The deadline for ISO 9001:2015 certifications is closer than many realize. Manufacturers that are ISO 9001:2008 certified cannot renew these old certificates if they do not comply with the requirements of the new edition of ISO 9001.
A lot has changed in this fifth edition of the ISO 9001 standard. For example, change management and knowledge management are each given a sharper focus. There is also an increased emphasis on risk mitigation in the revised version. Manufacturers will not only need to identify, assess and prioritize potential risks, but also develop a plan to minimize the impact of those risks. These activities must be clearly documented and tracked within a company’s quality management system.
Another change comes in the form of new terminology. The words “documents” and “records” have been replaced by “documented information,” allowing companies to store data in the format that supports their business processes. A good amount of quality management data can be processed efficiently as structured information instead of as documents, and the new edition of the standard no longer distinguishes those data types. This allows manufacturers to develop an intelligent information management strategy in order to earn certification or recertification.
What is Intelligent Information Management?
An intelligent approach to information management enables organizations to effectively and efficiently manage all types of content. Not just documents and other unstructured content like Word or Excel files, but also structured data objects such as parts and assemblies in an ERP system. An organization's information assets are stored and managed in a variety of repositories and business applications, such as CRM, ERP, file-sharing applications and network folders.
Information management solutions that leverage metadata can not only link disparate company systems and content repositories in order to ensure fast access to business-critical information, but they also deliver content in context, which injects a higher level of intelligence into this process. Establishing connections between related information to provide a 360 degree view, such that one can find whatever they are looking for from any starting point or stage of the process. It also enhances decision making processes while also delivering a greater level of traceability that allows them to tie each ISO 9001: 2015 requirement to all the associated content and processes across an enterprise. This allows stakeholders to quickly view, for example, the standard operating procedures (SOPs) that a quality deviation is related to, the processes it touches, and further, the employees that need to be trained to mitigate the risk from occurring again.
Intelligent information management enables manufacturers to provide clear documentation for how each ISO 9001: 2015 requirement is being met in practice since documented information can be tagged to different quality system requirements. This is critical for audits. Interactions with each file, changes to documents as well as all workflows are automatically recorded with metadata, so manufacturers can easily isolate very specific information with just a few clicks.
Perhaps most importantly, an intelligent information management strategy can help with risk management. Metadata-based systems can be used to automatically assign learning requirements for SOPs for the right business units or employees and ensure that the learning requirements are fulfilled before employees start performing certain tasks to prevent injuries and other damage. The ability to more effectively monitor, manage and analyze procedures and outcomes helps improve quality and performance across many areas of a manufacturing organization, enabling organizations to achieve ISO 9001: 2015 certification with greater ease.
A Smarter Approach to Certification
ISO 9001: 2015 and other certifications like it are becoming increasingly important in today’s marketplace. The roadmap it provides for quality management has been proven over more than five decades to help lower risks, especially in quality-intensive and highly regulated industries like manufacturing. Many potential customers require potential manufacturing partners to be certified because it indicates a focus on quality assurance.
By implementing a more intelligent approach to information management, manufacturers can more smoothly transition to the updated standard and begin realizing the business benefits sooner. What’s more, a modernized approach to information management is likely to yield many unanticipated benefits, such as better visibility into quality processes and methodologies.
Mika Javanainen is Vice President of Product Management at M-Files Corporation.