Quality Management System Design and Implementation

Turn to Altair for the expertise and experience you need to create a fully compliant ISO 9001:2000 Quality Management System.  We’ll work with you to shape a program designed to help your organization:

· Understand the requirements of a product to be built for a specific customer.

· Establish processes to meet those requirements.

· Provide resources to run and manage the processes.

· Monitor, control, and measure the performance and effectiveness of the processes.

· Improve the system continually based on the measures of process and product performance.

 

The components of our ISO 9001:2000 programs typically include the following modules as specificed in the Standard:

 

Quality Management System

Establishing your Quality Management System requires a series of initial steps that will later govern the shape of your quality program.  These activities include:

· Identifying the processes the program will encompass.

· Defining sequence and interaction of the processes.

· Planning adequate resources to run the program.

· Defining how to monitor and measure the performance of the processes.

· Establishing criteria used to judge how effective the process interactions are.

· Defining strategies to improve the quality management system based on performance measures.

 

Once the above is in place you can document the quality program through the design of the following types of program components:

· Quality objectives.

· Organizational Quality Policy.

· Quality Manual.

· Procedures to establish and maintain the quality manual.

· Procedures to allow proper versioning and access controls.

· Methods to document emerging quality records, and

· Methods to gather and store the quality records.

 

Management Responsibility

Section 5 of the Standard defines requirements that involve management’s responsibility for the Quality Management System.

 

Management Commitment – Management demonstrates its long–term commitment to the Quality Management System by establishing the Quality Manual, the Quality Policy, and communicating the importance of each to the organization.

 

Customer Focus - Management designs its quality objectives and the working of its QMS to specifically address the needs of customers as expressed by customer requirements.

 

Quality Policy – Management defines the Quality Policy to reflect the mission of the organization and to align it with established quality objectives.  Management then communicates this Policy to the organization at large and maintains it for on-going relevance and currency.

 

Planning – Management defines the business and quality objectives the QMS should address and then actively coordinates development of the processes and procedures that comprise the QMS and typically make up the Quality Manual.

 

Responsibility, Authority, & Communication – Management identifies the stakeholders of the QMS, appoints management representatives to oversee its use, and establishes communication channels to support the QMS throughout the organization.

 

Management Review – At regular intervals, management reviews the QMS, and analyzes inputs and outputs that indicate how well the system is performing for the organization.

 

Resources

Section 6 of the Standard requires management to assign adequate resources to manage organizational use of the Quality Management Systems and to ensure that customer requirements are appropriately accounted for.  This is done through three categories of resources:

 

Human Resources - Assign competent people to manage both the use and evolution of the QMS and the customer requirements, and also to periodically assess skills and job performance.

 

Infrastructure – Provide the team with the tools it needs to perform its various tasks.

 

Work Environment - Manage the work environment in a way that will support the quality objectives of the organization.

 

Product & Service Provisioning

Section 7 of the ISO 9001 Standard deals with the technical heart of the Quality Management System: how the products (or services) you create are planned, provisioned, and assembled.  This Section focuses on 6 broad areas.

 

Planning of Product Realization – Here you are required to thoroughly plan all the activities that will impact the production process.  This includes gathering and understanding the customer and product requirements, identifying which processes of the QMS will be used to manage the project, what verification, validation and testing activities will be employed, and what records will be created and kept to help control project activities and demonstrate general process program compliance.

 

Customer-Related Focus – Product assembly activities should always retain a focus on realizing what it is the customer has asked for.  This customer-related focus is central to the mission of the Quality Management System.  And so for planning you should highlight those customer requirements that are critical to customer satisfaction, and establish a customer communication plan that will foster two-communications across the project lifecycle.

 

Design and Development – The design and development activities represent a major portion of this part of the Standard. The involves ensuring that the right inputs are considered for the design, that the proper outputs are produced and used to further the production process, and that verification and validation procedures are undertaken to ensure that the components meet customer requirements and operate in the intended environments.

 

Purchasing – Part of Product Realization is the management of any purchasing activities that you undertake during the production process.  This area includes establishing criteria for selecting and evaluating potential vendors, creating a process for delineating purchasing information, and defining criteria for verifying that acquired products and components meet the needs of the organization.

 

Production and Service Provision – This section deals with the control of Product and Service Provision through proper configuration management and change control procedures.  It also deals with issues of identification and traceability, and the manner in which products can be tracked in the field.  Finally it defines requirements for the proper handling of customer property.

 

Measurement, Analysis, & Improvement

This final section in the Standard sets forth requirements for improving the QMS through the implementation of measurements and the analysis of the measurement data.  This is described in three subsections.

 

Conduct Measurement Activity – The section calls for establishing ways to measure customer satisfaction, ways to monitor and measure the performance of your processes, and ways to measure the quality performance of your products.

 

Control Nonconforming Product – The Standard sets forth requirements for controlling products and product components that fall out of specification.  These include guidelines for correcting faulty components and for isolating defective components that cannot be corrected.

 

Analysis of Data – This subsection defines requirements for taking corrective action to repair or remedy defective products, and for taking preventive action to remove the root cause of problems so that they do not recur.

 

 

 

 

Altair consultants offer you professional ITIL expertise with deep experience in IT services, Data Center operations, and administration.

 

Process Improvement using ISO 9001:2000

Altair offers fully authorized CMMI consulting, design, training, and appraisal services.

Contact Altair for full ISO program design and auditing services.