9001 2008 Iso Orientation

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9001:2008

ISO AWARENESS


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ISO stands for INTERNATIONALORGANIZATION for STANDARDIZARION.It is an organization base in Geneva,

Switzerland.

This is a comprehensive set of standards andguidelines for Quality Systems.

It is system-based and not product-based.

This is a distillation of Quality System thathave been tried and proven by the industry.

What is ISO 9001:2008?


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MARKET PRESSURE Tangible proof that the quality management system established by ourorganization meets the requirements of and internationally recognized standard.

Provide marketing edge over competitors It enhanced customers satisfaction an loyalty; because it is assured that their

requirements are met. Increased competitiveness and profitability as quality products are being delivered

and operational cost are reduced.

INTERNAL EFFECTIVENESS ANDPRODUCTIVITY BENEFITS

Increased productivity Less scrap and rework

BENEFITS TO THE EMPLOYEE It will ensure that they will have the training that they needs and information to do

their task effectively. Better working conditions, increased job satisfaction. Stability of employment.

Why is certification needed?


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Once our system is developed and documented , allmembers of the organization should follow theprocedures or rules and make improvements to thesystem.

Document our work procedures / systems

What we do

Who does do it

When we do it

How we do it

Ensure that the procedures are being followed in actualPRACTICE.

Keep RECORDS, minutes of what you practice

What must we do?


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1.1 General

It specifies requirements for a QMS; it enhance customersatisfaction through the effective application of the system,including processes for continual improvement of the system

and the assurance of conformity to customer and applicablestatutory and regulatory requirements.

1.2 Application

All requirements of this standard are applicable to allorganizations, regardless of type, size and product provided.

2. Normative References

3. Terms and Definitions

INTERNATIONAL ORGANIZATION forSTANDARDIZATION


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CODE

4 Quality Management System

5 Management Responsibility

6 Resource Management

7 Product and/or Service Realization8 Measurement, Analysis and

Improvement

MAIN GROUPING OF QMS REQUIREMENTS


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4 QUALITY MANAGEMENT SYSTEM

4.1 General Requirements

The organization shall establish, document, implement, maintainand continually improve the QMS to meet therequirements of this standard.

Define:

Processes needed for the QMS Sequence and interaction of process

Criteria and method needed to ensure operation and

control

Availability of resources and information

Monitor, measure and analyze these process

Implement actions to achieve planned result

Continually improve these processes


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4.2 Documentat ion requirements

4.2.1 General

QMS include :

Quality Policy

Quality Objective

Quality Manual

Procedures required by the standard

Documents needed for effective

planning, operation and control ofprocess

Note: Manuals dif fer due to size of org anizat ion and

type of act iv i t ies, com plexi ty of process and interact ion,

and com petence of personnel


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SUNNELIT PHILIPPINES CORPORATION IS COMMITTED TO:

S SHOW OUR PRODUCTS SUCH AS HUBS ANDOTHER PARTS, PROUDLY TO OUR

COMPETITORSAND CUSTOMERS.

P PROVIDE CUSTOMER SATISFACTION INTERMS OF QUALITY EXCELLENCE,

GLOBALLY COMPETITIVE COST AND JUST INTIME DELIVERY.

C COOPERATE IN ENHANCING QUALITY,PRODUCTIVITY, AND COST SAVINGSCHEME FOR OUR CONTINUOUS ANDSUCCESSFUL EXISTENCE.

QUALITY POLICY

THIS QUALITY POLICY IS OUR BASIC STRATEGY TO ATTAIN OUR GOAL AND BASIS FOR ESTABL ISHING

AND REVIEWING TARGETS. THIS QUAL ITY POLICY SHALL B E REVIEWED FOR APPROPRIATENESS.

SUNNELIT PHILIPPINES CORPORATION

HIROSHI FUNAKOSHIPresident

Original duly signed


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4.2.2 Quality manual

The organization shall established, maintained and

controlled a Quality Manual which includes

Scope and exclusion justification

Procedures and reference Description of interaction between processes 4.2.3

Contro l of documents

Documented Procedure is required to define controls

to approval prior to issue

review, updated and re-approved as necessary

changes and current revision are identified

relevant version of applicable are available at points of use


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documents are legible and identifiable

documents of external origin are identifiable and controlled

obsolete document are kept for unintended use

4.2.4 Contr ol of qual i ty record s

A documented procedure is required

Records shall be

Legible

Identifiable

retrievable

Define controls for

Identification and indexing

storage and protection

retention period and disposition


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5 MANAGEMENT RESPONSIBILITY5.1 Management Comm itment

Communicate importance of meeting

- customer

- regulatory

- legal requirementsEstablish quality policy and quality objectivesConduct management reviews

Ensure availability of necessary resources

5.2 Customer Focu s

Determine customer needs and expectations

Needs and expectations converted to requirementsand fulfilled

5.3 Quality Polic y

Appropriate for the purpose of the organization

Shows commitment to meeting requirements and to

continual improvement


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Provides framework for establishing/ reviewing quality objectives

Is communicated and understood at all levels

Reviewed and controlled

5.4 Planning

5.4.1 Quality ObjectivesMeasurable

Consistent with quality policy

5.4.2 Quality management system planning

the processes of the QMS

the resources needed

continual improvement of the QMS

5.5 Responsibility, Authority and Communication

5.5.1 Responsibility and authority

define and communicate interrelation of functions, responsibilities andauthorities


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5.5.2 Management representative

Appointed by top management

ensures processes of QMS are established and maintained

reports on performance of QMS

promotes awareness of customer requirements

5.5.3 Internal communication

Appropriate communication process are established at various levels & functions

5.6 Management Review

5.6.1 General

Quality policy

Quality Objectives

Evaluate need for changes to the QMs


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5.6.2 Review inp ut

results of audit

Customers feedbacks

Process performance and product conformity

Status of preventive and corrective actionfollow-up action on previous management review

changes of the QMS

Recommendation for improvements

5.6.3 Review ou tpu t

Decision and actions for the improvement of theQMS

improvement of products related to customer

requirement

resources needed


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6 RESOURCE MANAGEMENT6.1 Provision of Resources

To implement and improve the processes

To address customer satisfaction

6.2 Human resources

6.2.1 General

Competent personnel assigned based on education, skills and experience

6.2.2 Competence, awareness and training

Identify competency needs

Provide training

Evaluate effectiveness of training

Maintain records

6.3 Infrastructure

work space and related facilities

equipment, hardware and software

supporting services

6.4 Work Environmenthuman and physical factors of work environment


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7 PRODUCT REALIZATION

7.1 Planning of product realization

consistent with other QMS requirements

7.2 Customer-related processes

7.2.1 Determination of requirements related

to the product

specified and implied requirements

regulatory and legal requirements

7.2.2 Review of requirements related to the product

conducted prior to commitment to customer

amendments to agreements with customer

7.2.3 Customer communication

identify and implement arrangement for communications

7.3 Design and Development

7.3.1 Design and development planning

plan and control design/development of product


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7.3.2 Design and development inputs7.3.3 Design and development outputs

approved prior to release

7.3.4 Design and development review

done at suitable stages to evaluate ability to meet

requirements

7.3.5 Design and development verification

to ensure output meets design/ development inputs

7.3.6 Design & development validation

to confirm that product meets requirements for

intended use

7.3.7 Control of design & development changes


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7.4 Purchasing7.4.1 Purchasing process

to ensure purchased product conforms to requirements

evaluate/ select suppliers

define criteria for selection and evaluation

7.4.2 Purchasing information

describe product to be purchased

requirements for approval7.4.3Verification of purchased product

7.5 Production and Service Provision

7.5.1 Control of production & service provision

availability of work instruction as necessary

information describing the characteristic of product

use suitable equipment

use of monitoring and measuring devices

implementation of release, delivery and post delivery activities


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7.5.2 Validation of processes for production &

service provision

control of special process, specified method and procedures

criteria review and approval approval of equipment and qualified personnel

information describing the characteristic of product

7.5.3 Identification and traceability

identify products and control unique identification


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7.5.4 Customer property

care of customer property while under organizations control

informed customer for lost and damages

7.5.5 Preservation of product

from internal processing to delivery

includes identification, handling, packaging, storage andprotection

7.6 Control of Monitoring and Measuring Devices

calibrated against known standards

calibrate at planned interval

protected from adjustments and damage


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8 MEASUREMENT, ANALYSIS AND IMPROVEMENT

8.1 General

Plan, define and implement measurement and

monitoring activities

Use of statistical techniques

8.2 Moni tor ing and Measurement

8.2.1 Customer Satisfact ionDetermine method on getting customer expectation and

information

8.2.2 Internal Aud it


conduct audit at plan interval

consider status and importance of process

consider criteria, scope, frequency, method

selection of auditor is impartial and objective shall not audit their

own work

Issue audit report

Undue delay on action

Follow up or verified action


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8.2.3 Monito r ing and Measuremen t of Process

measure and monitor processes to meet customer

requirements

monitor and measure achievement of plan result

when planned result are not achieve correction and corrective action

shall be taken

8.2.4 Moni tor ing and Measurement of Product

measure and monitor product characteristics

monitor at appropriate stages

delivery shall not proceed until planned arrangements have beensatisfactorily completed

maintain records


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8.3 Control of Nonconforming Product


Nonconforming product identified, segregated and controlled

Eliminate non conformance

Release by concession

take action to preclude its original intended use or application

8.4 Analysis of Data

customer satisfaction and/or dissatisfaction

conformance to customer requirements

characteristicsof processes, products and their trends

Suppliers

8.5 Improvement

8.5.1 Continual improvementimprove the effective QMS through audit result, management review, corrective andpreventive action, quality policy,and quality objective


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8.3 Control of Nonconforming Product

8.5.2 Corrective Action


review the nonconformities

eliminate cause of nonconformities to prevent recurrence

determine and implement action needed

record the result

review corrective action taken


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8.5.3 Preventive Action


review the nonconformities

eliminate cause of potential nonconformities to prevent occurrence

determine and implement action needed

record the result

review corrective action taken


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STEERING COMMITTEE

9001 2008 Iso Orientation

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