ISO 9001 is the most widely used quality management standard worldwide. There are over 1m organisations across over 170 countries that are certified to this standard.
The latest edition ISO 9001: 2015 introduced major new requirements. The most important is Clause 7.1.6 as it sets the standards for the practical knowledge to support servicing customers and workers.
The most common instance of practical knowledge is the Standard Operating Procedure, which provides a step-by-step set of instructions written by an organisation to help workers carry out complex routine operations and for customers to make better informed
ISO 9001: 2015 Clause 7.1.6 defines the following requirements:
- The organisation 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.
- When addressing changing needs and trends, the organisation shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates.
The International Standards Organisation rationality behind ISO 9001: 2015 Clause 7.1.6 is for:
- Safeguarding the organisation from the loss of knowledge, e.g. through staff turnover; failure to capture and share knowledge.
- Encouraging the organisation to acquire knowledge, e.g. learning from experience; mentoring; benchmarking.
The ISO / IAF (International Accreditation Forum) Auditing Practices Group has provided guidance on organisational knowledge, which states:
- Knowledge is a resource needed for the organisation to support its quality management system processes, quality activities, and to ensure conformity of products and services.
- Organisational knowledge is the specific knowledge of the organisation coming either from its collective experience or from the individual experience of its people.
- Organisational knowledge held by people within an organisation may be documented such as into work instructions and embedded into processes, products and services.
- Knowledge and its management vary considerably according to an organisation’s context, the sector it operates in, and the competitiveness of its markets.
- Organisations should evolve knowledge through sources such as learnings from failures; near miss situations and successes; gathering knowledge from customers, suppliers and partners; capturing tacit knowledge that exists within the organisation; updating
the necessary organisational knowledge based on the results of improvements.
There is also an ISO 9001: 2015 Clause 9.1.3, which when applied to Clause 7.1.6 focuses upon the analysis and evaluation of appropriate data arising from the monitoring and the measurement of knowledge to ascertain the:
- Conformity of products and services.
- Degree of customer satisfaction.
- Performance and effectiveness of the quality management.
- Effectiveness of plans implemented.
- Effectiveness of actions taken to address risks and opportunities.
- Performance of external providers.
- Need for improvements.
ISO 9001: 2015 Clause 7.1.6 and its correlation with Clause 9.1.3 leads to quite a challenge to the management of quality.
Standard Operating Procedures are the most common form of documented organisational knowledge. By the very nature of this type of documented knowledge it makes transparency, traceability and measurement of decisions flow near impossible. The absence of evidence
covering the user decision journey through the myriad of choices, pathways and outcomes within documented organisational knowledge is the Achilles heel of ISO 9001: 2015.
Chatbots, if designed and controlled properly, can be used to create, share, measure and evolve organisational knowledge as a working and measurable asset. This type of knowledge asset, starting with Standard Operating Procedures, has the potential to set
a new benchmark for the implementation of ISO 9001: 2015 Clause 7.1.6, underpinned by Clause 9.1.3. This provides the potential for a global benchmark for the creating, sharing, measuring and evolving organisational knowledge, whilst leading the way for the
digital transformation of governance.
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