A quality management system (QMS) today must unify the design of product and services with the development, implementation, and improvement of business processes to focus on consistently meeting customer and stakeholder requirements and enhancing their satisfaction while meeting business goals.It also must be agile enough to support your customers and organizations needs to move quickly as technology changes. It must be aligned with your organization’s purpose and strategic direction. It must be expressed not on paper but in real-time as the organizational goals, policies, processes, information and resources needed to implement and sustain it. For most manufacturers The International Organization for Standardization (ISO) publishes a set of QMS standards for varying entities that describe the mechanics of sound quality management systems. However many organizations implement them too rigidly, and miss the real intention of its purpose.
ISO 9001:2015
Even though the ISO standards are reviewed every five years to ensure continued relevance to the market, the updates may not be keeping up with your customers’ or business needs. As such, the latest ISO 9001:2015 Standard was released in September 2015 and the pace of change in today’s business world is moving faster than the standard itself. The new standard does have several improvements that address the optimization of the Quality Management System. These improvements include:
- The term “product” now reads “product and services” to ensure applicability to service organizations
- Risk-based thinking is now more implicit than previous editions and to conform to the requirements of this International Standard, an organization needs to plan and implement actions to address risks and opportunities
- Organizations must now specifically determine the inputs required and the outputs expected from processes and determine the sequence and interaction of these processes
- Requirements for “top management” commitment and demonstration of support to the Quality Management System are defined in more explicit detail
- There is greater flexibility in documentation as the latest standard revision replaces the terms “documents” and records” with “documented information”
- “Interested parties” is now introduced to include owners, customers, partners, suppliers, regulatory, etc.
What is missing is the need to be agile, flexible and efficient. Unifying your QMS with your design methods, production methods and continuous improvement programs will enable your organization to stay ahead of the competition.
How Organizations Approach Quality Management
Organizations take varying approaches to addressing the latest standard requirements while unfortunately addressing the revisions in a “shotgun” tactical approach with little strategic thinking, planning and structure. They are not creating a detailed gap analysis of their current production, customer and quality needs and comparing them to the latest requirements and then putting together a proactive plan to address the gaps. Typically a reactive approach as opposed to a proactive approach to system review and improvement is undertaken. The Juran approach is different:
- We work with our clients and partners to take strategic business approach to developing, implementing and improving a Quality Management System that is effective and efficient.
- We move quickly to complete a complete an operational and Quality Management System review of the current culture embodied in the policies, procedures, work instructions, standard work, and management reviews.
- We compare this to the latest international standards and global best practices and prepare a “beneficial gap analysis and recommended improvements to your QMS ” that allows for unifying, streamlining and rapidly upgrading the Quality Management System.
- We review and work to eliminate Quality Management System documentation and unnecessary requirements that are no longer needed as this can dramatically streamline the system.
- We have noted organizations that eliminate as much as 50% or more old documents, procedures, inspections, tests, etc. that are no longer required and only inhibit an effective and efficient Quality Management System.
Juran can help your organization move its QMS to an agile QMS in three simple steps:
Step 1: Assess
Juran will conduct a rapid assessment of your current QMS to see if it is meeting your customers’ and business needs. This will result in a plan to design or improve your current system and quality function performance.
Step 2: Redesign
Juran will work with your team and design a system that will meet your new business needs faster, better and more efficiently.
Step 3: Improve:
We will work with you to implement the new design and begin seeing the benefits of higher quality and lower costs of poor quality. To find out how Juran can support your organization by implementing an agile QMS, please don’t hesitate to get in touch with the team today.
