Custom software for certificate scope and factory inspections
A manufacturer with certificates rarely holds just one. There are several, issued by different bodies, each with its own assessment guidelines, its own inspection frequency and its own list of products it covers. The question that most often goes wrong is the simplest one: does this product fall under this certificate?
What happens beyond the production file
Before a declaration of conformity is issued, the certification body carries out an admission assessment. This checks whether the declared values of the essential characteristics are met, assesses the other product characteristics, determines the performance in the intended application, reviews the processing instructions and establishes the conditions of use. For an attestation-with-product-certificate, the production process, the quality system and the internal production control scheme are added to that.
After certification, periodic reviews follow. The visit frequency is not the same for everyone: assessment guidelines link it to the revenue associated with the certified product, and businesses holding an ISO 9001 certificate may be given a lower frequency. That reduction only applies if the company's management statement confirms that production complies with the requirements of the assessment guideline.
During that assessment, the body looks at, among other things, whether a person is responsible for managing the quality system, whether the internal production control scheme is in place and actually operating, the measuring and testing facilities together with their calibration and state of maintenance, and the recording of measurement and test results and the results themselves.
In addition, during inspection audits the body itself selects an element from production. The supplier provides the identification of that element and the data related to its application in advance, and releases it for testing. This is a process with a lead time, not an action on the day itself.
How we build this
The core is the certificate and its scope. What falls under it determines what is inspected, what may appear on a declaration and what a new product needs first.
Which products, which systems and which production sites fall under which certificate, from which body and under which guideline.
The frequency follows from the schedule and from your situation. The system plans ahead instead of waiting for an announcement.
What the inspector requests, which element they select and which documents must be in place beforehand all depend on the visit itself.
Every finding is given an owner and a due date, because follow-up is where a sanctions process falls apart.
What the software actually does
Scope management holds the whole together. What else you need depends on the number of certificates and on whether you have several production sites.
Scope as the first question
For each product it is visible under which certificate it falls and whether it was already covered when it was supplied.
New product as a project
A product outside the scope first needs an admission assessment. That is a project with steps, not a tick box.
Inspection calendar per scheme
Several certificates mean several rhythms. The system places them side by side instead of in separate diaries.
Preparing the selected element
The body selects an element and you supply its identification and application data in advance. The system keeps track of that trail.
Findings and follow-up
What was found, by whom, with which deadline and what has been done about it. At the next inspection, that is the first conversation.
Calibration and facilities in view
The body assesses the condition of your measuring equipment. You should know before the visit what has lapsed.
Who we build for
Who keeps track of this differs from company to company. Four situations.
Quality managers
They monitor several schemes at once and only discover at an inspection that two of them ask for something different.
Manufacturing companies with multiple sites
For them, the scope differs from site to site, while the certificate is discussed at company level.
Companies that are expanding
A new product or a new system does not automatically fall under an existing certificate. That takes time, which should be scheduled in advance.
Management
They sign the director's declaration on which a lower inspection frequency is based, and want to know whether that claim still holds.
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Assessment guidelines are revised, certification bodies change their procedures, and schedules are added. Certificates, scope rules and frequencies should be configurable rather than hard-coded.
For the inspection company that has to schedule re-inspections per object within the deadline, there is our inspection planning software for inspection bodies.
Why Appfront
Scope is the first question, not the last
Whether a product falls under a certificate determines everything that follows. We build that as the core rather than as a feature.
A new product is a project in its own right
An admission assessment takes time. Those who treat it as an administrative step discover too late that they are not yet permitted to supply.
Multiple schemes do not simply add up
Two certificates sometimes require different things of the same production. That conflict should be visible before an inspector spots it.
We do not certify
The judgement remains with the certification body. We build the overview with which you enter the visit.
Security and privacy
Your certification files contain product specifications, measurement results and findings that reveal a great deal about your production. That is commercially sensitive, and sometimes shared with a body that also audits your competitors. We set access by role and by site, give an auditor temporary, limited access, and log that access. Integrations run through secure connections to your existing software.
For this subject, the reliability of the record in time is the point. A finding reworded after the visit, or a scope extended retrospectively, undermines exactly what the certificate is meant to demonstrate. We record amendments irreversibly with time and person, and make a correction a visible correction alongside the original entry. How we handle security ourselves is set out in our information security policy.
Frequently asked questions about certificate scope and inspections
The body checks whether the declared values of the essential characteristics comply, assesses the other product characteristics, determines performance in the intended application, assesses the processing instructions and sets the conditions of use. For an attestation-of-conformity certificate, the production process and the quality system are included in that assessment.
Assessment guidelines link visit frequency to the revenue associated with the certified product. Businesses holding an ISO 9001 certificate may be given a lower frequency, but only if the management statement confirms that production complies with the requirements of the guideline.
Among other things, the person responsible for the quality system, the presence and operation of the internal quality monitoring scheme, the measuring facilities with their calibration and maintenance status, and the recorded measurement results and the results themselves.
No. Outside the agreed scope, a review is needed first. That takes time, and it is the most common reason a delivery has to wait.
This covers the external side: scope, visits and findings. We describe the day-to-day checks, measurements and calibrations from your guideline on our page about certificate management and BRL dossiers.
Yes, and that is usually the very reason to build something. Each scheme has its own rules, but they sit in one calendar and one findings list.
Is your newest product already covered by your certificate?
Take the last product you put into production and check which certificate it falls under and since when. If that turns out to be an assumption, the question will come up again at the next visit. We build this as a standalone application and as part of a broader custom software development project.
If you would rather record the visit on the shop floor yourself, take a look at the inspection visit app for the production site.