Syncing the ISO 9001 Quality Management System With Your Business System 

The Essentials (and Priorities) to Know When Implementing ISO 9001 (Part 1)

Ideally, ISO 9001 should be utilized as a structured tool that syncs with a company’s business system to improve process performance, ultimately reducing firefights and problems, while meeting priorities and maintaining (or exceeding) customer satisfaction. When the business system and quality system are the same, you get management and cross functional buy-in and support for the quality system.

But where do you start in this process of ISO 9001 implementation?  SimpleQuE’s CEO, Jim Lee, has assisted many companies in attaining their quality management system certification and he has created a series of helpful articles as a guide for implementing ISO 9001 to prepare for certification.  Jim first recommends obtaining a copy of the ISO 9001 standard to understand the ISO 9001 requirements.  Clauses 4 through 10 provide the requirements that must be met for certification. As you read the standard, think about how you comply with each of the requirements and determine where there are gaps that must be addressed. It is best to do this as a management team, clause-by-clause, to compile a list of what needs to be done and identify where you already comply. ISO 9001 focuses on many business activities, not just quality control. If you don’t have the time or  resources internally to get a gap completed, a consultant can be hired to perform a gap analysis and provide the action items necessary to accomplish ISO 9001 certification. The exercise of reading and understanding the standard may identify the need for supplemental training to better understand the requirements and intent. This should be captured as one of the action items.

ISO 9001 training class by Jim Lee, CEO of simpleQuE

Key Point

Not having a full understanding of the ISO 9001 requirements and intent can lead to a quality management system that is overly complicated. This could preclude management support and buy-in if the quality management system is burdensome and non-value added to the business. This is an indicator you may need outside consulting assistance.

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It’s important to get support of managers and employees, and communicate the need for involvement from everyone to successfully and practically implement ISO 9001. For an idea of the obstacles you may face, read about the barriers and roadblocks to implementing ISO 9001. The gap analysis is the best way to show your current situation against where you need to get to for ISO 9001 certification. Those gaps, clearly listed as action items, provide the stepping stones and justification to make changes. Gantt charts are the most effective method for project management, but simple action item task lists also work if they show targeted completion dates and who has the responsibility to complete the task.

The consolidated list of what needs done is important for many reasons. When shared with the management team, it helps to show that the quality manager can’t do this alone, and helps identify other functional areas that have gaps to address. Assign each action item to a responsible person to address, note how much work each person has to do, in considering realistic timelines for completing the tasks. This creates the implementation plan, showing who needs to do what, and by when. This plan can be used to monitor and report on progress over time, and can help justify the reallocation of resources or change business priorities if action items are slipping.

An effective strategy is to ensure there is a team leader, an implementation team, an executive sponsor and internal competency and priority to get the tasks done. Small companies will have fewer people, and may have only a couple of people on the implementation team.

In Part 2 of the series:  ISO 9001 Implementation – What You Need To Know, Jim goes deeper into the section of the requirements regarding Scope, Context of the Organization, Processes and Interactions. What to Know When Implementing Your ISO 9001 QMS and Processes.

Click below for links to the series: ISO 9001 Implementation – What You Need To Know

Syncing the ISO 9001 Quality Management System With Your Business System and Priorities – Part 1

What to Know When Implementing Your ISO 9001 Quality Management System and Processes – Part 2

What to Know About Management Processes, Quality Objectives, QMS Documentation, and More When Implementing ISO 9001 – Part 3

What You Need to Know About ISO 9001 Internal Audits When Implementing your QMS – Part 4

SimpleQuE is a leader in AS, IATF® and ISO consulting, auditing and training.  Whether you are just beginning the certification process or looking for a partner for ongoing maintenance and internal audits, simpleQuE makes the process easier and more efficient. Contact us for a consult and see the difference that simpleQuE can bring to your quality management process.