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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
A documented procedure is required
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
A documented procedure is required
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
A documented procedure is required
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
A documented procedure is required
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