14 April, 2015 Terrance Holbrook, Senior Product Manager, MasterControl
For any organization that will need to transition to the new
ISO 9001:2015 standard, the time to start planning is now.
Quality management system (QMS) standard ISO 9001:2008 is about to undergo some significant changes soon, with the new ISO 9001:2015 due to be published later this year. As a result of proposed fundamental changes to the structure and contents of the standard, this revision will be important to organizations with, or seeking, ISO 9001 certification and those implementing ISO 9001 systems.
When the revised regulatory requirements go into effect, will your organization be prepared to implement the necessary changes smoothly? Will it be able to look at the requirements in a proactive way and turn the challenges of change into opportunities for success?
According to the draft international standard (DIS), ISO 9001:2015 will follow a new, higher-level structure to ensure that management system standards are aligned with a set of common requirements. In addition, there will be greater emphasis on risk-based thinking as a basis for the management system; increased focus on achieving value for the organization and its customers; more flexibility on the use of documentation; and increased requirements for top management commitment and involvement.
Many regulatory experts and analysts believe the combined effect of these and other changes to the standard could be more significant than the 2008 update and, possibly, have as great an impact as ISO 9001:2000 did.
Of course, change can be intimidating and managing it can be arduous. Yet when quality leaders manage change effectively, they can transition their organization into the new “business as usual” state more efficiently, with fewer pains and with more people open to accepting change.
For any organization that will need to transition to the new standard, the scale of change will depend on a number of factors – including the maturity of the QMS and efficiency of the organizational structure – yet, for all of these companies, change management will be important.
Change management, a systematic approach to dealing with change, is among the requirements in the ISO/DIS 9001, which says where an organization determines the need for change to the QMS, the change must be carried out in a planned and systematic manner.
While there is no single one-size-fits-all change management methodology, there are established practices that can be adopted and customized to better manage change and cultivate opportunity.
1) Accept the Change. Rather than view transitioning to the new standard as an obstacle, organizations can see it as an opportunity to develop a more robust QMS than they currently have. Companies can take a cue from the ISO/DIS 9001’s greater emphasis on risk-based thinking: while risk is commonly understood to be negative, in risk-based thinking, opportunity can also be found. Already, successful companies intuitively take a risk-based approach because of the benefits of a proactive culture of prevention and continuous improvement. Quality leaders could see the revised requirements as a path to business process optimization and performance excellence.
2) Communicate the Change. Companies that manage change most effectively typically are those that communicate the vision, mission and objectives of the change initiative early, clearly and often. From the very start of transition planning, people should understand how the changes will affect both the business and them personally, as well as the steps taken to ensure the transition is as seamless as possible. Of course, good communication is about more than just talking, meaning that companies should be alert to the changes’ impact on staff by establishing an environment of two-way communication and listening to all relevant feedback.
3) Engage Employees. While employee resistance will make already-difficult change initiatives even more challenging, engaged employees can enable a smoother transition. By welcoming input from every level of the organization and tapping into employees’ expertise early and often, the business is more likely to benefit. Front-line and mid-level employees can be great resources of knowledge about technical processes, potential obstacles and customer needs as they may relate to major change. Engagement efforts would be especially fitting in light of the ISO/DIS 9001 increasing the requirements for top management to be actively involved in the operation of the QMS.
4) Provide Adequate Training. Adapting to change often requires mastery of new processes and skills, and employee training can be an effective way to build knowledge about the change and the required competencies. Effective training can help employees feel more comfortable with the changes, and it can help top management lead employees through the changes. By creating an adequate training plan, companies will be better positioned to not only ensure everyone is up to speed on the revised requirements, but also make the transition – to new processes, new roles and, for some, new ways of thinking – more seamless.
5) Introduce Change Gradually. A three-year transition period is expected once the revised standard is published later this year, meaning organizations with existing ISO 9001 certification will need to be certified against ISO 9001:2015 by late 2018. Change is a process, meaning it takes place in several stages. Rather than rush to implement every revised requirement all at once, the shock of the major revisions can be lessened by phasing in the new processes, procedures and responsibilities over time. This means that companies can minimize disruption and achieve change management success, rather than see the initiative stall and fail.
For now, it would be premature for companies to implement significant changes related to expected ISO 9001 revisions. However, companies should currently be monitoring the revision process, familiarizing themselves with the proposed changes and starting to plan the change process now.
“The migration process to the revised standard starts now,” BM TRADA, a provider of independent assurance services, recently explained in an informative technical bulletin. “Internal planning and communication should start now, and include the preparation required to modify existing quality management systems as necessary. Top management needs to understand its new obligations and internal auditors will need to undergo training to equip themselves to assess against the new standard.”
After the revised standard is finalized and published, companies will be able to make the necessary adjustments to their QMS to earn certification. This means that processes and system documentation will have to be revised and be aligned with the new requirements, which companies can begin to do by developing an implementation plan and considering the steps outlined above.
Terrance Holbrook is a senior product manager of medical devices at MasterControl, where his responsibilities include product design and development and market research for features and functionality. Prior to joining MasterControl in 2014, Holbrook most recently served as VP of operations for packaging and labeling manufacturers. He has more than 18 years in manufacturing fields and six years in product development of medical devices. A certified Six Sigma Black Belt and ISO 9001:2008 lead auditor, Holbrook is also certified in lean manufacturing and total quality management (TQM). He is a member of the Project Management Institute (PMI). Holbrook earned his bachelor’s degree in business administration at Kaplan University and his MBA at Westminster College Gore School of Business.