Choose Success Before Software for ISO
Clients sometimes ask Cavendish Scott for advice on the best software for ISO. They generally seem to be hoping for a package that will provide the architecture for their standards, so they can simply follow all the prompts, check all the boxes, and thereby pass all their audits.
This expectation is realistic in some ways. Any good software package will lighten part of the burden of ISO. For example, with the right input, software can automatically send reminders and generate calibration databases. It’s essential in complicated systems and helpful in situations involving large, complex data sets. Sometimes in regulatory situations software can help clients make sure they don’t miss anything.
ISO Is Not Only About Software
But anyone who knows Cavendish Scott is aware the firm doesn’t take a check-all-the-boxes approach, but instead emphasizes systems and processes that result in success. With Cavendish Scott, the goal is success. Systems and processes are the means of reaching success, and software is one tool.
ISO is about discipline, organization and doing things right, not software.
Cavendish Scott recommends that clients first develop their strategy and processes and then consider how software may help those processes. Alternatively, Cavendish has observed that it’s sometimes helpful to develop strategy and processes, implement them manually, and then consider what software could make implementation easier without compromising quality. Clients may even find that software would be unnecessary or, in rare cases, a hindrance.
Comparing Software Packages for ISO Certification
The selection of software packages is as individual as the management systems they support.
Most clients find Microsoft Office includes all the common tools and does everything needed to support their systems. Outlook can be used for communications and Excel for databases. Microsoft Teams is great for online collaboration with auditors and others. The flexible programs can be set up in minutes and customized as needed.
But Microsoft Office and similar packages are generic. Software designed more specifically for ISO may make some jobs easier. For example, a specialized program may include a structured calibration database where analyses are readily available, whereas the same database would need to be set up and analyzed manually in Excel. Quality management systems for medical devices are highly specialized and regulated, so specific software may help organizations in this sector stay in compliance and in business.
For clients who have made the decision to invest in software for use in support of ISO and success, Cavendish Scott recommends the following:
- As a first step, develop a document similar to a request for proposal. Specify the features that are most important for the success of your management system. Be sure to include among the capabilities smooth integration with your organization’s software for accounting and enterprise resource planning, or ERP.
- Second, compare three to six different solutions so you can select the one that performs best for your situation. Be sure to think beyond the next audit cycle. Consider whether the software will meet organizational needs at least three to five years in the future, and what the expense may be to keep up to date.
- Make your software part of your strategic plan.
Cavendish Scott cautions clients against blindly relying on software that is bundled with an ISO solution package. The result can be that the client is stuck with software that isn’t right for the management system and isn’t flexible enough to be modified as needed. This approach may serve as a quick fix in getting certified at one point, but it’s not helpful to achieving long-term success.
Whatever software is selected, clients need to recognize its limitations. Software can reveal data and help in identifying problems. But human involvement is needed to effectively analyze problems and take actions that result in improved processes.
Strategize, Consider Generic, Shop Smartly
It makes sense for organizations to implement ISO with manual tools so they understand how things work, see what’s important, and get their hands dirty addressing the right things in the organization. Before deciding they can’t live without software, they should first address issues and fix problems.
After they identify the tasks that they want software to perform, they may first consider using Microsoft Office, which provides all the tools most organizations need.
But, for clients needing more specialized software, the best advice is to shop smartly, always keeping in mind that the goal is not making life easier, but designing for success.
Cavendish Scott offers consulting, training and auditing to help organizations obtain and maintain certifications and standards.