Do you need to hire a QA manager to gain ISO 9001 accreditation?

I received an email today from a Perth based company asking the following question:

Hi Mike,

I was trolling the internet and came across your site. Very impressive feedback.

Will you please advise me, “Must a company have their own QA Manager [employee] in order to gain and maintain ISO9001:2008 compliance?” another way of asking is does an ISO accredited company have to have employee[s] that are accredited auditors for internal audits and maintenance of the QMS or can they sub-contract all the QMS work out to a company such as yours?

There are really three questions here:

1. Do you need to hire a specialized QA manager to gain and maintain certification to ISO 9001?

2. If you can’t afford to hire an additional employee can you outsource the maintenance of my ISO 9001 system to Compliancehelp?

3. Does the person conducting your internal audits need to be an accredited auditor?

These are common questions so I thought I’d post my answers here:

Hi Mark (name changed),

Thanks for the questions.

The answer is “no”, there’s no requirement to hire additional employees to manage or maintain your ISO 9001:2008 compliance.

You do need to appoint a “management representative”, but that can be you if you are a solo operator or any of your existing employees.

The auditor who carries out your internal audits does not have to be accredited, although we usually provide a certificate to say the auditor is trained by us and therefore competent.

If you wish to subcontract out some of the maintenance of your ISO 9001 management system to a company like us, you can … however, 99% of our clients manage it themselves, even one-man companies.

If ISO 9001 is set up correctly it generally requires no more than 3 days a year of your effort to maintain, spread across the full year.

The only reason it would take longer is if the system was over-complicated or if you had 350 + employees with complex processes such as large scale manufacturing.

This is based on our 12 years’ experience working with over 250 companies.

Hope this helps,

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