ITF Consult

When a consultant is worth paying for

An honest answer, including the cases where you should do it yourself.

You need a consultant when you lack the time or the knowledge to interpret a standard and build the system, or when a deadline makes learning on the job too slow. You do not need one when someone on your staff knows the standard and has the time. Either way, no consultant can certify you.

Three routes drawn on one project line from the start to the certification audit, which is run by the body you choose. Full help, for new ground and a hard date: the system built with your people, the consultant alongside. Help at two points, for a lead with real time: a gap analysis at the start and an internal audit at the end, highlighted, with your team doing everything between. Yourself, for a quality lead with time: your team from start to end, the upkeep of a working system. In every route your people describe the work and own the system.STARTBEFORE THE AUDITFULL HELPNEW GROUND, HARD DATEHELP AT TWO POINTSA LEAD WITH REAL TIMEYOURSELFQUALITY LEAD WITH TIMEBUILT WITH YOUR PEOPLECONSULTANT ALONGSIDEGAP ANALYSISINTERNAL AUDITYOUR TEAM DOES EVERYTHING BETWEENYOUR TEAM, START TO ENDUPKEEP, NOT CONSTRUCTIONCERTIFICATION AUDITBY THE BODY YOU CHOOSEIN EVERY ROUTEYOUR PEOPLE DESCRIBE THE WORK AND OWN THE SYSTEM
Full help, help at two points, or noneThe middle route is the cheapest serious oneSwipe to pan

Four cases where the fee pays for itself

A consultant earns the fee on a first certification with a hard deadline, a regulator or customer requirement you do not understand, a failed audit, or a system that exists on paper and nowhere else. In each case the cost of learning slowly is higher than the fee.

The common thread is time pressure against unfamiliar ground. A first certification has a buyer's date on it and nobody inside who has done one. A regulator's requirement, like the documents behind an SFDA licence, has a sequence that is expensive to discover by trial. A failed audit has findings with a closure date. And a paper system needs rebuilding by someone who can tell which parts are real.

  • First certification, with a date set by a buyer or a tender
  • A regulator or customer requirement nobody inside can interpret
  • An audit that produced findings you have to close by a date
  • A system that exists in a binder and not in the work

Doing it yourself is often right

You do not need a consultant when you have an experienced quality manager with time, or when the system already works and only needs maintaining. Paying someone to run what your team already runs well is money spent on nothing.

One case deserves plain words. If what you want is someone to get you certified without your staff doing the work, no consultant can honestly do that. The auditor samples records your people produced and interviews the people who do the job. A system your team did not build is a system your team cannot answer questions about.

  • An experienced quality manager who knows the standard and has the time
  • A working system that needs upkeep, not construction
  • A goal of a certificate without your team's involvement, which nobody can deliver honestly

The middle route: help at two points

Many companies with a capable internal lead buy help at two points only: a gap analysis at the start, so they know exactly what to build, and an internal audit at the end, run the way the certification body will run it. The team does everything in between.

It is the cheapest serious way to do it. The gap analysis turns the standard into a list of specific gaps with owners. The internal audit tests the result before an outsider does, and gives the team findings to close while there is still time.

It works when the internal lead has real time for the project. It fails when the lead is also running production, and the project becomes the thing that happens after hours.

What to ask a consultant before you hire one

Ask what you will hold at the end, by name. A good answer lists documents, registers and reports. Ask how much of the work your team does, and ask how they will prove the system runs. Vague answers about getting you certified are the warning.

A consultant who writes everything for you leaves you with a system your people have never used. A consultant who promises a certificate is promising something only a certification body can decide. The useful consultant builds the system with your people and audits it hard before anyone else does.

  • The named documents and records you will receive
  • Which parts your team writes and runs, and which parts the consultant does
  • How the system will be tested before the certification audit
  • Whether certification body fees sit outside the quote, which they should
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Questions about hiring help

Q01

Can a consultant certify us?

No. Certification is decided by a certification body, and the standard those bodies are accredited to, ISO/IEC 17021-1, keeps certification and consultancy apart. You choose your certification body yourself.

Q02

Will using a consultant guarantee we pass?

Nobody can guarantee an audit outcome. What a consultant can do is make sure the system is real, the records exist and an internal audit has already found what an external one would.

Q03

How much of our staff's time does it take?

More than most people expect, with or without a consultant. Process owners have to describe their work, and someone internal has to own the system once it runs. If nobody can be spared, the certificate may come and the system will not.

Q04

Can we use a consultant for part of the work only?

Yes. A gap analysis or an internal audit can be bought on its own, and for a company with a capable internal lead that is often the right amount of help.

Find out which case you are

A gap call tells you whether you need full help, help at two points, or none. It starts from what your team already runs.

Book a gap call