CBG Inc. - Management System Professionals Support

When developing and implementing a QMS, quality managers often ask themselves these questions: Is this procedure mandatory?  Do I need to maintain those records? What are the documents required by ISO 9001? The new version of ISO 9001:2015 does not make the life of quality manager any easier stating that is it up to the Organization to choose what document should be considered mandatory. It is manager's job to establish and implement controls and ensure there is continual improvement. In the absence of specific guidance in performance standards (required procedures, records, or schedules) it is essential that management be able to demonstrate conformance to requirements. It is especially important when preparing for the audit (both internal and external). It is a good practice to maintain Quality Manual and Quality Standard procedures as documented information. More on Auditing for control and improvement - in the corresponding article by J.P.Russel ISO 9001:...

When implementing 14001 within existing 9001 should both systems - QMS and EMS be implemented as separate ones with separate documentation, or may EMS be included as one of QMS processes?  For example, may I have one internal audit procedure, internal audit plan and carried out integrated internal audit for both QMS AND EMS? Have one Management Review for both systems? Can I just build one system describing both standards? What is the common practice for integrated systems – how do you do it?  (We are planning to implement 27 001 and 20 000 eventually as well…) Integration of standard management systems, including 9001 and 14001 is not only possible, but also necessary! The most recent versions of Management Standards have identical structure namely for the integration purposes. All these makes the integration fairly simple. While integrating, ‘ including EMS as one of QMS processes ’ is not the best approach. It is better to build one system describing bot...

Emerging digital technologies, increasing competition and changing customer demands put extra pressure on the businesses. In order to survive in the digital age, companies have to adapt to the changes and modify their operations through digital transformation. While adapting new elements of digitization, the organization should bear in mind that that in order to achieve financial success, the investment into the digital transformation has to be combined with the clear vision of the process, careful coordination, engagement, and leadership. For more digital transformation information, its benefits, potential pitfalls and ways to reach the competitive advantage, refer to The Advantages of Digital Maturity ISO 9001:2015 does not directly require the organization to undergo digital transformation , though some of  ISO 9001:2015 requirements are aligned with it. MIT Sloan School of Management identifies 9 areas of digital transformation . Let’s review them with regards to the...

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...