Practical advice on Clause 7.1.6 of ISO 9001:2015
This requirement in ISO 9001:2015 is often poorly addressed and more importantly, the valuable opportunity it provides is frequently ignored.
What is ISO 9001:2015 Clause 7.1.6?
The Clause, entitled 'Organizational knowledge,' tells us:
The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services. This knowledge shall be maintained and be made available to the extent necessary. etc.
What is Organizational Knowledge?
Organizational knowledge is the specific knowledge of an organization coming either from its collective experience or from the individual experience of its staff.
The persons of the organization and their experience are the foundation of organizational knowledge. This knowledge is or can be used to achieve the organization's quality objectives or its intended results.
Capturing and sharing such experience and knowledge can generate synergies leading to the creation of new or updated organizational knowledge.
There were two primary reasons why organizational knowledge was introduced in the requirements for ISO 9001, namely:
1. to safeguard the organization from loss of knowledge, e.g.
- through staff turnover;
- failure to capture and share information;
- learning from experience;
Examples of Sources of Knowledge of Products and Services
- intellectual property,
- knowledge gained from experience,
- lessons learned from failures and successful projects,
- capturing and sharing undocumented knowledge and experience, and
- the results of improvements in processes, products and services;
- Conferences, and
- Gathering knowledge from customers or from external providers.
How to Demonstrate Organizational Knowledge When Implementing ISO 9001
A large, complex organization could choose to implement a formal knowledge management system. Whereas, a smaller, less complex organization might choose to use simpler methods, such as by maintaining logbooks on design decisions or on the properties and performance of chemical compounds that were developed and tested.
However you approach the challenge, here are some fundamental suggestions:
- Do introduce a mentoring scheme. This can be part of the induction and training of new recruits or of persons transferred to new positions. Just make sure that it's only good habits that are passed on – choose the mentors carefully.
- Do make sure that there is a formal succession plan, if yours is a small organization. Include the development of the persons who are expected to take over in the future, be that 5, 10 or more years ahead. You want to avoid the adage about family businesses – the first generation establishes it; the second generation builds it; the third generation destroys it!
- Do make deliberate use of older, experienced staff members as trainers when making training plans. Train them to be trainers, if necessary. Don’t exclude senior executives.
- Do record shared-knowledge in a database. The data concerned is likely to be of most use to those involved in research, design and development activities. Consider how you can make it most readily available and accessible to them.
- Don’t presume that you know it all. Just because you’ve fully specified your products and services, and have a set of procedures that have proven themselves adequate over a number of internal audit cycles does not mean you have no need for more thorough documentation.
- Don’t forget to make your database of information searchable. If people can’t easily find useful information, they tend to ignore it.
- Don’t undertake this exercise on your own. It’s the collective experience you’re trying to capture. It would be an ideal improvement project for your next Management Review.
Note: ISO/TS 9002:2016 was used in the preparation of this post.
Note@ First published in Sep 2017; revised and updated in Apr 2021.