ISO Compliance Software for Manufacturers

Q: How does MakerComply provide traceability of corrective actions?

Use Incident Manager to easily report, track, and trigger CAPA (corrective action / preventive action). Automated follow-ups help ensure improvement actually takes place, to prevent recurrences. Show ISO inspectors that you consistently maintain continuous improvement efforts with automated audit trails.

ISO Requirement

Without MakerComply

With MakerComply

Having documentation and records to prove conformance for ISO certification inspections

Auditors want to see effective,consistent implementation of your Quality Management efforts. Too often, that means you’re spending days assembling evidence to demonstrate conformance for the inspectors.

Your ISO compliance documentation is at your fingertips online, and directly linked to each relevant clause or standard. ISO inspections become streamlined and less stressful.

Conducting time-consuming recurring surveillance audits (without letting production slip or hiring more staff)

Paying consultants to “get us ready for ISO” or wasting time chasing evidence to prove conformance. Rinse and repeat, for annual internal audits.

Real-time updates to your documentation and records means you’re in a continual state of readiness, with a central repository keeping everything in one place. Easily do preparatory internal audits with automated gap analyses, to see what needs work before your next certification audit.

ISO wants traceability of corrective actions and non-conformances

Paper non-conformance forms go missing, or non-conformance data is manually entered into spreadsheets, with no mechanism to ensure effective follow-up and resolution.

Use MakerComply Incident Reporting software to easily report, track, and trigger CAPA (corrective action / preventive action). Automated follow-ups help ensure improvement actually takes place, to prevent recurrences. Show ISO inspectors that you consistently maintain continuous improvement efforts with automated audit trails.

Properly-managed training with full, up-to-date records

ISO calls for training requirements to be documented, then the resulting training must be provided to employees. But that’s not enough: they also need to see evidence of the training and competency levels of your workers, including gap analyses of what competencies your people are lacking. It adds up to a ton of documentation about training for compliance, which is laborious and error-prone when tracked manually.

You need a central repository for all training records, with automated training scheduling, reminders, and real-time reports. No more chasing employees to get their training, and manually updating records and reports.

From ISO Burden
to Competitive Advantage

Without ISO certification, you risk losing contracts to your bigger competitors. For SME manufacturers, ISO 9001 certification typically increases revenue by 5-20% with access to more contracts.

Using MakerComply manufacturing compliance software, you’ll get ISO-certified faster and more cost-effectively, without hiring more quality management staff and eroding profits.
You’ll be better able to show continuous improvement efforts, using MakerComply Incident Manager to help track and respond to incidents and problems that hurt productivity and cause re-work.
More effectively managing training with MakerComply Training Manager helps you keep staff ISO-compliant while maximizing their competence and productivity.
Best of all: you get your work-life balance back, and you sleep better at night knowing you’re ready for an audit at any time.

It’s not “one and done” – ISO certification is meant to be a tool for continuous improvement - but it’s as close as possible to “set and forget,” with MakerComply prompting self-serve training updates, automating CAPA follow-ups and tracking; and guiding you through regular internal audits with dynamic updates to crucial evidence of conformance.

ISO certification,without the time-suck

ISO certification,
without the time-suck