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

A quality professional should be his/her 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 skillsets.

ISO 9001:2015 introduced many changes—a few of which still aren’t fully understood by some quality professionals. As 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 QP article “Keep Calm and Prepare for ISO 9001:2015” discusses all the significant changes in ISO 9001:2015.¹ The article makes specific reference to the continued requirements for procedures and records, as defined in ISO 9001:2015, Annex A6.

While 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 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 skillsets to prepare for a new approach to auditing and quality management—there’s a lot to know and learning must be continuous.

© Originally published ASQ QP Magazine, June 2018, All rights reserved © Aston Technical Consulting Services

REFERENCES

1. Bill Aston, Susan L.K. Briggs, Charles A. Cianfrani, Deann Desai, Allen Gluck, Paul C. Palmes, Denise Robitaille and John E. “Jack” West, “Keep Calm and Prepare for ISO 9001:2015,” Quality Progress, September 2015, pp. 18-28.

BIOGRAPHY

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Bill has over 40 years of experience as a quality professional in the oil and gas industry. His audit experiences include conducting 1st, 2nd, and 3rd party audits at locations throughout the USA, Canada, South America, and the Middle East. His expertise as a quality professional and consultant include assisting companies with the development of quality systems for API Q1, Q2, and ISO 9001 certification as well as various API product monogram licenses. Other areas of expertise include risk management and Inspector and Auditor training.

Bill has conducted numerous training courses and workshops related to risk management, Lead Auditor, API Q1, API Q2, API product specifications, and internal quality system improvement. His Professional certifications include Exemplar Global, QMS Master Auditor, ASQ, Certified Quality Auditor, and PECB, QMS Lead Auditor. Trainer qualifications include Approved API-U Training Provider and Exemplar Global Recognized Training Provider. He is also a voting member of API Quality Subcommittee 18, and the US Technical Advisory Group (TAG) to ISO TC 176. Additionally, Bill has served as a Subject Matter Expert for ASQ’s “Ask the Expert” program since 2008 and has had articles published in the ASQ Quality Progress Magazine on frequent occasions since 2012.