comparison of the two systems iso 9001 and iso 9004 clause 5

Clause # 05

Management responsibility

ISO 9001 and 9004

National university of sciences and technology: Atta ur Rehman School of Applied Bio-sciences

RAFFIA SIDDIQUE ; UG4 batch ; Semester# 07 ; [email protected]

ISO 9001

ResponsibilityOf

Top ManagementIn establishing, implementing, maintaining and continually improving the organization’s QMS.

11/8/2014 Food safety and quality assurance 2

ISO 9004

Guidancefor

Organization’s Top Managementfor its management and the organization

ISO 9004 is more extensive then ISO 900111/8/2014 Food safety and quality assurance 3

Clause # 05 Management Responsibility

5.1 Management Commitment

5.2 customer Focus

5.3 Quality Policy

5.4 Planning

5.5 Responsibility

5.6 Management Review


ISO 9001


Clause # 05 Management Responsibility

5.1 General guidance

5.2 Needs and expectations of interested parties

5.3 Quality Policy

5.4 Planning

5.5 Responsibility, authority and communication

5.6 Management Review

ISO 9004

Clause 5.1


5.1 Management Commitment

Involvement of topmanagement isrequired

Purpose=commitment

required todeveloping,implementing, andcontinually improvingthe organization’s

quality managementsystem

ISO 9001

5.1 General guidance

5.1.1 Introduction

5.1.2 Issues to be consideredIntroductionprovides guidance onthe role ofmanagement’sleadership in theorganization’s QMS

5.1.2 recommends theorganization’s topmanagement to usethe 8 QMS principlesin developing,implementing QMS

ISO 9004

ISO 9001 Clause 5.1 ( Management Commitment)


• With entire organization about

• Customer and statutory requirementsCommunicate

• Organization’s quality policy

• Management reviews

Establish

conduct

• Establishment of quality objectives

• Availability of resources for activities related to QMS.

Ensure

Clause 5.1.1 Introduction

Top management’s responsibilitiesshould include identifying certainmethods used for measuringperformance of organization

• Using financial info

• Using external information(bench marking, evaluation) by3rd party

• Measuring satisfaction ofemployees

Clause 5.1.2 Issues to be considered

Use of 8QMS principles for developing, implementing and managing QMS.


ISO 9004 Clause 5.1 General guidance

Understa-nding

• Current and future needs, expectations and requirements

Planni-ng

• Future of organizations• Increasing awareness, motivation

Identif-ying

• Support process• Ensuring the effective operation of

organizations processes

Clause # 5.2


ISO 9001- Clause#5.2 (customer Focus)

ISO 9004- Clause#5.2 ( Needs and expectations of interested parties)

• 5.2.1 General

• 5.2.2 Needs and Expectations

• 5.2.3 Statutory and regulatory requirements

ISO 9001 clause5.2 “CustomerFocus”

This clause ensures top management

ensure that the organization determines

and fulfills the requirements of its customers, with the

aim of enhancing

customer satisfaction.


• Identifies interested parties-end-users of the organization’s products; owners, investors, and shareholders; the organization’s suppliers and partners; affected by the organization or its products.

5.2.1 General

• The organization’s employees:

• The organization’s owners, investors, and shareholders:

• The organization’s suppliers and partners

• Public health community

5.2.2 Needs and

expectations

• provides guidance relating to the organization’s knowledge of statutory and regulatory requirements that pertain to its products, processes, and activities.

5.2.3statutory and

regulatory requirements

ISO 9004 clause 5.2 “needs andinterests of expected parties”

There is no clause in ISO 9001 that corresponds to clause 5.2 of ISO

9004,which addresses the needs and

expectations of interested parties of an organization,

including its customer.

Clause # 5.3

ISO 9001

Quality Policy

ISO 9004

Quality Policy


Clause 5.3 Quality policyISO 9001 clause 5.3 “quality policy”

ISO 9004 clause 5.3 “quality policy”


Appropriate for purpose of organization,

communicated

Ensures commitment

of top management

Provides frame work for

quality objectives

Reviewed for continual suitability

Quality Policy

The quality policy should be used by top management in its efforts to improve the performance of the organization.

The quality policy should be an important and equal part of the organization’s overall policies.

Top management should consider the needs and expectations of all interested parties,

Clause # 5.4

ISO9001 5.4 Planning

5.4.1 Quality objectives

5.4.2 QMS Planning

ISO9004 5.4 Planning

5.4.1 Quality objectives

5.4.2 Quality Planning


ISO9001 Clause 5.4 “planning”

Clause 5.4.1 Quality objectives

Quality objectives specifies theresponsibility of topmanagement to ensure that theorganization’s quality objectivesare

• Established and documented

• quality objectives aremeasurable

• are consistent with theorganization’s quality policy.

Clause 5.4.2 Quality management system planning

• Planning must be carriedout in order that all therequirements of thequality managementsystem, as specified by thestandard, will beestablished

• all the requirementsspecified by the standardmust be maintained.


ISO 9004 clause 5.4 planningClause 5.4.1 Quality objectives proposes that the strategic planning and

quality policy established by an organization’s management should be thebasis for its quality objectives.

Clause 5.4.2 Quality planning proposes that an organization’s managementshould take responsibility for quality planning, which should focus on meeting

the organization’s quality objectives

Clause # 5.5 (Responsibility)

Same for both ISO 9001 and ISO 9004

(Responsibility)

Management Representative

Internal Communication


Responsibility and Authority

clause 5.5 “responsibility, authority and communication”

Clause 5.5.1 Responsibility and authority and for both ISO 9001 and 9004

specifies that top managementis responsible for defining theresponsibilities and authoritieswith respect to the variousprocesses within theorganization’s qualitymanagement system

Clause 5.5.2 Management representative for both ISO 9001 and 9004

Requires that top management

appoint a member of theorganization’s management whomust

• Establishing, implementing, andmaintaining the processes that arerequired for the organization’squality management system

• Reporting on the performance ofthe quality management system,

• Ensuring that awareness ofrequirements of the organization’scustomers


Clause 5.5.3 Internal communicationspecifies top management’sresponsibilityto ensure that processes forcommunication are established withinthe organization.

Clause # 5.6 (Management review)same for both ISO 9001 and ISO 9004

General

Review Input

Review Output


ISO 9004 and ISO 9001 clause 5.6 “management review”

Clause 5.6.1 General • proposes that an organization’s top

management should develop management review activities that go beyond verifying the effectiveness and efficiency of the organization’s quality management system.

• Reviews must evaluate improvement of the organization’s quality management system, and the need to make changes to the organization’s existing quality policy, quality objectives, and to the system.


ISO 9001 and 9004 Clause 5.5

Clause 5.6.2 Review input

• Results of various types ofaudits of the organization’sQMS(e.g., internal audits,customer audits, third-partyaudits)

• Information obtained fromthe organization’s customers

• Information on theorganization’s preventiveactions and correctiveactions

Clause 5.6.3 Review output

• Improvement actionstoward the effectiveness ofthe organization’s QMS

• Improvement actionstoward the organization’sproducts

• Decisions regarding theneed for resources withinthe organization



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