ISO 9001:2000 COURSE

FUNDEMENTALS OF ISO9001:2000 CLUSES

TUTOR: M . ANDALIB

BENEFITS OF REGISTRATION TO ISO-9000 QUALITY MANAGEMENT SYSTEM

INTERNATIONALLY RECOGNISED STANDARD

IMPROVED CONFIDENSE FOR CUSTOMERS AND EMPLOYEES

TREND TOWARDS FAIR COMPETITION BETWEEN SUPPLIERS

DEVELOPMENT OF ISO 9000 FAMILY

MIL-Q-9858A-1963 AQAP-1-1968 DEF STAN 05-08-1970
DEF STAN 05-21-1973-AQAP1-1984 DEF STAN 05-24-1973-AQAP3-1984 DEFSTAN 05-29-1973-AQAP9-1984

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

THE EVALUATION OF ISO 9000

1979
The introduction of British Standard for Quality Management System BS 5750

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

FUNDEMENTALS OF QUALITY MANAGEMENT & THE ROLE OF THE ERTIFICATION BODIES

Quality of Technical Documentation Quality of Shipping

QUALITY OF PRODUCT
Quality of Inspection

Quality of Bought-Out &Made -in-Items

Quality of Manufacture Quality of Physical Design

The Quality Circle

TC176 SURVEY RESULTS

ISO 14000 COMPATIBILITY PROCESS MODEL TAILORING CONTINUAL IMPROVEMENT EASY TO UNDERSTAND SUITABLE FOR ALL

Customers (ISO9001) and other Interested Parties (ISO 9004)

Continual Improvement of the Quality Management System

MANAGEMENT RESPONSIBILITY

Customers (ISO9001) and other Interested Parties (ISO 9004)

Resource MANAGEMENT

MEASUREMENT ANALYSIS IMPROVEMENT Output

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

TERMINOLOGY (ISO 9000)

QUALITY

degree to which a set of inherent characteristics fulfils requirements

(TERMINOLOGY (ISO 9000

Requirement
need or expectation that is stated, generally implied or obligatory

(TERMINOLOGY (ISO 9000

Quality Characteristic inherent Characteristic of a product, process or system related to a requirement

(TERMINOLOGY (ISO 9000

Inherent means existing in something

Assigned Characteristic (e.g.price of product) is not a quality characteristic

(TERMINOLOGY (ISO 9000

Quality Improvement
part of quality management, focused on increasing the ability to fulfil quality requirements

(TERMINOLOGY (ISO 9000

Continual Improvement
recurring activity to increase the ability to fulfil requirement

(TERMINOLOGY (ISO 9000

Quality Objective
something sought, or aimed for, related to Quality(pps)

Continual Improvement
Achieve Objectives Plan
Quality management system: support to achieve the objectives

Act Do Check

Moving Target

(TERMINOLOGY (ISO 9000

1994
Customer Supplier Subcontractor

2000
Customer Organization Supplier

(TERMINOLOGY (ISO 9000

Procedure
specified way to carry out an activity or process

(TERMINOLOGY (ISO 9000

Document
information and its supporting medium

ISO 9001 & ISO 9004 (a consist pair)

ISO 9001 : focuses on the effectiveness of the system in meeting customer requirement(8EL)
guide for moving beyond ISO 9001(20EL)

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

4.1. QMS GENERAL REQUIREMENTS

establish, document,implement,maintain a quality management system & CONTINUALLY IMPROVE ITS EFFECTIVENESS

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

ESTABLISHING THE SYSTEM

Identify processes needed sequence and interaction criteria and methods for operation and control information available for operation and monitoring measure,monitor and analyze implement action to achieve planned results and continual improvement

4.2. DOCUMENTATION REQUIREMENTS

4.2.1-General Quality Policy Quality Objectives (must be SMART) Quality Manual Documented Procedures required by Standard Documents required by the organization Quality Records

4.2.3 4.2.4 8.2.2 8.3 8.5.2 8.5.3

4.2. DOCUMENTATION REQUIREMENTS

4.2.1 Note
Size of organization and type of activity Complexity and interaction of processes Competence of personnel

4.2. DOCUMENTATION REQUIREMENTS

4.2.2-Quality Manual Scope of QMS Justification for exclusions Documented procedure/reference Description of interaction between processes

4.2. DOCUMENTATION REQUIREMENTS

4.2.3-Control of Documents

Approve,Review & Update Identify Changes & Current Revision Status Ensure availability Legible,Identifiable Control External Documents Control Obsolete Documents

4.2. DOCUMENTATION REQUIREMENTS

4.2.4-Control of Quality Records

Identification Storage Protection Retrieval Retention Time Disposition

Legible, Identification& Retrievable

5.1. MANAGEMENT COMMITMENT

Provide Evidence of Commitment to Development & Improvement Of Effectiveness of QMS

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)

Establishing at relevant functions and levels Measurable Consistent with Policy

5.4.PLANNING
5.4.2-Quality Management System Planning

Requirements of 4.1 (QMS General) Quality Objectives Integrity maintained during changes

5.5.RESPONSIBILITY.AUTORITY & COMMUNICATION

5.5.1-Responsibility and Authority

Responsibilities,Authorities and Interrelation Defined & Communicated

5.5.RESPONSIBILITY.AUTORITY & COMMUNICATION

5.2.2-Management Representative

Processes Established,Implemented & Maintained Report on Performance Report on Need for Improvement Ensuring Awareness of Customer Requirements

5.5.RESPONSIBILITY.AUTORITY & COMMUNICATION

5.5.3- Internal Communication

Communication Processes established including Effectiveness Of QMS

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

Decisions and actions related to:

improvement of the effectiveness of QMS and processes, improvement of product related to customer requirements, resource needs

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:

Education Training Skills Experience

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

Building,Workspace &Associated Utilities Process Equipment(Hardware & Software) Supporting Services

6.4.WORK ENVIRONMENT
Determine & Mange to Achieve Conformity to Product Requirement

7.1.PLANNING OF PRODUCT REALIZATION

Quality Objective and Requirements for Product Processes Documentation Resources Verification/Validation/Monitoring/Inspection/Test activities Records

7.2.CUSTOMER RELATED PROCESSES

7.2.1-Determination of requirements related to the product

Specified by customer Necessary for specified , known , intended use Statutory/Regulatory Additional

7.2.CUSTOMER RELATED PROCESSES

7.2.2-Review of requirement related to the product

Product information Enquiries,Contracts,Order handling customer feedback (Inc complaints)

7.4.DESIGN AND DEVELOPMENT

7.3.1-Planning 7.3.2-Inputs 7.3.3-Outputs 7.3.4-Review 7.3.5-Verification 7.3.6-Validation 7.3.7-Changes

NO SIGNIFICANT CHANGE

7.4.PURCHASING
7.4.1-Purchasing Process 7.4.2-Purchasing Information 7.4.3-Verification of Purchased Product

7.5.PRODUCTION AND SERVICE PROVISION

7.5.1- Control of Production and Service Provision

Controlled Conditions Information Work Instruction Suitable Equipment Availability & use of monitoring& Measuring Devices Implement Monitoring &Measurement Activities Release,Delivery&post Delivery Activities

7.5.PRODUCTION AND SERVICE PROVISION

7.5.2-Validation of Processes for Production & Service Provision 7.5.3-Identification & Traceability 7.5.4-Customer Property 7.5.5-Preservation of Product NO SIGNIFICANT CHANGE

7.6.CONTROL OF MONITORING & MEASURING DEVICES

Determine Monitoring & Measurement activities Determine devices needed Establish processes for performance Where necessary : Calibrate,Safeguard,Protect,etc NO SIGNIFICANT CHANGE

8.MEASUREMENT,ANALYSIS & IMPROVEMENT

8.1-General

Plan Implement
Monitoring,Measurement,Analysis & Improvement Processes
Conformity of Product Conformity of QMS Conformity Improve Effectiveness of QMS

Determine Applicable Methodologies(Inc SAT Techs)

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

Effectively Implemented and Maintained

8.2.3-MONITORING & MEASUREMENT OF PROCESSES

Suitable Methods to Demonstrate ability to achieve planned re

8.2.4-MONITORING & MEASUREMENT OF PRODUCT

Monitor and Measure characteristics of the product to verify that requirements are fulfilled
Appropriate Stages (as planned) Evidence of conformity(records) No release/delivery until all OK

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

SUMMARY OF KEY CHANGES

Process Approach Continual Improvement Competency and Awareness Quality Objectives Effective Communication Manual to define Scope and Exclusions Unstated Product Requirement Proactive Customer Satisfaction Measures Audits to confirm compliance to ISO 9001

IMPLEMENTION STRATEGY

1994 Certificate-max validity 15 December 2003

Guidance on specific topics

ISO 10006 for project management ISO 10007 for configuration management ISO 10012 for measurement systems ISO 10013 for quality documentation ISO/TR 10014 for managing the economics of quality ISO 10015 for training ISO/TS 16949 for automotive supplier ISO 19011 for auditing