If you manage a QMS, don't take a Lead Auditor Course!

You’re thinking, "But this is what Management Representatives have been doing for decades. Why shouldn't I take a lead auditor course?"

And you’re right!

Because, until now, there has been no better alternative available.

There are two areas of vital interest to the Management Representative, or other person(s) responsible for implementing and maintaining an organization’s Quality System, that are outside the scope of Lead Auditor Course.  These are:

Problem 1: The role of the Audit Programme Manager

One of the key responsibilities of the Management Representative is the role of the Audit Programme Manager, that is, the person responsible for managing the Internal (and external) auditing requirements of the quality system.  The activities here include:

1. Introduction

• Process flow – analysing the organization’s processes, and audit history, to establish an effective Audit Schedule
• Audit Programme content – both vertical and horizontal audit activities
• Types of Audit Programme – external (suppliers) and well as internal
• Audit Programme Procedures – allocating responsibility for all six stages of the audit cycle

1. Establishing the audit programme
2. Training and selecting suitable auditors
3. Implementing the audit programme
4. Audit programme monitoring
5. Taking corrective action where required and ensuring the effectiveness of such corrective actions
6. Reviewing and improving audit programmes

These activities are outside the scope of a Lead Auditor Course where the focus is on training auditors for work with Certification Auditors (and ISO Guidance Documents rarely get a mention).  Such bodies have their own auditing programmes and procedures (documented and approved as part of their accreditation) and so this area is excluded from Lead Auditor Courses.

What about the needs of the Management Representative?  Tough!

Problem 2: Implementing and Maintaining a QMS

Let's focus on ISO 9001:2015. 

No two quality management systems are the same, more so now that ISO 9001:2015 doesn’t even include any mandatory documented procedures. 

The structure, content, implementation and maintenance of a Quality System to meet ISO 9001:2015 requirements is simply beyond what could reasonably expect of a Lead Auditor Course.

The typical implementation of a QMS is undertaken in three phases:

• Phase A. Initiating (dealing with Parts 4 & 5 of the Standard)
• Phase B. Planning (dealing with Part 6)
• Phase C. Implementation (dealing with Parts 7, 8, 9 & 10)

Maintenance of the system involves a periodic review and audit of the three Phases of the system (incorporated into the mandatory internal audits and the management review activity).

So, what’s the answer? Lead Implementer Courses, of course!

It is, of course, a purpose-designed Course to meet the specific requirements of the Management Representative.

We have developed two such courses, with Auditor Certification:

• Course 032: ISO 9001:2015 Lead Implementer,

that, in addition to Auditor Training and knowledge of the Standard, also includes Audit Programme Management and the implementation and maintenance of the Management System.

The other Courses...

• Course 008: ISO 14001 Lead Implementer for Environmental Management Systems
• Course 035: ISO 13485 Lead Implementer for Medical Device Management Systems
• Course 011: ISO 27001 Lead Implementer for Information Securit Management Systems
• Course 038: ISO 45001 Lead Implementer for OH&S Management Systems.

Note: Originally published in 2017, this post was revised and updated in October 2020.