CBG Inc. - Management System Professionals Support

We listen to our customers' feedback and continuously improve our products. ISO 9001:2015 QSP 6.1-01 Actions to Address risks and opportunities has been recently updated. We have added 8 quality system forms relevant to the procedure: QSF 6.1-01-01 Risk management plan QSF 6.1-01-0 2 Risk criteria QSF 6.1-01-03 Risk List QSF 6.1-01-04 Risk treatment plan { .PNG preview } QSF 6.1-01-05 Risk Owner to Process Owner and to Risk Manager Report on the results of monitoring and review of risk management process, including improvement proposals.{ .PNG preview } QSF 6.1-01-06 Risk Manager to Quality Manager Current Report on the results of addressing risks and opportunities in QMS Processes. QSF 6.1-01-07 Risk Manager to Company Management information report on the productivity of the ‘Actions to address risks and opportunities’ Process QSF 6.1-01-08 Risk Manager to Company Management annu...

Question:  1. How and when to use Audit checklist?    Answer: 1.1 Internal auditors training  When utilized for internal auditors training, our ISO 9001:2015 Audit checklist : provides a complete understanding of how to verify compliance with the requirements of all ISO 9001:2015 clauses ; can be used as practice for internal auditors workshops.  1.2 Mandatory ISO 9001:2015 staff training  When conducting the mandatory ISO 9001:2015 staff training Audit checklist : Facilitates understanding of ISO 9001:2015 requirements; Allows every employee to check his/her activity performance in compliance with the new requirements of ISO 9001: 2015.  1.3 QMS transition to the ISO 9001:2015 version  Use Audit checklist as a guide in the QMS transition to the ISO 9001:2015 version applying ‘fill the gap’ methodology in four phases: Conduct internal audit based on our 9001:2015 Audit checklist.  Formalize the identified nonconfo...

How do you prove you meet the requirements of Clause 4.1 of ISO 9001:2015? The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review information about these external and internal issues. ISO 9001:2015 Cl.4.1 Information monitoring and internal and external issues components analysis are carried out in the QMS processes. 1) ‘ Marketing ’ process.  Information about external issues includes results of the analysis of political and legal issues, economic issues, demographic issues,  environmental issues,  cultural and scientific issues,  information from consumers, information from competitors,  information from external providers,  information from contact audiences, information from marketing intermediaries....

The Quality manual and the documented procedures regulate the activities necessary and sufficient to meet all the requirements of ISO 9001:2015. This is the main purpose of the procedures. Quality system forms are created by the decision of the Organization. We have updated some of our procedures with the Quality System Form templates.   QSP 7.1-01 Control of personnel : Annual training plan  Training efficiency evaluation sheet Talent search form  QSP 7.5-01 Control of documented information Master List of Documents  Master List of Records  QSP 8.7-01 Control of nonconforming outputs Nonconformity protocol  Hold Tag  QSP 9.3-01 Management Review MR meeting agenda MR meeting minutes QSP 10.2-01 Corrective actions CAR form CAR list

Question:  Can we conclude that System audit can/may include Technical audit since technical expert may be required during a System audit (1st, 2nd or 3rd party) as per ISO 19011? Technical Audit is an audit performed by an auditor, engineer or subject matter expert.  Technical audit covers the technical aspects of the project implemented in the organization  System Audit 1st Party - An internal audit that an organization performs on itself.  2nd Party - An external audit that an organization performs on a supplier of goods or services.  3rd Party - An external audit that is conducted by an independent organization upon another organization.   Answer:  1. Planning, conducting, analysis and improvement activities of Technical audit can be a part of the Internal audits program (1st party). 2. Results of Technical audit should be taken into account when planning the scope of the 2st party audit. 3. Technical audit can not cha...