Many companies need to comply with ISO 9001 requirements for quality management systems. This can be cumbersome at times, but technology has evolved to a state where it can also be quite easy: with a wiki!
Traditional ISO 9001 document control woes
The core idea of ISO 9001 is building a process-driven organization that is able to meet customer requirements and continually improve its operation. And when you build a process-driven organization, you need documentation. This makes control of documents and records one of the key aspects of ISO 9001. Traditionally, it has also been one of the most problematic things when attempting to comply with the standard.
Running an ISO 9001 document control process with paper copies is, strictly speaking, a nightmare. Documents need to be approved, reviewed and updated as necessary, their revisions identified, available at points of use, and discarded or properly identified in case they are obsolete. Apply this to tens or hundreds of paper copies and you have a major mess in your hands.
Purchasing traditional ISO 9001 QMS software makes things a little better, but not much. These systems tend to copy the cumbersome processes used with paper copies and retain lengthy approval and review cycles that make updating difficult and limited to very few people, not to mention that access to these systems can be difficult as well leading to a large number of paper copies still in circulation, which in turn makes it difficult to ascertain that they are all of the current version.. Back in square one, then.
Can there be a better way? What about a wiki?
Earlier this year, I was appointed the management representative of our quality management system. I was not happy with the state of the system: either the documents were on the verge of becoming obsolete because of lack of updates or they tied up too much time to remain current. Neither situation sounded good.
As I was already heavily involved with internal company wikis, the obvious question that came to mind was how to integrate the QMS to a wiki platform instead of the old separate QMS software. After all, the wiki was already more heavily used and drove engagement that was miles ahead of what the QMS software, as a totally separate island, was capable of.
After a little bit of searching on the internet, I came across a company that had already done what I was considering: Geometrica. What’s more, they have published a series of articles detailing their wiki QMS implementation:
- Using a Wiki to implement a QMS – revisited
- Sample QMS Wiki Organization
- Using a Wiki for Document Control
Much of what they have done is immediately applicable to other companies, and formed the baseline on which I have built QMS, wiki style.
ISO 9001 document control in a wiki
A wiki makes document control a breeze. The key takeaway from Geometrica is the philosophy that a change is by default approved as it is considered an improvement until proven otherwise, and only if it is found not to be one will it be rejected and the previous version restored.
A wiki reduces the workload needed for ISO 9001 compliant document control significantly, just consider the requirements of ISO 9001:2008 4.2.3 and how a wiki solves them all:
4.2.3. a) approve documents prior to issue – documents are approved by default, and the document owner is notified via RSS or email of any changes, and can then roll back to a previous version. If more control is deemed necessary, there are also wiki tools that enable draft versions and formal approvals (such as Ad hoc workflows for Confluence). However, I am positive that experience will show in all organizations that this extra step is, in fact, unnecessary.
4.2.3 b) review and update documents as necessary – in a wiki, the documents are alive and extremely easy to update on the spot if any errors are discovered. This can be supplemented by a process for corrective and preventive actions. Geometrica uses Bugzilla for such issue management, whereas I have used the same wiki platform for this as well.
4.2.3 c) ensure that changes and revision status are identified – wiki does this for you automatically, no action needed.
4.2.3 d) ensure that documents are available at points of use – wikis are usable with a web browser, most from anywhere in the world with any computer that has a browser. OK, you still need a computer, but the ease of use is miles ahead of traditional QMS software, many of which require you to be in the local network to use them.
4.2.3 e) ensure that documents are legible and readily identifiable – done automatically, no actions needed.
4.2.3 f) ensure that external documents necessary for the QMS are identified and their distribution controlled – you can put external documents in the wiki too and create links where needed.
4.2.3 g) prevent the unintended use of obsolete documents – done automatically, no actions needed.
The same document control requirements are in use, among other things, for the quality manual itself, work instructions, management reviews, and internal audits. Thus, a wiki extends all over the QMS.
Wiki and flowcharts
As ISO 9001 promotes a process-controlled operations model, flowcharts are a common tool for representing the process flow. These can prove problematic, as if they are drawn, for example, in Visio, only people with the appropriate software are able to update them, and the licenses may cost a fair bit of money.
We live in an awesome time in this regard as well, as nowadays it is possible to integrate flowchart software into your wiki and use it directly from the web browser.
As I have used Confluence as the wiki platform, the natural choice for me was Gliffy. It really works like a charm, enabling the creation of flowcharts from within the wiki and with all the version control goodies that a wiki brings. This makes all the process flowcharts editable by anyone in the organization.
One further advantage of this integration is that flowchart elements can include links to procedure instructions! This further promotes the ease of use of the system in a way that would be difficult to accomplish with static flowchart images created outside the wiki.
Continual improvement and corrective and preventive actions
A wiki also supercharges the continual improvement processes at a company. Whereas anyone can correct errors in documents when they are in a wiki, process changes are not always as straightforward to accomplish.
A wiki provide an excellent platform for process improvement and other feedback, as it makes such discussion much more visible and transparent and opens up opportunities for serendipity. I have blogged about social employee feedback systems before, and much of that is actually an implementation of ISO 9001:2008 section 8.5, ways to ensure and facilitate improvement.
With suitable page templates and a workflow plugin, a wiki can also serve as a platform for carrying out a full PDCA cycle and ensuring that each step is performed. Incidentally, PDCA is one of the problem-solving and improvement methods recommended by ISO 9001.
In my own work, I have implemented a page template and workflow that partially model a Toyota-style A3 report as a wiki page, complete with the full PDCA cycle. For further reading on this subject (not on wikis though), I highly recommend Understanding A3 Thinking: A Critical Component of Toyota’s PDCA Management System by Durward K. Sobek II and Art Smalley.
Determination of customer requirements and business intelligence
There is one more aspect where wikis shine: determination of customer, or perhaps more appropriately market, requirements.
On this subject, wikis fulfill the intent of ISO 9001 more than the letter of it, because a company should be able to gather customer requirements during sales without a wiki (although a wiki may help in documentation and change management), but the contribution of wikis is more related to what is happening on the market overall.
Maybe one of your engineers saw a supplier or product that could be useful to you? Maybe they noticed some things your competition does that you should consider? Maybe they noticed things that customers do that should affect your products or services?
A wiki is an excellent serendipity engine. This sort of information can be gathered and discussed in a wiki, which in turn helps you better satisfy customer requirements, which is, after all, what ISO 9001 is all about. There simply are no other tools that make information sharing as simple.
Meet customer requirements and continually improve your operation
To sum this up, ISO 9001 is about meeting customer requirements and continually improving your operation. It is not about scores of signatures and stamps on papers. Once upon a time, some of that may have been necessary in order to ensure stable operation, but nowadays technology enables focusing on that which is relevant and automating that which is merely necessary. Wikis are at the forefront of this push, and can provide competitive advantage to those who take full advantage of them.
Have you already implemented an ISO 9001 QMS on a wiki platform? What have you learned?
Photo: placid casual @ Flickr (CC)