ISO 9001 requirements – a short overview

ISO 9001 Clause (s) or Section

General content

Notes

Section 0 Introduction

Explanation of the “process
approach”, “PDCA”, the ISO 9000 process model and compatibility with other
management standards

This section sets the scene for the use of the standard. Its intent is to emphasise these important points of understanding. In reality few people pay it much attention as it is not formally “assessed” during an audit. This may explain why many companies that adopt ISO 9001 have a weak understanding of “process management” and “PDCA”

Section 1 Scope

Explanation of how the standard
should be applied in terms of its scope and reference points

This section identifies those parts of ISO 9001 that can be excluded from the assessment (only parts of section 7) and explains the only justification for such an exclusion (e.g. you may only exclude clause 7.3 “design and development” if you have no design function or process)

Section 2 Normative references

Explains how the terms used
within the standard should be applied

It identifies that all references within ISO 9001 should relate to ISO 9000 definitions

Section 3 Terms and definitions

Explanation of a small number
of key terms and definitions

Clarification of how the terms “product” and “supply chain” should be used

Note: sections 0-3 set the scene. They aim to help the effective and appropriate
use of the remaining clauses of ISO 9001. Sections 4-8 define the specific
system requirements. It is these requirements that are assessed during a full
systems audit to ISO 9001 by a third party certification body

Section 4 Quality Management
System

This section defines the
general and documentary requirements of the system. Section 4 defines the
requirements for the content of the manual (4.2.2), document control (4.2.3)
and control of records (4.2.4)

These requirements will be assessed at a high level during a stage 1 third party assessment. The auditor will take a general view whether there is a general sufficiency of documentation to make a more detailed (stage 2) assessment worthwhile

Control of Documents and Control of Records are  mandatory procedures

Section 5 Management
responsibility

This section identifies a set
of minimum requirements for direct and active top management involvement

These are aspects of the system that cannot be delegated in their entirety to the QA Manager. It includes requirements to provide resources, clarify responsibilities and reporting lines, ensure communication processes are effective and to actively participate in management review and objective setting

Section 6 Resource management

Section includes

·
Human Resources

·
Infrastructure

·
Environment

Often viewed almost as an “any other business” section of the standard, it includes Human Resource requirements (including training), Infrastructure requirements (ensuring sufficiency of workspace, equipment and so on), and environmental control requirements (this could cover maintenance of standards in a “clean room” or a “dark room”, or temperature, noise or humidity control requirements

Section 7 Product realisation

Defines the controls associated
with core operational processes of production or service delivery

Product realisation? Generally this is not a term in common everyday use and the title itself causes a certain amount of confusion. Let’s simplify it. “Product Realisation” can mean “Production” or “Manufacturing” in a manufacturing operation, or it would translate as “Service Delivery” in a service provider. Substitute these terms and it will all make so much more sense

The section covers a range of typical operational control issues, such as operation planning (7.1), ordering and contracts processes (7.2), Design (7.3), Purchasing – this includes supplier approval- (7.4), general process control – including preservation and prevention of damage to customer property and traceability (7.5) and calibration (7.6)

Clauses form this section may be excluded if they do not apply to the company’s sphere of work (clause 1.2  refers)

Section 8 Measurement, analysis
and improvement

This is the section that can be
considered to drive continual improvement. It identifies a set of mandatory
performance monitoring and review activities. The section includes:

·
Monitoring of processes

·
Monitoring of product

·
Customer satisfaction

Most of the clauses within this section have a direct interface with clause 5.6 (management review) as they generate important performance data that should be used to inform future policy and decision making. The remaining 4 mandatory procedural requirements are contained within this section, they are:

8.2.2 Internal audits

8.3 Control of non-conforming product

8.5.2 Corrective action

8.5.3 Preventative action