ISO 9001:2008 Quality Management System

Copyright 2010 @ Ismail Mohammad Latiff

 imlatiff@gmail.com ISO 9001 Home

Understand . Plan . Document . Implement . Audit . Review

Quality Management System (QMS) Requirements

 

The ISO 9001:2008 standard provides a quality management system model for determining and meeting customer requirements and enhancing its satisfaction.  It is generic and applicable to all kinds of organizations.  Therefore, organizations from both the public and private sectors, including non-governmental organizations can benefit from the ISO 9001 quality management system model, regardless of whether they are small, medium or large organizations.  The immediate benefit that can be realized from the implementation of ISO 9001 is the collective alignment of the activities of internal processes that are focused towards the enhancement of customer satisfaction which will result in many other benefits, whether internal or external.  The magnitude of these benefits are determined by how effective the processes are in achieving its objectives. 

 

In order to understand what the ISO 9001:2008 model is all about, give your fullest attention to Clause 4 of the standard.  This clause summarizes the QMS model and therefore giving you the understanding of the overall design of the QMS. 

 

 

Clause 4 Quality Management System

 

4.1  General requirements

The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standards.

The organization shall

  1. determine the processes needed for the quality management system and their  application throughout the organizations (see 1.2),

  2. determine the sequence and interaction of these processes,

  3. determine criteria and methods needed to ensure that both the operation and control  of these processes are effective,

  4. ensure the availability of resources and information necessary to support the  operation and monitoring of these processes, 

  5. monitor, measure where applicable and analyze these processes, and

  6. implement actions necessary to achieve planned results and continual improvement of these processes.

These processes shall be managed by the organization in accordance with the requirements of this International Standard. 

Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes.  The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.

 NOTE 1: Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization and measurement, analysis and improvement.

NOTE 2: An outsourced process is a process that the organization needs for its quality management system, and which the organization chooses to have performed by an external party.

NOTE 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory, and regulatory requirements.  The type and extent of control to be applied to the outsourced process can be influenced by factors such as

  1. the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements,

  2. the degree to which the control for the process is shared;

  3. the capability of achieving the necessary control through the application of Clause 7.4.

 

 

The second part of the clause (4.2) describes the documentation requirements for the QMS.   ISO 9001:2008 is not focused on the amount of documentation that must be established for the quality management system.  It only specifies documents (including records) that are necessary to demonstrate the effective planning, operation and control of  the quality management system.  The ISO 9001 is therefore a “documented quality management system”, and not a “system of documents”.   The extent and magnitude of an organization's documentation may depend on the size and type of its activities; the complexity of its processes and their interactions, and the competence of its personnel. And its documentation could be in the of paper, magnetic, electronic or optical computer disc, photograph, etc.   The ISO 9001:2008 standard explains that the quality management system documentation shall include:

  • documented statements of a quality policy and quality objectives;

  • a quality manual;

  • documented procedures required by this International Standard;

    • Clause 4.2.3 Control of documents

    • Clause 4.2.4 Control of records

    • Clause 8.2.2 Internal audit

    • Clause 8.3 Control of nonconforming product

    • Clause 8.5.2 Corrective action

    • Clause 8.5.3 Preventive action

  • documents (including records) needed by the organization to ensure the effective planning, operation and control of its processes, and

  • records required by this International Standard.

All the documents that form part of the QMS have to be controlled in accordance with clause 4.2.3 of ISO 9001:2008, or, for the particular case of records, according to clause 4.2.4 (Control of Documents & Control of Records procedures). 

 

ISO 9001 is all about controlling key areas of your organization to ensure customer requirements are met.

 

The ISO 9001 quality management system model is about placing quality controls in various strategic locations of your organization.  These controls are placed within the areas of management responsibility, resource management, product realization and, monitoring and measurement.  This means if your organization implements ISO 9001 as its quality management system model, these four areas are going to be controlled by ISO 9001 requirements.  What kinds of controls does the ISO 9001:2008 standard specify?  The following are the control elements of ISO 9001:2008:

 

1.0  Top management

Top management has the obligation of being committed to achieving the objectives of the quality management system, be focused on meeting customer requirements and enhancing their satisfaction, establishing the quality policy and objectives, establishing authority and responsibility, and internal communications, and reviewing the performance of the quality management system.

 

2.0  Resource management

In order to ensure that quality requirements are met, necessary resources are to be provided, such as competent human resources, adequate infrastructures and suitable work environment where work is to be performed.

 

3.0  Product realization

The product realization process shall be controlled in terms of its planning, communications with the customer, design and development, purchasing of raw materials and services, product creation activities, and calibration of monitoring and measurement equipments.

 

4.0  Measurement, analysis and improvement

Your organization shall monitor, measure, analyze and improve customer satisfaction levels, internal compliance to procedural requirements, performance levels of quality objectives and ability to produce conforming products.

 

When you have implemented all of the above, including satisfying the documentation requirements, you are effectively implementing a quality management system model that is conformant to the ISO 9001:2008 standard.

 

Read more the ISO 9001:2008 requirements here.

 

 
 

Comments or feedbacks? Write it here.