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7.1.6 Conocimientos de la organización
Te escribo porque tengo una pregunta. En la norma ISO 9001:2015 hay una nueva exigencia que se llama "7.1.6 Conocimientos de la organización". Podrías comentarme un poco sobre esta nueva clausula y también si hay documentos/formularios a presentar para mostrar el cumplimiento de esta exigencia ? -
Cláusula 7.4 de comunicación
La cláusula 7.4 Comunicación tiene mucho más énfasis en esta nueva versión. Pero ¿Qué información se puede mostrar en la auditoría de transición? ¿Qué proceso o área sería la más recomendable para ser auditada? -
Conocimientos de la organización
La cláusula 7.1.6 Conocimientos de la organización ¿cómo es recomendable auditarla? ¿A cada proceso o particularmente al área Gestión de Calidad?. Entiendo que podría ser de ambas formas pero tenemos el tiempo muy escaso y nos sería muy útil saber de su experiencia. -
ISO 9001 and procurement
"I am part of a procurement organization. Is this ISO9001-2015 specific to procurement and the entire supply chain management organization?” -
Risk with a positive and negative impact
"I am a Risk Management Practitioner and I use risk as a general term for Threats (risks with negative impact) and Opportunities (risks with positive impacts). When I started to learn about ISO standards I saw that all of them are using the word risk only for threats. I want to know if, for ISO 9001:2015 implementation it's mandatory to use risks and opportunities (as the standard required) or I can use risk (as I usually do).” -
Boundary in ISO 9001 scope
"The organization shall determine the boundaries and applicability of the quality management system to establish its scope. What is meant by boundary in ISO 9001 Scope?” -
Documentation and the process approach
"I am new to ISO with little experience. Our company has various departments which all have individual procedures and work instructions. I am not sure under which clause these procedures and Work Instructions must fall? A consultant assisted us and created a Clause 11 (Procedures), clause 12 (Work Instructions) and clause 13 (Flow Charts). According to my understanding ISO 9001 has only 10 Clauses so i'm confused. Please assist.?” -
In-house verification instead of outside calibration
"In ISO 9001 there is a section on calibration of equipment. Do you need to send verniers, dial gauges to a lab for calibration or can this be done in house as verification on a set of calibrated verification blocks?” -
Stage 1 and stage 2 audits
" I am also looking at what auditors look at when conducting stage 1 audit and stage 2 for ISO 22000 certification. Similarly, what questions i should expect for stage 2 audit of ISO 9001:2015 -
Implementation duration
"I have recently began working for a new company that is not certified but has their QMS based on the ISO9002/ 1994 standard. (which is 18 years obsolete!) I came from a company that was ISO9001/2008 certified and my job/ goal is to bring the QMS up to date and follow the 2015 standard. How big of a challenge do you think this will be for one person and how long might it take to implement?”