Quality Management System Understanding our QMS for the achievement of organization and business success.
Objectives of the Orientation To learn the benefits of implementing the requirements of the quality management system The effect of not following the requirements.
Course Outline What is ISO and Quality Management System Clauses and Benefits of ISO 9001:2008
ISO 9001:2008 So what about it? ISO 9001 is a standard for QUALITY MANAGEMENT SYSTEM
ISO 9001:2008 Quality Management Systems - a web of interconnected processes that are used to manage a business.
International Organization for Standardization ISO is not an acronym for International Organization for Standardization What isISO? The organization’s short name was taken from the Greek word “isos”, meaning “equal”.
1. CUSTOMER FOCUS 2. LEADERSHIP ISO 9001 3. INVOLVEMENT OF PEOPLE 4. PROCESS APPROACH 5. SYSTEM APPROACH 6. CONTINUAL IMPROVEMENT 7. FACTUAL APPROACH 8. MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS 8 MANAGEMENT PRINCIPLES
THE Process Based Approach When ISO updated the 9000 series from 1994 to 2000 they decided to focus on a process approach to the QMS versus the old functional approach. All work is a process. This means that in everything we do there are inputs and outputs, suppliers and customers, and means to get the work done.
The Customer-Supplier Chain Work team Output Input Customer Requirements Customer Feedback
Elements of a Typical Quality Management System Manual
4 Quality Management System 4.1 General Requirements 4.2 Documentation Requirements 1 1.1 General 1.2 Application Scope 2 Normative Reference 3 Terms and Definitions Contents
Contents (cont.) 5 5.1 Management Commitment 5.2 Customer focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, authority and communication 5.6 Management Review Management Responsibility 6 6.1 Provision of resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment Resource Management
7 7.1 Planning of product realization 7.2 Customer-related processes 7.3 Design and development 7.4 Purchasing 7.5 Production and service provision 7.6 Control of monitoring and measuring devices Measurement, Analysis and Improvement Product Realization Contents (cont.) 8 8.1 General 8.2 Monitoring and measurement 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement
Section 1: Scope Includes the design and construction of cleanroom, ventilation and air conditioning system, metal finishing system, environmental control system for automotive and other industrial or commercial applications. Exclusion
Design and development validation …
Section 2: Normative References ISO 9000:2005 ISO 9001: 2008 QMS ISO 9001:2000 QMS ISO 9002:1994
ISO 9002:1994 4.11 Control of inspection, measuring and test equipment 4.12 Inspection and test status 4.13 Control of nonconforming product 4.14 Corrective and preventive action 4.15 Handling, storage, packaging, preservation and delivery 4.16 Control of quality records 4.17 Internal quality audits 4.18 Training 4.19 Servicing 4.20 Statistical techniques 1. Scope 2. Normative Reference 3. Definitions 4.1 Management responsibility 4.1.1 Quality Policy 4.1.2 Organization 126.96.36.199 Responsibility and authority 188.8.131.52 Resources 184.108.40.206 Management representative 4.1.3 Management review 4.2 Quality System 4.2.1 general 4.2.2 quality system procedures 4.2.3 quality planning 4.3 contract review 4.4 design control 4.5 document and data control 4.6 purchasing 4.7 control of customer-supplied product 4.8 product identification and traceability 4.9 process control 4.10 inspection and testing Section 2: Normative References ISO 9001:2000 Elements 1. Scope 2. Normative Reference 3. Terms and Definitions 4. Quality Management System 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis and Improvement
Section 3: Terms and Definition Definitions Terms used by an organization:
Section 4: General requirements Processes, interaction, improvement The focus is on looking at:
Section 4: General requirements Documentation requirements
Control of document
Documents must show a control number, adoption and revision dates, in order to ensure use of the most recent information.
Control of records
Each record must be controlled in order to ensure uniform quality.
22 Section 4: General requirements LEVEL 1 - QUALITY MANUAL Quality Policy Quality Objectives Requirement Standard Other Statutory and Regulatory Requirements
Section 4: General requirements Documentation requirements
The quality manual describes our intent to establish a quality management system with an emphasis on continual improvement.
Section 4: General requirements Quality Policy The staff and management of ___ are committed to consistent provision of quality products and services that will satisfy the demands and expectations of customers by continual improvement of the QMS and conforming to local standards and prevailing codes of practice.
Section 4: General requirements Current Objectives Maintain good business relationship with the clients. Deliver quality products and services to the satisfaction of the clients Effect efficiency in operations by continual improvement of the Quality Management System. Improve employee’s competence through periodic evaluation and development of skills, knowledge and abilities by providing appropriate training. For revision
LEVEL 2 - QUALITY PROCEDURES Control of Documents Control of Records Internal Quality Audits Control of Non-conforming Products Corrective Action Preventive Action 26 Section 4: General requirements
27 Section 4: General requirements LEVEL 3 - QUALITY PLAN Incoming Inspection Plan In-Process Inspection Plan Final Test Report/ Inspection Plan Work Instruction
28 Section 4: General requirements LEVEL 4 - FORMS / FORMATS/RECORDS Testing Report forms Commissioning Report Forms Inspection forms Check Sheets/Check List Miscellaneous Documentation Forms
23 MANDATORY RECORDS Management Review Competence, Training and Awareness Planning and Production Review of Requirement Related to Product Design and Development Input 29 Section 4: General requirements
30 Section 4: General requirements 23 MANDATORY RECORDS (cont’n) Design and Development Output Design and Development Review Design and Development Verification Design and Development Validation Control of Design and Development Changes
31 Section 4: General requirements 23 MANDATORY RECORDS (cont’n) Purchasing Process Availability of Monitoring and Measuring Equipment Preservation of Product Customer Property Control of Monitoring and Measuring Equipment Standards used for Calibrating Monitoring and Measuring Equipment
32 Section 4: General requirements 23 MANDATORY RECORDS (cont’n) Identify and Enable Calibration Result of Calibration and Verification Internal Audit Monitoring and Measurement of Product Control of Non-conforming Product Corrective Action Preventive Action
Summary of Section 8 Measurement, Analysis and Improvement Perform remedial processes Monitor and measure quality Control nonconforming products Analyze quality information Make quality improvements This corresponds to:
What do you do when accepting a task?(Answerable by Yes or No) Before accepting an assignment, do you make sure you understand completely what you are supposed to do? Are the deadlines clear? Is it clear how much responsibility and authority you have in the project? Do you know which tasks you can perform on your own. Without reporting back to your boss? Do you let your boss know if a new assignment makes it difficult for you to do your other jobs?
What do you do when accepting a task (Continuation) Do you make suggestions to make priorities on how much time you will allow the project? Do you get the information and background material you need to do the job properly? Do you try to imagine all the problems and obstacles that could arise while you are doing the job – then plan accordingly? Is it clear who makes decisions when your boss is not available? If a problem arises that you can’t handle, do you talk to your boss about the situation?
Are You Quality-Conscious?(Answerable by True or False) When it comes to quality, there’s always room for improvement. Nobody can be aware of quality needs all the time. Customers pay little attention to quality. A quality program must mesh with the organization’s goals and profit plans. Quality means conformance to standards.
Are You Quality-Conscious?(Continuation) Quality should operate in all parts of a business Personal quality standards and business quality standards have little in common. Quality requires commitment. Quality relates to the process as much as to the goal. People who talk about quality are mostly idealists.
Now . . . TELL me what’s is going on !!! Reflection
Prepared by: Sid Calayag Presented by: Sid Calayag – Lead Auditor ISO 9001:2008 Reference: Quality Management System ISO 9001:2008