



CustomersCustomers

CustomersCustomers

Management

responsibility

Measurement,

analysis and

improvement

Resource

management

Requirements

Satisfaction

ProductProduct

realization

Input Output

Continual improvement of the

quality management system

Continual improvement of the

quality management system

Key

Value-adding activities

Information flow

Figure 1 - Model of a process-based quality management system

© ISO 2000

5.0

6.0

7.0

8.0



PROCESS

Set of interrelated or interacting activities

which transforms input into outputs. PRODUCT

Defined as result of a Process.

REQUIREMENT

Need or Expectation that is stated, generallyimplied or obligatory.

CAPABILITYAbility of an organisation, system or process

to relize a product that fulfil the

requirement



COMPETENCE

Demonstrated ability to apply knowledge

and skills.QUALITY POLICY

Overall intentions and direction of an

organisation related to quality.QUALITY OBJECTIVE

(Process effectiveness criteria)

Something sought, or aimed for related toquality. Quality objective are generally

specified for related functions and level inthe organisation.



QUALITY CONTROL

QC is the part of quality management focused on

fulfilling the requirement.QUALITY ASSURANCE

QA is the part of quality management focused on

providing the confidence that quality requirements

will be fulfilled.

QUALITY IMPROVEMENT

This is a part of QM focused on increasing the ability to

fulfil quality requirements.CONTINUAL IMPROVEMENT

Recurring activity to increase the ability to fulfil

requirements



EFFECTIVENESS

Extent to which planned activities are realized and

planned results achieved.

EFFICIENCY

Relationship between the result achieved and the

resources used.

ORGANISATIONThis is the group of people and facilities with an

arrangement of responsibilities, authorities and

relationship.

CONFORMITY

Fulfilment of a requirement.

NON CONFORMITY

Non-fulfilment of a requirement.



QUALITY PLAN

Document specifying which procedure andassociated resources shall be applied by whom and

when to a specific project, process or contract.

DOCUMENTInformation and its supporting medium (i.e. records,

specifications, procedures, drawings, reports,

standards.

RECORDDocument stating results achieved or providing

evidence of activities performed.



1. Customer Focus2. Leadership

3. Involvement of People

4. Process Approach5. System Approach

6. Continual Improvement

7. Factual Approach to Decision Making8. Mutually Beneficial Supplier Relationship



Principle 1

Determine customer

needs & expectations

Meet Customer Requirements

Strive to exceed

Customer Requirements



Leaders establish unity of

purpose, direction and

internal environment inwhich people become fully

involved in achieving the

organizations objectives.

Principle 2



People at all levels are

the essence of an

organization and their full involvements

enables their abilities

to be used for the

organization’s benefits Principle 3



A desired result is more efficiently achieved when

resources and activities are managed as a process.

Principle 4

The application of a system of processes within an

organization , together with the identification andInteractions of these processes , and their management to produce the desired outcome canbe referred as Process Approach

Process : Transformation of Input into out put

Input Process Output



INPUT OUTPUT PRODUCT

(RESULT OF A PROCESS)NCLUDE RESOURCES

ONITORING & MEASUREMENT OPPORTUNITIES

(BEFORE,DURING & AFTER THE PROCESS)

UNDERSTANDING THE PROCESS APPROACH

SCHEMATIC REPRESENTATION OF A PROCESS

PROCEDURE

"SPECIFIED WAY TO CARRY OUT AN ACTIVITY OR A

PROCESS"-MAY BE DOCUMENTED OR NOT)

PROCESS

("SET OF INTERRELATED OR INTERACTING

ACTIVITIES")

EFFECTIVENESS OF

PROCESS= ability to

achieve desired

res ults (Focus of

ISO9001:2008)

EFFICIENCY OF

PROCESS= Results

achieved vs reources

used



Identifying, understanding and managing a

system of interrelated processes for a given

objective contributes to effectiveness and

efficiency.

Principle 5







Mutual beneficial

relationships between an

organization and its

suppliers enhance the ability

of both organizations to

create value.

Principle 8



1. Quality service2. Increased

confidence inservice

3. Less number ofnon-compliance's.4. Improved

supply/Consistentquality

5. Helps in planning

activity6. Competitivepricing/lead timereduction

Customers –

Stake Holder

Company Employees

1. Customer/Marketshare

2. IncreasedCustomerSatisfaction

3. Consistency inOutput

4. Assured Reducednumber ofdefects

5. Reduction in costs

due to reductionof defects

6. Involvement ofpersonnel andconsequent higherproductivity

1. Defineddirections

2. Improvedperformance

3. Better andimproved relation.

4. Increasesmotivation

5. Job satisfaction6. Involvement

7. Pride of workingin an ISO 9000company





The Organization must:

a) Determine the process needed for QMS and their application

throughout the organization.

b) Determine the sequence and interaction of these processes.

c) Determine criteria and method needed to ensure that both the

operation and control of these processes are effective.d) Ensure the availability of resources and information necessary to

support the operation and monitoring of these processes.

e) Monitor , measure where applicable and analyze these

processes.

f) Implement actions necessary to achieve planned results andcontinual improvement of these processes.

Any process outsourced , must be controlled and defined within

the QMS





Six controlled documented procedure are

mandatory for QMS

1. Control of documents (4.2.3)

2. Control of records (4.2.4)

3. Internal audit (8.2.2)

4. Control of nonconforming product (8.3)

5. Corrective action (8.5.2)6. Preventive action (8.5.3)



Quality manual must Includes:

1. The scope of the QMS

including details and

justification of anyexclusions.

2. The documented

procedures established for

QMS or reference to them3. A description of the

interaction between the

processes



Documents required by the QMS must be controlled.

The procedure must be documented which must definecontrols needed.

• To approve documents for adequacy prior to issue.

• To review and update as necessary and re-approve documents.

• To ensure that changes and the current revision status of documents are identified.

• To ensure that documents remain legible and readilyavailable.

• To ensure that relevant versions of applicable documents

are available at points of use.• To ensure that documents of external origin are identified

and their distribution is controlled.

• To prevent the unintended use of obsolete documents andapply suitable identification to them .



Records established to provide evidence of conformity & of

effective operation of QMS shall be controlled. The organization shall establish a documented procedure

to define the controls needed for the

Identification

Storage Protection

Retrieval

Retention

Disposition of Records

Records must be

legible, identifiable

& retrievable



5.1 Management CommitmentTop management must provide evidence of its

commitment to the development and implementation of

the QMS and continually improving its effectiveness by

Communicating to organization the importance of meeting customer as well as statutory and regulatory

requirements.

Establishing the Quality policy

Ensuring that Quality Objectives are established Conducting management reviews

Ensuring the availability of resources.







We are continually striving to identify new

growing markets and products.We are committed to manufacture and supply

castings as per the requirement of the

Customers.

Customer satisfaction is the key word and our

aim is to become a reliable supplier.

We shall continually strive for improvement of

its performance by implementing

Quality management System.





5.5.1 Responsibility and Authority

Top management must ensure that responsibilities &

authorities are well defined and communicated withinorganization.

5.5.2 Management Representative

Top management must appoint a member of organization’s

management with following responsibilities.• As Management Representative primarily provide the feedback to

top management on the effectiveness of the QMS.

• Ensuring the process needed for the QMS is establishedimplemented and maintained.

• Ensuring the promotion of awareness of customer requirementsthroughout the organization.

5.5.3 Internal CommunicationTop management must ensure that appropriate communicationprocesses are established within the organization.



Top management must review organization’s QMS at

planned intervals, to ensure its continuing suitability,

adequacy & effectiveness. This review shall include

assessing opportunities for improvement and the need for

changes to QMS.

Management

Review



6.1 Provision of Resources

The organization must determine and provide the

resources needed to : To implement and maintain QMS and to

continually improve its effectiveness.

To enhance customer satisfaction by meetingcustomer requirements.



6.2 Human Resources

6.2.1 General

Personnel performing work effecting conformity to productrequirements must be competent on the basis of appropriate education, training, skills and experience.

6.2.2 Competence, Training and Awareness

The organization must Determine the necessary competence

for personnel performing work effectingconformity to product requirements

Where applicable provide training.

Evaluate effectiveness of action taken.

Ensure its personnel awareness abouttheir activities and their contribution.

maintain appropriate records.



The organization must provide and maintain infrastructure

which includes : Building, workspace and other utilities.

Process equipment

Supporting devices (transport, communication system).

6.4 Work Environment

The organization must determine and manage the work

environment needed to achieve conformity to productrequirements.

Best practice : 5s approach









Determine & implement effective arrangements

for communicating about :

Product information. Enquiry, contract/order handling including

amendments.

Customer feedback & customer complaints.

7.2.3 Customer Communication





Organization must determine & record the inputs related toproduct requirements.

Functional & performance requirements

Applicable statutory & regulatory requirements

Information derived from previous similar design(whererequired).

Other requirements necessary for design & development.

7.3.3 Design & Development Outputs

Meets the input requirements.

Provide appropriate information's for purchasing , production& services provision.

Contain or reference product acceptance criteria.

Specify the characteristics of product that are essential for

its safe & proper use.



At suitable stages, systematic reviews of design anddevelopment shall be performed in accordance with planned

arrangements: To evaluate the ability of the results of design and

development to meet requirements; and

To identify any problems and propose necessary actions.

Participants in such reviews shall include representatives of

functions concerned with the design and development stage(s)being reviewed. Records of the results of the reviews and anynecessary actions shall be maintained.

Plan & perform design & development verification

To ensure design & development output meets the input

requirements

Maintain the records of verification & subsequent action47



Plan & perform design & development validation to ensure

Resulting product is capable of meeting the requirements for application

or intended use where known

Whenever practicable, complete validation before delivery or

implementation of product

Prepare & maintain records of validation & subsequent actions

7.3.7 Control of Design & Development Changes

Identify & maintain records of design & development changes

Review, verify , validate & approve changes before implementation

Evaluate the effects of changes on

Constituent parts

Already delivered product

Prepare & maintain records of review of changes & subsequent actions



Organization must ensure purchased product conforms to ownspecified purchase requirements.

Establish criteria for selection , evaluation, & re evaluation of suppliers.

Evaluate & select suppliers based on their ability to meet the

requirements. Maintain records of suppliers evaluation & actions arising from

evaluation.

Process of supplier evaluation may include :

Evaluation of relevant experience in the field.

Monitoring & review of purchased product quality, Price, deliveryperformance & response to problem etc.

Performance of supplier against competitors.

Audit of supplier management system.





Organization must plan and carry out production & serviceprovisions under controlled conditions which include, as

applicable :

Availability of information that describes product

characteristics. Availability of work instructions, as necessary.

Use of suitable equipment.

Availability & use of monitoring & measuring devices.

Implementation of monitoring & measurement.

Implementation of release , delivery & post –delivery

activities.





Organization must identify the product by suitable

means throughout the product realization.

Organization must identify the product status with

respect to inspection & testing. Where traceability is a requirement , the

organization must control & record the unique

identification of the product.



Exercise care for customer property.

Identify ,verify , protect & safeguard.

Record & report the details in the

event of loss; damage & any other

unsuitability.

Customer property can include

intellectual property and personal

data.

Ensure product conformity is preserved during internalprocessing, delivery to the intended destination.

This include identification ; handling ; packaging ; storage ;protection.



Organization must determine :

The monitoring & measurement to be undertaken

Monitoring & measuring devices needed to provide evidence of

conformity of product

Establish processes to ensure that monitoring & measurement can be

carried out and are inconsistent with the requirements.

Where necessary measuring equipment be

Calibrated or verified at specified interval or prior to use with a referencetraceable to national/international standards.

Where no such standard exists, basis used for calibration or verification

must be documented.

Adjust or re-adjusted as necessary

Identified to enable calibration status

Protected from damage & deterioration during handling, maintenance &

storage





Organization must monitor information relating to customer perception.

Monitoring customer perception includes:

Quality performance of delivered parts.

User opinion surveys, Lost business analysis.

Delivery performance (including premium freight paid).

Customer notifications related to issues of quality & delivery.

Monitor manufacturing process performance to demonstrate

compliance to customer requirements related to

Product quality

Process efficiency



Conduct internal audit at planned intervals to determinewhether QMS conforms:

To planned arrangements

Requirements of this standard and QMS established by theorganization.

Has been effectively implemented and maintained.

Plan the audit programmed considering.

Status & importance of the processes and area being audited.

Results of previous audits.

Must have a documented procedure to define responsibilityand requirements for planning and conducting audits.

Management must ensure.

Proper corrections and corrective actions have been takenwithout delay.

Follow-up for verifications have been done.



8 2 3 Monitoring & Measurement of Processes



8.2.3 Monitoring & Measurement of Processes

Apply suitable method for monitoring & where applicable for

measurement of QMS processes.

To demonstrate ability of processes to achieve planned results. If planned results not achieve correction & corrective action must

be taken as appropriate to ensure conformity of product.

Monitor & measure product appropriate stages of product

realization processes.

Maintain evidence of conformity with acceptance criteria.

Product or service not released until all monitoring/measurement

completed unless otherwise approved by a relevant authority &where applicable by the customer.

Maintain records to indicate person(s) authorizing release of

product.



Organization must establish documented procedure to

identify & control non-conforming product. Organization must define the responsibilities & authorities for

dealing with non-conforming product.

Taking actions to eliminate the detected non –conformity.

Authorizing its use , release or acceptance under concession. Taking action to preclude its original intended use or

application.

Taking actions appropriate to the effects when nonconforming

product is detected after delivery or use has started. Maintain records of nature of non-conformities & subsequent

actions taken.

Perform re-verification on reworked product.



Determine ,collect and analyze data to

Demonstrate suitability & effectiveness of QMS

Identify areas of continual improvement

This include data generated as result on Monitoring andmeasurement and from other relevant sources.

Analysis of data shall provide information relating to

Customer satisfaction Conformity to product requirements

Characteristics & trends of processes & products

Suppliers



Continually improve the effectiveness of QMS

Facilitate continual improvement through use of

Quality policy

Quality objectives

Audit results

Analysis of data

Corrective & preventive action & Management review



8 5 3 Preventive Action



8.5.3 Preventive Action

The organization must determine action to eliminate the

causes of potential non conformities in order to prevent their

OCCURRENCE.

Documented procedure must be established to

Identify potential non-conformities & their causes

Evaluate the need for action to prevent occurrence

Determine & implementing the actions needed

Records the results of action taken Review effectiveness of preventive action taken











Strong Evidence of demonstrating conformity to clause.

Important management tool to continual improvement

Important input to management review.

Helps in assessing performance.

Richer in content since focused on company specific

needs Helps in assuring involvement of people.

Hierarchy

Lack of transparency

Egos

Auditor gets a limited view





Phasesof

Auditing

1.AuditPlanning

2. AuditPreparation

3. AuditPerformance &Review

4. AuditReporting

5. AuditFollow-up



This Includes Identifying objectives

Defining scope & criteria

Defining Frequency Setting Time Frame

Provision of adequate resources

Provision for monitoring & review

A di l



Audit plan covers:

Audit Objectives Criteria

Scope (functional units, processes & requirements)

Dates & places

Time & duration

Audit team members

Identify auditee representative

Language

Logistics arrangement



Conducting document reviewRelevant QMS documentation reviewed to assess conformity with

applicable audit criteria/ standard’s requirements.

Preparation of working documentsAuditor to review information relevant to their assignment.Prepare the following documents :

Checklists, Sampling plan, forms for recording information i.e.evidences verified, audit finding. Records of meeting etc.

ChecklistIt can be standard/specific to work procedure

Benefits of checklist are as belowAct as working document for reference.No activity/process escapes the auditPuts auditor on right trackAct as record





Methods & sources of information1. Interviews

2. Observation of activities

3. Review the documents and /or records

4. Machines (Identification, capability, maintenance)

5. Material (Identification, specification, storage)6. Method (Appropriate, adequate, current)

7. Documents (Policy, objective, plans, procedures,instructions, specifications, drawings, orders)

8. Records (Inspection, MOM, register, audit reports)9. Data summaries & performance indicators

10. Reports from other sources(customer feedback &supplier rating)



WHO - Responsibilities

WHAT - Information WHY - Understanding

WHERE - Locations

WHEN - Sequence

HOW - Process Show me - Collect Evidence

What if - Testing the system

Always ask questions

Efficient Open Ended

Elicit maxinformation

Avoid asking questions Inefficient

Closed Ended

Leading

Example Question

Do you record the complaint in the register? (Closed ended)

How do you record the complaint (Open ended)



What Evidence ?

Documents Records

Interviews

Facts witnessed

(Physical presence)

Why Examine ?

Availability

Accuracy of data

Completeness of information

Designated authorization

Data generation time & data



Evaluate audit evidence against audit criteria

Review checklists hand written notes etc

Generate audit finding

Audit finding to be reviewed

Audit finding may be :

A conformity

A non ConformityAn opportunity for improvement



NC are normally classified in to following groups

Major

A significant NC with a QMS requirementOR

A failure of or complete omission of a QMS requirement

ORA significant number of minor NCs concerning the sameQMS requirement

Minor

An isolated incident of a failure to comply with aprocedure or QMS requirement

Observation

A statement of facts made during the audit and

substantiated by objective evidence



Preferably , the audit report contains followinginformation (ISO 19011 guidelines)

Audit objectives Audit scope (Organization & functional units or processes)

Names of auditors & auditees

Audit date & Place

Audit Criteria (Ref of standard/document/procedure/WI) Audit Finding (Conformities, non-conformities)

Audit conclusion

Summary of audit process including obstacles encountered

Area not covered although within audit scope

Unresolved diverging opinions between auditor & auditee

Recommendation for improvements

Agreed follow-up action plan

Distribution list for audit report



Auditor Auditee

Non-Conformity Raised Understand it

Assign Responsibility

Analyze

Close Out Determine Root Cause

Verify Effectiveness Propose Corrective Action

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