Auditor time for initial audit - ISO/IEC Guide 62 or EN 45012

[Antonio Vieira]

Hi everyone,

In Accreditation bodies for quality management systems must fill the requirements of ISO/IEC Guide 62 or EN 45012 in Europe.

If we check annex 2 - Auditor time of the document “EA Guidelines on the application of EN 45012”, we can that generally Registrars are not using the Auditor time for initial audit stated in the table.
For example for a small company (30 people), according to that table the initial audit should take 4 auditor days, and last week a client of mine had his first one only in 2 working days.

This happens because of the competition between Registrars. They have to get the lowest prices on the market, otherwise they won’t have clients. The easiest way is to make auditing process shorter (even going against the standard they are accredited).
I think this is happening all around the world, not just here.
Shouldn’t this system be out of these competition problems?
When this process was made by a government Institute, these competition issues where never a problem. We changed for a worse solution – as normally happens here...

The document “EA Guidelines on the application of EN 45012” can be downloaded free at www.european-accreditation.org.

AV.

 

[howste]

Like in your country, I believe that registrars have been abusing this due to competition. The accreditation bodies in the US have been cracking down on the registrars lately to make sure that they aren't fudging their numbers in this regard. When they audit a registrar and they find records indicating audit days less than the number in the guidance table, they are looking for evidence to justify their actions.

The guidance document (in the US, IAF Guidance on the Application of ISO / IEC Guide 62:1996) does allow some flexibility.

Some factors requiring additional auditor time could be, as examples:
- Complicated logistics involving more than one building or location where work is carried out. e.g., a separate Design Centre must be audited
- Staff speaking in more than one language (requiring interpreter(s) or preventing individual auditors from working independently)
- Very large site for number of employees (e.g., a timberland)
- High degree of regulation (food and drugs, aerospace, nuclear power, etc.)
- System covers highly complex processes or relatively high number of unique activities
- Processes involve a combination of hardware, software, process, and service

Some factors permitting less auditor time could be, as examples:
- Organization is not “Design Responsible” and/or other Standard elements not covered in scope
- No/low risk product/processes
- Prior knowledge of organization system (e.g., already registered to another Standard by the same Registrar)
- Very small site for number of employees (e.g., Office complex only)
- Client preparedness for registration (e.g., already registered or recognized by another 3rd party scheme)
- Processes involve a single general activity (e.g., Service only)
- Maturity of management system
- High percentage of employees doing the same, simple tasks

All attributes of the organization’s system, processes, and products/services should be considered and a fair adjustment made for those factors that could justify more or less auditor time for an effective audit. Additive factors may be off-set by subtractive factors. In all cases where adjustments are made to the time provided in the Auditor Time table, sufficient evidence and records shall be maintained to justify the variation.