iso intrepretation of req

8/10/2019 ISO Intrepretation of Req

1/13

Interpretation of ISO 9001:2008-12 Requirements

with Consideration of ISO 9004:20096th revised edition

ISO 9001:2008


2/13

TV Media GmbH 1

ISO 9001:2008 Interp reta tion of the Requirements

On the use of this publication

This publication is intended for auditors, management representatives, organizations and consultants as well as allthose involved in the establishment and maintenance of a quality management system.

It interprets and explains the requirements of ISO 9001:2008 in conjunction with ISO 9004:2009, the guideline formanaging for the sustained success of an or ganization. The objective of the publication is to improve the under-standing of the requirements of the standard and provide reasonable suggestions for their direct implementation

based on numerous practical examples.

In Part A of this publication the reader is given an introduction to the objectives, structure and the most importantcharacteristics of ISO 9001:2008.

In Part B, the major part of this publication, the requirements of the standard are listed by keywords in a table andinterpreted with respect to its application in practice. Examples are provided with the intention to show the readerhow the fulfillment of requirements can be documented.

The recommendations of ISO 9004:2009 regarding sustained improvement of the overall performance of an organi-

zation were summarized as key aspects, avoiding redundancies with requirements of the ISO 9001:2008 standard.This provides the reader with a compact overview of compatibility between ISO 9001:2008 and ISO 9004:2009.

The key indicators examples in the last column reflect the options for managing continual improvement and mak-ing the results evident and transparent for interested parties and employees.


3/13


2 TV Media GmbH


4/13

TV Media GmbH 3


Table of contents

A ISO 9001:2008 An introduction

1 General information

1.1 Development of the standard

1.2 Application of the standard

1.3 Exclusion of requirements

1.4 The importance of the standard for the organization

2 Compatibility with other standards

3 Process approach and interactions

4 Quality management principles

5 Practical hints for sustained success (ISO 9004)

6 Continual improvement via key indicators7 Customer satisfaction

8 Adaptation of existing quality management systems

9 Required documentation for the management system

B ISO 9001:2008 Interpretation of the requirements of ISO 9001:2008 Table

Explanations of the table columns

Clause 4: Quality Management System

Clause 5: Management responsibility

Clause 6: Resource management

Clause 7: Product realization

Clause 8: Measurement, analysis, improvement

Annex Correspondence between ISO 9001:2008, ISO 9004:2009, ISO 14001:2004 and

OHSAS 18001:2007


5/13


4 TV Media GmbH

A ISO 9001:2008 An introduction

1 General

1.1 Development of the standard

The international standards organization (ISO) developed the ISO 9001:2008 standard in the technical committeeISO/TC 176. It was implemented in December 2008, replacing the previous standard ISO 9001:2000.

ISO 9001:2008 has no new requirements. The intention of the previous standard ISO 9001:2000 was simply madeclearer with explanations and changes to the text. Some requirements were formulated more distinctly and strict-ly by additional notes; others were limited with wording such as where applicable. The majority of changes areeditorial or of a linguistic nature.

1.2 Application of the standard

All the requirements defined in ISO 9001:2008 are of a general nature and are applicable to all organizations re-gardless of type and size and the nature of the products produced. Not to be overlooked, however, is that the word-ing in the standard is to some extent quite clearly oriented toward terms and expressions of production operations.Clause 7 Product realization, 7.6 Control of monitoring and measuring equipment or 8.3 Control of noncon-forming products are examples of this. Among other things, this led to the development of a series of sector-spe-cific standards using ISO 9001 as a basis and adapting it to the particular sector with additional requirements andspecific explanations. Here are a few examples:

Automotive supply industry: ISO/TS 16949

Aerospace industry: EN 9100

Food industry: ISO 22000

Crop production: ISO 22006

Medical device manufacturers: ISO 13485

Medical device packaging: ISO 15378

Transport packaging for dangerous goods: ISO 16106

Software: ISO/IEC 90003

Health care: IWA 1

Educational organizations: IWA 2

Local government: IWA 4

Transportation: EN 12507 and 12798

1.3 Exclusion of requirements

If one or more requirements cannot be applied due to the nature of an or ganization and its products, these re -quirements can be considered for exclusion. However, your visitation must exclude only those requirements fromquality management system which do not adversely af fect the capacity or responsibility of the organization tomake products which meet customer requirements and the relevant statutory and regulatory requirements. Suchexclusions are limited to requirements within Clause 7. Exclusions must be justified in quality manual (see alsoClause 4.2.2). Here the following can be considered:

Product type

Customer requirements


6/13

TV Media GmbH 5


Statutory and regulatory requirements

Scope of responsibility

Consequently, all requirements of Clauses 4, 5, 6 and 8 must be met completely to verify conformity. This means,for example, that development cannot be excluded if the organization bears full responsibility for the product.

1.4 The importance of the standard for the organization

The development, introduction and implementation of a quality management system is regarded as a strategic cor-porate decision to ensure competitiveness of the organization. This can be achieved in an effective and sustainedmanner with the introduction and application of the management system based on this standard.

The design and implementation of an organizations quality management system is influenced by its environment,its changes and the risks associated with this environment, by the requirements of the or ganization and the mar-ket, the strategic objectives, the products produced and the processes used as well as the size and structure of theorganization. The present standard explicitly demands no unification of the structures and documentation in theorganizations.

2 Compatibility with other standards

After the revision of ISO 9004 in 2009, both standards are similar in structure but are not a consistent pair of stan-dards as before. The standards complement each other but can also be applied independently. Whereas the focusof ISO 9001 is primarily on customers, ISO 9004:2009 covers requirements and expectations of all relevant in-terested parties (customers, suppliers, employees, owners/shareholders, the public, etc.) and provides guidance tosystematic, sustained improvement of the organizations overall performance.

ISO 9001:2008 is oriented with respect to the standard ISO 14001:2004 Environmental management systems Requirements with guidance for use to increase the compatibility of both standards in favor of the user commu-nity.

The table in the annex of this publication provides an overview of how the requirements of ISO 9001:2008correspond to the requirements of other management system standards such as ISO 14001 and OHSAS 18001 (oc-cupational safety management).

3 Process approach and interactions

Each activity in which input can be converted to the desired output can be regarded as a process. In order to op-erate effectively, organizations must identify, define and control the interactions of processes associated with oneanother. Often, the result of one process constitutes the direct input of the next one. The systematic identification,analysis and control of these various processes in an organization and particularly their mutual interactions are re-ferred to as a process approach and must be implemented by the organization. ISO 9001:2008 supports this pro-cess approach to quality management. Figure 1 shows the ISO 9001:2008 process model.

The organizations top management defines the requirements and takes responsibility for implementation and ap-plication of the requirement (Clause 5 of the standard); the means necessary are defined and deployed under aResource management (Clause 6 of the standard); processes with their interactions are developed and appliedaccording to the Product realization (Clause 7 of the standard); the results are determined and analyzed underMeasurement, analysis and improvement (Clause 8 of the standard). The systematic review of the QM system(Clause 5.6 of the standard), causes a feed-back of informations to the top management, which is responsible forapproving changes to the QM system or initiating improvements.

For Product realization, it is very importat that customers and other interested parties clearly define their require-

ments for the product. Process management handles all processes required for implementing the product and veri-fies or validates the process results. Measuring of the satisfaction of customers and other interested parties pro -vides the basis for reviewing product quality.


7/13


6 TV Media GmbH

Cointinual measurement of customer satisfaction reinforces the trust of customers in the or ganizations ability todeliver quality. It is an importan t condition for documenting continual improvement. Efforts regarding these re-quirements must be verified.

Regarding process interactions, the provision of resources such as

material, machines, energy, environment

and necessary information such as

methods, requirements, data, facts, analyses and timetables

must be considered. Displaying the processes and their interactions by a process flow chart can be helpful. Exam-ples of this are shown in Figures 2 to 4.

Clear definitions of processes and easy-to-understand visual workflows, focussed on the value chain, are someof the mayor benefits of a process-based QM system. They make it easy for each employee to recognize his own

processes and lead to a better understanding and more acceptance in carrying out committed duties. Moreover, thepotentially motivated employees are tending to support a process of continual improvement for increasing cus-tomer satisfaction.

4 Quality management principles

Each organization pursues an adequate purpose. Accordingly, the requirements and expectations of customers andother interested parties (employees, suppliers, owners and shareholders) play a decisive role. Moreover, gainingcompetitive advantages preferably in an effective and efficient manner as well as achieving, maintaining andimproving organizational performance and capabilities are extremely important.

In ISO 9000:2005 and 9004:2009, Annex B, eight principles of quality management for achieving the named ob-jectives are defined. The application of these principles not only provides direct advantages for increasing the ca-

pability to deliver quality, but also makes an important contribution to the management of cost and risk; consider-ing the benefits, costs and risks is decisive for the success of the organization.

These principles are summarized as follows:

1) Customer focus

Organizations depend on their customers and should therefore understand the present and future needs oftheir customers, meet the requirements and strive to exceed their expectations.

2) Leadership

Leaders bring the purpose and direction of the organization together. They should create and maintain theinternal environment in which people can become fully involved in achieving the or ganizations objec-tives.

3) Involvement of employees

Employees at all levels are the essence of an or ganization, and their complete involvement enables theirabilities to be used for the organizations benet.

4) Process approach

A desired result can be achieved more efciently if the activities and associated resources are managed as

a process.

5) System approach to management

Identiying, understanding and managing interrelated processes as a system contribute to the organiza-tions effectiveness and efciency in achieving its objectives.

6) Continual improvement Continual improvement of the organizations overall performance schould be a permanent objective of the

organization.


8/13

TV Media GmbH 7


Continual improvement of the quality management system

Customers

Customers

Require-

ments

Satisfaction

Product-

realization

Management

responsibility

Resource

management

Measurement,

analysis and

improvement

ProductInput Output

Value-adding activities

Information flow

Key

Fig. 1: ISO 9001:2008 process model

Fig 2: Example of a process flow chart

Management processes

Key processes

Supporting processes


9/13


8 TV Media GmbH

Design andDevelopment

Purchasing

CustomerService

ProductionPlanning

Production Sales

Human ResourcesPlanning

Agreementon Objectives

FinancialPlanning

QualityAssurance

Maintenance InformationManagement

Fig 3: Example of interactions between the processes

Fig 4: Excerpt of a flow chart for work processes

Customer Needs

Marketing

Design andDevelopment

Program Planning

Registration/Invitation

Purchasing

AssignmentTrainer

Servicing/Maintenance

Planning/Reali-zation Trainings

CustomerSatisfaction

Proposals, Improvement System, Complaints


10/13

TV Media GmbH 9


7) Factual approach to decision making

Effective decisions are based on the analysis of data and information.

8) Mutually benetial supplier relationships

An organization and its suppliers are dependent on each other. A mutually benecial relationship increas-es the ability of both to create value.

5 Practical hints for sustained success

Basically, the objectives of ISO 9001 are improving the quality of products and processes as well as increasing cus-

tomer satisfaction, whereas ISO 9004:2009 provides a wider framework on quality management and addresses the

needs and expectations of all interested parties. In this respect, ISO 9004:2009 provides guidance to systematic, con-

tinual improvement of the organizations overall performance aiming towards the organizations sustained success.

This objective explicitly includes efficiency and increased profits and thus the economic success of the organiza-tion. Quality management is thus a primary concern for top management. The customer does not only benefit froma stable desired quality of the product, but also from the better profitability of the supplier. On the other hand, the

supplier also benefits from the organizations improved competitiveness.

In order to provide the user of ISO 9001 with the recommendations of ISO 9004:2008 as well, the table in Part Bof this publication contains the column Practical hints for sustained success with recommendations for improv-ing the organizations overall performance.

6 Continual improvement via key indicators

The requirement for continual improvement is a recurrent theme in all requirements of the standard. To verify thefulfillment of the requirement, it is necessary to define, measure and compare key indicators.

Key indicators are a core element for continual improvement and advancement of management systems.

An oranization remains fit for the customer if the criteria measured are precisely those which are decisive for thecustomer, who wants to achieve competitive advantages.

Key indicators enable the companys potential for improvement to be identified and the progress of measures forimprovement to be monitored systematically. Furthermore, key indicators enable internal benchmarks to be ap-

plied, allowing internal performance competitions.

However, the definition of key indicators must be done in a manner specific to the organization and should be part of

defining quality objectives. They must be defined or confirmed by top management, for example using the Balanced

Score Card. In this regard, it must be considered that too many key indicators increase the effort of measurement, re-

ducing the benefit. Moreover, it must be considered that employees must be able to influence key indicators and qual-

ity objectives. The key indicators must also be updated permanently, at least periodically, as part of the quality targets.

The review of the quality management system should be based on key indicators and should provide evidence ofcontinual improvement. In addition, this requirement is emphasized by the fact that the requirements for correctiveand preventive actions have been defined as separate requirements see Clause 8.5.2 and 8.5.3.

7 Customer satisfaction

Increasing customer satisfaction, the foremost objective of ISO 9001, is intended to be achieved by effective ap-plication of the quality management system. This also includes compliance with legal and regulatory requirements.Customer satisfaction must be monitored and measured continually, considering a great number of indicators. Forexample, reducing the rate of complaints is an important indicator, but not the only one by far. Quality costs, salesand profit figures, increasing occupational safety as well as the results of an active customer survey are other ex-amples of important indicators.


11/13


10 TV Media GmbH

8 Adaptation of existing quality management systems

The purpose of the ISO 9001 and ISO 9004 standards is to define appropriate requirements for an organizationsquality management system and to provide top management with a guideline for introducing and using the qual-ity management system to improve the overall performance of the organization. ISO 9004 in particular offers aguideline to achieve sustained success in an environment which is constantly changing. The combined application

of ISO 9001 and 9004 can contribute effectively and efficiently to customer satisfaction while at the same time ef-fect benefits for other interested parties.

The organization should review whether its current QM system meets the detailed requirements of ISO 9001.

The following aspects should be reviewed in particular:

Identication of customer expectations

The obligation to determine and assess customer satisfaction

Documentation and assessment of continual improvement

Evaluation of the effectiveness of training courses

Description of resource management

Providing more precise evidence of the management systems effectiveness

Identication and denition of the processes required for the system, their sequence and interactions

9 Required documentation for the management system

The extent of the QM documentation can differ from one organization to another due to the size of the organiza-tion, the complexity of the products and processes and the competence of employees. For this reason, the standardrequires the following content as a minimum:

Description of the quality policy and the quality objectives

Establishing a quality management maual

Description of the documented procedures required by the standard

Description of documents and records necessary to ensure the effective planning, operation and conrol of

the processes

The following minimum content is required for the quality manual:

Scope of the quality management system

Justication for any exclusion of requirements

Description of the following 6 processes required by the standard (documented procedures):

Control of documents

Control of quality records

Internal audits

Control of nonconforming products

Corrective actions

Preventive actions

Description of the interaction between the processes of the quality management system

To satisfy the further requirement of the standard for written records, at least the record type is to be defined in the

quality manual and its annexes.


12/13

TV Media GmbH 11


B Table for interpretation of the requirements

To support the user of the standard in the practical implementation of the requirements and in the preparation andperformance of internal audits, the following table provides an interpretation of the standard requirements and ad-ditional useful information. A consistent set of columns is used for this purpose throughout this section:

Requirements of theISO 9001:2008

Interpretation/Activities Documentary examples/Conformity evidence

Practical hints for sustained

success (ISO 9004:2009)

Examples of keyindicators

Explanations of the table columns

1 Requirements of the ISO 9001:2008

The requirements are listed by keywords, not the full wording. This facilitates work in practice, but it does not sub-stitute for knowledge of the original text of the standard.

2 Interpretation/Activities

This column explains what is meant by the requirement and/or which activities are needed, for example, for prac-tical implementation of the requirement.

3 Documentation examples/Conformity evidence

This column contains examples of documentary evidence which enable fulfillment of the requirements of the stan-dard to be verified.

4 Practical hints for sustained success (ISO 9004:2009)

This column lists additional aspects of ISO 9004:2009 which can be considered for systematic,continual improve-ment of the organizations overall performance.

If there is no information in this column, ISO 9004 has nothing further to add to this aspect. Conversely, ISO 9004contains aspects for which there are no equivalents in ISO 9001.

5 Examples of key indicators

This column lists practical examples of key indicators. These examples provide guidance, but should not be as -sumed to cover all aspects.

The following table uses an asterisk (*) after headings to indicate that the standard requires objective evidenceof the fulfillment of this requirement (records).

Two asterisks (**) indicate that the corresponding procedure must also be documented.


13/13


12 TV Media GmbH

Clause 4: Quality Management System

Requirement

ISO 9001:2008

Interpretation/

Activities

Documentary

examples/Confor-

mity evidence

Practical hints for

sustained success

(ISO 9004:2009)

Examples of

key indicators

4.1 General requirements

Process identification

Process sequence and

interactions Process management

Process resources

Process monitoring

Process improvement

Establishment of acustomer-focused organi-zation by definition and repre-

sentation of appropri-ate and understandableprocesses, their se-quence and interac-tions

definition of efficiency

criteria consideration of type,

scope and manage-ment of excluded pro-cesses

with the objective ofprogress in the organiza-tion

Quality manual

Process/procedure in-structions and otherapplicable documents

Process flow diagrams

Management review

Investment plans

Action plans

Organization charts

Self-assessments

Analysis plans

Test plans

Application of the

8 QM principles (4.1,Annex B), in particu-lar the process approach

and the system approach

to management(7.1)

Development of the

QM system with theobjective of efficient use of

resources decision-making

based on facts consideration of all

relevant interestedparties, not justcustomers (4.1)

regular process review

and improvement (7.1)

Process quality

Process performance

Process time

Process costs

Process flexibility

Operating margin

Profit/Loss

Benchmarking (rank-ing)

Degree of target speci-fications fulfillment

Capacity figures (re-sources)

4.2 Documentation requirements

4.2.1 General

Quality policy

Quality objectives

Quality manual

Process documenta-tion

Quality records

Definition of docu-mentation for efficientoperation of the QMsystem and processes byconsidering

contractual require-ments and other cus-tomer requirements

laws and standards

Corporate strategy

wishes of other inter-ested parties

for implementing qualitypolicy and achievingthe quantified qualityobjectives.The documentationshould be compilatedconsidering the follow-ing:

Functional efficiency User-friendliness

Resources required

Information manage-ment

Interfaces to custom-ers, suppliers and oth-er interested parties

Quality manual with Justification of exclu-

sions Process environment

Quality objectives for

specific areas, backedby key indicators

Process/procedure in-structions

Commitment for con-tinual improvementand review

Intermediation in the

organization Description of interac-

tions Test plans

Process flow diagrams

Drawings

Organization charts

Order records Production documen-

tation Logs

Checklists

Test records

Capability evidence

documents Declarations of con-

formity Other documented ev-

idence of conformitywith requirements

Note:ISO 9004 provides nospecifications for docu-mentation of the qualitymanagement system

Time/cost for docu-mentation revisions

Time/cost for informa-tion research

Content preparation

and maintenance costs Distribution costs

Intervals for checking

Archiving period and

costs Coordination effort

Handling effort

iso intrepretation of req

Documents