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ISO 9001 Requirements and Structure

Author: Mark Hammar

The ISO 9001 requirements provide a set of standard elements that will guide you in the implementation of a Quality Management System (QMS). The requirements are designed to be applicable to any company in any industry – both production and service based, and as such the requirements tell you what elements are mandatory in a QMS, but not how to implement these necessary elements.

The ISO 9001 requirements are broadly separated into eight sections (called ISO 9001 clauses), five of which contain mandatory requirements for a QMS: general Quality Management System requirements (clause 4), Management Responsibility (clause 5), Resource Management (clause 6), Product Realization (clause 7), and Measurement, Analysis and Improvement (clause 8). All elements of these five clauses are mandatory with the exception of the Product Realization section, which allows for a company to exclude portions that are not applicable. Clauses 1 through 3 include no requirements, but instead deal with the scope of the standard, references to understand the standard better, and terms and definitions.

Quality Management System

This section deals with general requirements for a QMS, as well as all documentation requirements. It also includes the requirements for the necessary Quality Manual, Control of Documents, and Control of Records.

Management Responsibility

The section on Management Responsibility outlines the requirements for customer commitment and focus, and the important Quality Policy and Quality Objectives. The elements of planning in the QMS are covered, along with the need to define responsibility, authority and communication in the company. Finally, the requirements of the management review, including the mandatory inputs and outputs for the review, are included.

Resource Management

The short section on resources covers the requirements for management to provide resources, including infrastructure, work environment and human resources. The importance of competence, awareness and training for human resources is emphasized.

Product Realization

This section is the only part of the structure where a company can choose to exclude sections of the requirements (such as excluding the design requirements if your company does not do design work). The requirements deal with planning for product (or service), starting with determining and reviewing the product requirements, design and development and purchasing, which leads to the provision to create and supply the product or service. The final requirements deal with the control of any equipment used to monitor or measure the product or service.

Measurement, Analysis and Improvement

The last section deals with how you know your QMS is working and improving. The Monitoring and Measurement section outlines requirements for assessing customer satisfaction, Internal Audit, and monitoring the product and processes. The section deals with how to control non-conforming product, since this will happen in any business, and how you will analyze and improve, including corrective and preventive actions.

Some Difficulties in Implementation

The greatest difficulty of implementing the standard requirements is to ensure that the resulting collection of policies, procedures, processes and records meets the needs of the company and their customers, while still allowing for improvement of the system. Improvement of the system is one of the main reasons for implementing a QMS, as it benefits the company in the long run.

To learn more about the requirements and structure of ISO 9001, read this free white paper: Clause-by-clause explanation of ISO 9001:2015.

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