9001:2008
stands for INTERNATIONAL ORGANIZATION for STANDARDIZARION. It is an organization base in Geneva, Switzerland.
PRODUCTIVITY BENEFITS
Increased productivity Less scrap and rework
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.
Ensure that the procedures are being followed in actual PRACTICE. Keep RECORDS, minutes of what you practice
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
CODE
4 5 6 7 8
Quality Management System Management Responsibility Resource Management Product and/or Service Realization Measurement, Analysis and Improvement
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
4.2
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
PROVIDE CUSTOMER SATISFACTION IN TERMS OF QUALITY EXCELLENCE, GLOBALLY COMPETITIVE COST AND JUST IN TIME DELIVERY.
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.
President
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 Control of documents 4.2.3 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
4.2.4
Records shall be
Identification and indexing storage and protection retention period and disposition
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 Quality Policy Appropriate for the purpose of the organization Shows commitment to meeting requirements and to continual improvement
5.3
Provides
5.4 5.4.1
framework for establishing/ reviewing quality objectives Is communicated and understood at all levels Reviewed and controlled Planning Quality Objectives Measurable Consistent with quality policy
5.4.2
the processes of the QMS the resources needed continual improvement of the QMS
5.5
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
5.6.1
Management Review
General Quality policy Quality Objectives Evaluate need for changes to the QMs
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
RESOURCE MANAGEMENT
6.1 Provision of Resources To implement and improve the processes To address customer satisfaction Human resources General Competent personnel assigned based on education, skills and experience
6.2 6.2.1
6.2.2
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 Work Environment human and physical factors of work environment
6.4
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
conducted prior to commitment to customer amendments to agreements with customer 7.2.3 Customer communication identify and implement arrangement for
communications
7.3
7.3.1
7.3.4
7.3.5
7.3.2 Design and development inputs 7.3.3 Design and development outputs approved prior to release Design and development review done at suitable stages to evaluate ability to meet requirements Design and development verification to ensure output meets design/ development inputs
7.3.6
to confirm that product meets requirements for intended use 7.3.7 Control of design & development changes
7.4 7.4.1
7.5 7.5.1
Purchasing 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 Production and Service Provision 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
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
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 and protection
7.6
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
8.2.3
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
8.3
8.4
8.5 8.5.1
8.3
recurrence
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
STEERING COMMITTEE