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Showing posts from June, 2016

Certification of Suppliers

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If a Company is ISO 9001 certified, is it mandatory for the Supplier of the materials to have the ISO 9001 in place or the Company’s certification is sufficient. There are three available options . 1.     Option #1 – to evaluate supplier of a particular material in accordance with the Supplier evaluation methodology established in the the Organization at specified intervals, for example, annually . 2.     In case the Supplier becomes permanent by the decision of the Organization leadership to transfer the production process of a particular material to the external provider, the second and/or third options could be chosen. 2.1. Option #2 - conduct 2 nd party annual audit of the supplier utilizing the resources of the Particular material production process Quality Assurance System internal auditors. This System should include the supplier processes that directly affect the quality of the particular material (this is – the 2 nd pa...

ISO 9001 based QMS Key Performance Indicators

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ISO 9001:2015 requires to determine objects for monitoring and measuring to determine the performance and effectiveness of the QMS. The term Key Performance Indicator (KPI) refers to the chosen measurements. Some examples of commonly used KPIs are given in Mark Hammar's article How to define Key Performance Indicators for a QMS based on ISO 9001 : 'First Pass Yield : What percentage of your product or service is acceptable the first time it is created? If you have a high rework cost, a focus on this might help improve the processes of your QMS. Downtime : Are there problems with equipment maintenance and unexpected service outages? Downtime could be useful for you to track and improve. Reject Ratio : Like first pass yield this focuses on non-conforming product and if it is within an expected/acceptable rate. Many companies try to improve in this area, and understanding the performance is the first step. Customer Satisfaction : One of the most important measures fo...

Using Knowledge as a Resource

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New quality system procedure has been added to the ISO 9001:2015 documents and templates collection - Control of Organizational Knowledge . QSP describes the organization activity to implement the new requirements of ISO 9001:2015 of using the knowledge as a resource for the QMS processes. QSP regulates the implementation of the ‘ Control of organizational knowledge ’ process, which aims at transforming the internally and externally sourced information flows into the Organization’s knowledge bank. The process involves four stages: definition of the necessary knowledge ;  creation of the organization knowledge bank ;  maintaining and providing access to knowledge ;  QMS processes improvement through acquired knowledge.  ‘Control of organizational knowledge’ process model diagram is displayed in the diagram below.   Download a free PDF preview of the QSP that contains the Process model diagram and the detailed description of the Process i...