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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...

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’...

This Methodical Manual summarizes 15 years of field risk management experience at the workplace. For the organization, the regulatory framework for actions to address risks and opportunities in the Quality Management System (QMS) consists of: ISO 9001:2015 cl.6.1 requirements - relevant to the entire QMS , ISO 9001:2015 cl.4.4.1.f requirements - relevant to the process , ISO 31000 Guidelines - relevant to the entire QMS . Based on the good industrial practice, it is advisable to carry out actions to address risks and opportunities on two levels and, therefore, describe them in two documents. >>Level 1 - the entire QMS Document 1 - QSP 6.1-01 ‘Actions to address risks and opportunities’ Describes risk management process, including four sub-processes:  - ‘Planning of actions to address risks and opportunities. Project of risk management framework’;  - ‘Integration and implementation of actions to address risks and opportunities in...

Procedures vs . Work Instructions I was recently working with a process owner to modify one of his procedures. And part of the conversation was that, in my opinion, his procedure looked more like a work instruction. He felt that those details were necessary to perform the job and my answer was that those could be written in a work instruction for the specific task. What has been your experience in this situation? Many spears were broken when arguing on this comprehensive issue. Here below we express only an opinion. 1. It is not a good idea to argue about terminology, but worth agreeing upon it . This fully applies to the names of the QMS documented information. Each organization sets its own documented information ‘pyramid’. The requirements of ISO 9001:2015, as well as the 2008 guidelines of ISO 10017 and the recommendations 176 TC reports give full freedom to the organization. Therefore, it is better not to talk about the requirements, but better about good pra...

Marketing Quality System Procedure regulates the operation of the ‘Marketing’ process in compliance with ISO 9001:2015 . The QSP ensures relationship with other QMS processes and interested parties , as well as obtaining information for understanding the context of the organization and creation of a database for obtaining and maintaining of the organizational knowledge . This procedure’s requirements apply to the marketing department and/or persons performing marketing activities. ‘Marketing’ process model diagram is displayed on Fig. 1.   Please refer to the QSP 8.1 Marketing Preview.PDF full description of process Inputs . Information to understand the context of the organization is obtained in the course of ‘Marketing’ process and includes information about the internal and external issues . External issues information includes the results of the analysis of : political and legal issues,  economic issues,  demographic issues, en...

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...