The first annual International Conference on Quality Standards (ICQS) hosted by the American Society of Quality took place on November 9-10, 2015 in Indianapolis, Indiana. The Quality Management System standard (ISO9001) revision was finalized in September 2015 and published in October 2015.
The networking opportunities included in the conference allowed the attendees to meet with members of the Technical Advisory Group (TAG 176) responsible for revising the Quality Management System standard to:
- better understand the changes in the standard and
- discuss how to best implement the changes
Conference topics included implementing risk-based thinking, determining when documentation is really needed, and defining the context of the organization.
One of the changes made in the 2015 revision of ISO 9001 established a more systematic approach to considering risk versus treating “prevention” as a separate component of a quality management system. Risk-based thinking is expected to assure consistency of quality of products and services, establish a proactive culture of improvement, and assist with regulatory compliance.
Risks and opportunities are mentioned in a number of sections within the ISO 9001:2015 including, but not limited to, the sections on top management leadership and commitment (section 5.1.1 and 5.1.2), the section on understanding the organization (section 4), and the section on management review inputs (9.3.2).
Section 6.1.2 NOTE in theand include “avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining the risk by informed decision” specifically mentions options to address risks and opportunities in theand include “avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining the risk by informed decision.”
One presentation at the conference focused on a practical application of using risk, i.e. using evaluations of risk to determine when to perform corrective action vs. just performing a correction and trending.
In the past, some organizations have updated procedures as a default response to address audit observations. Now the focus is more on results vs. just updating a procedures.
New terms from ISO9001:2015 Documented Procedures and Instructions Maintained information and Record Retained Information:
The ISO9001:2015 includes requirements for retained information and maintained information, but does not specifically mention “how to” complete the documentation. If an organization knows when and how much to document, along with selection of appropriate alternatives to documentation, the organization can achieve equal or improved process performance at lower costs and reduced employee frustration.
One presentation mentioned that detailed procedures may not be needed for complex tasks if only employees with specific knowledge, skills, training and experience complete those tasks. For example, an airline pilot completes a checklist before he takes off on a plane, but does not have a specific procedure that he or she follows for “how” to fly the plane.
Organizations need to determine the appropriate balance for documentation; too much documentation may discourage the use of good judgement and too little documentation may result in poor products/performance.
Rather than specifically mentioning exclusions, the ISO9001:2015 revision mentions that organizations must understand external and internal issues that are relevant to the organizations purpose and strategic direction. To accomplish this, several speakers recommended integrating the quality plan withthe business plan vs. having separate quality and business plans.
How to implement the changes:
One speaker mentioned the importance of creating “value propositions,” which encourages an organization to implement the changes included in the 2015 revision of the standard by seeing the value it can create. Another speaker used examples of how different Lean tools could be used to implement the various sections of the standard. One attendee mentioned that his organization now embraces standards as an opportunity to benchmark best practices.
The final version of the ISO9001:2015 standard lists a reference to some free public information regarding the standard: www.iso.org/tc176/sc02/public. The free information available on this website includes a correlation matrix between the ISO 9001:2008 and ISO 9001:2015 and a white paper on risk-based thinking. The actual ISO9001:2015 can be purchased through www.asq.org.
Besides sessions on ISO9001:2015, the conference also had a session on “Developments in ISO 13485: International Standardization of Quality Management System Requirements for Regulatory Purposes in the Medical Devices Industry” and a session on “ISO 14001:2015 (Environmental Management System) Major Changes and Significant Challenges.”
The conference was organized to allow networking between presenters and attendees. The price of the conference included breakfast and lunch for all attendees as well as an extended time between presentations for networking.
Conference presentations became available to registered attendees via a download from the conference website.
The American Society of Quality intends to schedule another International Conference on Quality Standards sometime next year.
About the author:
Alaina Blanchard has diverse experience in the pharmaceutical, medical device and biotechnology industry. She provides value to an organization by simplifying complex processes and reducing regulatory compliance risk. She can help bring order out of chaos, without going overboard. She collaborates with multiple levels of an organization to achieve results. Her strengths and expertise include performance metrics, Root Cause Analysis of significant trends, organizational management, writing investigation reports, and audit preparation.
Alaina has a Master in Public Health in Biostatistics from the University of Michigan and holds the following ASQ certifications: Manager of Quality and Organizational Excellence, Quality Auditor, and Quality Engineer. She also has a Lean Six Sigma certification from Baxter Healthcare.