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ISO 9001 audit of top management

ISO 9001:2015 requests top management example, commitment and leadership. Think about auditing top management about management review, about quality policy and objectives, complaints and customer satisfaction, context and risks and strategic orientation. I wrote this article about the topic of auditing top management - How to perform an ISO 9001 audit of top management without fear - https://advisera.com/9001academy/blog/2019/05/15/iso-9001-top-management-audit-how-to-perform-it-successfully/

You can find more information below:

• To what extent should top management be involved in your QMS? - https://advisera.com/9001academy/blog/2016/11/22/to-what-extent-should-top-management-be-involved-in-your-qms/
• How to comply with new leadership requirements in ISO 9001:2015 - https://advisera.com/9001academy/knowledgebase/how-to-comply-with-new-leadership-requirements-in-iso-90012015/
• Free webinar – How to perform management review according to ISO 9001:2015 - https://advisera.com/9001academy/webinar/how-to-perform-management-review-according-to-iso-9001-2015-free-webinar-on-demand/
• Enroll for free course - ISO 9001:2015 Foundations Course - https://advisera.com/training/iso-9001-foundations-course/
• Book - Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
   

Environmental impact assessment methodologies for ISO 14001:2015

Unfortunately, we don’t have published methodologies for environmental impact assessment. Environmental impact assessment is about analyzing and understanding the environmental implications of projects prior to construction. For example, a new airport must be built and there are several possible locations. What can be the environmental consequences of building and operating an airport at each of those possible locations? ISO 14001 is about organizations already operating and the focus is on performing an environmental assessment to determine environmental aspects and impacts.

The following material will provide you more information about aspects and impacts:

• 4 steps in identification and evaluation of environmental aspects - https://advisera.com/14001academy/knowledgebase/4-steps-in-identification-and-evaluation-of-environmental-aspects/
• Environmental aspect identification and classification - https://advisera.com/14001academy/blog/2019/08/27/key-iso-14001-benefits-to-customers/nowledgebase/environmental-aspect-identification-and-classification/
• Free webinar - Free webinar - ISO 14001: Identification and evaluation of environmental aspects - https://advisera.com/14001academy/webinar/iso-14001-identification-and-evaluation-of-environmental-aspects-free-webinar-on-demand/
• Enroll for free in this course – ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
• Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/

Purpose of process flow diagram after APQP

The process flow diagram is one of the first documents to be prepared for process design in the new product launch process. As you know, it starts from the incoming inspection of the product and should show all stages in order until the product is shipped to the customer. It is prepared before PFMEA and the process flow sequence should be the same as the PFMEA and control plan. If there is any change in the process flow, the flow diagram, PFMEA, Control Plan must change accordingly. Therefore, it is a living document and should be followed by revision number, date, etc.
 

Pre-implementation stage

I must tell you that before starting to answer this question I was doing what I consider the main difficulty in the pre-implementation stage of an environmental management system. It is the mix of clauses 6.1.2, 6.1.3 and 9.1.2 in an initial environmental assessment.

Before starting with anything else we need to have a clear and trustful picture of what legislation is applicable to the organization and what is the present state of compliance. In older industrial settings it is critical to not miss anything that can put certification in jeopardy because something found at the certification audit will take months to overcome with a big investment in the facilities.

You can find more information below:

• Compliance requirements according to ISO 14001:2015 – What has changed? - https://advisera.com/14001academy/blog/2015/09/14/compliance-requirements-according-to-iso-140012015-what-has-changed/
• Enroll for free in this course – ISO 14001:2015 Foundations Course - https://advisera.com/training/iso-14001-internal-auditor-course/
• Book – The ISO 14001:2015 Companion - https://advisera.com/books/the-iso-14001-2015-companion/

Following up on pending issues

Let us first make some comments to your wording.

There is no definition in ISO 9000:2015 or in ISO 19011:2018 about what is an audit observation. So, I will assume in this answer that an observation is the same as an opportunity for improvement (OFI). What is included in the text of the observation is not a non-conformity (NC), but an invitation to evaluate, to consider improving something.

Normally, audits generate NC. During the follow-up of an audit a NC may require a correction and a corrective action.

About observations. After the audit, relevant management, must evaluate the relevance of each observation and decide if any change will be made. The decision, and the action may be recorded in a meeting minute about the follow-up of the audit.

About NC. After the audit, relevant management, must analyze each NC and define what correction is needed and if a corrective action is needed. Normally, organizations have a form, for example Corrective Action Request (CAR), where the correction, corrective action if needed, verification of implementation and effectiveness and closure is recorded. Please check this example from our Documentation Toolkit - ISO 9001 document template - Procedure for Internal Audit - https://advisera.com/9001academy/documentation/procedure-internal-audit/

You can find more information in the following links:

• Major vs. minor nonconformities in the certification audit - https://advisera.com/27001academy/blog/2014/06/02/major-vs-minor-nonconformities-in-the-certification-audit/
• Free webinar on demand - How to perform an ISO 9001:2015 internal audit - https://advisera.com/9001academy/webinar/how-to-perform-an-iso-9001-2015-internal-audit-free-webinar-on-demand/ (includes a slide about the follow-up)
• You can enroll for free in this course - ISO 9001:2015 Internal Auditor Course: https://advisera.com/training/iso-9001-internal-auditor-course/
• Book - ISO internal audit: A plain English guide: https://advisera.com/books/iso-internal-audit-plain-english-guide/

Contexto de la organizacion

Determinar el contexto de la organización se trata de un requisito de la norma ISO 9001:2015 y que se encuentra recogido en la cláusula 4. Básicamente con este requisito se pide que una organización considere las cuestiones internas y externas que pueden tener un impacto sobre sus objetivos estratégicos y a la planificación del Sistema de Gestión de Calidad. 

La norma no obliga a tener un documento que certifique que se ha determinado el contexto de la organización, sin embargo durante una auditoría, debe de existir evidencia de que sí se ha llevado a cabo este requisito. Es decir, que se podría evidenciar además de con un documento donde se vean reflejadas las cuestiones internas y externas de la organzación, con por ejemplo, una entrevista con la alta dirección.

Para más información sobre el contexto de la organización vea los siguientes materiales: 

- Cómo identificar el contexto de la organización en ISO 9001:2015: https://advisera.com/9001academy/pt-br/kit-de-documentacao-da-iso-9001/nowledgebase/como-identificar-el-contexto-de-la-organizacion-en-iso-90012015/

- Formación gratuita en línea – Fundamentos de ISO 9001:2015 : https://advisera.com/es/formacion/curso-fundamentos-iso-9001/

- Libro – Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

Primer paso para ISO 9001

El primer paso para la impelmentación es contar con el apoyo de la alta dirección de su organización, que va a ser crucial durante la implementación de ISO 9001:2015, porque que proporciona los recursos tanto económicos como de personal.

Luego puede llevar a cabo un análisis GAP o de brecha, que le va a ayudar a identificar aquellos requisitos con los que ya cumple y aquellos con los que aún debe aún cumplir. Aquí puede llevar a cabo el análisis de forma gratuita: https://advisera.com/9001academy/iso-9001-gap-analysis-tool/

Es importante que antes de la implementación de la norma conozca cada una de las cláusulas con las que tiene que cumplir para poder llevar a cabo el proyecto de implementación de ISO 9001. En este white paper puede encontrar información resumida sobre cada una de ellas - Clause by clause explanation of ISO 9001: https://info.advisera.com/9001academy/free-download/clause-by-clause-explanation-of-iso-90012015

Posteriormente puede escribir un plan de proyecto en el que determine responsabilidades, defina la documentación que va a escribirse, los plazos de implementación, etc. En este enlace puede descargarse una plantilla - Plan de Proyecto para la implementación de ISO 9001:https://info.advisera.com/9001academy/es/descarga-gratuita/plan-de-proyecto-para-la-implementacion-de-iso-9001-ms-word

Luego ya podría empezar con la implementación de la norma: la definición de la política de calidad, los objetivos de calidad y planes para llevarlos a cabo, el contexto de la organización y sus partes interesadas, el alcance del SGC, etc...hasta llegar a la auditoría interna y la revisión por la dirección, que sería el paso previo para certificarse. En este enlace puede descargarse un checklist para la implementación de la norma - Porject checklist for ISO 9001:2015: https://info.advisera.com/9001academy/free-download/project-checklist-for-iso-9001-2015-implementation

Estos materiales pueden ayudarle con la implementación de ISO 9001:2015:
- Libro – Discover ISO 9001:2015 through practical examples: https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/
- Formación gratuita en línea – Fundamentos de ISO 9001:2015 : https://advisera.com/es/formacion/curso-fundamentos-iso-9001/

Applicability of ISO 9001

ISO 9001 is a generic international standard designed to be applicable in all economic sectors regardless of organization’s size.

ISO 9001 is used by organizations to demonstrate their ability to systematically provide products and services that meet requirements and to satisfy customers and other interested parties.

The following material will provide you more information:

• What is ISO 9001? - https://advisera.com/9001academy/what-is-iso-9001/
• The history and future of the ISO 9000 series of standards - https://advisera.com/9001academy/blog/2019/04/15/history-of-the-iso-9000-series-of-standards-and-what-to-expect-next/
• Free online training ISO 9001:2015 Foundations Course – https://advisera.com/training/iso-9001-foundations-course/
• Discover ISO 9001:2015 Through Practical Examples - https://advisera.com/books/discover-iso-9001-2015-through-practical-examples/

Validation of software of machines and equipment related to production process

Yes, you need to validate software of machine and equipment related to the production process, but only when there is a new revision of the software; when you get information from the machine manufacturer that there is a necessity to update the software. 

If that is not the case, then you do not need to regularly validate that software.  

You can see how records of software validation look in ISO 13485:2016 Documentation toolkit on the following link:

• Record of Software Validation https://advisera.com/13485academy/documentation/record-of-software-validation-iso-13485-2016/