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3. Getting Started with your ISO 9001 Quality Management System

There are several things you can do to prepare the ground for implementing an ISO 9001 Quality Management System. These steps will save you time and money, particularly if you are using an outside consultant to help you prepare documentation. Your initial preparation will create a solid foundation on which to build the Quality Management System.

Leadership and Commitment (previously "Select your Management Representative")

In the ISO 9001:2015 revision, the concept of a "Management Representative" as a specific role was removed. The 2015 version introduced a more holistic approach to quality management that emphasizes the involvement and accountability of top management throughout the entire quality management system (QMS). The idea behind this change was to promote a culture of quality throughout the organization and integrate quality management into overall business strategies. 

Top management is now expected to demonstrate direct involvement and engagement in the QMS including the setting of the quality policy and objectives, conducting management reviews, ensuring adequate resources, and promoting customer focus and continual improvement.

The 2015 revision makes it clear that quality management is now seen as an integral part of overall management functions rather than a separate entity. 

We have published some blogs on the topic of Management Review :

1. Management review topics
2. Roles and Responsibilities of Top Management in the QMS

Construct a Process Map

A process map is a visual description of the activities in your business. You will need to identify your key business processes and how they interact.

Your process map will need to include your processes for:

• resource management – people and infrastructure
• product/service realisation – purchasing from suppliers, actual production, customer services, delivery, etc
• management activities – planning, system review, document control
• measurement, analysis and improvement – customer complaints, audits, corrective and preventive actions,

(An example is provided here)

Select a Certification Body

Talk to several companies and compare prices. Make sure that the certification body you select has auditors with experience in your industry. You should book them in early and keep them informed of your system development program.

(here is a typical timeline).

Identify key documents / forms / templates

It is essential that you start to identify key documents that you are already using that may need to be brought under version control in the quality system. These will be documents that affect/control the quality of the product and/or service you provide. For example:

• External Documents – Standards, Customer supplied documents / drawings
• Forms / Templates
• Work Instructions
• Safe Work Procedures
• Standard Operating Procedures
• Policies
• Quality Plans
• Inspection & Test Plans
• Meeting Minutes
• Material Safety Data Sheets

To prepare for bringing these documents into the quality system, you should:

• Make hard copies of all forms / templates used throughout the organisation.
• Identify who “owns” each document – they will become the “document controller” for that document.
• Identify where the “masters” of these documents are located eg., on a server, someone’s hard drive, etc.
• Review current version control procedures – by date of issue, revision numbers?

Draft an Organisation Chart

This is critical, as without this essential information you will be unable to correctly delegate effective roles and responsibilities for the development and maintenance of your quality system.

You should:

• Specify full names
• Establish correct job titles
• Locate any existing job/position descriptions and review them with appropriate personnel & managers.