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Documents of the ISO 9001:2008 QMS

Documents of the ISO 9001:2008 QMS

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11/14/2013

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MANAGEMENT SYSTEMS ISO 9001:2008 QUALITY
Mr. José Manuel García Pantigozo
calidadtotal@hotmail.com
ISO 9001:2008 Overview
Adopt a system Quality Management is a

strategic decision of the organization. The design and implementation of the S ystem of Quality Management in an organization is influenced by different needs, business goals, products provided, processes used, size and organizational stru cture. This is used to evaluate the ability of the organization to meet custom

er requirements, the regulatory and the organization's own.
ISO 9001:2008 Process Approach
Cutting processes all data.
CUSTOMER NEEDS
CUSTOMER SATISFACTION
ISO 9001:2008

Training Infrastructure Working Environment
Structure and Responsibilities Commitment Quality Planning Policy

Customer Satisfaction Planning Internal Audits of the implementation requirement s related to product design and development Product Purchasing Control Performan ce Monitoring and Measurement Devices Measurement Monitoring and Continuous Impr ovement Nonconformities

4ISO 9001:2008

Relationship with the NTP-ISO 9004:2001
Norm R SO 90 04 2001
SGC: • Guidelines for improving • Satisfaction of interested parties • • Efficie
ncy • Evaluation

No rma ISO 90 04: 20 01
Norm R SO 90 01:2 008

SGC: • Requirements,
No rma ISO 90 1:20 01
ISO 9001:2008

Compatibility with other management systems

During the development of ISO 9001:2008 have been considered the provisions of I SO 14001: 2004 to increase the compatibility of the two standards for the benefi t of the user community. Since the ISO 9001:2008 requirements may be given for p roducts or processes. Having a QMS is a sound basis for moving towards a model o f excellence.

Model Quality Management System ISO 9001:2008
PROCESS MODEL AND ITS INTERACTIONS 7
3. ISO 9001:2008 Implementation

QUALITY MANUAL
Procedures (PSGC) Working Instructions (ISGC) Formats and physical records (FSGC
) Electronic Records (RSGC)
ISO 9001:2008

2. Purpose and Scope 1.1 General
QMS Requirements: c) needs to demonstrate its ability to consistently provide pr
oducts that meet customer requirements and applicable regulatory requirements, d
) aims to increase customer satisfaction through the effective implementation of
the system, including processes for continuous improvement of the system and en
suring compliance with customer requirements and applicable regulatory requireme
nts.

ISO 9001:2008

2. Purpose and Scope 1.1 General
QMS Requirements: c) needs to demonstrate its ability to consistently provide pr
oducts that meet customer requirements and applicable regulatory requirements, d
) aims to increase customer satisfaction through the effective implementation of
the system, including processes for continuous improvement of the system and en
suring compliance with customer requirements and applicable regulatory requireme
nts.

ISO 9001:2008

2. Purpose and Scope 1.2 Application
• The organization can exclude those QMS requirements do not affect his ability,
nor absolve its responsibility to provide products and services that meet custo
mer requirements and / or regulations that apply. • These exclusions are limited
to the requirements of Clause 7 and may be due to: a) the type of product or se
rvice. b) The requirements of the customer. c) The applicable regulatory require
ments.

ISO 9001:2008 2. Normative References
Restructuring of the family of NTP-ISO Standards
Consolidating more than twenty 9000:2000 standards and documents in four main ru
les:

NTP-ISO 9000:2007 - QMS Fundamentals and Vocabulary. NTP-ISO 9001:2009 - QMS Req uirements NTP-ISO 9004:2001 - QMS Guidelines for performance improvement. NTP-IS O 19011:2003 - Quality Audit Guide

ISO 9001:2008 3. Terms & Definitions
13

The terms used in the editing of this NTP to describe the chain of product or se
rvice are:
CLIENT ORGANIZATION PROVIDER

ISO 9001: 1994 Supplier Subcontractor
ISO 9001: 2008 Organisation Provider
Product: It is the result of a process (Hardware, software, services and / or pr
ocessed materials).

ISO 9001:2008
4. Gestión14 Quality System 4.1 General Requirements
The organization shall establish, document, implement and maintain Quality Manag
ement System and continually improve its effectiveness. To implement the QMS the
organization must: a) Identify the processes needed for the QMS and its impleme
ntation across the organization; b) Determine the sequence and interaction of th
ese processes;€c) Determine criteria and methods required to ensure that the ope
ration and control of these processes is effective, d) Ensure availability of re
sources and information necessary to support the operation and monitoring proces
ses; e) Measure, monitor and analyze these processes; f) Implement the correctiv
e action necessary to achieve planned results and continual improvement of proce
sses.

ISO 9001:2008
4. System Quality Management 4.2 Requirements Documentation
4.2.1 General The QMS should include: a) Establish a policy and quality objectiv
es documented b) A Manual of Quality. c) Documented procedures required by the s
tandard d) Documents required by the organization to ensure the planning, operat
ion and effective control of its processes e) quality records required by this s
tandard

TYPES OF RECORDS MANAGEMENT SYSTEMS ISO 9001:2008 QUALITY
Mr. José Manuel García Pantigozo
calidadtotal@hotmail.com

TYPE OF DOCUMENTS (1) oManual oManuales Installation of the CMS Quality oProcedi
mientos OPLAN oProgramas institutional OPLAN oTUPA oMAPRO oInstructivos oReglame
ntos OCAP
17

TYPE OF DOCUMENTS (2) ÖNORM (personnel, testing, quality, etc..). Working oInfor
mes oOrdenes Omemo oHojas smelled map oEspecificaciones check the product (good
and / or service). oDibujos, sketches, drawings, photographs, videos, etc.. oOrg
anigramas meeting AOCRS oFormularios or register
18

It is the fundamental document of the QMS and is:
SGC MANUAL

• Communicate the policy and quality objectives of the IE • Define and describe
the GSC. • Define the different responsibilities in each of the matters covered
by the QMS. • Allow customers and organizations know the lines on which it is ba
sed on GSC.
The MC is a document 20 commitment by

QUALITY PROCEDURES
Are those that respond more directly to the requirements of the standard. By con
trast, the Standard Operating Procedures indicate the level of detail required i
n each case, who, how, when and where an activity takes place. These documents e
nable greater control of the activities of the IE so as to achieve a quality edu
cational service 21. quality

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