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Cumplir con la cláusula referente a recursos 7.1
Hemos adquirido unas plantillas para un sistema de gestión integrado 9001-14001 y tengo algunas dudas; por ejemplo:
¿Cómo le doy cumplimiento al apartado 7.1.3 de la norma en el cual se debe determinar, proporcionar y mantener la infraestructura necesaria para la operación de sus procesos...?.
¿Cómo le doy cumplimiento mediante las plantillas adquiridas con ustedes al apartado 7.1.4 que hace referencia al Ambiente para la operación de los procesos?. -
Diferencias ISO 9001:2015 vs. ISO 9001:2008
Como tengo disponible información esparcida sobre las novedades 2015 de la ISO, la idea es, en lo posible, tenerla condensada y de una sola fuente.
La consulta es: ¿es posible acceder a un archivo que centralice y ofrezca todos esos documentos obligatorios? -
Quality objectives and roles, responsibilities and authorities
"I need more information on quality objectives and what standard says about Quality objectives. Also understanding is required on roles, responsibilities and authorities.” -
Safety and ISO 9001:2015
"I would like to know - if safety is incorporated into the ISO 9001:2015 standard?” -
External and internal context and interested parties
"Can you please guide me on what all external and internal issues would be there for a lubricant quality control Lab. Also who all would be the interested parties and how would I know their requirements?” -
Design validation
"We manufacture standard product through a catalog with high customization adders. They are made to order applications. When standard product was originally designed, a full verification and validation process was performed. The ISO9001 auditor says I actually have no "validation" step. I cannot create a prototype for a one-time project. What is the implication of the "validation" in a make to order design and manufacturing?” -
Quality policy and quality objectives
"I want to know how to design Quality Policy and how to convert in measurable form. Need some examples” -
Risks and opportunities and organizational knowledge
1) What are the best samples to show on the auditor for R & O (Risk and Opportunities)? My company are doing the injection molding for plastics product. Our process need to do the FMEA for our customer but I am not sure how to link with the R&O. -
ISO 9001 certification
"I need set up ISO 9001 for our corp. if we are not manufacture, we are only purchase material from other manufacture, inventory and ship direct to our customer. Is that qualify for apply ISO9001? Or need ISO14001 or others?” -
Quality Manual content
"I am looking to simplify my organisation’s quality manual. Before I can do that, I am needing a comprehensive knowledge of the structure of the manual. What is a quality manual? What is the simplest way to structure it?”