2018 is here, and that means one of two things:
1. You must update your Quality Management System to the new ISO 9001:2015 standard or,
2. It’s time to finally get ISO 9001 certified and level the playing field amongst your competitors.
Back in 2014, we addressed some basic concerns about the ISO 9001 certification which still stand true (See Part 1 of this article).
In the previous version of ISO 9001, a lot of documents were written to show the auditor how awesome we were. Many times, the documents landed in a binder, not to be touched until the surveillance audit one year later. This phenomenon occurred because the standard used to be more prescriptive with lots of “shalls”, “wills” and directives telling us how to run our businesses.
Thank goodness the ISO Technical Committee (ISO/TC 176) took a long look at the standard and agreed that successful businesses, in general, already know what they are doing.
Most businesses just need some guidelines to help them demonstrate that they have embraced world class business practices and applied them to their organization. Previous versions of the standard focused on the manufacturing industry and required a lot of adaptation to apply the principles to the service industry and organizations with intangible deliverables. The 2015 version allows for much more flexibility and options to demonstrate compliance.
So, now that we have a shiny, new ISO standard, you may be asking, what is actually required to transition or obtain registration for the first time? One of the first things that you may discover when discussing the new standard with quality professionals is that binders of documents, including the Quality Manual, are no longer required. This is a true statement, however allow us to clarify this concept and keep you out of trouble.
ISO 9001:2015 allows an organization flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to determine the correct amount of documented information needed to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS. Documented information can be used to communicate a message, provide evidence of what was planned has been done, or knowledge sharing. This was taken straight out of the ISO/TC 176 document, Guidance on the requirements for Documented Information of ISO 9001:2015.
Keep in mind that an organization can only be audited on two things:
• Documented information required by this International standard;
• Documented information determined by the organization as being necessary for the effectiveness of the quality management system.
Documented Information does not equal “piles of paper”. The standard allows documents to be in any form or type of medium, including, but not limited to paper, magnetic, electronic or optical computer disc, photograph, and master samples. Your team can determine what is appropriate for your organization to demonstrate compliance to the standard and your own processes.
The documented information that organizations must maintain (plans, policies and documents that are subject to change) includes:
• The scope of the quality management system (4.3).
• Documented information necessary to support the operation of processes (4.4).
• The quality policy (5.2).
• The quality objectives (6.2).
The documented information that organizations must retain (records that are not changed after they are released) includes:
• Monitoring and measuring equipment calibration records* (22.214.171.124)
• Records of training, skills, experience and qualifications (7.2)
• Product/service requirements review records (126.96.36.199)
• Records about design and development (8.3)
• Product and Service requirements (8.5.1)
• Records about customer property (8.5.3)
• Change control records (8.5.6)
• Record of conformity of product/service with acceptance criteria (8.6)
• Record of nonconforming outputs (8.7.2)
• Results of the quality objective data that is monitored and measured (9.1.1)
• Internal audit reports (9.2)
• Management review meeting minutes (9.3)
• Results of corrective actions (10.1)
Whew! That’s seems like a lot, but we can almost guarantee that your organization is already retaining these types of records. ISO 9001:2015 will simply guide your team to consistently collect and retain the required information.
Did you notice what was not on the list? Procedures. Your organization can determine the best method of organizing and communicating the methods of how you conduct business from the top executives of the organization to the people who affect how the business runs daily.
For mature organizations with standardized processes, cohesive teams and consistently delivered desired outputs, very little “paper” is required. For organizations new to the ISO standard, we recommend that you determine the minimum amount of “paper” required to ensure that your team understands what they are supposed to do and the desired outputs are achieved consistently. Remember, “paper” is just an example of how compliance can be demonstrated.
Another new concept in ISO 9001:2015 allow businesses to align the standard with strategic business goals instead of implementing a QMS as a separate, almost disjointed project. The context of the organization (4.1) encourages organizations to look at the strengths, weaknesses, opportunities, threats (SWOT) and risks in their industry that could jeopardize the business or allow it to outperform competitors.
Employee Awareness (7.3) ensures that everyone not only understand the Quality Policy, but also understands how their cog fits into the entire wheel of the organization. Everyone must be aware that what they do or fail to do every day can positively or negatively influence business performance.
Lastly, gone are the days when the ISO Auditor and Management Representative sit sequestered in a conference room for several days and come out with an ISO certificate. Today’s ISO auditor is going to talk with the top executive first and work through the entire organization to get proof that the QMS is a way of life and not just a row of neat binders on a shelf.
Core Business Solutions is here to help you navigate through the standards and make your journey to certification surprisingly simple.