Today's global manufacturing industry demands that companies negotiate compliance mandates all over the world. Certainly,
gives your company much more flexibility when making the most out of your compliance initiatives. In essence, integrated quality management systems allow your organization to streamline compliance and audit processes in a single system. Even ISO 9000, the most fundamental compliance framework, entails various certification and approval processes if your company coordinates operations among globally dispersed manufacturing sites. As such, an integrated QMS must be agile enough to accommodate the variances in certification procedures abroad. By adopting an agile solution, you may be able to identify savings in document management that add to the strength of your business case to C-level executives.
From a slightly different perspective on quality compliance requirements, consider the challenges that aerospace and defense companies face. Too many manufacturers in aerospace and defense still deal with inefficient, paper-based systems that cannot handle the rapidly expanding scope and breadth of compliance documentation required by standards such as AS 9100. An integrated quality management system helps aerospace and defense companies
by giving quality professionals a single document repository to reference. Your quality management project must show stakeholders that integrated quality management systems can actually lower the cost of non-compliance by eliminating missing or redundant documents. For example, in paper-based systems, gaps can appear in supplier quality documentation that can potentially lead to a failed audit, raising compliance costs substantially.
Like manufacturers in the aerospace and defense industry, automotive manufacturers
face a similar set of challenges related to quality compliance. Document management is one of the most common reasons why companies fail compliance audits, so at the very least, your integrated quality management system must be able to allow for easy search and retrieval of critical compliance documentation. In paper-based systems, reviews and follow-ups can be ineffective as the amount of time needed to compile all compliance documentation
creates a performance bottleneck. Whether it's ISO 9000 or TS 16949, an integrated quality management system allows you to accommodate multiple standards and audits in a holistic system
. You should always remember that inadequate document control processes are one of the most common reasons why manufacturers fail compliance audits.
You could argue that FDA-regulated manufacturers have the toughest compliance challenges to overcome. For instance, medical device manufacturers must be able to meet standards such as FDA GxP, 21 CFR Part II, ISO 14971 and ISO 13485
. In an integrated quality management system, it simply makes more sense to use the cherished "single version of the truth" to meet compliance standards domestically and abroad. From a similar perspective, rapidly changing FDA standards make your task more difficult as you need to adjust your quality management system quickly - and at a reasonable cost to executive leadership. For instance, like manufacturers in aerospace and defense, automotive manufacturers must be able to accommodate an expansive amount of documentation during an audit. An integrated quality management system helps solve this problem by removing paper-driven processes and reducing workflow bottlenecks during compliance audits. The overall theme among compliance challenges is that integrated quality management systems allow your company to tackle two of the biggest pain points of meeting compliance mandates: document management and audits. In the final segment of this blog series, you will learn how to choose the software vendor that best suits your needs to tie together all aspects of how to prepare your QMS project for quick capital approval.
<<Part 1: 5 Questions to Prepare your QMS Project for Quick Capital Approval
<<Part 2: 5 Key Steps to Integrating Your QMS Project with Corporate Initiatives