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Recently ISO has published a new document that is intended to help users with Quality management system implementation: ISO/TS 9002, Guidelines for the application of ISO 9001:2015 . The new document contains practical ISO 9001:2015 clause-by-clause guidance real life examples additional QMS implementation tips ISO/TS 9002, Guidelines for the application of ISO 9001:2015 is suitable for any organization, regardless of its size. ISO 9001:2015 QMS Transition Program Checklist Other ISO 9001:2015 Documents and Templates Free downloads ISO 9001:2015 QMS Implementation program

What was the rational behind TC 176 changing from Control of Monitoring and Measuring Devices to Monitoring and Measuring Resources? It is obvious, that TC 176 made the change to the ISO 9001:2015 to include all components of Monitoring and Measuring to the Quality Management System. ‘Control of Monitoring and Measuring Resources’ process includes 4 sub processes: • Creating data for monitoring and measuring; • Control of Monitoring and Measuring Devices (ISO 9001:2008 requirements were relevant to this sub process only ) • Control of monitoring and measuring methodologies; • Training of personnel who conducts monitoring and measuring. This approach has been implemented in our quality system procedure QSP 7.1-02 Control of Monitoring and Measuring Resources .

We have added a new Procedure to our ISO 9001:2015 QSP collection: Control of Infrastructure . This QSP regulates the execution of ‘ Control of Infrastructure ’ process as part of Organization’s resources, including: Defining the required infrastructure;  Ensuring the availability of infrastructure;  Maintenance of the infrastructure. QSP requirements apply to Technical director activities;  Maintenance manager service;  IT manager activities;  Quality management system (QMS) process owners activities, including ‘Production and service provision' process.  ‘Control of Infrastructure’ process model diagram is displayed below: Free download : Control of Infrastructure QSP Preview .PDF that contains the Process Model diagram and process flows description. The following Quality System forms are included with the Procedure purchase: QSF 7.1-02-01 Infrastructure object Commissioning certificate  QSF 7.1-02-02 Annual routine...

Question:  1. Which ISO 9001:2015 clause refers to the change management in the Process ?    Answer: Speaking about ISO 9001:2015 clauses that refer to the Change in process, first of all we should point out the clause 6.3 Planning of changes . This clause even has a reference to clause 4.4 on the process approach implementation. The requirements of cl.6.3 apply to all QMS processes . In addition to that, ISO 9001:2015 contains requirements to manage changes in particular processes: 8.2.4 Changes to requirements for products and services – relevant to ‘Contract analysis’ process. 8.3.6 Design and development changes – relevant to ‘ Design and development of products and services ’ process. 8.5.6 Control of changes – relevant to ‘ Production and service provision ’ process. Question:  2. What are the minimum requirements to notify a customer regarding the change? Change include: change in process change in machine deviation from approved ...