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How to perform an internal audit using ISO 19011

How to perform an internal audit using ISO 19011

White paper, PDF format

This white paper is intended for companies that need to perform an internal audit as part of their ISO 13485 management system. Learn how ISO 19011 can help you, and read about principles of auditing, auditor characteristics, and steps for internal auditing according to this standard.

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How can ISO 13485 help your business grow?

How can ISO 13485 help your business grow?

White paper, PDF format

This white paper is intended for quality managers, decision makers, consultants and other employees in companies planning to implement ISO 13485:2016. This helpful document gives an overview of benefits that the implementation of the ISO 13485 can bring to your company, and explains how does this standard fit with small enterprises.

Click to download
List of questions to ask an ISO 13485 consultant

List of questions to ask an ISO 13485 consultant

Checklist, MS Word format

Before deciding which ISO 13485 expert to engage for the implementation, consider asking these questions to help you determine whether this is the right option for your company. This list contains prepared questions that are relevant to helping you find the best possible consultant for your business.

Click to download
Why ISO 13485? – Awareness presentation

Why ISO 13485? – Awareness presentation

Presentation, MS PowerPoint template

This short presentation, intended for employees, shows what ISO 13485 is all about. It covers the benefits for the company, and the employees’ role in different aspects of medical devices quality management.

Click to download

ISO 13485 White papers (25)

How to perform an internal audit using ISO 19011

How to perform an internal audit using ISO 19011

White paper, PDF format

This white paper is intended for companies that need to perform an internal audit as part of their ISO 13485 management system. Learn how ISO 19011 can help you, and read about principles of auditing, auditor characteristics, and steps for internal auditing according to this standard.

Click to download
How can ISO 13485 help your business grow?

How can ISO 13485 help your business grow?

White paper, PDF format

This white paper is intended for quality managers, decision makers, consultants and other employees in companies planning to implement ISO 13485:2016. This helpful document gives an overview of benefits that the implementation of the ISO 13485 can bring to your company, and explains how does this standard fit with small enterprises.

Click to download
What to expect at the ISO certification audit: What the auditor can and cannot do

What to expect at the ISO certification audit: What the auditor can and cannot do

White paper, PDF format

This white paper is intended for quality managers, CEOs, and consultants in companies which already implemented quality standard(s) and need guidance on what to expect at the ISO certification audit.

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Clause-by-clause explanation of ISO 13485:2016

Clause-by-clause explanation of ISO 13485:2016

White paper, PDF format

This document explains each clause of ISO 13485:2016 in plain English to help you better understand the requirements of the standard. The document provides guidelines on what needs to be done to meet each requirement of the standard.

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How to budget an ISO 13485 implementation project

How to budget an ISO 13485 implementation project

White paper, PDF format

Implementing a project like ISO 13485 can be costly if you do not budget in advance. This white paper aims to help you budget effectively, and prevent any unnecessary expenses from occurring. Not only will you learn budgeting benefits and tips, but also how different implementation options can impact your overall budget.

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Implementing ISO 13485:2016 with a consultant vs. DIY approach

Implementing ISO 13485:2016 with a consultant vs. DIY approach

White paper, PDF format

Deciding which method to follow when implementing ISO 13485:2016 can be difficult and confusing. This white paper outlines the pros and cons of both going it alone, and hiring a consultant. It offers detail on both techniques, as well as what to look for in a good online solution, helping you make an informed decision on the best approach for your business.

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ISO 13485:2003 vs. ISO 13485:2016 matrix

ISO 13485:2003 vs. ISO 13485:2016 matrix

White paper, PDF format

This matrix shows the relationships between the requirements of ISO 13485:2003 and the new ISO 13485:2016, while providing an overview of requirements common to both versions. It also offers tips on how to make the transition to the new version with as little stress as possible.

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Twelve-step transition process from ISO 13485:2003 to the 2016 revision

Twelve-step transition process from ISO 13485:2003 to the 2016 revision

White paper, PDF format

This white paper is intended for companies that have implemented the ISO 13485:2003 standard, and are planning to transition to the 2016 revision. The paper describes the suggested steps in the transition process.

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¿Cómo puede ISO 9001 ayudar a que su negocio crezca?

¿Cómo puede ISO 9001 ayudar a que su negocio crezca?

White paper, PDF format

El crecimiento de su negocio es esencial si quiere ser competitivo. Este informe señala cómo ISO 9001 puede ayudar a su empresa a hacer mejor los procesos, y a mejorar la satisfacción del cliente. También aprenderá cómo la Norma puede ayudarle a superar retos enfrentados por muchas Pequeñas y Medianas Empresas.

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In che modo la ISO 9001 può aiutare la tua azienda a crescere?

In che modo la ISO 9001 può aiutare la tua azienda a crescere?

White paper, PDF format

El crecimiento de su negocio es esencial si quiere ser competitivo. Este informe señala cómo ISO 9001 puede ayudar a su empresa a hacer mejor los procesos, y a mejorar la satisfacción del cliente. También aprenderá cómo la Norma puede ayudarle a superar retos enfrentados por muchas Pequeñas y Medianas Empresas.

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Lista de Verificación de la Documentación Requerida de Manera Obligatoria por ISO 9001:2015

Lista de Verificación de la Documentación Requerida de Manera Obligatoria por ISO 9001:2015

White paper, PDF format

Informe que enumera todos los documentos y registros obligatorios, y que también describe brevemente cómo estructurar cada documento. Este informe es ideal para todas las organizaciones que han empezado la implementación de su SGC – les da una visión amplia acerca de cuáles documentos son requeridos, y dónde colocarlos.

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Checklist della documentazione obbligatoria richiesta dalla ISO 9001:2015

Checklist della documentazione obbligatoria richiesta dalla ISO 9001:2015

White paper, PDF format

Libro bianco che elenca tutti i documenti e le registrazioni obbligatorie, oltre a descrivere brevemente come strutturare ciascun documento. Questo elenco è ideale per tutte le aziende che stanno cominciando l’implementazione del proprio SGQ: offre una perfetta panoramica di quali siano i documenti richiesti e di dove collocarli.

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Checklist of Mandatory Documentation Required by ISO 13485:2016

Checklist of Mandatory Documentation Required by ISO 13485:2016

White paper, PDF format

Knowing what documents and records are necessary for ISO 13485:2016 can be confusing. This white paper is designed to clear up any misunderstandings regarding documents required by this standard, as well as outlining non-mandatory documents that are commonly used. It also offers help on structuring these documents, in a straight-forward and easy-to-follow format.

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Documentación obligatoria requerida por ISO 9001:2008

Documentación obligatoria requerida por ISO 9001:2008

White paper, PDF format

Muchas empresas se exceden con la documentación creyendo que necesitan documentar cada uno de los procesos vigentes en su organización; pero no se dan cuenta que esto no es indispensable para cumplir los requerimientos de la norma ISO 9001.

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Cómo las herramientas online están revolucionando la implementación de ISO 9001

Cómo las herramientas online están revolucionando la implementación de ISO 9001

White paper, PDF format

Hasta ahora, había sólo dos maneras para certificarse en ISO 9001: uno podía buscar docenas de recursos y ponerlos todos juntos o podía traer un consultor experto para que hiciera todo el trabajo.

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Presentations (3)

Why ISO 13485? – Awareness presentation

Why ISO 13485? – Awareness presentation

Presentation, MS PowerPoint template

This short presentation, intended for employees, shows what ISO 13485 is all about. It covers the benefits for the company, and the employees’ role in different aspects of medical devices quality management.

Click to download
Project plan for ISO 13485 implementation presentation

Project plan for ISO 13485 implementation presentation

Presentation, MS PowerPoint template

Short presentation intended for quality managers, project managers, and other employees. This presentation will help clearly define the objectives of the medical devices Quality Management System implementation project, documents to be written, deadlines, and roles and responsibilities in the project.

Click to download
Project proposal for ISO 13485:2016 implementation

Project proposal for ISO 13485:2016 implementation

Presentation, MS PowerPoint template

When it’s time to present your ISO 13485:2016 implementation project to top management, you need to show them clearly and briefly why this project is important for your company. With our Project Proposal template in PowerPoint, you’ll have a head start in earning management’s support.

Click to download

Templates (4)

Project proposal for ISO 13485:2016 implementation

Project proposal for ISO 13485:2016 implementation

Template, MS Word format

Implementing a project like ISO 13485:2016 is easier with the support of management. Use our project proposal template to help achieve the approval and commitment necessary from top management to progress. Plus, you’ll gain invaluable insights about the project itself.

Click to download
Project Plan for ISO 13485 implementation

Project Plan for ISO 13485 implementation

Template, MS Word format

During implementation of ISO 13485, it’s critical to manage all aspects of the project. You’ll need to oversee everything from project milestones to individual roles and their responsibilities. With this Project Plan template, you can effectively organize your ISO 13485 implementation.

Click to download
Propuesta de proyecto para la implementación de ISO 9001

Propuesta de proyecto para la implementación de ISO 9001

Template, MS Word format

El implementar un proyecto como el ISO9001 será mucho mas fácil de soportar ante la gerencia.  Utilice nuestras plantillas de presentación para ayudarlo a obtener la aprobación y compromiso que usted  necesita de la alta gerencia.  En el proceso, usted también aprenderá una información invaluable acerca de su propio proyecto.

Click to download
Plan de Proyecto para la implementación de ISO 9001

Plan de Proyecto para la implementación de ISO 9001

Template, MS Word format

Durante la implementación de ISO9001 es crítico el administrar todos los aspectos del proyecto.  Usted tendrá que ver todo desde los hitos del proyecto hasta los roles de los individuos y sus responsabilidades. Con esta plantilla de Plan de Proyecto, usted puede organizar efectivamente la implementación de su ISO 9001.

Click to download

Checklists (7)

List of questions to ask an ISO 13485 consultant

List of questions to ask an ISO 13485 consultant

Checklist, MS Word format

Before deciding which ISO 13485 expert to engage for the implementation, consider asking these questions to help you determine whether this is the right option for your company. This list contains prepared questions that are relevant to helping you find the best possible consultant for your business.

Click to download
List of questions to ask an ISO 13485 certification body

List of questions to ask an ISO 13485 certification body

Checklist, MS Word format

With so many different companies to choose from, finding the right ISO 13485 certification body to work with can be confusing. Using the prepared questions outlined in this free list, you can plan in advance exactly what to ask each prospective body. Clear explanations for each question will help you to find the perfect ISO 13485 certification body for your certification.

Click to download
Project Checklist for ISO 13485:2016 Implementation

Project Checklist for ISO 13485:2016 Implementation

Checklist, MS Word format

This checklist will enable you to easily keep track of all the steps of your ISO 13485 implementation project. There are 12 major steps and 43 tasks, starting with obtaining management support all the way through to your certification audit.

Click to download
Diagram of ISO 13485:2016 Implementation Process

Diagram of ISO 13485:2016 Implementation Process

Diagram, PDF format

Planning the implementation of ISO 13485:2016 is a crucial step in the success of your Medical Device Management System. With our ISO 13485:2016 Implementation Diagram you can see at a glance the step-by-step process to follow, ensuring nothing is forgotten.

Click to download
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