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Time frame for corrective action

If you have in mind major and minor nonconformities raised during a certification or surveillance audit it is best to contact your certification body because there may differences between them. For example, I’m looking right now to an audit report from a certification body with these time durations:

Major nonconformity

• Certification audit – 6 months
• Surveillance and recertification audits – 1 month

Minor nonconformity

• Certification audit – 6 months
• Surveillance and recertification audits – 3 months 

You can find more information in the following links:

• How to deal with nonconformities in an ISO 9001 certification audit - https://advisera.com/9001academy/blog/2015/06/09/how-to-deal-with-nonconformities-in-an-iso-9001-certification-audit/
• ISO 9001:2015 Lead Auditor Training Course - https://advisera.com/training/iso-9001-lead-auditor-course/
• Book - ISO internal audit: A plain English guide: https://advisera.com/books/iso-internal-audit-plain-english-guide/
   

Environmental aspects of a Reticulation system

This is a very specific question and, unfortunately, I have no experience of working with reticulation systems.

So, I would consider the life cycle of reticulation systems to identify environmental aspects related with:

• Raw materials and components bought
• Assembling of reticulation systems
• Installation and startup of reticulation systems
• Use of the reticulation system by the client
• Disposal of the reticulation system or parts of it after lifetime.

Please check this information below with more detailed answer:

• How does product life cycle influence environmental aspects according to ISO 14001:2015? - https://advisera.com/14001academy/blog/2016/03/21/how-does-product-life-cycle-influence-environmental-aspects-according-to-iso-140012015/
• 4 steps in identification and evaluation of environmental aspects - https://advisera.com/14001academy/knowledgebase/4-steps-in-identification-and-evaluation-of-environmental-aspects/
• What makes an environmental aspect significant in ISO 14001? - https://advisera.com/14001academy/blog/2015/03/09/what-makes-environmental-aspect-significant-in-iso-14001/
• 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/

ISO 9001 Pregunta

El fin de documentar el sistema de gestión es principalmente cumplir con los requisitos de la norma, ya que hay algunos documentos obligatorios como en ISO 9001:2015 la política de calidad, los objetivos de calidad, etc. También otro objetivo es evidenciar mediante documentos y registros, que realmente se están cumpliendo con los procedimientos establecidos por la organización así como con otros requisitos de la norma. 

Para más información sobre la documentación en ISO 9001:2015, vea los siguientes materiales: 

- 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/

- Curso gratuito - Curso Fundamentos de la norma ISO 9001:2015: https://advisera.com/es/formacion/curso-fundamentos-iso-9001/

- Libro - Gestión de documentación ISO: una guía en un lenguaje sencillo: https://advisera.com/books/gestion-de-documentacion-iso-una-guia-en-un-lenguaje-sencillo/

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

ISO 9001 Business lines certification within a large organization

Audit for a supplier

I will answer your question according to the automotive management system IATF 16949: 2016 standard.

When a factory changes location, the product and manufacturing process must be validated again. This is done in 2 ways.

First of all, the supplier presents you with the PPAP file according to the new location. After the PPAP file has been approved by you, the customer (you) must carry out a full process inspection at the new factory. Applications to be made after such changes are also given in AIAG's PPAP rev 4 books.

PPAP approval of the new factory product and production process must be given to your supplier as a documented information and signed of part submission letter (PSW).

Class IIa product

Following steps are necessary for the getting ISO certification:

1. First, you need to implement the ISO 13485:2016 in your management system and everyday work.
2. Then you need to ask for the certification according to the ISO 13485:2016 from the certification body.

It is rather hard to estimate how much time you will need for the implementation process because it depends on many things like: number of the employees, do you have any experience before with quality management systems, how complicated your processes are, and so on. On average, we can say that for the company with 10 employees it will take up to 3 months, for the company with up to 50 employees, 3-6 months. But, once again, this is just the estimation.

Considering how much money you will spend, again depends on your previous knowledge about quality management systems and the availability of your employees to dedicate to the implementation of a quality system. You can do it by yourself, which if you do not have previous experience, can be the longest way. You can hire a consultant or you can buy a documentation toolkit - pre-prepared template with all the necessary requirements from the standard and you just have to adapt them to your processes and needs.

Following articles can help you more to understand this process:

• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• Six key benefits of ISO 13485 implementation - https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
• How to get ISO 13485 certified? - https://advisera.com/13485academy/iso-13485-certification/
• Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

Following same model by the health authorities or by ISO standards

What you have described here are custom made devices. Since these are defined as medical devices according to the MDR 2017/745 Article 2, all manufacturers of medical devices need to have implemented a quality management system as described in Article 10. The quality management system shall cover all parts and elements of a manufacturer’s organization dealing with the quality of processes, procedures, and devices. It shall govern the structure, responsibilities, procedures, processes, and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.

Also, manufacturers need to be in compliance with harmonized standards published by the Offical Journal of the European Union as described in Article 8. On that list, the only standard that covers the quality management system is ISO 13485:2016 so it is expected that all manufacturers have to implement this standard.

For more details about MDR, please see the following articles:

• EU MDR Article 2 Definitions - https://advisera.com/13485academy/mdr/definitions/ - see point 3)
• EU MDR Article 10 General obligations of the manufacturers - https://advisera.com/13485academy/mdr/general-obligations-of-manufacturers/ - see point 9)
• EU MDR Article 8 Use of harmonized standards - https://advisera.com/13485academy/mdr/use-of-harmonised-standards/
• EU MDR Article 52 Conformity assessment procedures - https://advisera.com/13485academy/mdr/conformity-assessment-procedures/ - see point 8)
• EU MDR Annex XIII Procedure for custom made device - https://advisera.com/13485academy/mdr/procedure-for-custom-made-devices/

Here is the link to the List of the harmonized standard:https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2020:090I:TOC

To understand what harmonized standards are, please see the article on the following link:

• What are EU harmonized standards? https://advisera.com/13485academy/blog/2020/06/12/what-are-eu-harmonized-standards/

For more information regarding ISO 13485 please see the following links:

• What is ISO 13485? - https://advisera.com/13485academy/what-is-iso-13485/
• Six key benefits of ISO 13485 implementation - https://advisera.com/13485academy/knowledgebase/six-key-benefits-of-iso-13485-implementation/
• Checklist of ISO 13485 implementation and certification steps - https://advisera.com/13485academy/knowledgebase/checklist-of-iso-13485-implementation-and-certification-steps/

• Collection of evidence

  I'm assuming you are referring to the term "Point of Contact" mentioned in section 3.1 "Receipt and classification of incidents, weaknesses, and events".

  Considering that, the term "Point of Contact" refers to the person or role to which all communication related to an issue must be directed to, and for its implementation, you only need to define a person or role in your organization to perform it.

  For example, for the information and communication technology-related events you can define the IT manager as the Point of Contact, and for other events, you can define the Operational manager.

  These articles will provide you a further explanation about the incident management:

  • How to handle incidents according to ISO 27001 A.16 https://advisera.com/27001academy/blog/2015/10/26/how-to-handle-incidents-according-to-iso-27001-a-16/
  • Using ITIL to implement ISO 27001 incident management https://advisera.com/27001academy/blog/2015/11/10/using-itil-to-implement-iso-27001-incident-management/t/