Wouldn’t it be nice if an ISO 9001 documentation templates package came wrapped up in a little box with a red bow? Ready to use and that delivered the magic of a quality product, streamlined processes resulting in efficiency, and satisfied customers.
Aside from the requirements for records the ISO 9001 standard, many find it surprising that ISO 9001 does not really require a manual or any documented procedures! So are all those companies selling you ISO 9001 documentation templates providing you value for money or is this just snake oil?
ISO 9001 has not really re-invented the wheel and most companies when they get down to implementing the standard realize that they cover most of the requirements in practice. After all it really is just business 101. In this article we will cover why to document your system, how to document your system, and how you can do so while not increasing the burden for your personnel.
Why is ISO 9001 documentation such a challenge for U.S. manufacturers?
ISO 9001 is often synonymized with documentation. Companies tend to document every little thing they do— the tiniest of detail. This approach creates a documentation burden for their users with information being duplicated in multiple records, information duplicated in multiple procedures and so on.
U.S. Manufacturers often seek ISO 9001 systems not for the benefit that a quality management system when implemented well will provide. Often the need for this is driven by a need for certification that is required by a customer or a potential customer. Time is of the essence in many of these cases and ISO 9001 documentation templates provide an easy out. While in the initial lifecycle of the system this may result in certification, over time it becomes a compliance burden. Something that is spruced up before audits. Before customer visits and that outside of those rare visits rarely see the proverbial light of day.
Most U.S. small and medium businesses further may not have the in-house expertise and/or the resources needed to invest in a consultant to support this effort.
What documents are actually required under ISO 9001?
ISO 9001 does not require any mandatory procedures. Before we dive further into this topic let us look at some definitions.
- Process – a series of actions or steps taken to achieve a particular end (the what)
- Procedure – an established or official way of doing something (the how)
- Documented procedure – A documented way of doing something
In essence, a procedure or process, as referenced in ISO 9001 does not imply a documented procedure. ISO 9001 asks organizations to determine the risk of not having something documented and as a result determine what they would like to document.
The only documented requirements, outside of required records, in ISO 9001 are the following:
- The scope of the management system including a justified non-applicability
- The Quality Policy
- The Quality Objectives
Which documentation mistakes cause audit failures?
In documenting the management system, it is of the utmost essence that companies appreciate their management system. What does this mean? It means each company has a way of doing things that have brought them this far. In aligning your system to ISO 9001 always begin by capturing how you are currently doing work. Measure it up against the requirements of ISO 9001 and determine where gaps exist.
In documenting your system take into account the competence of personnel, the structure of the organization and the complexity of the processes. DO NOT document your system to satisfy an auditor!
Common documentation mistakes that organizations make include:
- Over documentation – This often occurs when activities are documented by a person not close to the process, done to please an auditor, done in cases where there is high personnel turnover. This becomes an issue for users because there may be a conflict in the requirements for personnel, too many “shall” that become difficult to meet, and confusing to reference.
- Missing records – Where records are not located in the right location, have not been maintained or have been inadvertently deleted/destroyed.
- Uncontrolled documents – This often occurs when personnel print documents for use or take copies and then do not go back to the main repository to validate that they are using the most current version of the document. This may also occur in companies where the document control process may be non-existent.
From recent data, here are statistics that highlight how these mistakes show up in audit failures:
According to isoTracker’s “6 Top Reasons for Failing an ISO 9001 Audit,” common causes include inadequate document control, undocumented employee training, neglecting internal audits, and weak corrective & preventive action (CAPA) processes. (isoTracker)
In another study, companies certified to ISO 9001 significantly outperform non-certified ones in product quality, customer satisfaction, operational and market performance. This suggests that well-implemented documentation (among other system aspects) correlates strongly with improved business outcomes. (ResearchGate)
How can ISO 9001 documentation templates simplify compliance?
While at QMII we do not recommend ISO 9001 documentation templates, what we do recommend is using standardized formats for documentation created by the company. This means that your documents based on document type will have a standardized header and footer and overall document content structure. These standardized formats help personnel with creating new documents ensuring that relevant content is captured.
If you decide to create a risk register to meet the requirements of ISO 9001 Clause 6.1 then you can create a spreadsheet for this as also a risk criterion so that all risks are uniformly assessed using the same criteria. Over time you will create custom audit checklists for your processes that will help your auditors with a baseline of things to check for in an audit.
While templates may not provide the intended success a well-documented system can.
Real-world example: How one U.S. factory cut audit prep time using templates
QMII has helped numerous clients, over the years, set up management systems that capture how work is done at the company. This makes it easy for people to follow the process and easy to conform and comply.
A small business in the aerospace industry reached out to QMII after trying the template approach and failing. They spent the small money to buy the template and then struggled to fill in the blanks. Worse, they could not keep up with the amount of documentation provided in the template and struggled to meet customer requirements because the templates did not reflect how work at the site was actually done. Personnel struggled to follow the documented procedures and morale was low.
QMII helped set up a lean documented user-friendly system that with time help build morale, increase teamwork and resulting in time and cost savings. The company personnel were trained in QMII’s globally recognized ISO 9001 lead auditor course where they learned how to analyze and document processes and also create custom checklists for their internal audits. The improved operations set the company up for success and lead to a successful merger with a large business.
To reinforce how powerful a well-designed documentation system can be: manufacturing companies certified under ISO 9001 generally outperform non-certified peers in product quality, customer satisfaction, operational and financial performance. (ResearchGate)
What’s the easiest way to build lean documentation without overcomplicating it?
For over 39 years QMII has been helping small to large organizations implement systems that help them meet objectives and enhance customer satisfaction. Our approach sets organizations up to succeed with resilient systems that enable the company to adapt to changes. QMII consulting uses a methodology that does not include a cookie cutter approach. For each company and their system is unique. Thus, you need a unique solution that fits your needs. While ISO provides the foundation, we help build the house, customized to your product/service, that will allow you to succeed.
To learn more about our methodology visit https://www.qmii.com/developing-your-system/
