9001 2008 ISO ORIENTATION

ISO AWARENESS : 

9001:2008 ISO AWARENESS

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ISO stands for “INTERNATIONAL ORGANIZATION for STANDARDIZARION”. It is an organization base in Geneva, Switzerland. This is a comprehensive set of standards and guidelines for Quality Systems. It is system-based and not product-based. This is a distillation of Quality System that have been tried and proven by the industry. What is ISO 9001:2008?

Why is certification needed? : 

MARKET PRESSURE Tangible proof that the quality management system established by our organization meets the requirements of and internationally recognized standard. Provide marketing edge over competitors It enhanced customer’s 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 AND PRODUCTIVITY 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?

What must we do? : 

Once our system is developed and documented , all members of the organization should follow the procedures or rules and make improvements to the system. 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 actual PRACTICE. Keep RECORDS, minutes of what you practice What must we do?

INTERNATIONAL ORGANIZATION for STANDARDIZATION : 

1.1 General It specifies requirements for a QMS; it enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. 1.2 Application All requirements of this standard are applicable to all organizations, regardless of type, size and product provided. 2. Normative References 3. Terms and Definitions INTERNATIONAL ORGANIZATION for STANDARDIZATION

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CODE 4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product and/or Service Realization 8 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, maintain and continually improve the QMS to meet the requirements 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 Documentation 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 of process Note: Manuals differ due to size of organization and type of activities, complexity of process and interaction, and competence of personnel

QUALITY POLICY : 

SUNNELIT PHILIPPINES CORPORATION IS COMMITTED TO: S SHOW OUR PRODUCTS SUCH AS HUBS AND OTHER PARTS, PROUDLY TO OUR COMPETITORS AND CUSTOMERS. P PROVIDE CUSTOMER SATISFACTION IN TERMS OF QUALITY EXCELLENCE, GLOBALLY COMPETITIVE COST AND JUST IN TIME DELIVERY. C COOPERATE IN ENHANCING QUALITY, PRODUCTIVITY, AND COST SAVING SCHEME FOR OUR CONTINUOUS AND SUCCESSFUL EXISTENCE. QUALITY POLICY THIS QUALITY POLICY IS OUR BASIC STRATEGY TO ATTAIN OUR GOAL AND BASIS FOR ESTABLISHING AND REVIEWING TARGETS. THIS QUALITY POLICY SHALL BE REVIEWED FOR APPROPRIATENESS. SUNNELIT PHILIPPINES CORPORATION 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 Control 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 Control of quality records 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 RESPONSIBILITY 5.1 Management Commitment Communicate importance of meeting - customer - regulatory - legal requirements Establish quality policy and quality objectives Conduct management reviews Ensure availability of necessary resources 5.2 Customer Focus Determine customer needs and expectations Needs and expectations converted to requirements and fulfilled 5.3 Quality Policy 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 Objectives Measurable 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 and authorities

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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 input results of audit Customers feedbacks Process performance and product conformity Status of preventive and corrective action follow-up action on previous management review changes of the QMS Recommendation for improvements 5.6.3 Review output Decision and actions for the improvement of the QMS improvement of products related to customer requirement resources needed

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6 RESOURCE MANAGEMENT 6.1 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 Environment human 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 inputs 7.3.3 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 Purchasing 7.4.1 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 approval 7.4.3Verification 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 organization’s control informed customer for lost and damages 7.5.5 Preservation of product from internal processing to delivery includes identification, handling, packaging, storage and protection 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 Monitoring and Measurement 8.2.1 Customer Satisfaction Determine method on getting customer expectation and information 8.2.2 Internal Audit 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 Monitoring and Measurement 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 Monitoring and Measurement of Product measure and monitor product characteristics monitor at appropriate stages delivery shall not proceed until planned arrangements have been satisfactorily 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 characteristics of processes, products and their trends Suppliers 8.5 Improvement 8.5.1 Continual improvement improve the effective QMS through audit result, management review, corrective and preventive 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

Importance of ISO : 

If SUNNELIT PHILIPPINES CORPORATION is already “ ISO CERTIFIED”, this will widen the capability of SUNNELIT PHILIPPINES CORPORATION to compete in the “WORLD MARKET” and this will ensure that all the requirements for “EXPORT” will be maintained. Importance of ISO

ISO 9000 – What are its Origins?EVOLUTION OF ISO 9001 : 2000 : 

ISO 9000 – What are its Origins?EVOLUTION OF ISO 9001 : 2000 International Organization for Standardization (ISO) ISO 9000 First Published in 1987 Headquartered in Geneva Switzerland 90 Member Countries (ISO technical Committee 176) BS 5750 ANSI Q90~94 USA (ANSI) United Kingdom (BSI) Sweden (SIS) Germany (DIN) France (AFNOR) China (SACS) Malaysia (DSM) Other member body (country Standard National Body) BS 5750 Quality Management System 1972 BS 4891 Guide for Quality Assurance Published in Europe as NATO AQAP SERIES 1960s US Military Standards

STEERING COMMITTEE : 

STEERING COMMITTEE

What is ISO 9000? : 

Under ISO 9001:1994, there are three types of system: ISO 9001 – Model of Quality Assurance in design, development , production, installation and servicing. ISO 9002 – model for Quality Assurance in production, installation, and servicing. ISO 9003 – Model for Quality Assurance in final Inspection and Test. 9000 is the number of the document issued in 1987 which discussed this set of standards. Any Company or organization may apply for certification under one of the above models. For the ISO 9001:2000 there is only one model but companies may excluded from clause (7) What is ISO 9000?

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM : 

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM CUSTOMERS Management Responsibility Product Realization Measurement, analysis and improvement Resource Management Satisfaction Requirements Output CUSTOMERS