Tuesday, November 22, 2016

New ISO quality management standard: Guidelines for the application of ISO 9001:2015

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

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ISO 9001:2015 QMS Implementation program

Tuesday, November 15, 2016

Monitoring and measuring resources

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.

Sunday, November 13, 2016

Control of Infrastructure Quality System Procedure

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 maintenance and preventive maintenance schedule 
  • QSF 7.1-02-03 Annual overhauls schedule 
  • QSF 7.1-02-04 Maintenance instructions 
  • QSF 7.1-02-05 Equipment unit maintenance journal 
  • QSF 7.1-02-06 Records of buildings and utilities inspection 
  • QSF 7.1-02-07 Confidentiality Agreement 
  • QSF 7.1-02-08 Information structure to communicate matters relevant to quality management system 

Review the complete description of the Control of Infrastructure Procedure.

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Friday, November 11, 2016

Management of Change

1. Which ISO 9001:2015 clause refers to the change management in the Process ? 

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:
2. What are the minimum requirements to notify a customer regarding the change? Change include:
  • change in process
  • change in machine
  • deviation from approved control plan.

Communicating changes to the customers:
  • Has to be implemented in compliance with cl.8.2.4 Changes to requirements for products and services when the products/services requirements defined by the Contract, have been changed. A good practice is to notify the customer in a form of Protocol of Disagreements or Contract Amendment.
  • May be conducted when provisioning serviced in accordance with cl.8.5.6 Control of changes, if, by the decision of the Organization, those notifications are ‘… necessary actions arising from the review’.
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