Clause 7.1.6 of the ISO9001:2015 Standard – Organisational Knowledge is a new section and can be a bit of a challenge for some. It's not uncommon for organisations to have differing views internally about what organisational knowledge is, add in the external auditor's 3rd viewpoint and you can have some very interesting discussions about it. As an organisation then, you need to be 100% clear what organisational knowledge is, for you. 

What is Organisational Knowledge​ 

 Organisational knowledge is, to an extent, the Intellectual property, the collective experience of your teams who have the knowledge of how you do things, the lessons learned, the tricks of the trade of how your organisation delivers its services or products. It's built up with years of experience, training and through the hiring of your staff.

The ISO Requirement​

The ISO9001:2015 standard requires the organisation to review the organisational knowledge it believes is required to deliver its products or services and assess this requirement against what is available to them. The standard requires organisations to assess the gap between what they believe they need and what they believe that already have. As part of this they should do a few things:

• ​Understand how they will maintain this knowledge over time,
  
• What training is required and how long will that training take (i.e. how long is the knowledge Leadtime),
  
• What documentation options do you have to lock in that knowledge?
  
• Have the required training & development plans within the organisation.
  
• Think about where the organisation is going in the future and have a regular review of what knowledge will be required in the future and some plans on how to acquire this knowledge and in what timeframe.

Knowledge Sources

There are 2 important footnotes to clause 7.1.6 of the 9001:2015 standard which is around where the knowledge source is. Like every professional and every student learns, you don't have to know everything, you just need to know how to find the information you need. It's the same here, the organisation itself doesn't have to have all the knowledge itself internally. For example, I spent many years working in the electronics industry, invariably manufacturing issues cropped up that needed us to dig into the macrostructure of the metals that we used. It would be uneconomical and unreasonable to expect our organisation to have an on-site metrology lab or meteorology expect so we bought that in as required.

You should, then, consider your organisational knowledge to be the same irrespective of it being internal or external to your organisation. You may just list it under two separate classifications for example

• ​Internal- Experience over time, training, documents (and undocumented) knowledge results of improvements and so on
  
• External – Standards, conferences, external experts, customers, academia

Summary

The new Organisational Knowledge requirement of clause 7.1.6 in ISO9001:2015 means that organisations need to understand what knowledge is required to produce their products and services now and in the future. They need to have a plan on how to maintain it over time and know where they will be able to get external knowledge as required. Organisational systems such as process documentation, training records and training plans will help, but before all of that, an agreement within the organisation about what the knowledge actually is really is essential.