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Showing posts from July, 2016

Important steps to start implementing Risk management in the QMS

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What are the important steps to start implementing Risk management in the QMS? It is important to accept that the main task of the initial implementation of risk management in the QMS - making actions to address risks and opportunities an integral part of management decision-making at all levels .  Then the keyword is " simplicity ". Implementation of risk management into the QMS processes (ISO 9001:2015 cl.4.4.1.f, cl.6.1 and step " Do " - ISO 31000) consists of four phases: Risk identification , Risk analysis, Risk evaluation, Risk treatment. 1) Risk identification consists of finding, recognizing and describing the risk. The ultimate objective of risk identification is to draft a comprehensive Risk list. At this phase, the following is important: •       A common approach to risk wording for all processes. A good practice is to word the risks through the "Event" category - an adverse event that may occur with some likelih...

Control of nonconformities in provision of services

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Control of nonconformities in provision of services often causes additional questions.   The new documented procedure QSP 8.7-02 regulates the execution of ‘Control of nonconformities in provision of services’ process in relation to the QMS of Organizations that specialize in the provision of services.   The Procedure describes the implementation of ISO 9001:2015 requirements, which often cause issues when applied to the services: ensuring the identification of nonconformities, conducting correction, including the possibility of suspension of the service provision, communicating the nonconformity to the customer, follow-up, including the analysis. More information about the QSP 8.7-02 Control of Nonconformities in Provision of Services   The diagram of ‘Control of Nonconformities in Provision of Services’ process is shown below: Inputs 1 - Nonconformity Outputs 2 - Nonconformity protocol 3 - Information a...

Employees' Awareness (ISO 9001:2015 Cl. 7.3)

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The organization shall ensure that relevant persons doing work under the organization’s control are aware of: c) their contribution to the effectiveness of the quality management system, including the benefits of improved performance; ISO 9001:2015 Cl.7.3.c I am looking for ideas on how to implement the requirements referenced above.  How do you communicate to your employees that their efforts contribute to the success of the company in a way that everyone will understand? A good practice is to form quality objectives at the subdivision level based on the principle of expanding the strategy and policy chain: The quality objectives of the subdivision consists of two components: 1) Subdivision objectives to implement Annual organization development program; 2) Objectives to develop and improve subdivision activities. In this case, the analysis of subdivision quality objectives fulfillment means the analysis of the subdivision employees’...