NORMA ISO 9001:2015

CAMBIO MAYOR
taller inicial

Dr. Leonel S. de la Roca C.

Guatemala, Junio de 2012

 15 marzo 1987: primera norma ISO 9001
Ahora tenemos 25 aos de tener la norma
ISO 9001
Mas de 1.3 millones de usuarios
Aumentan expectativas de clientes en
confiabilidad de productos y servicios
Aumento de uso ISO 9001 por comercio
global.
Nuevos sectores de inters
Credibilidad de la certificacin de 3 parte.
 Preocupacin hacia mayor eficiencia
Mayor sofisticacin de las
herramientas de gestin
Mayor nfasis regulatorio sobre salud
y seguridad publica
Mltiples normas de sistemas de
gestin, programas y esquemas.
 Reunin desde hace 2 aos con TC
176/SC2
Renovacin mayor de la norma ISO
9001
INICIO junio 2012
El fin de esta nueva norma es tener
empresas competitivas para 2020
 Actualizar ISO 9001 para reflejar
practicas de negocio moderno
Mantener el enfoque a procesos
Cambio mayor desde ao 2000
Mejor conformidad de producto
Poder integrar otros sistemas de
gestin.
 Jun 2012 Work Draft Cero WD0
Nov 2012 Work Draft Uno WD1
Mar 2013 Comitee Draft CD1
Ene 2014 Draft Intern.Std. DIS
Sep 2014 Final DIS borrador FDIS
Ene 2015 FDIS VOTO FDIS
Sep 2015 ISO 9001 :2015
Interaccin SC1 trminos
Verificacin /Validacin
Unin IAF / CASCO Transicin
 30 % aproximadamente
 El nuevo enfoque de las normas es
alinearlas con la ISO 9001 :2015
ISO 22000, 50001, 30301, 22301,
13485, 14001, 27001, 20121,
18000, 39001
TODAS LAS NORMAS TENDRAN
AHORA UNA ESTRUCTURA DE
ALTO NIVEL: 10 REQUISITOS!!
 1. ALCANCE
2. REFERENCIAS NORMATIVAS
3. TERMINOS Y DEFINICIONES
4. CONTEXTO DE LA ORGANIZACIN
5. LIDERAZGO
6. PLANIFICACION
7. SOPORTE
8. OPERACIN
9. EVALUACION DEL DESEMPEO
10. MEJORA
4.1 ENTENDIENDO EL CONTEXTO
DE LA ORGANIZACIN
4.2 ENTENDIENDO LAS
NECESIDADES Y
EXPECTATIVAS DE LAS
PARTES INTERESADAS
4.3 DETERMINANDO EL ALCANCE
DEL SISTEMA DE GESTION
4.4 SISTEMA DE GESTION XXXX
5.1 GENERAL
5.2 COMPROMISO GERENCIAL
5.3 POLITICA
5.4 ROLES ORGANIZACIONALES,
RESPONSABILIDAD Y
AUTORIDAD
6.1 ACCIONES PARA
DIRECCIONAR EL RIESGO Y
SUS OPORTUNIDADES
6.2 OBJETIVOS DE XXX Y PLANES
PARA ALCANZAR ESTOS.
7.1 RECURSOS
7.2 COMPETENCIA
7.3 TOMA DE CONCIENCIA
7.4 COMUNICACIN
7.5 INFORMACION DOCUMENTADA
7.5.1 GENERAL
7.5.2 CREADA Y ACTUALIZADA
7.5.3 CONTROL DE INFORMACION
DOCUMENTADA
 8.1 PLANEACION Y CONTROL
OPERACIONAL
9.1 MONITOREO, MEDICION,
ANALISIS Y EVALUACION
9.2 AUDITORIA INTERNA
9.3 REVISION GERENCIAL
10.1 NO CONFORMIDADES Y
ACCION CORRECTIVA
10.2 MEJORA CONTINUA
 ISO 10014
ISO 9004:2009
Sarbanes Oxeley
ISO 31000
ISO 9001 Small Business Handbook
Comment 296
ISO 9001:2008 Quality systems handbook
David Hoyle (sixth edition) Using the
standards as a framework for business
improvement ISBN number 978-1-85617-684-2
Conformity Assessment Body
AICQ (Cultural Association)
 ISO/IEC 20000-1 First edition 2005-12-15
Information technology - Service management
Part 1:Specification
ISO/IEC 20000-2 Information technology
Service management Part 2: Code of
practice
SOX
Balanced Scorecard
Sandford Liebesman, Mitigate SOX Risk with
ISO 9001 and 14001, Standards Outlook,
Quality Progress, September 2005, 91-93.
William Stimson, ISO 9001 & Sarbanes-
Oxley,Paton Press LLC, Chico, CA 2006.
SEC 17 CFR Part 241 Commission Guidance
Regarding Managements Report on Internal
Control Over Financial Reporting
Guidance on Monitoring Internal Control
Systems by COSO (2009)
The IIA-Institute of Internal Auditors should be
 ISO 10018 for developing Communication Plan
ISO 14001 Environmental Management
Requirement
ISO 14063 - Environmental Management -
Environmental Communication Guidelines and
examples.
ISO 22000 Food Safety Management Systems
CD ISO 26000 Guideline Social
Responsibilities
Conformity Assessment Body
AICQ (Cultural Association)
 ISO TC/176 N917 Communique
Output of the SC3/Ad Hoc group on Time,
Speed and Agility
 ISO 10018: 20XX
 http://www.netmba.com/marketing/pricing/
Consultants
See the attached document 9001 in High Level Structure.
Identical to Annex C of the document Swedish comments
Key Major Areas ISO 9001, which was distributed in the
folder TG Future Revision of ISO 9001 - Initial Submissions,
2009-02.
See figure in new ISO 9001 (see attached file) which is
intended to replace Figure 1 in ISO 9001:2008.
Consider other business excellence models as well as IWA 2
and IWA 4.
TS 16949
Sandford Liebesman, Down with Silos, Quality Progress,
September 2008, 64-67.
Ansoff Model for Strategic Management
Underwood, J. (2002). Thriving in e-chaos: corporate
strategy for uncertain times. New York; Writers Club Press.
OCEG Illustrated Series
 AS9100 Aerospace Standard most recent edition
ISO 31000 Risk Management Principles and
Guidelines
ISO 31010 Risk Management, Risk Assessment
Techniques
ISO/IEC 16085:2006 Information technology.
Software life cycle processes. Risk management
17766
14971
ISO 90000-3:1991
BSI 25999-1(Business Continuity)
Document: ISO/TC 176/SC2/N852
CMMI has a Risk and Opportunity Management
process area.
.
 Dispositions (in Mexico) issued by Comisin Nacional
Bancaria y de Valores (INLAC input 1) and Banco de
Mxico (INLAC input 2).
Wikipedia.com: Risk management
Survey results if available
Article - Sandford Liebesman, How to Manage Risk in a
Global Economy, Quality Progress, March 2008, 58-60.
Article - Committee of Supporting Organizations of the
Treadway Commission (COSO), Enterprise Risk
Management integrated framework, and
Strengthen Enterprise Risk Management for Strategic
Value, www.coso.org.
Article - The Committee of Sponsoring Organizations of
the Treadway Commission, Enterprise Risk Management
Integrated Framework; Executive Summary Framework,
American Institute of Certified Public Accountants, Jersey
City, NJ, 2004
AVENIDA LA REFORMA, 3-48 ZONA 9
EDIFICIO ANEL OF. 403
LDELAROCA@INLAC.ORG.GT
WWW.INLAC.ORG.GT