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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 ...

ISO has released the 2015 Survey report, that provides data on the total certifications to ISO 9001, ISO 14001 and other management standards across the world. A free copy can be downloaded from ISO website. 2015 numbers: Total of Standards that were surveyed: 9 (ISO/IEC 20000-1:2011 Information technology – Service management – Part 1 Service management system requirements has been added in 2015). Total Certificates issued worldwide: 1,519,952  - a 3% increase compared to 2014. Companies that are currently certified under ISO 9001:2008 should be looking at re-certification now even if their certification doesn't run out until 2018. Better to be prepared than run into issues during review time.  Our ISO 9001:2015 documents and templates will help you with re-certification !  20% off the complete set of ISO 9001:2015 Quality System Procedures in October -November 2016  

We listen to our customers' feedback and continuously improve our products. ISO 9001:2015 QSP 8.2-02 Contract Analysis has been recently updated. We have added 8 quality system forms relevant to the procedure: QSF 8.2-02-01 Contract(s) to deliver products (services). QSF 8.2-02-02-a Disagreements protocol(s) ( .PNG preview ) QSF 8.2-02-02-b Amendment agreement(s) (if necessary); QSF 8.2-02-03 Reconciliation sheet(s). ( .PNG preview ) QSF 8.5-01-02 Certificate of acceptance/transfer.   Save 20% on the Complete set of ISO 9001:2015 quality system procedures Other ISO 9001:2015 Documents and Templates 

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...

Question:   Some of the current controls we have are "Customer requirements", PFMEAs, DFMEAs, Six Sigma, etc. Would those count as being part of the COTO?  We also go over these types of changes during management reviews.   Answer:  It goes without saying that, the results analysis during implementation of PFMEAs, DFMEAs, Six Sigma, etc. are part of meeting the requirement «The organization shall monitor and review information about these external and internal issues.» (Cl. 4.1 Understanding the organization and its context, ISO 9001: 2015). Understanding the organization and its context can be effectively combined with the control of organizational knowledge that is described in the QSP 7.1-03 Control of Organizational Knowledge . Free downloads:  PFMEA and DFMEA templates  Preview of Control of Organizational knowledge quality system procedure

'The organization shall retain documented information that: a) describes the nonconformity; b) describes the actions taken; c) describes the concessions obtained; d) identifies the authority deciding the action in respect of the nonconformity.' ISO 9001:2015 cl.8.7.2 Q: Does the requirement 8.7.2 of ISO 9001:2015 mean that EVERY Nonconforming output must be recorded?  Even if it is just corrected (as allowed)?  This could become a rather overloaded list of Nonconforming outputs.   A: Yes - EVERY Nonconforming output must be recorded , at least for two reasons. 1. Information about all nonconformities is essential for analysis and improvements. Otherwise, there is a risk to 'sink' in the pool of tiny nonconformities. The issue is not the recording itself, but the consequences of nonconformities. 2. It is impossible to word and regulate a clear distinction between the phrases ‘ A nonconforming output that must be recorded ’ and ‘ A nonconforming o...

How to address ISO 9001:2015 clause 6.3 (Planning of changes)? Could you provide risks and opportunities examples or references for small companies? Planning of changes (cl.6.3 in ISO 9001:2015) is carried out as part of the Management review by the Coordinating Council or an equivalent.  The First leader, area managers including Quality manager are part of the Council.  Decisions on changes are recorded in the Minutes as the Coordinating Council decisions (for minor changes), or implemented based on individual projects. It is expedient to describe the planning of changes in sec. 6.1 of Quality Manual . Wherein it is necessary to pay attention to the following: Sec. 6.1.a. Objective and Rationale of changes are worded by the Initiator, usually a Quality manager. The potential consequences of changes are reviewed in the form of risks and opportunities assessment for examples in accordance with MM 6.1-01-01 Actions to address risks and opportunities in QMS processes...

Q: I'm putting together a quality risk register for our business and looking for some examples other people have used for their definitions of ' high ', ' moderate ' and ' slight ' risk.  For example, ' high ' risk could be:  major financial loss to business,  major loss of company reputation,  complete break-down of management system,  loss of accreditation.    A: The examples above refer to the high consequences wording. At Risk analysis and Risk evaluation phases, it is necessary to take into account likelihood , a mandatory risk component. Major financial loss to business, major loss of company reputation, complete break-down of management system, loss of accreditation – all these examples could be attributed to the ' slight ' level of risk when likelihood is close to 0 . Based on our experience, the risks in the Risk list should be worded in terms of an ‘event’ – an adverse event that may occur with a certain likelihood...

Can a company afford errors in our highly competitive world? 'A company with a highly developed culture of quality spends, on average, $350 million less annually fixing mistakes than a company with a poorly developed one.' The pressure is rising, so is the possibility of making a mistake. The quality-improvement studies helped identify the Essentials areas and actions that will help companies improve in each area.  They four essential quality areas are: leadership emphasis,  message credibility,  peer involvement, and  employee ownership of quality issues. Maintain leadership emphasis on quality. Reduce (eliminate) the gaps between what they say and what they do. Ensure message credibility - make messages believable , keep them up to date . Encourage peer involvement. Increase employee ownership of quality issues. More in the new article by Ashwin Srinivas and Bryan Kurey Creating a Culture of Quality in Harvard Business Review....

The execution of  ISO 9001:2015 ‘ Control of Monitoring and Measuring Resources ’ process includes definition of the requirements, ensuring availability and maintenance of the three components of monitoring and measuring resources: measuring equipment (ME); monitoring and measuring methodologies; personnel conducting monitoring and measuring. The diagram of ‘ Control of Monitoring and Measuring Resources ’ process is shown below: ISO 9001:2015 ‘Control of Monitoring and Measuring Resources’ Quality System Procedure requirements apply to the activities of metrology department; owners of quality management system(QMS) processes, where the monitoring and measuring is carried out, including ‘Production and service provision’ process;  responsible for monitoring and measuring in QMS processes;  ‘Design and development’ process production engineers.  Download the complementary description of ‘ Control of Monitoring and Measuring Resources ’ process i...

What are the important steps to start implementing Risk management in the QMS? It is important to accept that the main task of the initial implementation of risk management in the QMS - making actions to address risks and opportunities an integral part of management decision-making at all levels .  Then the keyword is " simplicity ". Implementation of risk management into the QMS processes (ISO 9001:2015 cl.4.4.1.f, cl.6.1 and step " Do " - ISO 31000) consists of four phases: Risk identification , Risk analysis, Risk evaluation, Risk treatment. 1) Risk identification consists of finding, recognizing and describing the risk. The ultimate objective of risk identification is to draft a comprehensive Risk list. At this phase, the following is important: •       A common approach to risk wording for all processes. A good practice is to word the risks through the "Event" category - an adverse event that may occur with some likelih...