We already have a Quality Assurance Manual in place but it is my understanding that in ISO 9001:2015 there is no longer a requirement for a manual. How do we handle this transition? Our ISO 9001:2008 standards are currently kept in our Quality Manual. If a manual is no longer required for ISO 9001:2015, where are we to keep our standards?
It is true that ISO 9001:2015 does not require a Quality Manual BUT that doesn’t mean that you can’t have one. The “Quality Manual” from 9001:2008 is basically a method of organizing your quality system’s documentation to ensure that everything is in one place and accessible. In the past decade, technology has changed and grown, and the ways in which organizations maintain information continues to evolve. In 2008 the vast majority of companies kept everything on paper, and so a Quality Manual made perfect sense. As technology has evolved, many companies are looking to do away with paper…and many are finding creative ways to document their policies, procedures and work instructions.
You will notice that the 9001:2015 standard has also removed the term “documentation” and replaced it with “documented information”. The word “documentation” typically means paper records, whereas “documented information” can refer to a wide variety of things – flowcharts, graphs, pictures, diagrams, videos, etc. This shift in the 2015 standard is intended to embrace this evolution and offer you the flexibility to document things in the manner that suits you best. Believe it or not, some organizations have replaced all their work instructions with videos that demonstrate the proper steps (this obviously works well in manufacturing, but can also work well when companies create videos of how to complete forms or carry out administrative steps on computer software, etc.). Or maybe you want to replace some of your written procedures with flowcharts that are more visual and easier/quicker for employees to interpret. With the change in 2015 you don’t have to try to retain all of this documented information within a traditional “Quality Manual”.
The 2015 standard, in a number of places, indicates that certain types of documented information must be retained. As long as you are retaining this information in a format and method that works for you…you will meet the requirements. You are not required to scrap your Quality Manual if you find it to be an effective method of organizing your documented information. You can keep the structure just as it has been, and you can continue to store copies of standards there as well. Should you choose to scrap the Quality Manual then there are a number of places to keep the standards – with quality records, with corporate policies/procedures, or even as an electronic document stored on a file server, etc.
Hope this has been helpful to you!
- Ted Annis, BRC President