ISO/IEC 17025 moves to final stage of revision

September 19th, 2017

Calibration as well as testing and analyzing a sample is the daily practice of more than 60,000 laboratories worldwide, but how can they reassure customers about the reliability of their results?  Over the years, ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories, has become the international reference for testing and calibration laboratories wanting to demonstrate their capacity to deliver trusted results.

However, the laboratory environment has changed dramatically since ISO/IEC 17025 was last published in year 2005.  After 15 years with all the significant changes and market conditions worldwide, it is time for a revised standard. Developed jointly by ISO and IEC in the Committee on conformity assessment (CASCO), the new version of ISO/IEC 17025 will replace the 2005 version and is scheduled for publication at the end of 2017.

For more information on the main changes to the standard, see the article on the ISO Website.

ISO 19011:2018 – Expected Changes

August 18th, 2017

After the recent meeting of the international committee ISO/PC 302 JWG1, the revised ISO 19011—Guidelines for auditing management systems has become much clearer. Here’s an example of a change:

Risk-based approach:

This has been the most significant addition to ISO 19011 so far.  The High Level Structure requires that planning be done based on the organization’s risks and opportunities (section 6.1), which in turn should be derived from the organizational context and its internal and external issues (sections 4.1 and 4.2). The current ISO 19011:2011 includes risk considerations only in relation to the actual audit program and individual audits, that is the risks of not achieving the audit objectives and the risks to the auditee as a result of the audit activities.  A significant new addition to the text of ISO 19011, starting with the inclusion and definition of a new auditing principle:

“Risk-based approach is an audit approach that considers risks and opportunities. The risk-based approach should substantively influence the planning, conducting, and reporting of audits in order to ensure that audits are focused on matters that are significant for the auditee and for achieving the audit program objectives.”  

This addition in Section 5—Managing the audit program, suggests that consideration be given to the organization’s identified risks and opportunities and the actions taken to address them when preparing the audit program. While the High Level Structure requires internal audits “be conducted at planned intervals,” the new ISO 19011 suggests that audit priority should be given to allocating resources and methods to matters in a management system with higher inherent risk and lower performance.  STAY TUNED…

Configuration Management-2017

July 6th, 2017

ISO 10007:2017, “Quality management – Guidelines for configuration management“, provides guidance on the use of configuration management within an organization. It is applicable to the support of products and services from concept to disposal.  The purpose of this third edition of ISO 10007 is to enhance understanding of the subject, promote the use of configuration management, and assist organizations applying configuration management to improve their performance.

If your familiar with the previous version of ISO 10007 Configuration Management, the language, for example, configuration status accounting has been removed, and thank goodness this version is much more clearer for the user and applicable interpretation to your business configuration needs.  Configuration management is a management activity that applies technical and administrative direction over the life cycle of a product and service, its configuration identification and status, and related product and service configuration information. Configuration management documents the product or service configuration. It provides identification and traceability, the status of achievement of its physical and functional requirements, and access to accurate information in all phases of the life cycle.

Configuration management can be used to meet the product and service identification and traceability requirements specified in ISO 9001:2015, 8.5.2.  Purchase  the ISO 10007:2017 Standard here.

Feedback Sought for ISO Standards Survey

June 12th, 2017

The American National Standards Institute (ANSI) is seeking stakeholder feedback to gather information for the future International Organization for Standardization (ISO) survey, focused on service standards and management system standards.

The responses will be considered for a survey that highlights ISO’s strategy for service standardization, which was adopted in February 2016 to accomplish multifaceted results:

  • Increase ISO’s visibility as a developer of International Standards for services;
  • Support ISO members during challenges associated with the development of standards for services;
  • Gain a better understanding of market interests and trends in the services sector.

You can fill out the ANSI survey via This Link by the deadline of Friday, June 30, 2017.

 

New ISO 20400 Standard for Procurement Processes

May 8th, 2017

A new standard published in April 2017, ISO 20400, Sustainable Procurement-Guidance, will help organizations integrate sustainability into their procurement processes. The standard, intended for stakeholders involved in or impacted by procurement processes and decisions, will be released after a nearly four-year development process with 37 countries participating through voting and/or comment. Procurement plays a large role in any organization, large or small.

Who an organization buys from has just as big an impact on its performance as what it buys. Ensuring suppliers have sound and ethical practices – across everything from working conditions and risk management to their environmental impact – has the potential to not only make businesses work better, but to improve the lives of everyone in the communities where they are situated. ISO 20400 provides guidelines for integrating sustainability into an organization’s procurement policy strategy and process, defining the principles of sustainable procurement such as accountability, transparency, respect for human rights and ethical behavior.

The ISO 20400 standard can be purchased from your national ISO member or through the ISO Store.