ISO 9001 and 14001 Certification Audits

January 13th, 2018

A notice from the International Accreditation Forum (IAF) that an official resolution has been reached regarding audits performed to ISO 9001:2008 and ISO 14001:2004.

A key aspect of this resolution was the following mandate:

“Effective March 15, 2018, all audits performed to ISO 9001 or ISO 14001 must be performed to the 2015 year revision.”

As the three-year transition for ISO 9001 and ISO 14001 moves into its final year, IAF (the global association for developing the principles and practices for the conduct of conformity assessment) has passed a resolution that as of 15 March 2018, conformity assessment bodies must conduct all ISO 9001 and ISO 14001 initial, surveillance and recertification audits to the new versions – ISO 9001:2015 and ISO 14001:2015.

Any organizations who need to move to the new version of ISO 9001 and ISO 14001 should contact their conformity assessment body as soon as possible to make arrangements for their audit.  Note that failure to achieve certification to the 2015 standard by the deadline means that your certification is no longer valid and this may affect your ability to supply to all markets.   A copy of this resolution can be obtained from the IAF Here.

ISO Management System Standards Certifications Continue to Rise

November 5th, 2017

Use of ISO management system standards continues to rise.  The number of valid certificates to ISO management system standards (MSS) rose 8 % in 2016 compared to 2015, according to latest figures of the ISO Survey.  The ISO Survey is an annual survey of valid certifications to ISO management system standards issued by accredited certification bodies worldwide. It is the most comprehensive overview of certifications to these standards currently available.

The ever-popular ISO 9001, Quality management systems – Requirements, and ISO 14001, Environmental management systems – Requirements with guidance for use, were up 7 % and 8 % respectively, with 1,106,356 and 346,189 certificates issued, while more recent additions to the survey, such as ISO 50001 for energy management and ISO/IEC 27001 for information security, rose by 69 % and 21 % respectively, amassing 20,216 and 33,290 certificates worldwide.

As ISO does not perform certification, the figures in the ISO Survey represent the number of valid certificates reported to ISO by accredited certification bodies as at 31 December 2016.  View the executive summary and full results on the ISO Survey page.

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…