When should you look at the specific ISO Standard?
Only after you fully understand all of your processes and the controls that you have in place, can you then take out the ISO Standard. The importance of a very good ISO Gap Analysis comes clear at this stage. This allows you to look for conformance to the requirements in the standard for each process. You will most likely find many of the ISO requirements that are not currently addressed by your company.
How do you look at the ISO Gap Analysis regarding the ISO Standard?
Let’s take ISO 9001:2015 as an example. Look for conformance to the requirements in the standard. For each process, look to the requirements and see which apply. During the gap analysis you identified the key processes in your organization (finance, sales, engineering, shipping, etc.) and you may struggle to find where they are addressed in the standard (such as section 8) but worse than that, there are a lot of ISO requirements unaccounted for. Typically, what happens is that when doing the gap analysis, organizations forget to consider the supporting processes in the organization. It’s often difficult to guess which are important and which are not. But the standard has the answer. An experienced ISO 9001:2015 employee or consultant can look at the standard and account for complete processes with specific clauses and requirements. Document control can be an easy step. There are more complex requirements in ISO that your team needs to find processes for. There are no substitutes for knowing the standard well. If you don’t know it well, you don’t know where to look. There are some instances where the requirements are addressed in multiple processes and sometimes in many processes.
Capture All Lines of Business (LOB)
There are many processes that address one or more requirements in ISO 9001:2015. For instance, if you have two completely separate systems for controlling procedures in your organization versus engineering drawings, then there are two processes that are applicable to 7.5. A production or service provision process may include many ISO requirements – such as those in 8.1, 8.5, 8.7, 9.1, etc. Often there are two separate production or service delivery processes – perhaps a company manufactures commercial grade aluminum and rubber squeegees, but also provides a repair service, then obviously there are two processes that apply to all of these ISO requirements (except if the processes are subtly different – perhaps the service process doesn’t have nonconformance). This layer of complexity can be missed and can impact the business if the manufacturing side is spot on with ISO and not on the service side.
ISO Bottom Line
Your team, whether led by a consultant or not, needs to make sure that they have captured all of the ISO requirements, and has defined a management system that is meaningful to the organization and which is in conformance with the requirements of the standard. In other words, in order to fulfill the true benefits of ISO or any quality management system is to ensure that it improves your business model and it meets the requirements of the quality organization (www.iso.org). Trying to game the process just to meet the requirements doesn’t work, and using the standard just to improve your business, doesn’t give you the marketplace benefits of the ISO certification.
ISO Implementation Temptations
Some firms find new requirements in a standard and these may not relate to a known company process. The temptation is to define a process to address the requirement. While this can be achieved in document control, there are cases when it is not appropriate. ISO 9001:2015 section 6.1 Risk and opportunity is one standard but is it one process? Risks are not like opportunities, and you must know how to handle them in the standard. Is nonconformance customer complaints? Or is it earlier in the processes in material receiving, production or in the final inspection? If you have these questions and these temptations, you have not fully embraced the goals of a Quality Management System and you may need some help from someone like Manex’s team of QMS/ISO/AS consultants.
Contact Manex at 925-807-5100 or firstname.lastname@example.org.
About the Author
As Manex President and CEO, Gene Russell is a driving force behind the firm’s successful track record in helping California manufacturing companies grow and thrive. He has held three successful CEO positions over a 20-year period for businesses that included early-stage, private equity, and non-profit. He has served as senior leadership for global Fortune 100 and iconic consumer-branded companies. Prior to Manex, Russell led a turnaround at a California midsized manufacturer. His experience in global sourcing and manufacturing over several decades led him to Manex where he brings real-world experiences, and as a result, a personal passion to restore and invigorate domestic USA-based manufacturing.