ISO 9001 Training
Understanding ISO 9001:2008
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ISO 9001 TrainingUnderstanding ISO 9001:2008
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8 Measurement, Analysis and Improvement 8.4 Analysis of Data The organization shall determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data shall provide information relating to: a) customer satisfaction (see 8.2.1), b) conformity to product requirements (see 8.2.4), c) characteristics and trends of processes and products, including opportunities for preventive action (see 8.2.3 and 8.2.4), and d) suppliers (see 7.4). |
ISO 9001 Training - Key
Explanation Points and Tips:
It is amazing
how many organizations have wonderful systems for collecting data, but do a poor job in sorting, summarizing and
presenting this data for decision-making. You must sort and summarize the data you collect into TGR and TGW (things
gone right and things gone wrong) and present them separately. Management can then focus on continual improvement
of TGR and take corrective action on TGW.
You must collect and analyze QMS data that relate to the effectiveness and efficiency of
products; services; QMS processes; production output; supplier performance; use of resources; cost of poor quality;
customer satisfaction; etc. Do year over year trend analysis to determine longer-term progress, identify
opportunities for further improvement or prioritize correction action for negative
trends.
Your process for data collection and analysis
must address the type of data to be collected; how it should be sorted and classified (remember TGR and TGW); use
of appropriate information systems and data gathering tools and techniques; assignment of responsibility and
authority to review and act; competency and training in use of tools and data analysis; that the data is gathered,
analyzed and acted upon on a timely basis.
A summary of QMS performance data must be included in your periodic management review
(see clause 5.6).
Compare trends in quality and operational
performance against your business plans; competitors and industry benchmarks, where practical. Focus on key
customer-related trends to prioritize prompt solutions to problems; to determine longer-term planning for
performance improvement; and to enhance customer satisfaction.
Performance indicators to measure the effectiveness of processes for data collection and analysis may
include - reduction in cycle time to gather and evaluate data; reduction in inaccurate and incomplete data;
increase in improvement opportunities obtained from data analysis; etc.