ISO 9000 – Quality Management

SystemsElements, Requirements and

Interpretation of ISO 9000:2000

Presented By,Hinglajia Hetal Ratilal, Roll no. 01,M.pharm, Pharmaceutics , Sem-II

Guided by,Dr. B. G. Prajapati

ISO 9000 - An Introduction

• ISO stands for International Organization for Standardization.

• ISO 9001:2000 is an international standard for the implementation and management of a quality assurance system.

• ISO 9000, can be adopted by all types of organizations producing and supplying all kinds of goods, services and software etc.

ISO 9000 - General Overview

• ISO 9000 series constitute ISO 9000, 9001,

9002,9003 and 9004.

• ISO 9001, 9002, 9003 are three quality system

models for external quality assurance.

• ISO 9001 is for design , manufacturing, installation

and servicing system,

• ISO 9002 covers manufacturing and installation

• ISO 9003 covers only final product inspection and

test.

ISO 9000 - General Overview

• An example of the impact created by the initiation

of ISO 9000 is that most government, military,

European, and multi-national company contracts

make it mandatory to possess registration to one

(or more) of the standards.

• ISO 9004 provides guidelines for internal use by a

manufacturer developing its own quality system to

meet the business needs.

ISO 9000 - General Overview

• To attain ISO 9000 registration , a manufacturer

must provide evidence that its management is

actively involved in its quality process, that its

supplier and customer assured that there is

consistency in supply .

• It also require the control on documentation of

design , production ,inspection, handling ,storage

and delivery of all materials and product

ISO 9000 - General Overview

• In the years since the introduction of ISO 9000, several issues have arisen, including the application of the standards to cover services, software development, pharmaceutical, processing industries, the concept of an expanded stakeholder accountability beyond customers, the needs of the smaller organizations, and the needs of other specialized industry sectors, such as medical devices (ISO 13485/13488).

ISO 9000 - The Quality Loop

Customer/Consumer

Producer/Supplier

Marketing andMarket Research

Disposal afterUse

Sales andDistribution

Design/SpecificationEngineering andProduct Development

Procurement

Process PlanningAnd Development

ProductionInspection, Testing,And Examination

Packing andStorage

Installation andOperation

Technical Assistance andMaintenance

ISO 9000 - Objectives

• The objectives of any good quality

management system are the following:– Assure that the customer receives the service or product

that is expected and remains satisfied

– Prevent errors in all operations

– Prevent delivery delays

– Reduce costs of operation

– Increase productivity

– Increase the reliability of service or product

– Meet all the quality requirements specified by the customer

ISO 9000 - Prerequisites of a Quality System

• Whatever the definition of quality, one

must first focus on three fundamental

elements: Quality Policy, Quality

Management, and Quality System.

• ISO 9000 family distinguishes between

requirements for quality management

systems and requirement for products.

ISO 9000 - Prerequisites of a Quality System

• Quality Policy: Overall quality objectives and

direction of an organization pertaining to key

elements of quality such as fitness for use,

performance, safety and reliability, as formally

expressed by top management.

• Quality System: The organizational structure,

responsibilities, procedures, processes, and

resources used for implementing quality

management

ISO 9000 - Prerequisites of a Quality System

• Quality Management: That aspect of the

overall management function that establishes

and implements the quality policy.

• Determining the needs and expectation of

customers and other interested parties.

• This can lead to increased satisfaction of

customers than other interested parties an to the

success of the organization.

ISO 9000 - The Philosophy

• Basically, there are two mindset approaches to ISO 9000 registration.

• First, to view the ISO 9000 series as a set of standards which needs to

be addressed sooner or later.

– This first approach is invariably and primarily motivated by a

commercial/marketing/business set of convictions.]

• The other approach sees the ISO 9000 standards as something more

than just a model for quality assurance.

– This philosophy will more often than not see in ISO 9000 an

opportunity to improve managerial style.

– Most experts speak of ways in which the various ISO 9000 models

can help a company reduce internal cost and/or increase efficiency.

ISO 9000 - Documentation

• Policies, Procedures, and the Manual: Basically, the quality manual consists of varying stages or tiers. There are typically 3 or 4 tiers comprised of different levels of information.

Level 1

Level 2

Level 3

Level 4

Quality manual

Operational (procedure,SOPs Protocols

Instruction to operations

Formats, records

ISO 9000 - Documentation

• Tier 1 consists of the Quality Policy, business unit policies

and objectives.

• Tier 2 consists of the departmental procedures and

responsibilities for each of the pertinent ISO elements.

• Tier 3 consists of the procedures reflecting the individuals’

day-to-day business activities (Work Instructions, Plant

Equipment Instructions, etc.).

• Tier 4 (sometimes not applicable) consists of any business

supporting documentation (Accounting data, scheduling,

etc.).

ISO 9000 - Execution• When people realize that a significant portion of the executing

efforts required to achieve registration consist of documenting what you say you do, some individuals develop an allergic reaction to ISO.

• To them, the real issue is total quality management. To achieve that objective, everyone must be involved to solve a multitude of problems which may have accumulated over several years.

• Such criticisms are not well founded for several reasons. First of all, the ISO series of standards is a model for the management of a quality assurance system designed to insure that at a minimum, a series of steps are taken to ensure that you do indeed satisfy your customer requirements.

• Whereas it is true that ISO 9000 will never question your technical ability to satisfy your customer specifications, some of its paragraphs have specifically been written to verify that you have an effective system in place to do so.

ISO 9000 –Management commitment

• Role of Employees: In its simplest form, by saying what they do and doing what they say, the employees effectively ensure the continued success of any quality system. This holds true for ISO 9000 as well. In fact, it is the foundation upon which registration lies.

• Role of Employers: here proprietor , owner should responsible for business growth, provide commitment, with conviction to develop QMS system .

ISO 9000 –Management commitment

• Role of the Internal Quality Assurance

Individual(s):

The conduct of internal audits is clearly specified by ISO. To ensure

compliance, most companies enroll their designated quality

assurance individual(s) into one of the many Quality Auditor

courses currently offered by the few “officially approved”

agencies or registrars. The individual(s) shall also be responsible

for the upkeep and maintenance of all the documentation

included in the company’s quality manual and quality records,

ensure that the system continues to function effectively over

time, and act as the main liaison with the registrar.

ISO 9000 –Management commitment

• Role of the Registrar: Once the quality

assurance system has been documented and

implemented, an accredited registrar must be

consulted to conduct a review of the quality

manual and to perform a third party audit.

Accreditation in Canada is granted by the SCC

(Standards Council of Canada). At present there are

around 16 accredited registrars in Canada alone.

ISO 9000 –Management commitment

• As most businesses begin to implement a quality

assurance system, they quickly notice that a vast

network of internal customer/supplier relationships

begin to develop. When done properly and in a

spirit of cooperation, the setting-up of an ISO 9000

quality assurance system can lead to a sharing

and exchange of information across previously

impermeable departmental barriers.

ISO 9001:2000 - The Standard

• The ISO 9001:2000 standard consists of 5 main sections addressing some 23 different elements of compliance.

• Section 1 identifies the ‘Scope’ of the standard,• Section 2 deals with the ‘Normative Reference’ of the

standard,• Section 3 addresses the ‘Terms and Definitions’ of the

standard.The Main Sections:• Section 4 - Quality Management System • Section 5 - Management Responsibility• Section 6 - Resource Management• Section 7 - Product Realization• Section 8 - Measurement, Analysis and Improvement

ISO 9001:2000 - The Standard

Section 4 - Quality Management System:• This Section deals with the establishment,

implementation, and maintenance of the QMS with regards to the control of documentation and records

Section 5 - Management Responsibility:• This Section serves to provide evidence of

management’s commitment to the development and implementation of the QMS and to continually improve its effectiveness

Section 6 – Resource Management:• This Section covers the organization’s provision of

requirements such as Human Resources, Infrastructure, and Work Environment

ISO 9001:2000 - The Standard

Section 7 - Product Realization:• This Section serves to confirm how the organization

plans and develops the processes needed for product realization

Section 8 - Measurement, Analysis and Improvement:• This Section deals with the planning and

implementation of the monitoring, measurement, analysis and improvement processes needed to – (a) demonstrate conformity of the product, – (b) ensure conformity of the QMS, and – (c) continually improve the effectiveness of the QMS

ISO 9000 - The Strategy

• Basically there are 6 working phases to successfully map out any worthwhile quality management system:–System Investigation–System Analysis–System Design–System Development–System Implementation–System Maintenance

ISO 9000 - Summary• Study current

documentation• Conduct interviews

and/or perform surveys• Observe individuals

actually performing the activities

• Create new documentation

• Meet with executive management of responsibility to critique & approve the new documentation

• Finalize and control new documentation

• Train all staff

• Perform internal audits of the ISO 9001:2000 Standards’ elements

• Identify all major and/or minor non-conformances

• Recommend corrective actions

• Perform ‘follow-up’ internal audits to confirm the effectiveness of the corrective actions

• Have the Quality Manual reviewed and approved by an accredited ISO Registrar

• Have the QMS audited by the Registrar