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
4
ISO 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
WORKING INSTRUCTIONS
Are those documents detailed work.
22
QUALITY RECORDS
They arise from the practical application of MC, procedures or work instructions
. Are of great importance, as they are sometimes the only source from which are
available to ensure that a particular work has been completed successfully. The
i.e. of the Constitutional Province of Callao develop a set of records, the amou
nt varies depending on if you are: Home Educational Institution Level 23
DOCUMENTS THAT DEFINE THE SGC
SGC Manual Procedures Manual Work Instructions Quality Records Annexes
BENEFITS document a QMS
Globalizing the idea of i.e. Define responsibilities favoring self-control. of
i.e.
Allows for better coordination. Da trust, is a support for audits. It is a
communication tool. It is a baseline.
Easy access to procedures. Text of staff training. CMS separates the peopl
e. MKT element with the client.
SGC BENEFITS OF A DOCUMENT
Instrument to improve suppliers.
DOCUMENTS SHOW THE EXISTENCE OF A QMS documents containing evidence
objective in accordance with the GSC are the records and forms.
TYPE
IDENTIFICATION AND SUBMISSION OF DOCUMENTATION
CODE TITLE HOME EDITION NUMBER DELIVERED Who QUIN THE REVIEW WHO a
pproves or FREE
MANUAL OF QUALITY MANAGEMENT SYSTEM (MC) ISO 9001:2008
Mr. José Manuel García Pantigozo
calidadtotal@hotmail.com
Quality Documentation Manual
ISO 9001:2000 structure 0. Introduction 1. Purpose and scope 2. Rules for consul
tation in March. Terms and definitions 4. Quality Management System 5. Managemen
t Responsibility 6. Resource Management 7. Product realization 8. Measurement, a
nalysis and improvement requirements
31
Structure of the Quality Manual 0. Organizational structure and a process map. P
urpose and scope 2. Definitions and terminology 3. Presentation i.e. 4. Quality
Management System 5. Management Responsibility 6. Resource Management 7. Provisi
on of service 8. Measurement, analysis and improvement
Quality Documentation Manual
4. SYSTEM OF QUALITY MANAGEMENT This chapter sets out the general requirements t
o be followed for the development and implementation of a system of quality mana
gement. 4.1 General requirements 4.2 Requirements 4.2.1 General Documentation. 4
.2.2 4.2.3 Quality manual 4.2.4 Control of documents Control of records
32
Documentation Documentation Manual Quality Manual Quality
0. Organizational structure and process map and scope 2.Aim
"The purpose of this Quality Manual is to define the system of quality managemen
t of IE, which includes, among others, the processes for consultation and sharin
g of relevant documents to the educational community. It ensures that the i.e. p
rovides management support necessary to access the educational community meets t
he needs and expectations they had at the time of your request. The scope of the
quality system as documented processes are represented in the processes of map
IE
2. Definitions and terminology 3. Presentation of the Educational Institution
33
Manual Documentation Quality Documentation Quality Manual 4.2.3 Control of docum
ents
The i.e. establishes the procedure PTI-00005 "Control of Documents GSC where you
define the controls necessary to comply with paragraph 4.2.3 of ISO 9001:2000 a
ctivities modification, updating, dissemination and archiving of the quality man
ual are the responsibility quality of the senior technician member of the office
of promotion and quality assessment. To support the SGC documentary i.e. using
the computer application.
4.2.4 Control of records
PTI-00009 "Control of the QMS records" to define the controls necessary to ident
ify, collect, code, accessing, archiving, storing, keeping up to date and give a
final destination for the records included in the quality management system qua
lity.
34
Quality Documentation Manual
5. Management Responsibility
In this chapter the standard requires management commitment in quality managemen
t, to lead this effort and to conduct periodic reviews of the system of quality
management.
5.1 5.2 5.3 5.4 Management Commitment Customer Focus Quality Policy Planning
5.4.1 Objectives 5.4.2 Quality management system planning quality
5.5 Responsibility, authority and communication.
5.5.1 5.5.2 Responsibility and authority Management representative Internal comm
unication 5.5.3
5.6 Management review by management
5.6.2 General Information 5.6.1 revision 5.6.3 Results of the review 35
Documentation Documentation Manual Quality Manual Quality 5.5.3 Quality Policy
"Being a i.e. excellent in the field of regular basic education according to the
philosophy of total quality in order to achieve the satisfaction of students, p
arents, ... ... ... ... ... ... ... ... ... ... .... in general through differen
t services offered. That is, i.e. becomes committed to meeting those requirement
s as an institution is set to its customers and to use appropriate methods to co
ntinuously improve the system of quality management. "
This quality policy, which will be reviewed by those responsible for IE for it i
s continually updated, will provide a framework for setting and reviewing qualit
y objectives of the institution. In addition, the institution shall ensure that
within the organization, including members of the educational community, the pol
icy shall be disseminated and understood.
36
Quality Documentation Manual
5.5. Responsibility, authority and communication
5.5.1 Responsibility and authority. Inclusion of the Statutes i.e. which defines
the general structure of it, as well as the responsibilities, powers and relati
onships. Allusion to the list of jobs EI are the responsibilities, powers and re
lations of jobs. 5.5.2. 5.5.3 Management representative Internal communication 5
.6. Management Review of Quality Council shall, annually, a revised system of qu
ality management to ensure its suitability, adequacy and effectiveness. The proc
ess of reviewing the procedure is reflected in the PTI-00010 "Review of Quality
System."
37
Quality Documentation Manual
6. RESOURCES MANAGEMENT is necessary to show that properly managed all resources
that are necessary for the completion of service and maintain and increase cust
omer satisfaction. 6.1 Provision of resources. 6.2 Human Resources 6.2.1 General
6.2.2 Competence, awareness and training 6.3 Infrastructure 6.4 Work environmen
t
38
Manual Documentation Quality Documentation Quality Manual 6.2.2 Competence, awar
eness and training.
"The i.e.: A) determines the necessary competence for personnel performing admin
istrative and service jobs that affect the quality of service (...) in the List
of Jobs (RPT) and / or in the job specifications. b) provide training or take ot
her action to meet those needs. (...) C) evaluates the effectiveness of actions
taken. d) ensures that its personnel are aware of the relevance and importance o
f their activities and how they contribute to achieving the quality goals, and e
) maintain appropriate records of education, training, skills and experience. Th
is whole process is contained in the FTI process sheet-00009 "Training of staff"
. "
39
Quality Documentation Manual
6.3 Infrastructure
• • Description of necessary infrastructure EI to achieve compliance with the re
quirements of the service. "For the supply of material and equipment, the Direct
or claims that the material or equipment ... ... ... ... ... ... .... by letter.
This letter is preserved until the material or equipment is received and review
ed. In the letter of request is written OK Review, the date and signature of the
person checked. For the purchase of computer systems also consult the general p
rocedure PTI-00013. "" The systematic approach to maintaining the infrastructure
is reflected in the information process FTI-00010 "Maintenance". "
•
40
Documentation Documentation Manual Quality Manual Quality
7. PRODUCT CREATION
It is described as the service plan, as designed the service, which is the procu
rement process, how to carry out the processes ... 7.1 Planning of realization o
f the product 7.2 Customer-related Processes 7.2.1. Determination of requirement
s related to the product. 7.2.2 Review of requirements related to the product. 7
.2.3 Customer communication. 7.3 Design and Development
41
Documentation Documentation Manual Quality Manual Quality
Shopping 7.4 7.4.2 7.4.1 Purchasing process Purchasing information 7.4.3 Verific
ation of purchased products 7.5 Production and service provision 7.5.1 Control o
f production and service provision 7.5.2 Validation of processes production and
service provision 7.5.3 Identification and traceability 7.5.4 Customer Property
7.5.5 Preservation of product 7.6 Control of monitoring and control devices
42
Documentation Documentation Manual Quality Manual Quality
7.4.1 Procurement Process "The i.e. ensures that the asset acquired meets specif
ied purchase requirements. The methodology required to be documented in the form
FBI00000 process "acquisitions and income" Evaluation of suppliers described in
general procedure PBI-00011 "Evaluation of suppliers."
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Documentation Documentation Manual Quality Manual 7.5.1 Control Quality service
delivery
"The i.e. plans and carries out the development of services under controlled con
ditions. This has information describing the characteristics of documentary mate
rial. Furthermore: - documenting all procedures and records necessary process. T
his documentation is available to staff in the Document Management module of the
software application and the procedure is controlled by PTI-00005 "Control of t
he QMS documents." - Use all resources, both human and material needed, the repo
rt said MBI-00002 "Resource Management" activities are conducted as necessary mo
nitoring and measurement as outlined in the document MBI-00008 "Measurement, Ana
lysis and Improvement . "
44
Documentation Documentation Manual Quality Manual Quality
8. MEASUREMENT, ANALYSIS AND IMPROVEMENT
To improve the current situation we measure for an analysis of the data, decide
which is the best way forward. Therefore, we must know information on the evolut
ion of our processes, the services offered and especially the opinions of our cu
stomers. 8.1 General
8.2 Monitoring and measurement 8.2.1. Customer satisfaction. 8.2.2 Internal audi
t. 8.2.3 Monitoring and measurement of processes. 8.2.4 Monitoring and measureme
nt of product. 8.3 Control of nonconforming product. 8.4 8.5 Data Analysis Impro
vement 8.5.2 Continual improvement 8.5.1 Corrective Action. 8.5.3 Preventive act
ion.
45
Documentation Documentation Manual Quality Manual Quality Measurement 8.2.1 Cust
omer Satisfaction.
"The i.e. periodically measuring levels of customer satisfaction. The results ar
e analyzed by the IE Address€to establish improvement actions at all times if de
emed necessary and will be reported to the Quality Council in reviewing the qual
ity system. The established method for the realization of these measurements are
described in the procedure PBI-00012, "Measuring Customer Satisfaction." "
46
Documentation Documentation Manual Quality Manual Quality
8.5.2 Corrective and Preventive Action
The i.e. PTI has set the procedure-00008 "Managing Corrective and Preventive" to
define the scheme to a) identify actual or potential nonconformities and their
causes, b) assess the need to take necessary corrective or preventive actions, c
) determine and implementing action needed, d) record the results of actions tak
en, and e) review the effectiveness of actions taken.
47
MANUAL OF PROCEDURES FOR QUALITY MANAGEMENT SYSTEM ISO 9001:2008
Mr. José Manuel García Pantigozo
calidadtotal@hotmail.com
Documentation Documentation Documentation General Procedures Manual for Quality
ManualProcedimientos
Quality Manual 4. Quality Management System 5. Management Responsibility General
Procedures
3. 4. 6. 7. 8. 9.
Control of Documents Control SGC SGC Records Functions of the Quality Management
Review Notifications Internal Communication System
6. Resource Management 7. Provision of service 8. Measurement, analysis and impr
ovement
11. Staff Training 12. Maintenance 13. Control Equipment 15. Supplier Evaluation
17. Internal Audits 18. Measuring Customer Satisfaction 19. Managing Corrective
and Preventive Actions
49
Quality Manual Documentation Documentation Documentation General Procedures Gene
ral Procedures
PTI-00007. Internal Audits
RESPONSIBLE FOR QUALITY AUDITS AUDIT TEAM RESPONSIBLE FOR RESPONSIBLE AUDITED
Prepares Plan Audits (audits creating and defining the Audit Team)
Approval Procedures Documentation yGenerales Audit Plan Planner
SI
Shipping planning
Examine audit planning
NO
Preparation
Execution
Close and send report
Browse closing report (Optionally you can enter comments)
50
Documentation Quality Documentation Procedures Manual SUMMARY: General DOCUMENTA
RY SUPPORT OF GSC
Level
I II III IV V
Quality Policy and Objectives
I. They provide a reference point to guide the organization and determine the de
sired results (WHY) II. Outlines the system of quality management (WHAT) III. Cr
eated in order to comply with the requirements of Standard IV. Describe how to p
erform tasks (HOW, WHEN, WHERE AND BY WHOM) IV. Squad, or printed form that prov
e the development of an activity
General Procedures Manual Instructional Quality Records
51
TYPES OF RECORDS MANAGEMENT SYSTEMS ISO 9001:2008 QUALITY
Mr. José Manuel García Pantigozo
calidadtotal@hotmail.com