ISO 9001 Mandatory Procedures

There are 6 mandatory procedures required by the ISO 9001 standard.

Mandatory Procedures

4.2.3 Control of Documents

4.2.4 Control of Records

8.2.2 Internal audit

8.3 Control of non-conformance

8.5.2 Corrective action

8.5.3 Preventive action

To make things easier, you can actually combine the last 2, the corrective action and the preventative

action procedures together to simplify your documentation. This is because when a CAR (Corrective

Action Request) is lodged, not only is an action suppose to be implemented to fix or rectify the situation,

it is highly recommended to provide details of how an incident can be prevented.

It is actually not very hard to memorize these mandatory procedures. You'll notice that 2 occur in section

4.2 and the rest are in section 8.

Section 4.2 deals with how documents are controlled, and how records are controlled. By records, we are

talking about meeting minutes, filled out forms that have been signed, audit reports, audit schedules,

etc.

Section 8 is all about Measurement, Analysis and Improvements. In particular, internal audits are used to

gauge the effectiveness or health of your QMS. ie How effective is it in:

Meeting the ISO 9001 standard?

Your own Quality Management System?

Customer and regulatory requirements?

The next three should be easy to remember as well. It deals with how one controls non-conformity, how

one takes steps to correct or eliminate these non-conformities and taking this to the next level of

preventing non-conformities.

ISO 9001 Recommended Procedures

The following lists optional but recommended procedures for your quality manual.

Recommended Procedures

5.5.3 Internal Communication

5.6 Management Review

6.2.2 Training & Awareness

6.3 Facilities Management

7.1 Product Realisation & Planning

7.2.2 Contract Review

7.3 Design & Development Control

7.4 Purchasing

7.5.1 Control of Production and Service Provision

7.5.2 Validation of processes

7.5.3 Identification & Traceability

7.5.4 Control of Customer Property

7.5.5 Preservation of product

7.6 Control of Monitoring & Measuring Equipment

8.2.1 Customer Satisfaction

8.2.4 Monitoring and measurement of product

8.4 Analysis of Data

8.5.1 Continual Improvement

No matter what industry you are in, all these procedures will apply. Remember that product also means

services. Many people incorrectly assume that if you offer a service such as consulting, you can exclude

Product Realization and Planning. Service Realization and Planning is very relevant and very important.

That is, how do you plan to provide your service?

In addition to this, in a service industry you may not be purchasing raw materials, but you could be

bringing in another expert in the field, hence the procedure for "evaluating a supplier" is no different to

evaluating an external expert resource.