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Monday, 14 November 2011

ISO 9001 Factsheet

What is ISO 9001?

A Quality Management system  for turning customer requirements into customer satisfaction.
Provides the mechanism for continual improvement.  A set of common sense guidelines for running a successful business

What are the benefits of ISO 9001 Registration?

Internationally recognised quality mark.  Certificates awarded by independent accredited organisations.  Customers do not have to do their own checks on a supplier.

How many ISO 9001 Certificates have been issued?

Over  1 million worldwide.

The Model for ISO9001   


What is covered by ISO9001?

BS EN ISO 9001:2008  requires 5 main sections to be addressed, these are:
   
  1. Quality Management System;
  2. Management Responsibility;
  3. Resource Management;
  4. Product Realisation;
  5. Measurement, Analysis and Improvement
Each section is subdivided as required and covers all elements of the business having an impact on quality.

How long does it take to obtain certification?

This obviously varies from organisation to organisation, but the prime requirement is that the organisation must have three months of ‘track record’ from completion of  the document set.
As rough guide 9001 can be achieved in about 8-10 months.

What documentation is needed?

A Quality manual and procedures/processes for operating the systems.

Once the certificate is issued what happens next?

The certification authority will carry out surveillance visits each year to ensure continued compliance.



Sections of ISO9001:2008

  1. General Requirements
    1. Documentation Requirements
      1. General
      2. Quality Manual
      3. Control of Documents
      4. Control of Records
  2. Management Responsibility
    1. Management Commitment
    2. Customer Focus
    3. Quality Policy
    4. Planning
      1. Quality Objectives
      2. Quality Management System Planning
    5. Responsibility, Authority and Communication
      1. Responsibility and Authority
      2. Management Representative
      3. Internal Communication
    6. Management Review
      1. General
      2. Review Inputs
      3. Review Outputs
  3. Resource Management
    1. Provision of Resources
    2. Human Resources
      1. General
      2. Competence, Training and Awareness
    3. Infrastructure
    4. Work Environment
  4. Product Realisation
    1. Planning of Product Realisation
    2. Customer-Related Processes
      1. Determination of Requirements Related to the Product
      2. Review of Requirements Related to the Product
      3. Customer Communication
    3. Design and development
    4. Purchasing
      1. Purchasing Process
      2. Purchasing Information
      3. Verification of Purchased Product
    5. Product Provision
      1. Control of  Product Provision
      2. Validation of Processes for Product Provision
      3. Identification and traceability
      4. Customer Property
      5. Preservation of Product
    6. Control of Monitoring and Measuring Equipment
  5. Measurement, Analysis and Improvement
    1. General
    2. Monitoring and Measurement
      1. Customer Satisfaction
      2. Internal Audit
      3. Monitoring and Measurement Monitoring of Processes
      4. Monitoring and Measurement of Product
    3. Control of Nonconforming Product
    4. Analysis of Data
    5. Improvement
      1. Continual Improvement
      2. Corrective Action
      3. Preventive Action

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