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Shortning the quality manual
My client is a small company of approx. 20-25 people operating from 4 different locations. The company is a supply and service provider of firefighting and safety equipment to the marine industry. They do have a QMS today that was made several years ago, and I believe it was based on the ISO 9001:2008. However, it was never audited by a certification body. Company management now plans to take the next step and proceed with writing a revised QMS to meet the ISO 9001:2015 standard. In the current company QMS there are some sections that may not be specifically mentioned as requirements of the 2015 standard. F.inst.: Mission/Vision statement Code of Ethics and Business Conduct Quality, Safety, Health & Environment Protection Policy Job preparation (very detailed check-list of tools and spares to bring to the worksites when doing service onboard cruise vessels, one list for each product type, portable fire extinguishers, fixed fire fighting systems, breathing apparatus etc.) Emergency & Hazardous Preparedness. (Company is b ased in Florida where there are frequent hurricane threats) Many of the chapters in the current manual are very good, but in order to keep the new QMS as short as possible, should some of these chapters be taken out and perhaps be part of a separate “Operational Manual” or an Employee Handbook? The current manual is extensive in size…90 pages. It even includes employee performance reviews which perhaps should be included in the employee handbook… -
Risk based approach
"As a Consulting Engineer, I understand that for ISO 9001-2015 and also for ISO 14000-2015; Risk Analysis is a major new development. Also, the idea of Risk Analysis has been carried over into other standards such as ISO/IEC Standard 17025-2017; and other ISO standards which use the same template. With this background, my main concerns are two. 1. How to do a good job of Risk Analysis in a Test Lab setting (ISO/IEC Std. 17025-2017) in an Inspection Body setting (ISO/IEC Std. 17020-2012) and in a Product Certification Body setting (ISO/IEC Std. 17065-2012 and ISO/IEC Std. 17067-2013). 2. How do I use ISO 31000 to do Risk Analysis in the above standards. If you can kindly answer these in the webinar, I will be very grateful. Another good idea is to provide a guidance paper with a template for Risk Analysis.” -
Risks and context
"What would be the risks addressed and connect to the context of the organisation on document?” Actually no documented information required but If I want to make then what will be ?” -
ISO 9001 warehousing requirements
The company I work for is ISO 9001 certified through 2017 at least. I assume that the current certification includes all our warehouses and facilities but I am checking. My boss has asked me to look at a possible audit of the regional warehouse (HUB) in preparation, I assume, for getting certified for this year. The warehouse operations are as most. We receive, pick, pack, store and ship. When I look at the audit checklist it has very little that is applicable to warehouse operations. When I look at a Quality Manual or system again I find that there is a lot of data included but not warehouse related. How do I go about answering my boss? -
Process approach in a school environment
"We are in the education sector. We have three divisions the curriculum division, school governance operations division and the school's division office (finance, administrative, legal and ict). We have difficulty in identifying the QMS process. Can you give us an example on how we can form it.." -
Process mapping?
"Is it a requirement of the new standards to map all your key processes? If so , can they be documented text procedures, or do they have to be flow charts? Would a PDCA Chart work either? We are a facilities services company.” -
Análisis de riesgos y acciones preventivas
He recibido esta pregunta: Tengo una duda de como aplicarían las acciones preventivas los fabricantes en la industria farmacéutica si se cambia por análisis de riesgo, Hay que hacer un análisis de riesgos a cada no conformidad.... Mi respuesta En la nueva versión de la norma en vez de un único proceso de acciones preventivas unidireccional, el cual generalmente se llevaba a cabo a un nivel bajo de la organización y permanece allí, ahora existe un proceso de enfoque basado en riesgos presidido por el equipo que tiene toda la información disponible del negocio, que es la alta dirección. En ISO 9001:2015 la alta dirección de la organización está involucrada en el proceso de identificación, registro, eliminación, y mitigación del riesgo. En enfoque basado en riesgos por lo tanto puede considerarse un proceso más eficaz que las acciones preventivas de la antigua versión de la norma. Para más información, vea el siguiente artículo: "El enfoque basado en riesgos reemplazando las acciones preventivas en la ISO 9001:2015: los beneficios" https://advisera.com/9001academy/pt-br/kit-de-documentacao-da-iso-9001/ nowledgebase/el-enfoque-basado-en-riesgos-reemplazando-las-acciones-preventivas-en-la-iso-90012015-los-beneficios/ En cuanto al análisis del riesgo no existen unos requisitos en la norma sobre cómo hacerlo. Puedes llevar a cabo mediante la forma más sencilla, que sería con una reunión del personal más relevante de la organización, o realizar un análisis DOFA, de debilidades, oportunidades, fortalezas y amenazas, y a partir de ahí determinar las acciones para abordar los riegos y oportunidades más relevantes. Para más información, vea el siguiente artículo (en inglés) "cómo abordar riesgos y oportunidades en ISO 9001": https://advisera.com/9001academy/blog/2016/06/21/how-to-address-risks-and-opportunities-in-iso-9001/# Estos materiales también le pueden ayudar con la implementación de ISO 9001: - Libro "Preparación para el proyecto de implementación ISO: una guía en un lenguaje sencillo": https://advisera.com/books/preparacion-para-el-proyecto-de-implementacion-iso-una-guia-en-un-lenguaje-sencillo/ - Formación gratuita en línea: Curso de fundamentos ISO 9001 https://advisera.com/es/formacion/curso-fundamentos-iso-9001/ - Conformio (herramienta gratuita en línea para ISO 9001): https://advisera.com/conformio/ -
Numbering documents
"My company is ISO 9001: 2008 going to 2015 in June. Does an electronic document still need a document number?”