By Bill Aston
Changes in every industry, standard, specification and code are inevitable. So is the need for quality professionals to keep up with these changes as they occur. Trained and experienced quality professionals—such as quality assurance and quality control managers; health, safety and environmental managers; auditors; and consultants—all play essential roles in the continued success of organizations. It’s vital that they stay abreast of changes in their industry and applicable standards. Management systems are continually changing and so must the quality professionals who implement, audit, and maintain those systems.
Understanding ISO 9001:2015 changes
Quality professionals should be their organizations’ relied-upon source of information and guidance for all things quality related. To be that, he or she must be committed to continually learning new skills and technologies, as well as regularly refreshing his or her existing knowledge and skill sets.
ISO 9001:2015 introduced many changes—a few of which still aren’t fully understood by some quality professionals. As an example, there is still a surprising number of people who were unfamiliar with ISO 9001:2015’s requirements regarding procedures and records. The removal of specific references to “documented procedures” and “documented records” within the standard continues to be a source of confusion or uncertainty for some people.
Quality professionals who have completed ISO 9001:2015 transition training, or otherwise familiarized themselves with the standard, realize that although some wording has changed, requirements for maintaining procedures and records are still part of the standard.
The September 2015 Quality Progress article “Keep Calm and Prepare for ISO 9001:2015” (written by myself, Susan L.K. Briggs, Charles A. Cianfrani, Deann Desai, Allen Gluck, Paul C. Palmes, Denise Robitaille, and John E. “Jack” West) discusses all the significant changes in ISO 9001:2015. The article makes specific reference to the continued requirements for procedures and records, as defined in ISO 9001:2015, Annex A6.
Although ISO 9001:2015 no longer identifies six documented procedures to be maintained, like previous versions of the standard did, the responsibility has been appropriately placed on the organization to determine the procedures and records that it requires to address identified risks and opportunities. This is the main point of mandating risk-based thinking (RBT): to identify and address (control) risks and opportunities.
An organization must determine its internal and external risks and opportunities via RBT and ensure they are addressed. The organization isn’t required to perform a formal risk assessment, but it should be able to demonstrate how risks are identified and addressed.
It’s important to keep in mind that ISO 9001:2015 is a generic standard for quality management systems (QMS). Every organization is responsible for determining the QMS standard that best matches its needs based on known risks associated with the industry or customer, or the product or service provided.
Consider the oil and gas industry, in which risk and the consequences of loss could be devastating to human and animal life, as well as the environment. In this case, more rigid standards, such as American Petroleum Institute (API) Q1, API Q2, or ISO TS 29001, are more suitable than ISO 9001:2015. These quality systems are more prescriptive and address known risks among equipment and services providers in the oil and gas industry.
The future belongs to the prepared
Today, auditors are expected to possess knowledge and skills that go well beyond yesterday’s audit practices of verifying the availability of a quality manual and required number of procedures. An auditor must be able to evaluate an organization’s use of RBT and understand the risk assessment process, which includes risk identification, analysis and evaluation, and root cause analysis strategies. The effectiveness of the quality professional is based on his or her knowledge of these and other considerations that may include knowledge of risks associated with the industry, product, services, system, and processes to be audited.
Consider this: What if you had a medical, financial, legal or other family services provider that didn’t stay abreast of the latest technologies or other changes in their areas of expertise? Imagine the potential effect that could have on your well-being.
It’s similar with an organization that depends on competent and experienced quality professionals to ensure that reliable information is provided to management, to facilitate fact-based decision making.
Obtaining new skills to meet updated standard or specification requirements, along with periodic refresher training to maintain existing skills, are essential for quality professionals to remain relevant in their organization and to their client base. Today’s quality professionals must rethink and retool their existing knowledge base and skill sets to prepare for a new approach to auditing and quality management—there’s a lot to know and learning must be continuous.
About the author
Bill Aston is the managing director of Aston Technical Consulting Services LLC and Petro Quality Systems Auditors, Coldspring, TX. He is an ASQ senior member, ASQ-certified quality auditor, Exemplar Global master auditor and Recognized Training Provider, an Approved API-U Trainer, and a Professional Evaluation and Certification Board-certified lead auditor. Aston is a voting member of American Petroleum Institute’s (API) Quality Subcommittees 18 and U.S. Technical Advisory Group to ISO Technical Committee 176. He is a regular contributor to Quality Progress’ “Expert Answers” department and ASQ’s “Ask the Experts” blog.
A version of this article originally appeared in the June 2018 issue of Quality Progress and is published here with permission.