Practical advice on ISO 9001:2015 Clause 7.1.6
This requirement in ISO 9001:2015 needs to be addressed more effectively, 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 to operate its processes and to achieve conformity of products and services. This knowledge will be maintained and made available to the required extent. 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, creating new or updated organizational knowledge.
Why was the Organizational Knowledge requirement introduced?
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;
- mentoring;
- benchmarking.
Examples of Sources of Knowledge of Products and Services
Internal Sources
- 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;
External Sources
- Standards,
- Academia,
- Conferences, and
- Gathering knowledge from customers or external providers.
How to Demonstrate Organizational Knowledge When Implementing ISO 9001
A large, complex organization could implement a formal knowledge management system. A smaller, less complex organization might choose to use more straightforward methods, such as 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's
- Do introduce a mentoring scheme. This can be part of new recruits' induction and training or persons transferred to new positions. Just ensure that it's only good habits 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 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 will likely benefit those involved in research, design, and development activities. Consider how you can make it most readily available and accessible to them.
DON’T's
- 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 several internal audit cycles does not mean you do not need more thorough documentation.
- Don’t forget to make your database of information searchable. If people can’t easily find helpful 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 to prepare this post.
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