iso 9000-2000 overview of requirements-2

8/4/2019 Iso 9000-2000 Overview of Requirements-2

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OVERVIEW OF ISO 9001:2000

REQUIREMENTS

By Annette Nabbengo-ITP-Student


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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


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ISO 9000:2000 Standards

There are now three Standards

ISO 9000:2000Quality Management

System - Fundamentals and vocabulary ISO 9001:2000Quality Management

System - Requirements

ISO9004:2000Quality ManagementSystem - Guidance for performanceImprovement


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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 improvean organizations overall quality

performance

.Includes ISO 9001:2000 requirements

with explanatory notes


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AboutISO9001:2000

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


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ISO 9001:2000

QMS Requirements

Five Key Activities (Paragraphs)

4. Quality Management System

6 Resource Management7. Product Realization.

8. Measurement, Analysis and Improvement

5. Management responsibility


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4.0 Quality Management System

4.1 Requirements

The organization ShallEstablish,

Document,

Implement,

Maintain

Continually improve

a Quality Management System


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Quality Management System

To implement the QMS organisations shall

a) identify processesb) 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 achieveplanned 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 andquality objectives

quality manual

documented procedures

documents required by the organization to ensureeffective 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 requirementsand continuous improvement

provide a framework for establishing and reviewingquality objectives

be communicated and understood within theorganization

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 organizationbe measurable

be consistent with the quality policy

include those objectives needed to meetproduct 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 QMSor reference to them

description of interaction between QMS

processes


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Documented Procedures are

required in this International Standard

Documents are required by an

organization toensure effective

operation and control of its processes.

Procedures


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Documented Procedures required

under ISO 9001:2000

Among the company operating procedures,the following specific areas shall haveformal documented procedures

Control of documentsControl of quality records

Internal audit

Control of non-conforming product

Corrective action

Preventive action


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ISO 9001:2000

5 Management responsibility5.1 Management Commitment

5.2 Customer focus

5.3 Quality Policy

5.4 Planning

5.5 Responsibility, authority andcommunication

5.6 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 CommunicationTop 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 QMSto establish and maintain the quality policy and quality objectives

of the organizationto promote the quality policy and quality objectives in theorganization to increase awareness, motivation and involvement

to ensure focus on customer requirements

to ensure that appropriate processes are implemented to enablefulfillment 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

7.6 Control of Monitoring & Measuring

Devices.

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


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7.2 Customer related processes

Requirements related to the products shall bedetermined 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

productany additional requirements determined by the

organization


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Review of (customer) requirements

related to the productRequirements of the product shall be reviewedprior 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 beconfirmed before acceptance

Where orders are changed, the relevantdocuments shall be amended accordingly

and relevant personnel made aware of thechanges


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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 customercomplaints


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7.4 PurchasingPurchasing process shall ensure that

purchased product conforms to specified requirements

controls applied to supplier and purchased productshall be dependent upon the effect of the purchasedproduct on subsequent product realization process or

the final product.

Evaluate and select supplies based on their ability tomeet the specified requirements

Establish criteria for selection and evaluation ofsupplies

Maintain records of the results of evaluations and anynecessary 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 atthe suppliers premises, this should be stated

together with specified method of product release

in the purchasing information


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Sales Design Purchasing Production

Identification

Control Of Measuring

& Monitoring Devices

CustomerProperty Handling,

packaging,

storage,preservation anddelivery

SpecialProcess

Controlled Processes

Note :- Exclusions to the scope of the quality management system are onlypermitted from these activities.

ISO 9001:20007. Product realization


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ISO 9001:2000

8.0 Measurement, analysis and

improvement

8.1 General

8.2Monitoringand Measurement

8.3 Control of Nonconforming Product

8.4 Analysis of data8.5 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 specifyingresponsibilities and requirements for planning andconducting audits

Management responsible for areas being audited shallensure that actions are taken without delay to eliminate

detected non-conformities and their causesFollow-up activities to include the verification of theactions 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