Five Reasons ISO 9001:2015 Should Be On Your Dashboard: Now
September 20, 2016
1. Leadership and Full Integration
If your company is already ISO 9001:2015 certified, congratulations, the next recertification process is upon you. As I’m about to share with organizations considering ISO certification, leadership involvement is critical. The increased focus on leadership in ISO9001:2015 (as opposed to management of responsibilities) is intended to elevate the Quality Management System (QMS) into a company’s overall business framework to drive true business performance. In essence, the new standard (and others that are based on the same high-level structure, more about that in a minute) requires that leaders integrate the requirements into the company’s business processes and take accountability for its effectiveness.
It’s been widely acknowledged that in order for your company to adopt ISO and maintain certification, you’ll need buy-in from the top down. With the increased emphasis on leadership, this translates to not just an approval to move forward, but legitimate, fully-integrated leadership involvement. This involvement must start during the planning for the QMS right through to the assessment of its effectiveness and efforts to continually improve the system.
With the new standard requiring leadership to take on a more involved role, this is a great opportunity to initiate a discussion and to develop a more appreciative understanding of the requirements of the standard and how an effective, integrated QMS can contribute to the overall success of the business.
2. Common Structure with Other Standards
The ISO9001:2015 standard was created adopting a format that is now common among all standards, technically referred to as Annex SL. This common structure will enable companies to more easily integrate their QMS with other standards, (e.g. industry specific or environmental standards). Elements of Annex SL will also make it easier to integrate and align your company’s QMS to your overall business strategy. By including the concept of identifying and considering organizational context, for instance, this new structure requires leaders to consider elements commonly found in most sound business plans.
From this example, you should be able to see a reinforcement of the key concepts mentioned above, leadership involvement and integration. It’s changes like these that will enable your company to derive more value from your QMS.
Though risk assessment and management were hinted at in ISO 9001:2008, many companies may not have picked up on it. The result is many QMS systems are designed for reaction rather than prevention. Ironically, most companies apply a “risk-based thinking” approach automatically and often subconsciously; their real approach just isn’t reflected in their QMS.
The new standard makes it very clear – risk-based thinking is a tremendous tool. It commonly shows up in most, best practices and business models and is designed to avoid and mitigate problems before they occur. By including it in the planning section of the new standard, ISO is requiring companies to conciously apply what they do instinctively, using their defined context as the starting point.
4. Process Approach
The process approach has long been an ISO:9001 staple. It made its first appearance in the 2000 version of the standard and has been reinforced in all subsequent versions. Broadly defined, the process approach is the systematic definition and management of processes, their inputs and outputs and their interactions. It integrates these processes into a holistic system in order to achieve strategic and operational objectives. The benefits of adopting the process approach include:
- increased accountability
- improved internal integration
- alignment of processes toward achievement of company objectives
- more consistent results
- greater customer confidence in the organization
The new standard strengthens the adoption of the process approach by requiring companies to define the inputs required and the outputs expected of their processes, strengthening the language around evaluating processes to ensure they achieve their intended results, and requiring companies to assign responsibility and authorities for their processes. It also explicitly requires companies to address risks and opportunities that are determined through the application of Risk Based Thinking mentioned above.
The concept of “quality” has evolved over the years from ensuring product quality via inspection to quality as an integral part of a business strategy. The ISO9001 standard has evolved along with this trend, however it has not always been interpreted this way. The standard took a big step in 2000 with its focus on process and customer. The 2015 version continues this evolution, providing the opportunity for companies to leverage their investment in quality to drive business value.
Taking advantage of this opportunity will require a mind-shift in how you view both quality and the ISO9001:2015 standard. Rather than considering the requirements as a prescriptive approach to organize your documents, procedures and records, you should view the new standard as a flexible guide to incorporate your quality processes into your overall business processes and strategy.
There are a lot of good things in the new version of ISO 9001:2015 and you don’t have to wait to take advantage of them. In fact, you probably shouldn’t wait. We are roughly one year through the 3-year transition period, and with the new industry-specific standards being released in the coming months, there will be a lot of industry activity as companies and certification bodies work towards the September 15, 2018 deadline.
Need some help? CONNSTEP provides on-site support to help guide your business through the time-sensitive updates required to maintain or apply for certification status, helping you gain a clear understanding of the requirements and to capitalize on the opportunities they represent. Our consultants can also assist with planning and implementing your QMS by working with your Leadership, Quality and Audit teams to ensure a successful outcome.
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