Strahinja Stojanovic Although the latest version of ISO 9001 no longer has a requirement to document the Quality Manual (for more information, see: The future of the Quality Manual in ISO 9001:2015), IATF 16949 still requires organizations to include a Quality Manual in their QMS (Quality Management System) documentation.
Considering the importance of the Quality Manual, many companies adopt the approach of “the more the better,” which cannot be further from what is required and expected from the manual. Very often, the manual is basically the text of the standard that transforms “you shall” into “we will” and provides no added value to the company and the QMS. I assume that was one of the reasons why ISO 9001 no longer requires it. However, IATF 16949 does require the manual, so the headache is back again.
What does the standard require?
Whether you are just starting to implement IATF 16949 or you are making the transition, the most important thing is to determine what the standard actually requires and avoid copying the text of the standard.
The previous version of the standard didn’t have any additional requirements to the ones stated by ISO 9001:2008. The manual should have contained the scope of the QMS, with details about the exclusions and justifications, documented procedures (or references to them), and finally, a description of the interactions between the processes of the QMS.
To start, let’s see what each of these requirements means:
The scope of the QMS: This is in place to define the boundaries of your QMS, and the scope will be stated in your new IATF 16949 certificate. Basically, the scope explains in short what your company does, for example: “wire and harness production” or “seat belt production.” Besides the type of business you are in, you need to define locations and processes that are included in the scope, as well as the exclusions and justifications for those exclusions. Remember that in IATF 16949, the only permitted exclusion is from clause 8.3 product design and development.
The documented procedures established for the QMS (or references): In contrast to ISO 9001, IATF still has requirements for documented procedures, and it is safe to assume that the company will create some additional ones that are not required by the standard, but are necessary for an effective QMS. Simply put, if you need to have a written procedure to make sure that mistakes are not made, you need to have a written procedure. If these procedures are simply in flowchart form they could be incorporated into a short Quality Manual, but more than likely they will include some additional information, and most companies will have some additional procedures as well, so references in the Quality Manual are the simplest thing to do. This also gives you a quick place to look when trying to find a procedure.
A description of the interactions between processes: This is most simply done with a flowchart that identifies all the processes in the organization, with arrows showing how they connect. While an in-depth flowchart may help you to better understand the interactions between processes in your organization, a simple top-level flowchart is all that is needed for most people to understand the basics. This is what is needed in the Quality Manual.
The latest version of ISO 9001 has no requirements for the manual, so IATF 16949 has clause 7.5.1.1, which defines the requirements for QMS documentation, including the Quality Manual. In addition to the requirements of the previous version of the standard, the new IATF 16949 requires the Quality Manual to include a document (i.e., matrix) indicating where within the organization’s QMS the customer-specific requirements are addressed.
Customer-specific requirements: Depending on the approach you take to develop the manual, you will have different options to meet this requirement. The standard itself mentions the matrix as one way of documenting this requirement, so you can just develop a separate document where you will connect the customer-specific requirements with elements of your QMS that are related to those requirements. If you decide to incorporate the correlations of the customer-specific requirements and your QMS into the manual, you can do it the same way as the manual refers to the requirements of the standard.
Considering that the changes in requirements are minor, the first step for the companies that are making the transition is to review the existing manual and see to what extent it already meets the requirements of the new version, and see how the existing manual can be improved.
The Quality Manual is a reflection of your company
The manual is a document that connects all parts of your Quality Management System, and by reading the manual, one can learn a lot about the company’s QMS – not only whether the requirements of the standard are met, but also how they are met. It is very common for many companies to ask for a Quality Manual when they are first assessing a potential supplier, and this is why making your manual an easy-to-read, informative brochure can be helpful. If the person assessing your manual can easily see that you have everything in place for a successful QMS, then they are more likely to look further into your capabilities and capacity to fulfill their business needs. So, when creating your manual, think to yourself, “What do I want customers to see?” Is it a lot of words that will take some time to wade through; or would it be better to give them everything in one easy document so that they can move on to placing an order?
If you want to learn more about IATF 16949 implementation, check out this free IATF 16949 Implementation diagram.
