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 Nov 2012 Mar 2013 Ene 2014 Sep 2014 Ene 2015 Sep 2015

Work Draft Cero WD0 Work Draft Uno WD1 Comitee Draft CD1 Draft Intern.Std. DIS Final DIS borrador FDIS FDIS VOTO FDIS 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 5.2 5.3 5.4

GENERAL COMPROMISO GERENCIAL POLITICA 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 9.2 9.3

MONITOREO, MEDICION, ANALISIS Y EVALUACION AUDITORIA INTERNA 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 & SarbanesOxley,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