ISO 9001:2008

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Januar 2011



This publication was initially developed to support the TÜV Rheinland auditors in performing their audits. The report contains the requirements of ISO 9001:2008 listed in a table and is providing answers to the following questions:

· What needs to be done by the organization to meet these requirements?

· What documentary evidence is required?

· What does ISO 9004:2009 recommend to improve performance and efficiency?

· What are the key factors that indicate continual improvement and customer satisfaction?

The main benefits of this publication are the clear layout, the concise contents and the high practical relevance. It is particularly suitable to prepare for internal and external audits as well as to develop quality management systems to a higher level. Moreover, it is ideal for those who want to get a first impression of the requirements of ISO 9001:2008.


By purchasing the e-book, you will acquire a single-user license (for a PC) and will be permitted to make a printout. The document bears a personalized imprint showing the data of the customer. If you want to purchase a multi-user license, please contact Uwe Lingscheid, phone +49-221-806-3516,


1;ISO 9001:2008 - Interpretation of Requirements;1 2;Impressum;2 3;On the use of this publication;3 4;Table of contents;5 5;A ISO 9001:2008 An introduction;6 5.1;1 General;6 5.1.1;1.1 Development of the standard;6 5.1.2;1.2 Application of the standard;6 5.1.3;1.3 Exclusion of requirements;6 5.1.4;1.4 The importance of the standard for the organization;7 5.2;2 Compatibility with other standards;7 5.3;3 Process approach and interactions;7 5.4;4 Quality management principles;8 5.4.1;Fig. 1: ISO 9001:2008 process model;9 5.4.2;Fig. 2: Example of a process flow chart;9 5.4.3;Fig. 3: Example of interactions between the processes;10 5.4.4;Fig. 4: Excerpt of a flow chart for work processes;10 5.5;5 Practical hints for sustained success;11 5.6;6 Continual improvement via key indicators;11 5.7;7 Customer satisfaction;11 5.8;8 Adaptation of existing quality management systems;12 5.9;9 Required documentation for the management system;12 6;B Table for interpretation of the requirements;13 6.1;Explanations of the table columns;13 6.2;Clause 4: Quality Management System;14 6.2.1;4.1 General requirements;14 6.2.2;4.2 Documentation requirements;14;4.2.1 General;14;4.2.2 Quality manual*;15;4.2.3 Control of documents*/**;15;4.2.4 Control of records*/**;15 6.3;Clause 5: Management responsibility;16 6.3.1;5.1 Management commitment;16 6.3.2;5.2 Customer focus;16 6.3.3;5.3 Quality policy*;17 6.3.4;5.4 Planning;17;5.4.1 Quality objectives*;17;5.4.2 Quality management system planning;18 6.3.5;5.5 Responsibility, authority and communication;18;5.5.1 Responsibility and authority;18;5.5.2 Management representative;18;5.5.3 Internal communication;19 6.3.6;5.6 Management review;19;5.6.1 General*;19;5.6.2 Review input;19;5.6.3 Review output;20 6.4;Clause 6: Resource management;20 6.4.1;6.1 Provision of resources;20 6.4.2;ISO 9004:2009, Section 6.2: Financial resources;21 6.4.3;6.2 Human resources;21 6.
4.3.1;6.2.1 General;21;6.2.2 Competence, training and awareness*;22 6.4.4;6.3 Infrastructure;22 6.4.5;6.4 Work environment;23 6.4.6;ISO 9004:2009, Clause 6.7: Knowledge, information and technology;23 6.4.7;ISO 9004:2009, Clause 6.8: Natural resources;24 6.5;Clause 7: Product realization;24 6.5.1;7.1 Planning of product realization;24 6.5.2;7.2 Customer-related processes;25;7.2.1 Determination of requirements related to the product;25;7.2.2 Review of the requirements related to the product*;25;7.2.3 Customer communication;26 6.5.3;7.3 Design and development;26;7.3.1 Design and development planning;26;7.3.2 Design and development inputs*;27;7.3.3 Design and development outputs;27;7.3.4 Design and development review*;28;7.3.5 Design and development verification*;28;7.3.6 Design and development validation*;28;7.3.7 Control of design and development changes*;29 6.5.4;7.4 Purchasing;30;7.4.1 Purchasing process*;30;7.4.2 Purchasing information;30;7.4.3 Verification of purchased products;31 6.5.5;7.5 Production and service provision;31;7.5.1 Control of production and service provision;31;7.5.2 Validation of processes for production and service provision*;31;7.5.3 Identification and traceability*;32;7.5.4 Customer property*;32;7.5.5 Preservation of product;32 6.5.6;7.6 Control of monitoring and measuring equipment*;33 6.6;Clause 8: Measurement, analysis, improvement;34 6.6.1;8.1 General;34 6.6.2;8.2 Monitoring and measurement;34;8.2.1 Customer satisfaction;34;8.2.2 Internal audit*/**;35;8.2.3 Monitoring and measurement of processes;36;8.2.4 Monitoring and measurement of product*;36;ISO 9004:2009, Clause 8.3.4: Self-assessment;37;ISO 9004:2009, Clause 8.3.5: Benchmarking;37 6.6.3;8.3 Control of nonconforming products*/**;38 6.6.4;8.4 Analysis of data;38 6.6.5;8.5 Improvement;39 6
.6.5.1;8.5.1 Continual improvement;39;8.5.2 Corrective action*/**;39;8.5.3 Preventive action*/**;40;ISO 9004:2009, Clause 9.4: Learning;40 7;Annex: Correspondences between ISO 9001:2008, ISO 9004:2009, ISO 14001:2004 and OHSAS 18001:2007;41


2 Compatibility with other standards (S. 5-6)

After the revision of ISO 9004 in 2009, both standards are similar in structure but are not a “consistent pair of standards” as before. The standards complement each other but can also be applied independently. Whereas the focus of ISO 9001 is primarily on customers, ISO 9004:2009 covers requirements and expectations of all relevant interested parties (customers, suppliers, employees, owners/shareholders, the public, etc.) and provides guidance to systematic, sustained improvement of the organization’s 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 community. The table in the annex of this publication provides an overview of how the requirements of ISO 9001:2008 correspond to the requirements of other management system standards such as ISO 14001 and OHSAS 18001 (occupational 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 operate effectively, organizations must identify, define and control the interactions of processes associated with one another. 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 referred to as a “process approach” and must be implemented by the organization. ISO 9001:2008 supports this process approach to quality management. Figure 1 shows the ISO 9001:2008 process model.

The organization’s top management defines the requirements and takes responsi
bility for implementation and application of the requirement (Clause 5 of the standard); the means necessary are defined and deployed under a “Resource management” (Clause 6 of the standard); processes with their interactions are developed and applied according to the “Product realization” (Clause 7 of the standard); the results are determined and analyzed under “Measurement, 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 for approving changes to the QM system or initiating improvements.

For Product realization, it is very importat that customers and other interested parties clearly define their requirements for the product. Process management handles all processes required for implementing the product and verifies or validates the process results. Measuring of the satisfaction of customers and other interested parties provides Cointinual measurement of customer satisfaction reinforces the trust of customers in the organization’s ability to deliver quality. It is an important condition for documenting continual improvement. Efforts regarding these requirements 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. Examples 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 some of 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, the potentially motivated employees are tending to support a process of continual improvement for increasing customer satisfaction."
EAN: 9783824914951
Untertitel: Interpretation of ISO 9001:2008-12 requirements with consideration of ISO 9004:2009, 6th revised eddition 2011. Sprache: Englisch. Dateigröße in MByte: 1.
Verlag: TÜV Media GmbH
Erscheinungsdatum: Januar 2011
Seitenanzahl: 44 Seiten
Format: pdf eBook
Kopierschutz: Wasserzeichen
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