language: Deutsch   Français   italiano   Español   Português   日本語   russian   arabic   norwegian   swedish   danish   Nederlands   finland   ireland   English  

ISO 9001:2015 Certification Package | All-In-One Easy 9001 Toolkit | complaint definition iso

This user-friendly worksheet includes instructions to make it particularly easy to meet ISO 9001:2015, clauses 4.1 requirements.

5 Pages – MS Word Document

Form 30: Training Evaluation Form The “Training Evaluation Form” is designed to make your employees evaluate training sessions by focusing on the benefits to the company. Use this form to make your in-house training more efficient and to evaluate training providers. The “Training Evaluation Form” can be used to easily demonstrate compliance with several ISO 9001 requirements (ISO 9001:2015, clauses 7.2, 7.3, 8.4 and 9.1.3).

1 Page – MS Word Document

Form 31: Training Plan This professionally designed “Training Plan” template allows you to not only meet the three ISO 9001 requirements for the planning of training, evaluation of training, and maintaining training records easily; it also requires considering the benefits to the company before actually approving a training request. The “Training Plan” has a double benefit: it allows you to easily meet key ISO 9001 requirements (ISO 9001:2015, clauses 7.2 and 7.3), and it potentially saves your company much unnecessary training expenses.

1 Page – MS Word Document

Form 32: Training Record Form Our “Training Record Form” is not just a sign-in sheet to keep the ISO 9001 required training records. We designed the “Training Record Form” to focus on training objectives and potential follow-up training, in addition to easily establishing all ISO 9001 required training records (ISO 9001:2015, clause 7.2) in one easy step.

2 Pages – MS Word Document

17. Customization Instructions - ISO 9001 Forms & Checklists

Most companies will find that our ISO 9001 forms and checklists will need very little customization. However, we prepared these simple “Customization Instructions - ISO 9001 Forms & Checklists” to give you guidance in case that your company's circumstances require additional modifications.

13 Pages – PDF File (use the free Acrobat Reader to view)

18. Set of 10 Employee Newsletters

This “Set of 10 Employee Newsletters” is designed to educate all employees in ISO 9001, to keep them involved and to keep them aware of the company-wide ISO 9001 implementation effort. Employee acceptance and involvement is crucial for the success of ISO 9001, and this series of easy-to-read and eye-opening newsletters will make a great contribution.

Topics include updates on the ISO 9001 implementation project, changes to corporate procedures, ISO 9001 facts, flowcharting basics, document control tips, and much more.

10 Newsletters (each 1 or 2 pages) – MS Word Documents

19. PowerPoint Presentation “ISO 9001 for Everybody”

This professionally designed PowerPoint presentation is a great tool to keep employees and management involved in the ISO 9001 implementation and train them in important ISO 9001 issues. Topics of “ISO 9001 for Everybody” include: What is ISO 9001, Quality Management versus Quality Control, Process Approach, Documentation Requirements, Factors for Success, How to implement ISO 9001, Writing Instructions, and many more.

17 Slides – MS PowerPoint

[back to top]

20. Internal Auditor Position Description

The “Internal Auditor Position Description” includes a description of job requirements, work environment and qualifications of your company's internal ISO 9001 auditor. The purpose of this document is to advertise the internal ISO 9001 auditor position, select the ideal candidate, and document the requirements for the internal ISO 9001 auditor position.

2 Pages – MS Word Document

21. Instructions for Internal ISO 9001 Audits

The “Instructions for Internal ISO 9001 Audits” will make auditing easy for your company's internal auditor. These instructions, though concise, are a valuable guide loaded with details.

5 Pages – MS Word Document

22. ISO 9001:2015 Audit Checklist

Your company's internal ISO 9001 auditor will use the “ISO 9001:2015 Audit Checklist” as an invaluable and time-saving tool that makes any internal ISO 9001 audit as easy as possible. The audit checklist will not only guide the auditor through the entire ISO 9001 audit (using the process approach), but it is also used to accurately record all audit findings with direct references to the correct ISO 9001 requirements. A separate section of the “Checklist for Internal ISO 9001 Audits” is designed to make the audit of executive management as easy and painless as possible.

78 Pages – MS Word Document

23. Audit Report Form

The “Audit Report Form” is used by the internal ISO 9001 auditor to document and communicate the findings of the internal audit. The form is professionally designed to be clear and easy to use while, at the same time, present the complete audit findings to company management in a professional manner.

2 Pages – MS Word Document

[back to top]

24. Insider Secrets for a Successful ISO 9001 Certification Audit

Passing the ISO 9001 certification audit is the goal; access to insider information will make achieving this goal so much easier. Our “Insider Secrets for a Successful ISO 9001 Certification Audits” have been compiled over many years in working with numerous ISO 9001 auditors and registrars throughout the world. These secrets contain detailed audit preparation instructions that will be of invaluable help to you and your employees in preparing for a successful ISO 9001 certification audit. Especially the following chapters of our “Insider Secrets for a Successful ISO 9001 Certification Audit” are loaded with insider information:

Tips for your Audit Preparation, and

Typical Auditor Questions.

11 Pages – PDF File (use the free Acrobat Reader to view)

25. Powerful Marketing of your ISO 9001 Certification

This concise guide will help you define a powerful marketing strategy in order to reap the full marketing benefits of your ISO 9001 certification: increased sales, increased market share and increased profits. Put the numerous tips and instructions of “Powerful Marketing of your ISO 9001 Certification” to work as soon as you passed your ISO 9001 certification audit, and start leveraging your ISO 9001 certification through successful marketing.

9 Pages – PDF File (use the free Acrobat Reader to view)

Plus ... 24. 24/7 Expert Customer Support

You are not alone during your ISO 9001 implementation! Our team of senior ISO 9001 experts is standing by to assist you with personal customer service throughout the entire ISO 9001 implementation project. Please contact us anytime 7 days a week, and you can expect a competent and detailed response that addresses all your questions.

[back to top]

Completely revised for ISO 9001:2015

The All-In-One Easy 9001 Toolkit ™ is periodically reviewed and revised (last in July 2017) to ensure that it is up-to-date to the latest requirements and interpretations of ISO 9001, as well as remains fully compliant with all requirements and agreed interpretations of ISO 9001:2015.

Special Features

Complete ISO 9001 package that includes everything you need to start your ISO 9001 implementation from the very beginning and reach ISO 9001 certification easily and quickly without prior experience in ISO 9001.

Designed to allow you achieve ISO 9001 certification easily, quickly and without unnecessary changes to your company. This way you can quickly start reaping the powerful marketing benefits that come with ISO 9001 certification.

All components of the All-In-One Easy 9001 Toolkit ™ are user-friendly, straight-forward and easy to understand.

The All-In-One Easy 9001 Toolkit ™ is ideal for you if ...

you are looking for a complete ISO 9001 package, and if

you want to implement ISO 9001 most economically and without expensive consultants, and if

you want to keep the ISO 9001 implementation as easy as possible on yourself and on your company, and if

you want to set up ISO 9001 without making unnecessary changes to your company, and if

you want to achieve ISO 9001 certification as fast as possible so that you can quickly enjoy its marketing benefits, and if

your organization is a small to midsize manufacturing or service company of any industry and in outlet-moncler-milano-via-pisani-rid-3884411.html. moncler crystal baby onesie snowsuit any country, and if

you are anywhere from complete beginner to expert in ISO 9001 quality management systems.


Easy 9001 Implementation Guidebook - Table of Contents & Introduction

ISO 9001 Procedures Manual - Table of Contents

ISO 9001 Procedures Manual - Sample

Customization Instructions - ISO 9001 Procedures Manual - Sample

Forms & Checklists - Sample

System Requirements

Windows (Vista / Windows 7 / Windows 8 / Windows 10) - or - Mac (OS X)

Microsoft Office (version 2007 & newer)

Adobe Acrobat Reader (version 5 & newer) - or - other PDF viewer

15 MB of free disk space

Internet connection (to download our product)

All-In-One Easy 9001 Toolkit™

Number of Documents : 66 File Size : 12 MB Version : 2017 Language : English ISBN/ASIN : B001TO4YEE Product Delivery : Instant Download

Price: US$ 995

complaint definition iso

moncler polo shirts mens
moncler 'vancouver' shearling boot
moncler mens sneakers
moncler outlet new york city
discount moncler mens jackets ISO 13485: Just the Facts December 30, 2008 BNP Media Staff Reprints One Comment In an ever-shrinking world, the need for regulatory harmonization and quality assurance has become increasingly important. Consumers are becoming more educated about the safety and efficacy of medical devices. The inherent nature of these products has implications for the health and safety of the people who use them.

As the median age and the percentage of the population over 65 continues to grow, the need for medical devices will continue to increase. The medical device industry is expected to grow 4.6% through 2011, despite the worldwide financial crisis. ISO/IEC 13485: 2003 represents the management system requirements for companies that want to maintain compliance with medical device regulations. 13485 could be implemented by companies that manufacture everything from cotton swabs to pacemakers, contraceptives to examination tables or companies that provide related services, such as sterilization, packaging or labeling. Like other sector-specific standards, 13485 follows the structure and plan-do-check-act philosophy of ISO 9001: 2008. However, there are differences between these two standards. Development and Oversight The goal in developing 13485 was to create a management system standard that assists companies in meeting regulatory requirements for medical devices in whichever economy they choose to sell and manufacture their devices. In order to ensure that these management systems are audited in a way that meets the intent of global consistency, the Global Harmonization Task Force was developed to provide specific guidelines for certification bodies in how these assessments are to be conducted, from auditor training requirements to audit practice. Accreditation bodies and national governments enforce procedural oversight to registrars and notified bodies. Registration to ISO 9001: 2008 Some sector-specific standards that use 9001 as the foundation for requirements allow the company to register both to the generic 9001 standard and its sector-specific relative. However, such is not the case with 13485 because the requirements associated with 9001 are not completely addressed in 13485. Annex B of the standard provides a clause-by-clause comparison of 9001 and 13485 as well as an explanation of why the wording is different. The result is that companies must register to each of these standards separately. Some of the 9001 requirements are recognized by 13485, and currently registered clients may be able to perform an upgrade audit of reduced time.

Some core differences between 13485 and 9001 follow.

1. Maintenance vs. Improvement
One of the core principles of 9001 is that a certified company must continually improve the effectiveness of its management system. These improvements can relate to processes, products or services that the company provides to its customers. In the regulatory world of medical devices, however, improvements, though well intended, can affect the safety and effectiveness of the product or services provided by the company. So, rather than require that companies continually improve, 13485 requires maintenance of the effectiveness of the quality management system’s processes. Consequently, continual improvement efforts may be limited to those areas in the management system that do not pose a significant risk to product or process safety and effectiveness.

2. Customer Satisfaction vs. Customer Feedback
Another core principle of 9001 is the requirement that certified companies must monitor customer perception and subsequently use the results to improve the system. For 13485, this requirement is replaced by the obligation to monitor whether a company has met customer requirements. There is a difference between achieving customer satisfaction and meeting customer requirements. For example, while a customer may not be satisfied because a medical device causes discomfort, the device may still be effective and safe; the emphasis in 13485 is on safety and effectiveness.

Customer perception in 9001 focuses on customer satisfaction from the customer’s point of view. It is not enough to use the absence of customer complaints as evidence of customer satisfaction; customer perception requires an organization to actively seek the customer satisfaction levels.

3. Exclusions
Section 1.2 of 13485, Application, states that a company may justifiably exclude the requirements for design and development if a regulatory requirement allows for it, regardless of whether or not the company engages in such activities. As always, a company needs to be careful how they define an exclusion. Even though the company may not have primary responsibility, it still may have activities that impact the excluded requirements. Auditors will test companies to ensure exclusions are justified.

4. Risk Management
Given the nature of the product being manufactured or service being provided, 13485 requires that companies calculate, analyze and mitigate the risks associated with the product and processes. This is not unlike the requirement in the automotive sector for companies to conduct failure mode and effects analysis (FMEAs) and develop preventive measures to prevent undesirable results. Additional guidance can be found in ISO 14971: 2007 – Application of Risk Management to Medical Devices.

5. Additional Requirements
As is the case for other sector-specific standards, 13485 has additional requirements that go beyond its 9001 foundation. Many of these requirements call for the development of additional documents and documented procedures. Additional requirements include:

Documenting procedures for design and development; purchasing; servicing; validation of the application of computer software and sterilization processes; identification of returned goods; traceability; control of product with a limited shelf life or requiring special storage conditions; monitoring and measurement of product, customer feedback and rework; and issuance and implementation of advisory notices, for example, as in the case of a product recall.

Conducting formal risk analysis in product and service planning.

Addressing additional controls for cleanliness of product and contamination control, work environment, and document and record control.

Documenting requirements for installation, service and sterilization activities and processes as well as active implantable and implantable medical devices, risk management, maintenance activities, cleanliness and installation.

While a company seeking dual certification does not have to necessarily maintain two sets of quality management system documentation-one for 9001 and one for 13485-the company must identify and implement the unique requirements in each standard. To ease the initiative to develop a 13485-conformant system, the standard contains Annex B, which allows one to compare the requirements of 13485 with those of 9001. Who Needs 13485? With all of this being considered, one may wonder if pursuing 13485 certification is the right decision. The following are some common questions and answers to help with this decision.

Who can be certified to 13485?
If an organization designs or manufactures medical devices, raw materials or provides services related to medical devices-for example, sterilization, installation, labeling, technical publication-it can be certified to 13485.

Must a medical device manufacturer become certified?
Part of the answer lies in what is required by the regulatory agencies of the countries in which devices are sold. For certain types of devices, companies must have their quality management system certified to 13485 to legally sell or market devices in Canada and the countries of the European Union, for example. It also can help companies in obtaining the product certification CE mark for their devices.

Companies considering 13485 certification need to understand the regulatory requirements of the countries in which product is to be sold. It also is important for companies to choose a service provider that is recognized in the market they intend to enter. For example, only certificates accredited under the Canadian Medical Devices Conformity Assessment System (CMDCAS) by the Standards Council of Canada will be recognized by Health Canada in applying for a medical device license. For EU member countries the service provider must be a notified body.

What if a company has the capability of manufacturing components for medical devices or providing services to medical device companies?
This is a strategic decision. If a company intends to diversify into medical devices, 13485 would be recommended. Many companies with an existing 9001-based system have little trouble adopting the requirements of 13485.

Is there a deadline?
There are no mandated deadlines. However, not having 13485 certification will prove to be a barrier when attempting to sell product in economies that require it.

In today’s globalized world, the need for regulatory harmonization is greater than ever, particularly in the growing and highly regulated medical industry. Achieving 13485 certification will help manufacturers of medical devices and providers of medical services compete today-and may prove absolutely crucial in the future. Q Quality Online For more information on ISO/IEC 13485 and ISO 9001, visit www. to read these articles: “Dispelling the Myths of ISO 9001”
“The Importance of ISO”
“Understanding ISO 13485” Tech Tips 13485 represents the management system requirements for companies that want to maintain compliance with medical device regulations.

Like other sector-specific standards, 13485 uses the general 9001 standard as a foundation, but adds many additional requirements.

In certain countries, a medical device manufacturer must be certified to 13485 to legally sell product.

Did you enjoy this article? Click here to subscribe to Quality Magazine. 

Recent Articles by BNP Media Staff Tecnatom, Marietta NDT Sign Collaboration Agreement Crash Course in Data Management Speeds Up Huge Simulation Task Quality 101: Implement an Integrated Data Collection System Creating a Quality Management System Tackle Internal Audits Related Articles Understanding ISO 13485 Quality Management: The Need for ISO 13485 ISO 13485: Medical Devices and Risk Management Quality 101: Tracking Gage Calibration with a Spreadsheet Related Products The Non-Idiot's Guide to ISO 9001:2015: Understanding and Using the Quality Management System Standard to your benefit The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition A Practical Field Guide for ISO 9001:2008 Lean ISO 9001 Related Events ISO 14971 Hazard Analysis at Medical Device - 2017 Medical Devices for Risk Management Techniques 2017 The ASSEMBLY Show What is the Market View on Quality Management? Related Directories AIC Quality Services LLC NSAI CARR Quality Assurance Consulting IQS Inc. You must login or register in order to post a comment. Report Abusive Comment

Understanding ISO 13485 January 2, 2008 Steve Wichelecki Reprints No Comments

ISO 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488. Though based on ISO 9001, 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes.

Today, some medical device manufacturers are requiring their sub-tier suppliers to attain ISO 13485 certification. Source: Ticona Polymers Inc.

ISO 13485: 2003 represents the requirements that medical device manufacturers must incorporate into their management systems. The current document supersedes its 1996 incarnation as well as EN 46001, EN 46002 and ISO 13488.

TECH TIPS 13485 emphasizes meeting regulatory as well as customer requirements, risk management and maintaining effective processes. 13485 is in part designed to produce a management system that facilitates compliance to the requirements of customers and global regulators. Benefits can be reaped from being both 9001 and 13485 certified, because 9001 focuses on business aspects not found in 13485 that are good for all businesses.

Though based on ISO 9001, 13485 removes 9001’s emphasis on continual improvement and customer satisfaction. In its place is an emphasis on meeting regulatory as well as customer requirements, risk management and maintaining effective processes, namely the processes specific to the safe design, manufacture and distribution of medical devices. 13485 is in part designed to produce a management system that facilitates compliance to the requirements of customers and-preeminently-various global regulators. While being certified to 13485 does not fulfill the requirements of either the FDA or foreign regulators, the certification aligns an organization’s management system to the requirements of the FDA’s Quality System Regulation (QSR) requirements as well as many other regulatory requirements found throughout the world. Therefore, 13485 certification serves to create a management system that can be thought of as a framework on which to build compliance to various regulatory and customer requirements. Christian Lupo, general manager of Ann Arbor, MI-based NSF International Strategic Registrations states, “If the proper management system framework is in place it should facilitate the identification and implementation of country-specific requirements for the management system of medical device manufacturers. ISO 13485 is not specific enough to contradict country specific requirements, and should serve as a baseline management system for all.” 13485 dictates that risk management must be thoroughly documented and conducted throughout a product’s entire lifecycle, from initial concept to delivery and post-delivery. However, the standard leaves the specifics to a related standard, ISO 14971: 2001, Application of Risk Management for Medical Devices. While 13485 states that a manufacturer’s management team is charged with the management of device-related risks and the development of risk management plans, 14971 defines a list of steps to be taken by management in order to fulfill risk-related requirements. While it is not mandatory that a manufacturer be 14971 certified in order to attain 13485 certification, being certified to the former standard can ease the attainment of certification to the latter. “The fact that ISO 13485 counsels the application of ISO 14971 speaks to its importance for those seeking 13485 certification,” says Mairead Ridge, marketing associate for IBS America (Lexington, MA). “Compliance programs for both standards, when implemented together, can help manufacturers build an enterprise program for risk management and quality assurance.” Evidencing the consistent assessment and mitigation of risks throughout all stages of a product’s lifecycle is important for achieving certification to both 13485 and 14971.

Issues and Trends

The purpose of 13485 certification is sometimes misunderstood. 13485 certification does not fulfill the requirements of 9001, nor is it equivalent to or have the ability to take the place of any country-specific requirement for medical device manufacturers. As previously mentioned, the standard is in part meant to serve as a means to the creation of a management system that aligns with the requirements of various regulators. Phillip C. Dobyns, technical manager for Wayne, PA-based HSB Registration Services, elaborating on this idea, says, “The ISO 13485 accomplishes a harmonization by writing specific medical device requirements in a generic framework that allows any specific or unique needs of local regulation to be addressed.” Medical device manufacturers also should realize the importance that risk management bears in a 13485 management system. “A lot of places typically look at risk management only at the design and development function and they don’t carry it through the entire lifecycle of the product or process,” says Nadia Perreault, medical device technical manager for National Quality Assurance USA (NQA, Acton, MA). “People think that it is just a little snippet in time during the design and development phase.” While Perreault points out that medical device manufacturers are not giving risk management its due gravity in their management systems, IBS’ Ridge reports that the recognition of the need for thorough enterprise-wide risk management practices is growing. “Risk assessments have become a key activity that manufacturers perform throughout the product lifecycle, whether they are designing new products, choosing suppliers, inspecting finished goods or performing corrective actions based on customer complaints,” says Ridge. A combination of increased regulation and technological advances is forcing medical device manufacturers to couple their management systems with enterprise-wide risk management programs. 13485 is no longer thought of as pertaining solely to finished medical device manufacturers. Today, such manufacturers are requiring their sub-tier suppliers to also attain 13485 certification. Of this phenomenon, Arlen Chapman, quality systems director for NQA, notes, “Medical device manufacturers want to realize better products and better services. I see it more from the financial standpoint for them-for cost savings, making sure they have good suppliers, that they’re communicating with them properly and managing them properly.” This is risk management enacted to establish supplier quality, as it is difficult for a manufacturer to single-handedly regulate the quality programs of its suppliers.


An ISO 13485 management system can be thought of as a framework on which to build compliance to various regulatory and customer requirements. Source: Fresenius AG The Certification Process

Like any ISO certification, medical device manufacturers wishing to obtain 13485 certification first need to educate themselves on the requirements of regulators and customers, as well as what a 13485-compliant management system will entail. Then a management system that conforms to the standard’s requirements needs to be implemented within the organization. The first step to creating the management system should be drafting a quality manual; the quality manual outlines an organization’s goals, processes and procedures for compliance and quality management. An employee with the know-how to develop and implement such a program can create the management system internally; otherwise, a hired consultant with an expertise in the 13485 market can be used. After the quality manual has been written and a management system has been implemented, the organization needs to seek a certification body it is comfortable with. When seeking a certification body, the organization needs to be sure that the registrar is accredited by an accrediting body to include 13485 certification in their scope. The organization seeking certification should ask to see credentials and references from a prospective registrar. For example, in North America, certification bodies will be accredited through an organization such as ANSI/ASQ National Accreditation Board (ANAB). There are accreditation boards in every major country that review certification bodies to ensure they meet requirements. It also is important to keep the target market in mind. For instance, if a medical device manufacturer wants to sell in North America, it should seek certification through a registrar accredited by a North American accreditation body to ensure they will meet country-specific or customer requirements. Lupo notes that countries are reluctant to accept 13485 registration from another country’s accreditation body. “For example, Health Canada and the European Union do not accept an accredited registration from an ANAB accredited registrar,” says Lupo. “ANAB is part of the IAF MLA, yet U.S. accreditations are not accepted anywhere except for medical device manufacturers that only trade in the United States.” If a consultant is required, the organization needs to be sure that the prospect has expertise in 13485, and requesting referrals from an accredited registrar also can aid in finding the right match. It is important that the consultant understands the organization’s business, that the consultant has dealt with organizations of a similar size before and has had experience with similar product lines. Also, an organization should be wary of consultants that endeavor to radically change a management system that is already performing well. Steve Upton, medical device business unit manager for NQA, states, “The consultant should come in and align their knowledge with your requirements and the customer requirements, and that will work time after time.” The steps to attaining 13485 certification are similar to those of 9001, with some type of off-site document review followed by a preassessment and then assessment. After certification, an organization will be subject to on-going surveillance by its certification body. The duration of the assessment is contingent on an organization’s scope-its size, number of personnel, and type and complexity of products manufactured. Taking these elements into consideration, an organization can expect an assessment to last anywhere from a couple of days to more than a month. The frequency of surveillance assessments will be determined by an organization’s scope as well as its performance, though they will usually be conducted annually or semi- annually. However, organizations should expect a complete reassessment three years after initial certification. A surveillance assessment takes into account concerns such as the fulfillment of management responsibilities, the execution of internal audits and how an organization is performing in relation to the state of the industry and customer expectations.

ISO 13485 Tomorrow

An increase in 13485 certification and further regulatory harmonization are possibilities in the standard’s future. Dobyns says that at present few organizations voluntarily seek this sector-specific certification, but that that will change as customers elect to mandate it. The Global Harmonization Task Force, a voluntary organization with members ranging from registrars to government agencies to top individuals in the medical device industry, is endeavoring to bring international harmonization to medical device certification through 13485. The organization is pushing for the use of 13485 in place of country-specific regulatory requirements. 

For more information on the companies mentioned in this article, visit their Web sites:

ANAB, HSB Registration Services, IBS America, National Quality Assurance USA (NQA), NSF International Strategic Registrations, Quality Online

Visit www. and type “medical device standards” into the search engine to find related articles. Among the results you’ll find:

“Quality Standards: Harmonizing Standards,” by Kenneth Slickers, Ph.D. Quality 101: Quality Standards Defined” “The Traceability Advantage,” by Mark Symonds “MES Reduces FDA Compliance Costs,” by Joseph Vinhais “Quality Management: SOPs Relay Knowledge,” by Cindy Fazzi Benefits of Dual Certification: 13485 & 9001

Medical device manufacturers can benefit from being both 9001 and 13485 certified. While such manufacturers are not required to have 9001 certification, it can bring further business benefits, because it focuses on business aspects that are good for all businesses-for example, the emphasis on customer satisfaction and continuous process improvement that a 13485 management system omits. Manufactures of medical devices also will need to acquire 9001 certification if they want to branch out to other industries, as 13485 certification will not be honored where 9001 is required.

Did you enjoy this article? Click here to subscribe to Quality Magazine. 

Recent Articles by Steve Wichelecki Design: Design that Means Business Tech Showcase: Hardness Testing Options Special Report: Viva La Green Revolution? One Man's Quality Crusade Tech Showcase: An In-Depth Look at Borescopes Steve Wichelecki is Assistant Editor. Related Articles Updating ISO/IEC 17025 The Automated Management System Making It in Medical Calibrating Correctly Related Products The Non-Idiot's Guide to ISO 9001:2015: Understanding and Using the Quality Management System Standard to your benefit How to Audit ISO 9001 2015 A Handbook for Auditors The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices, Second Edition Lean ISO 9001 Related Events Medical Devices for Risk Management Techniques 2017 ISO 14971 Hazard Analysis at Medical Device - 2017 How to Pass a Medical Device Audit Related Directories H.W. Fahrlander and Assoc. Orion Registrar Inc. AIC Quality Services LLC TUV SUD America You must login or register in order to post a comment. Report Abusive Comment