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Christian Rockwell
Published: Monday, January 16, 2017 - 12:01 Sponsored Content The year 2017 is finally upon us, so Happy New Year one and all! For many, it will take a little while to get used to this turn of the calendar. Others however, particularly in the quality space, may already have their eyes on 2018. That’s because next year is the deadline for organizations to complete their transition from ISO 9001:2008 to ISO 9001:2015. After the three-year transition deadline passes toward the end of next year, registrations written to the 2008 version of ISO 9001 will no longer be valid. For some of you, that thought may be a bit overwhelming. There are some significant language changes in the new standard that affect the way in which organizations assign responsibilities, consider customers, manage risk, and more. Many, if not most (and in some cases, all) members of the organization will need to understand these changes and how they will cascade throughout their day-to-day work activities. One operational structure that will be deeply affected by the language of the new standard is the complex and all-important area of supplier management. Earlier versions of ISO 9001 merely required one to keep record of the criteria used to select, evaluate, and re-evaluate suppliers. ISO 9001:2015, however, will also require records of those selection and evaluation criteria, plus supplier-performance monitoring. Rather than be intimidated by these changes, it’s important to see the new language found in the standard as an opportunity to create positive business outcomes for you and your suppliers. As always, registration to any standard, and most certainly ISO 9001, is less about pointing to a certificate on the wall and more about the positive effects that the process of registration can have on the organization. The value is in the journey more than the destination. With that in mind, let’s consider some of the new language and processes found in ISO 9001:2015. Embracing these concepts can bring greater value to your organization in managing suppliers. You should also be comforted by the realization that powerful tools are available to help in this endeavor. Guidance document ISO 9000:2015—“Quality management systems—Fundamentals and vocabulary,” which assists users in implementing ISO 9001:2015, defines risk as the “effect of uncertainty.” This is a good definition, albeit one that’s necessarily (and probably intentionally) vague. The framers of the new version of the standard took pains to avoid being prescriptive—their intentions were to craft the requirements so that they would be relatively broad and flexible to fit the processes of registering organizations. Yet on a basic level, demonstrating competence with risk-based thinking should be inherent in the various quality management system (QMS) processes of organizations registered to ISO 9001:2015. The standard calls out risk in several places, including Clause 5 (“Leadership”), Clause 6 (“Planning”), and Clause 9 (“Performance evaluation”). It’s not difficult to see how a proper appreciation of risk can help organizations manage their suppliers. From natural disasters to late deliveries to labor issues to higher-than-expected defects, problems with the supply chain have the potential to severely and negatively affect the quality of the finished products that you wish to deliver to your customers. By understanding, addressing, and mitigating the risks of these and countless other potential problems, you can improve your chances of normal operations even in the face of key supplier difficulties. Extending your QMS to suppliers helps reduce these kinds of uncertainties. Working from a single integrated end-to-end environment, you can track nonconformances, subsequent investigations, and resulting corrective and preventive actions. You’ll have greater visibility into your broad-based QMS and thereby ensure consistent quality from suppliers. Even better, this type of proactive approach demonstrates a firm grasp of risk-based thinking and can help insulate your company from issues that may arise from key stakeholders outside your four walls. ISO 9001:2015, Clause 4.1, defines context of the organization as the “external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.” Clause 4 of ISO 9001:2015 requires registrants to define the various elements influencing your organization’s QMS, both internal and external elements. In the case of external influences, you should consider how extending your QMS to suppliers can help address pressures from regulatory bodies, competitors, and customers. There are several factors that could affect your suppliers’ ability to continue serving you properly, especially those companies that reside in foreign nations. These factors, which should also be considered as forms of risks discussed earlier, could include (but are not limited to) economic shocks, governmental instability, technological change, and shifting legal or regulatory frameworks. An appreciation for the context in which your organization operates, and the extent upon which you rely on your suppliers, provides some insulation against the unexpected. Top management should regularly consider the organization’s strengths, weaknesses, opportunities, and threats—this tactic, known as a SWOT analysis, ties in nicely with context of the organization’s thinking and helps to properly position your suppliers in your QMS. Being able to speak the same “language” of performance excellence, and having the ability to track compliance accordingly, is a key step toward ensuring that your external suppliers can meet your requirements for quality deliverables. Clause 5.1 of ISO 9001:2015 is titled, “Leadership and commitment,” and it lays out the role that must be assumed by top management (defined in ISO 9000 as the “person or group of people who directs and controls an organization at the highest level.”) One of the key changes in this new version of the standard is that the requirement for a management representative has been eliminated. To be clear, organizations that still wish to have a designated representative to oversee the QMS are still free to do so. However, Clause 5 clearly states that top management itself is ultimately responsible for the successful implementation of the QMS and all processes and procedures that support it. When it comes to suppliers, the organization’s leaders must take an active role to ensure that these key stakeholders are managed effectively. A centralized, automated QMS system that is easily accessible by these managers is thus more important than ever before. Leaders will have the information they need at their fingertips to make faster and better decisions. Visibility into supplier performance is the key to effective management, and for top executives with several pressing and competing concerns, this type of insight is invaluable. If you still rely on manual systems like paper, phone, fax, email, or spreadsheets, consider implementing QMS software to help you transition to the new thinking embodied by ISO 9001:2015. Automating the processes that support new ISO standards will help create greater visibility within your organization and with suppliers. That may not sound monumental, but consider how critical a comprehensive quality system becomes when addressing concerns centered on risk, context of the organization, and leadership. It’s nearly impossible to adhere to those standards without a unified system in place. Luckily, QMS systems are no longer the monolithic applications of yesteryear. There are now rapidly deployable and economical cloud solutions that can help you to extend your QMS throughout your company and out to suppliers. There are also solutions that can accommodate hybrid infrastructures and extend the capabilities of on-premise systems to the cloud, while keeping quality data and processes synced and secure. So, whatever the current state of your company’s QMS, there’s a software solution that can help you to effectively manage suppliers within the context of ISO 9001:2015 requirements. Quality Digest does not charge readers for its content. We believe that industry news is important for you to do your job, and Quality Digest supports businesses of all types. However, someone has to pay for this content. And that’s where advertising comes in. Most people consider ads a nuisance, but they do serve a useful function besides allowing media companies to stay afloat. They keep you aware of new products and services relevant to your industry. All ads in Quality Digest apply directly to products and services that most of our readers need. You won’t see automobile or health supplement ads. So please consider turning off your ad blocker for our site. Thanks, Christian Rockwell serves as Global Vice President of Marketing for Sparta Systems. In this role, he is globally responsible for all aspects of Marketing including Corporate Communications, Product Marketing, and Field Marketing. Christian holds a BA from Hamilton College and an MBA from the Johnson Graduate School of Management at Cornell University.ISO 9001:2015 and Supplier Quality Management
New language and new thinking require new tools
Risk-based thinking
Context of the organization
Leadership and commitment
An automated approach makes for more effective supplier management
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Christian Rockwell
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