Changes in ISO 9001: 2015 and Any Effects on Worker Training

by Dean Prigelmeier, President of Proactive Technologies, Inc.

There are many excellent business reasons for employers to capture the best practices, knowledge and expertise of their star performers before they leave the organization through separation or retirement. In a recent Proactive Technologies Report article entitled, “Retiring Workers and the Tragic Loss of Intellectual Property and Value,” explains the high cost of this missed opportunity, leading to the subsequent inability to more quickly and completely train new workers to replace them. Also explained is how so few employers are taking the challenge seriously.

Re-certification audit planning for the new standard must be performed at least 90 days prior to expiration, in other words by September 14, 2018, and the last audit day cannot exceed the deadline or a full, initial audit must be performed.

The new standard includes a couple of changes that make the new standard easier to implement with other management systems, and focuses more on management commitment and performance and less on prescriptive measures. The standard has a new structure called a “High Level Structure” and introduces the concept of “risk-based thinking.” The emphasis is on organizations identifying risks to standardize quality performance and taking measures to “ensure their management system can achieve its intended outcomes, prevent or reduce undesired effects and achieve continual improvement.” The revised standard also puts increased emphasis on achieving value for the organization and its customers; in other words “output matters.”

The process approach introduced in 2000 as the desired model for quality management systems will become an explicit requirement of ISO 9001: 2015. The standard requires understanding the needs of the clients or customers, end users, suppliers and regulators and the words “document” and “record” were replaced by “documented information,” acknowledging the need to broaden the concept in recognition of the advancement in information handling technology.

The new standard has more emphasis on requirements for competent performance of personnel, competence meaning “being able to apply knowledge and skill to achieve intended results.” The important role that structured on-the-job training has played so far in ISO/AS/IATF compliance now becomes even more critical.

Those companies that already have the Proactive Technologies’ PROTECH© system of managed human resource development  in place already in place already meet the requirements structurally with regard to personnel competency, but management may need to show more commitment and understanding of the important role this plays in quality control. Those who have not addressed the earlier requirements for process-driven training in all the major models of quality management – ISO/IATF/AS – should begin now to build the infrastructure if they want to meet that requirement under the new standard.

From the early days of ANSI, which later became the basis of ISO, AS and IATF quality models, there was a basic requirement for process performance. A written process had to standardize to the best practice and written in a procedure to ensure high quality compliance and repeatability, which provided a basis for audits of personnel to ensure compliance. Although not all organizations took this requirement literally – some processes were written intentionally ambiguous to avoid “getting gigged by too specific a procedure in an audit” – standardized quality is nearly impossible without standard processes.

With the high rate of turnover and the inconsistent level of core skills and abilities of candidates for jobs these days, there is little guarantee that even if the process is written and accurate that everyone can follow the procedure and get the same outcome. That is why structured on-the-job training is needed for the “accelerated the transfer of expertise™”  from the subject matter expert to the trainee and ensure that best practice performance is assured and documented. It is as simple as that and in compliance with ISO, AS and IATF requirements that require: 1) the process be documented; 2) workers are trained to perform the process to specification; 3) mastery of the task is documented and 4) 2 and 3 are updated whenever 1, the process, changes (e.g with LEAN, continuous process improvement and changes in technology). These requirements will be more critical in complying with ISO 9001: 2015.

The new standard employs the PDCA (Plan-Do-Check-Act) cycle and risk-based thinking. Risked based thinking “…enables an organization to determine factors that could cause its processes and its quality management system to deviate from the planned results, to put in place preventative controls to minimize negative effects and to make maximum use of opportunities as they arise.” Standardized best-practice procedures ensure that each worker learns and masters the tasks. This is a powerful step is risk mitigation of threats to quality output. Building a training and documentation structure around that provides the audit trail and information database to measure, control and improve processes while meeting the ISO 9001: 2015 standard for documented information.

With the new ISO 9001: 2015 standard, any organization certified, or seeking certification, under the new requirements will need to examine the internal and external risks and opportunities. Processes and system documentation may need to be revised and realigned. Do not overlook the broadest and most obvious control in any quality model, including ISO/AS/IATF: defining best practice procedures and training workers to ensure each can fulfill the quality standard for a consistent, high quality output.

Visit the Proactive Technologies, Inc. website for more information.