Toughest ISO 9001:2000 Requirements (6.3)

In the December, 2003 newsletter, I identified twelve ISO 9001:2000 clauses as the toughest requirements to understand and meet with conforming practices. Clauses 4.1, 5.1, and 5.4.1 were addressed in the past two newsletters.

This article picks up with clause 6.3, Infrastructure. The next article in this newsletter deals with clause 7.3.1, Design and Development Planning.

4.1  General Requirements (and 0.2 Process Approach) – article in December, 2002
   5.1  Management Commitment – article in January, 2003
5.4.1  Quality Objectives – article in January, 2003
5.4.2  Quality Management System Planning – article in February, 2003
6.2.2  Competence, Awareness, and Training – article in February, 2003
6.3  Infrastructure
7.3.1  Design and Development Planning 

7.5.2  Validation of Processes for Production and Service Provision
8.2.1  Customer Satisfaction
8.4  Analysis of Data
8.5.1  Continual Improvement
8.5.3  Preventive Action

Clause 6.3, Infrastructure, states (in part):

The organization shall determine, provide, and maintain the infrastructure needed to achieve conformity to product requirements.

What is an infrastructure? According to the American Heritage Dictionary of the English Language, Fourth Edition, the term “infrastructure” began in 1927 to refer collectively to the roads, bridges, rail lines, and similar public works required for an industrial economy to function. Perhaps because of the its technical sound, people now use “infrastructure” to refer to any substructure or underlying system.

In fact, ISO 9000:2000 defines it as a “system of facilities, equipment, and services needed for the operation of an organization”. Without this underlying base or foundation, an organization would be unable to carry out the activities needed to deliver quality products and services. Although the infrastructure requirement is new to ISO 9001, it was always necessary, even if not directly stated.

Since it wasn’t a specified requirement, the functional areas responsible for the infrastructure may not have been subject to internal and external audits. These departments will now be part of the audit agenda. So, the first step is for management to determine what buildings, equipment, workspace, tools, and supporting services are being used (or required) to produce conforming products. Next, management must provide that infrastructure and begin planning for future needs.

When we talk about workplace requirements, the line begins to blur between 6.3, Infrastructure, and 6.4, Work Environment. For manufacturing, you may have to consider the control of heat, humidity, light, air flow, noise, and vibration. For services, it may be adequate customer waiting areas and restrooms. Or, in the food and drink industry, there may be stringent requirements for sanitation and hygiene. For software development, it is a computing environment with the necessary equipment, networks, tools, and service level agreements.

Since we must also “maintain” the infrastructure, an organization has to maintain its equipment and facilities. It could even imply contingency planning to identify and mitigate any risks. Of course, the maintenance type and frequency should be based on the criticality and usage of that part of the infrastructure. And, remember there may be environmental issues associated with the infrastructure, such as, conservation, pollution, waste, and recycling.

Clause 6.3, Infrastructure, concludes with:

Infrastructure includes, as applicable

a) buildings, workspace, and associated utilities
b) process equipment (both hardware and software), and
c) supporting services (such as, transport or communication).

This part of the requirement gives examples of the elements that make up an infrastructure, and thereby, help clarify what is meant be the term “infrastructure”. The utilities mentioned could be electricity, water, natural gas, or compressed air.

Remember the old requirement in clause 4.9 of ISO 9001:1994 to maintain equipment for continued process capability? Well, it has resurfaced in 6.3.b. Your organization must determine, provide, and maintain its process equipment (both hardware and software).

Two examples are given for supporting services: 1) transport and 2) communication. However, don’t overlook 3) information technology.

In conclusion, it is important to note that by placing the infrastructure requirements under Resource Management, rather than Production and Service Provision, it must be in place to support all the processes of the system.