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ISO 9001:2008

Basics of the Standard Stage 0 of the implementation in DS

Made by QMS team

What is ISO?
International Organization for Standardization It is a network of the national standards institutes of 162 countries, one member per country (AENOR, Spain), with a Central Secretariat in Geneva, Switzerland, that coordinates the system. ISO is a non-governmental organization that forms a bridge between the public and private sectors.

What is ISO 9001:2008

Standards show how should be a product or how should work a service in order to be safe and adapted to meet the needs of each client.

ISO 9001: international standard that applies to the Quality Management System (QMS)
Quality management elements needed by a company to get an effective system (to manage and improve its products or services)

What is QMS?
This means what the organization does to fulfill:
The customer's quality requirements, and Applicable regulatory requirements, while aiming to Enhance customer satisfaction, and Achieve continual improvement of its performance in pursuit of these objectives

It is the way to work in order to assure the customer satisfaction:

Plan, keep and improve continously the performance of the processes Under the idea of efficiency and efficacy


Get better satisfaction of customer Increase productivity and efficiency Reducction of cost (poor quality products) Work organization Internal communication Develope competitive advantage


Customer focus Leadership Involvement of people Process approach (+) System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships

4. General requirements
Develop your QMS:
Establish Document Implement Maintain Improve
The standard specifies six compulsory documents: Control of Documents (4.2.3) Control of Records (4.2.4) Internal Audits (8.2.2) Control of Nonconforming Product / Service (8.3) Corrective Action (8.5.2) Preventive Action (8.5.3)

Document your QMS

Manage QMS documents Prepare QMS manual Control QMS documents Establish QMS records

5. Management requirements
Show your commitment to QUALITY Focus on your customers Support your quality policy Carry out your QMS planning Allocate QMS responsibility and authority Perform QMS management reviews

7. Realization requirements
Control product realization planning Control customer-related processes Control product design and development Control purchasing and purchased products Control production and service provision Control monitoring and measuring equipment

8. Measuring, analysis and improve

Establish monitoring and measurement processes Monitor and measure customer satisfaction Identify and control nonconforming products Collect and analyze quality management data Make improvements and take remedial actions

Continual improvement of the QMS

Management responsibility
Customers Customers Resource management Measurement, analysis and improvement Satisfaction



Product Realization


Process approach for management systems

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the process approach.
In sub clause 0.2 Process Approach (ISO9001:2008)

Process approach for management systems

A Process can be defined as a set of interrelated or interacting activities, which transforms inputs into outputs. INPUT
Requirements Specified (including resources) RESPONSABILITY DEFINED EFFICIENCY OF PROCESS = Results achieved vs. Resources used

Monitoring and measuring

Interrelated or interacting activities and control methods


Requirements Satisfied (Result of a process)

EFFECTIVENESS OF PROCESS = Ability to achieve desired results

Meetings with every department:
Define processes where the dept. is involved Define which procedures are necessary to establish (determine procedures with several dept. involved) Designate responsibles (control QMS documents) Templates, document procedures,

Start to develop the procedures:

Purpose Scope Responsibilities

Need of new templates Feedback for continual improvement


1.- Make the approach 2.- Identification of the involved processes 3.- Designate responsibles 4.- Create the wok team 5.- Establish the processes map 6.- Elaborate the documentation 7.- Staff training 8.- Intern audits 9.- Corrective action 10.- Contact with the certification organization 11.- Certification audit

13.- And now starts the hard work.: Keep and improve the QMS Renewal of certification every 3 years.

Standard UNE-EN ISO 9001:2008 Standard UNE-EN ISO 9000:2005 Standard UNE-EN ISO 19011:2002