Management System Professionals Support | CBG Inc.

What are the new things - which you ignored about your Quality Management System - did/does the new edition of ISO 9001:2015 teach you? Our experience in consulting the transition of the organizations to the new version of ISO 9001:2015 showed that the main « new things that were previously ignored » are the following four . 1. System-level analysis of internal and external context of the Organization.     1.1 Gathering information and analysis of the Context components in the following processes : ‘Management review’, ‘Marketing’, ‘Control of personnel’, ‘Design and development or products and (or) services’, ‘Production and service provision’, ‘Control of documented information’.    1.2 Distribution of information about the context internally in the Organization within the framework of control of organizational knowledge and documented information    1.3 Use of information about the context in QMS processes when planning and making manageme...

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...

Q: ISO 9001:2015, does it require a documented risk register ?  Will it become a requirement, indirectly?  I plan to identify and review all risks and opportunities in the MRM but still unsure about maintaining a separate register (document).  A: 1. ISO 9001:2015 does not require neither development, nor maintenance of a Risk register . Risk register is a part of risk management methodology. Risk register development is a good practice, but not the Standard requirement. Risk- based thinking initiates the consideration of multi-variant approach in decision-making. It may be represented as a possibility of the expected result offset into a negative or positive part of a certain ‘scale’ depending on disturbances in the result achieving process. Usually, the ‘ risk register ’ development includes three stages : 1) risk formulating (naming the possible disturbances); 2) risk identification (digitization), as a rule, the negative consequences are considered; 3) ris...

Here are some of Key Risks Wording for the 'Control of Personnel' Process: suboptimal personnel competence (including education, confirmed qualification, additional training, work experience);  inadequate system of motivation and stimulation;  lack of employee awareness ... And some of the Risk Treatment areas : correction of procedures for determining the necessary expertise;  correction of hiring procedure, including New employee orientations;  use of mentoring;  ... More Key Risks Wording and Risks Treatment areas in Risk Management in QMS Processes Quick Reference Guide Download the Risk Management in QMS Processes Sample Slides and use them in your ISO 9001:2015 internal auditor and personnel training. Other 9001:2015 documents and templates

ISO 9001:2015 requires to address the risks and opportunities in each process of the QMS. The principal questions of risk management are: Key Risks Wording and  Risk Treatment Areas    Here are some of Key Risks Wording for the ' Management Review ' Process: failure to achieve strategic goals;  failure to fulfill quality objectives;  slowdown in company activity performance indicator growth;  undesirable and not timely recognized QMS changes ... And some of the Risk Treatment areas : regularity and depth of Context of Organization analysis, communication and consideration for the decision-making;  analysis and review of QMS processes resources, including resources for monitoring and measuring;  improvement of planning methods ... More Key Risks Wording and Risks Treatment areas in Risk Management in QMS Processes Quick Reference Guide Other 9001:2015 documents and templates

A complete list of Risk Management Requirements Implementation in ISO 9001:2015 Clauses Objects of Control Subjects of Control Recommended Regulatory document (if provided in the Standard) Download Free Presentation also available in table format