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Example of iso 9000

Example of iso 9000



Example of iso 9000

Example of iso 9000



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    Example of iso 9000 Example of iso 9000 Document Transcript

    • Example of iso 9000IntroductionOne of the requirements of ISO 9001:2000, specified in the paragraph 4.2.2 c), requires acompany to develop a quality manual that, among other attributes, shall contain "adescription of the interaction between the processes of the quality management system."Through my experience, as a professional auditor, with dozens of companies around theworld, I found that very few businesses had developed practical approaches to addressthis requirement. Attempts to document process interactions range from busy and hard toread flow charts to establishing cross-reference tables in the quality manual. I observedone of the best tools to address process interaction requirement at Quality Works, a smallon-line publishing company.Initiation of the projectQuality Works, a small Internet-based publishing company, has set a goal to establishcompliance with ISO 9001:2000 standard. The Management Team assigned thecompanys Business Manager to develop and implement documentation to address newrequirements of the standard. While most of the new requirements were simply addressedthrough preparation of the corresponding procedures and work instructions,documentation of the interaction of the processes created some difficulties. Attempts todocument interaction of processes through traditional flow-chart resulted in a hard to readbusy document that did not impress the management team.BrainstormingTo address this issue, the management group conducted a brainstorming session to searchfor a new tool. The group determined that there were two types of the processes:processes related to product realization and processes related to the management systemas follows:Business management processes:- Documentation management- Management review- Internal audit program- Non-conformity and Corrective & Preventive Action (NC-CAPA) System- Communication- Resource management- Record management- Information technology
    • Product realization processes:- Market analysis- Product design- Verification- Validation- Product release- Order processing- Product delivery- Customer satisfaction- Continual improvementIdentification of process interactionsAnalyzing system and product realization processes, the management team concludedthat virtually all system processes are interrelated. For example, management review mayreceive inputs from corrective actions, communication, internal audits, etc. Internal auditprocess receives inputs from all processes within the company and provides feedback orinput into all those processes.Product realization process was found to be more linear than system processes. Forexample, results of the market analysis initiate product design. Product design leads toverification. If verification is successful, validation of the product takes place. Validationof the product results in product release and finally communication regarding availabilityof the product. Customer satisfaction and continual improvement close this sequence witha possibility of providing inputs into Product delivery, Order processing, Product release,etc.To document process interactions, the company elected two tools. The first, top-leveldefinition of the process interaction was documented in the Process Interaction Matrixshown in Figure 1 (see links below). The second tool was a well-known technique offlow-charting for those processes that required graphical illustration.AfterwordUse of the Process Interaction Matrix at Quality Works proved that it is a helpful concisemethod of defining and documenting interaction of processes for an ISO 9001:2000quality management system. Based on our experience, we also realized that the samematrix might be successfully used for other standards requiring definition of theinteraction of the processes, such as ISO 13485:2003, ISO/TS 16949 [3] and others.AcknowledgmentsThe author would like to express his gratitude to Maria Allen, the President of QualityWorks, for her willingness to conduct and publish this case study.
    • References[1] ISO 9001:2000 Quality management systems - Requirements[2] ISO 13485:2003 Medical devises - Quality management systems - Requirements forregulatory purposes[3] ISO/TS 16949 Quality management systems - particular requirements for theapplication of ISO 9001:2000 for automotive production and relevant service partorganizations.If you want to download over free 50 ebook for iso 9001 standard, you can visit:http://iso9001ebooks.infoBest regards