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Determining context of the organization
Hello, -
Liderazgo
La implementación de liderazgo con que herramienta o metodología lo puede establecer. -
Formulating questions during internal audit
I am trying to understand when conducting an internal audit what you questions are focusing on. for example do you pick a certain section of the standard for HR. -
Providing evidence for clauses without mandatory documents
Please share some tips of verifying the clauses in which documented information is not the requirement. How we can audit them? For example internal and external issues , interested parities needs and expectations , actions to address risks.. how we gonna verify the evidences of these clauses? -
SA 8000 and ISO 9001 and OHSAS 18001
I completed SA 8000 basic auditor course. I want to be social compliance auditor. Next step i want to do OHSAS 18001. But i have confusion whether i will go ISO 9001 or 18001 will u clarify me. -
Nonconformities and corrective actions
I recently started working for this company and I noticed that when an audit finding is observed and it is warranted for a CAR, they initiate not only a CAR but also a NCR. When asked, it was explained to me that the audit finding is a nonconformance, therefore they initiate a NCR to document the nonconformance and use CAR to request for corrective action plan. -
Planning the QMS and clause 6.1.1
In clause 6.1.1 it states: "When planning for the quality management system...." I was wondering if the planning here is referring to the addition of a new process to the quality management system or if it means that within the quality management system processes that risks and opportunities are considered. -
Updating ISO 9001 and ISO 13485
we are manufacturer of medical devices product i.e syringes etc, what type of update need our quality manual as per iso 9001-2008? iso 13485-2016 or ISO 9001-2015? -
Documentación opcional
He recibido esta pregunta: en la nueva certificación ISO 9001 por que se dice documentos obligatorios y opcionales? Mi respuesta La nueva versión de la norma tiene algunos documentos y registros obligatorios que se necesitan para cumplir con la ISO 9001. El resto de la documentación es opcional, como el procedimiento para determinar el contexto de la organización y las partes interesadas u otra clase de documentos que pueden ser útiles en la implementación y especialmente en el posterior mantenimiento del SGC Para más información vea "Lista de documentos obligatorios requeridos por la ISO 9001:2015": https://advisera.com/9001academy/pt-br/kit-de-documentacao-da-iso-9001/nowledgebase/lista-de-documentos-obligatorios-requeridos-por-la-iso-90012015/ -
Documenting Design History File
What is the difference between a design and development file AND a design history file (DHF)?