Organizational knowledge in ISO 9001:2015

organisational-knowledge

 

One of the areas included in the ISO 9001 :2015 is 7.1.6 Organizational knowledge. The stated requirement is:

"The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services."

The organizational knowledge requirement in ISO 9001: 2015 is to ensure an organization determines and preserves the knowledge necessary for processes to operate efficiently and effectively, as well as ensuring the organization conforms to the regulation.

It's part of the Resources section, and shares a space with People and Infrastructure, so it is clearly seen as important. As it stands, however, it's a vague and very non-prescriptive requirement. You could un-pick it such that the organization needs to demonstrate that its knowledge is:

  • Maintained
  • Made available / shared
  • Used
  • Linked to organization's objectives

However, it doesn't offer any suggestions, let alone rules, as to how this might be achieved. It should not be a great challenge for any organization to declare compliance.

The 'glass-half-full' here is that Knowledge Management appears in ISO 9001. The 'glass-half-empty' is that it is so very high-level in its stated requirement. It's barely even a guideline.

Document control requirements in ISO 9001:2015, what you need to know

That leaves the way clear for the perpetuation of a tendency to pay lip-service to the business - critical nature of organizational knowledge. As one leading expert on search technology has put it:

"Organisations know that information is a business-critical asset but pay little attention to ensuring that the information that has been expensively created by an employee is then discoverable by anyone else in the organisation that has a need for it." - Martin White (2014)

It feels like there is a very wide chasm between the ISO/FDIS 9001:2015 requirement and better/good practices as seen by Information Management professionals. They know from their data and experience how important it is. For example, a 2011 AIIM survey found that the productivity of professional staff would be improved by 30% if they could find internal information and documents as quickly and as easily as they find information on the Web.

Not everyone in an ISO 9001 certified organization is necessarily an information worker, but a lot of them are. A 2012 IDC survey showed that overall 9.8% of their time was wasted on non-productive activities (e.g. searching for, but not finding documents). That would equate to adding the time/resources of nearly ten extra staff for every hundred people in the organization.

If you work in the interface between Information Management and Quality Management, as we do, there is an extra responsibility to worry about "Findability" and organizational knowledge in the corporate workplace. It is because a 2014 AIIM survey found that 42% of those companies who currently do not have any search tools are most likely to acquire them as part of an Enterprise Content Management (ECM) / Document Management (DM) / Records Management (RM) project. One tool is acquired as a result of choosing another tool.

We have a special responsibility to build on clause 7.1.6 of ISO/FDIS 9001:2015, and promote its importance. There is a large body of work concerning topics such as:

  • Categorisation
  • Enterprise Search
  • Tagging, Meta-data
  • Auto-classification
  • Knowledge Base / FAQs

that we can call on. I plan to explore those topics in a follow-on post.

To round off this post, in the spirit of the Leadership requirements of ISO/FDIS 9001:2015 it would be prudent to remind every CEO and senior management team that they need to understand two things:

  1. Problems of information findability cost the company through waste and extra resources required
  2. Problems of information findability in their company are not primarily a task for IT to solve, at least not in the first instance.

This post was originally written in August 2015 and has since been revised and updated.

Guide NPD to NPI Process

Tags: ISO 9001:2015, Quality Management System, Document Management and Control, New Product Development

Paul Walsh

Written by Paul Walsh

Paul Walsh was one of the founders of Cognidox. After a period as an academic working in user experience (UX) research, Paul started a 25-year career in software development. He's worked for multinational telecom companies (Nortel), two $1B Cambridge companies (Ionica, Virata), and co-founded a couple of startup companies. His experience includes network management software, embedded software on silicon, enterprise software, and cloud computing.

Related Posts

8 tips for documenting your SOPs (Standard Operating Procedures)

There are many reasons why organisations need to document their SOPs. From ensuring uniformity in ...

Should you use Microsoft software to build your own digital QMS?

SMEs creating a digital Quality Management System (QMS) will often reach for the most familiar ...

Document Control requirements in ISO 9001:2015; what you need to know

Document control is a key part of any Quality Management System (QMS) and, therefore, a requirement ...

Data integrity in life sciences: the vital role of ALCOA principles

Data integrity is central to the safe development and manufacturing of every life-science product ...

ISO 13485:2016: What does it take to meet medical device QMS requirements?

Navigating the complexities of ISO 13485:2016 can seem daunting, but understanding its requirements ...

4 challenges you'll face moving from a paper based QMS to an eQMS

The case for ditching paper based QMS (Quality Management Systems) can seem like a no-brainer. But ...

Why not just use SharePoint for your Medical Device QMS?

A Quality Management System (QMS) is a requirement for medical device developers across the globe. ...

Why not just use Dropbox as a document management system?

Dropbox is an easy to use cloud storage and sync application that is increasingly used in work ...

Should you use Microsoft software to build your own digital QMS?

SMEs creating a digital Quality Management System (QMS) will often reach for the most familiar ...

8 tips for documenting your SOPs (Standard Operating Procedures)

There are many reasons why organisations need to document their SOPs. From ensuring uniformity in ...

Pros and cons of a phase gate process in new product development

Will a phase gate process hold back or enhance your new product development? What are the pros and ...

The evolution of a Quality Management System

A focus on a quality management system shouldn’t just mean a ‘box ticking’ exercise for an ...