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BS:
BS/EN/ISO 9001 BS/EN/ISO 9002 BS/EN/ISO 9003
5750(PT I-II-III)
IS/ISO IS/ISO IS/ISO 9001 9002 9003
1987
Amalgamation of BS 5750 with international standards organization 9000 series and European Norm 29000 series
1994
issue of BS EN ISO 9000 series- which has discarded the title BS 5750
QUALITY OF PRODUCT
Quality of Inspection
ISO 14000 COMPATIBILITY PROCESS MODEL TAILORING CONTINUAL IMPROVEMENT EASY TO UNDERSTAND SUITABLE FOR ALL
MANAGEMENT RESPONSIBILITY
Resource MANAGEMENT
INPUT
PRODUCT REALIZATIONt
Product
2000 FAMILY
ISO 9000: ISO 9001: FUNDEMENTALS AND VOCABULARY REQUIREMENTS
ISO 9004: GUIDELINES FOR PERFORMANCE IMPROVEMENTS ISO 19011: GUIDELINES FOR AUDITING MANAGEMENT SYSTEMS
QUALITY
Requirement
need or expectation that is stated, generally implied or obligatory
Continual Improvement
Achieve Objectives Plan
Quality management system: support to achieve the objectives
Act Do Check
Moving Target
2000
Customer Organization Supplier
ISO 9004 :
THE CHANGES-GENERAL
ISO 9001 : 1994 20 elements
ISO 9001: 2000 Quality Management System(4) Management Responsibility(5) Resource Management(6) Product Realization(7) Measurement,Analysis&Improvement(8)
INTRODUCTORY SECTIONS
1. Scope
2. Normative Reference 3. Terms & Definitions
CONTINUAL IMPROVEMENT
Defining , Measuring & Analyzing existing situation Establishing objectives for improvement Searching for possible solutions Evaluating solutions Implementing selected solution Measuring, verifying,analyzing results of implementation
Approve,Review & Update Identify Changes & Current Revision Status Ensure availability Legible,Identifiable Control External Documents Control Obsolete Documents
Communication Importance of Meeting Requirements Establishing Quality Policy & Objectives Conducting Management Reviews Providing Necessary Resources
5.2.CUSTOMER FOCUS
Aim : to enhance customer satisfaction
ensure customer requirements are Determined and Fulfilled
5.3.QUALITY POLICY
Appropriate to purpose of organization Commitment to comply with requirements Commitment to continually improve effectiveness Framework for setting and reviewing quality objectives Communicated and understood Reviewed for continuing suitability
5.4.PLANNING
5.4.1-Quality Objectives (must be SMART)
5.4.PLANNING
5.4.2-Quality Management System Planning
Requirements of 4.1 (QMS General) Quality Objectives Integrity maintained during changes
Processes Established,Implemented & Maintained Report on Performance Report on Need for Improvement Ensuring Awareness of Customer Requirements
5.6.MANAGEMENT REVIEW
5.6.1-General
Planned intervals Suitability , Adequacy , Effectiveness Opportunities for improvement Need for changes to QMS , Policy , Objectives Records
5.6.MANAGEMENT REVIEW
5.6.2-Review input
Audit results Customer feedback Process performance Product conformance Preventive/Corrective actions Actions from previous reviews Changing circumstances Recommendations for improvements
5.6.MANAGEMENT REVIEW
5.5.3-Review Output
6.1.PROVISION OF RESOURCES
Derermine & Provide to Implement &Mahntain QMS Continually Improve Effectiveness Enhance Customer Satisfaction
6.2.HUMAN RESOURCES
6.2.1-General Competent on the basis of:
6.2.HUMAN RESOURCES
6.2.2-Competence,Awareness and Training
Determine necessary competence Satisfy needs(training or other actions) Evaluate effectiveness of action Awareness of relevance/importance of activities Records
6.3.INFRASTRUCTURE
Determine , Provide & Maintain
6.4.WORK ENVIRONMENT
Determine & Mange to Achieve Conformity to Product Requirement
Specified by customer Necessary for specified , known , intended use Statutory/Regulatory Additional
NO SIGNIFICANT CHANGE
7.4.PURCHASING
7.4.1-Purchasing Process 7.4.2-Purchasing Information 7.4.3-Verification of Purchased Product
Controlled Conditions Information Work Instruction Suitable Equipment Availability & use of monitoring& Measuring Devices Implement Monitoring &Measurement Activities Release,Delivery&post Delivery Activities
Plan Implement
Monitoring,Measurement,Analysis & Improvement Processes
Conformity of Product Conformity of QMS Conformity Improve Effectiveness of QMS
8.2.1-CUSTOMER SATISFACTION
Monitor Information Customer Perception Determine Methods
Proactive not Reactive
8.2.2-INTERNAL AUDIT
Planned intervals Determine QMS Conforms to
Planned arrangements
ISO 9001
Organization requirements
8.3.CONTROL OF NONCONFORMITY
Identified and Controlled Prevent Unintended use or Delivery Corrected and re-verified
8.4.ANALYSIS OF DATA
Suitability & Effectiveness of QMS plus Continual Improvement Opportunities Customer Satisfaction Conformance to Product Requirement Characteristics for Preventive Action Opportunities for Preventive Action Suppliers
8.5.IMPROVEMENT
8.5.1-Continual Improvement Continually improve effectiveness of QMS using:
Quality Policy Quality Objectives Audit Results Analysis of Data Corrective/Preventive Action Management Review
8.5.IMPROVEMENT
8.5.2-Corrective Action
Review(Inc Complaints) Determine Cause Evaluate Need for Action Determine & Implement Action Record Results Review
8.5.IMPROVEMENT
8.5.3-Preventive Action
Determine Cause Evaluate Need for Action Determine & Implement Action Record Results Review
IMPLEMENTION STRATEGY