OVERVIEW OF ISO 9001:2000 REQUIREMENTS By Annette Nabbengo-ITP-Student

ISO 9000:2000 STANDARDS

Introduction
It is a requirement of the International Standards Organizations that standards are reviewed every 5 years Previous issues were in 1987 and 1994

ISO 9000:2000 Standards

There are now three Standards ISO 9000:2000 Quality Management System - Fundamentals and vocabulary ISO 9001:2000 Quality Management System - Requirements ISO 9004:2000 Quality Management System - Guidance for performance Improvement
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ISO 9001:2000
Replaces ISO 9001 - 1994 ISO 9002 - 1994 ISO 9003 - 1994 with one standard
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ISO 9004 :2000

Gives guidance on all aspects of a quality management system, to improve an organizations overall quality performance Includes ISO. 9001:2000 requirements with explanatory notes
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About ISO 9001 :2000

The 8 Quality Management Principles
Customer focused organization Leadership Involvement of people Process approach System approach of management Continual improvement Factual approach to decision making Mutually beneficial supplier relationship
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ISO 9001:2000
QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
An Overview

ISO 9001:2000 QMS Requirements

Five Key Activities (Paragraphs) 4. Quality Management System 5. Management responsibility 6 Resource Management 7. Product Realization. 8. Measurement, Analysis and Improvement
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4.0 Quality Management System 4.1 Requirements The organization Shall Establish, Document, Implement, Maintain Continually improve a Quality Management System
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Quality Management System To implement the QMS organisations shall a) identify processes b) determine the sequences and interaction of the processes c) determine criteria and methods to ensure effective operation and control of the processes
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Quality Management System To implement the QMS organisations shall d) ensure availability of resources and information to support operation and monitoring of processes e) monitor, measure, and analyze the processes f) implement actions necessary to achieve planned results and continuous improvement of the processes
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4.2 Documentation Requirements The extent of the QMS is dependant on :

a) size and type of organization b) complexity and interaction of process

c) competence of personnel
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4.2 Documentation requirements

Quality system documentation shall include: documented statement of a quality policy and quality objectives quality manual documented procedures documents required by the organization to ensure effective planning, operation and control its processes (quality related) records

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The Quality Policy

The quality policy shall: be appropriate to the purpose of the organization include commitment to comply with requirements and continuous improvement provide a framework for establishing and reviewing quality objectives be communicated and understood within the organization be reviewed for continuous suitability

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The Quality Objectives

The quality objectives shall: be established at relevant functions and levels within the organization be measurable be consistent with the quality policy include those objectives needed to meet product requirements
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The Quality Manual

The quality manual shall include: the scope of the QMS including justification for exclusions (under clause 7) documented procedures established for QMS or reference to them description of interaction between QMS processes

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Procedures
Documented Procedures are required in this International Standard Documents are required by an organization to ensure effective operation and control of its processes.
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Documented Procedures required under ISO 9001:2000

Among the company operating procedures, the following specific areas shall have formal documented procedures
Control of documents Control of quality records Internal audit Control of non-conforming product Corrective action Preventive action
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ISO 9001:2000
5 Management responsibility 5.1 Management Commitment 5.2 Customer focus 5.3 5.4 5.5 5.6 Quality Policy Planning
Responsibility, authority and communication

Management review
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Management Commitment
Top management shall provide evidence of its commitment to: the development of the QMS the implementation of the QMS continually improving the effectiveness of the QMS

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Responsibility, Authority and Communication

Top management shall: ensure that responsibilities and authority are defined & communicated within the organization appoint a Management Representative to
ensure establishment and implementation of processes needed for the QMS report to Top Management on performance of QMS ensure promotion of awareness of customer requirements ensure communication processes are established and communication takes place

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Role of Top Management within the QMS

to establish and maintain the quality policy and quality objectives of the organization to promote the quality policy and quality objectives in the organization to increase awareness, motivation and involvement to ensure focus on customer requirements to ensure that appropriate processes are implemented to enable fulfillment of customer and regulatory requirements to ensure establishment and maintenance of an efficient QMS to ensure the availability of necessary resources to review the quality management system periodically to decide on actions regarding the quality policy and objectives to decide on actions for improvement of the QMS

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ISO 9001:2000
6. Resource Management 6.1 Provision Of Resources 6.2 Human resources 6.3 Infrastructure 6.4 Work environment

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ISO 9001:2000
7. Product Realization
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 & Measuring Devices.
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7.2 Customer related processes

Requirements related to the products shall be determined on the basis of:
requirements specified by customer (including delivery and post delivery activities) requirements not stated by the customer but necessary for intended use (where known) statutory and regulatory requirements related to the product any additional requirements determined by the organization
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Review of (customer) requirements related to the product

Requirements of the product shall be reviewed prior to the organizations commitment to supply products to the customer The review shall determine and ensure that:
product requirements are defined contradicting contracts or orders are resolved the organization has ability and capacity to meet the defined requirements

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Review of requirements related to the product

Records of the review should be maintained Verbal contracts (with no documented statements of requirements) shall be confirmed before acceptance Where orders are changed, the relevant documents shall be amended accordingly and relevant personnel made aware of the changes
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Customer Communication
Determine and implement effective arrangements to communicate with customs on:
product information inquires, handling of contracts and orders customer feedback including customer complaints
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7.4 Purchasing
Purchasing process shall ensure that
purchased product conforms to specified requirements controls applied to supplier and purchased product shall be dependent upon the effect of the purchased product on subsequent product realization process or the final product. Evaluate and select supplies based on their ability to meet the specified requirements Establish criteria for selection and evaluation of supplies Maintain records of the results of evaluations and any necessary actions assuring thereof.
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Purchasing Information
The information should describe the product to be purchased including: requirements for approval of product, procedures, processes and equipment requirements for qualification of personnel QMS requirements

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Verification of Purchased product

Establish and implement the inspection or other activities necessary for ensuring that purchased products meet specified requirements Where there is intention to perform verification at the suppliers premises, this should be stated together with specified method of product release in the purchasing information

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ISO 9001:2000
7. Product realization Controlled Processes

Sales

Design

Purchasing

Production

Identification

Customer Property

Control Of Measuring & Monitoring Devices

Handling, packaging, storage, preservation and delivery

Special Process

Note :- Exclusions to the scope of the quality management system are only permitted from these activities.
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ISO 9001:2000
8.0 Measurement, analysis and improvement 8.1 General 8.2 Monitoring and Measurement 8.3 Control of Nonconforming Product 8.4 Analysis of data 8.5 Improvement
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Internal Audits
Conduct internal audits at planned intervals to determine whether the QMS: conforms to the planned arrangements conforms to this international standard conforms to QMS requirements established by the organization is effectively implemented and maintained
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Internal audits
Select auditors and conduct audits to ensure objectivity and impartiality Auditors not to audit their own work Establish procedure for internal audit specifying responsibilities and requirements for planning and conducting audits Management responsible for areas being audited shall ensure that actions are taken without delay to eliminate detected non-conformities and their causes Follow-up activities to include the verification of the actions taken and the reporting of verification results
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Improvement
Continually improve the effectiveness of the QMS through : quality policy quality objectives audit results analysis of data corrective and preventive actions Management review
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