ISO 13485:2016 is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices throughout the world. Certification to the standard requires its quality system to pass a third party Medical Device Single Audit Program, or “MDSAP” audit.

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1. SIS, Swedish Standards Institute is a member-based, non-profit association specialised in national and international standards. The market leader in standards in Sweden, SIS is recognised for its professionalism, expertise and openness in relation to customers, employees, suppliers and partners. If we add customer benefit and job satisfaction, we have cited all the key values that define SIS.
2. Jul 7, 2018 0 comments. Recent Articles. ISO Clauses: – “The needs and expectations of interested parties”.
3. Jul 7, 2018 0 comments. Recent Articles. ISO Clauses: – “The needs and expectations of interested parties”.
4. ISO, the International Organization for Standardization, is a nonprofit organization that develops and publishes standards of virtually every possible sort, ranging from standards for information technology to fluid dynamics and nuclear energy.

ISO 13485 = ISO 9001 + Additional Medical Device Requirements

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ISO 13485:2016 is the latest, and most current version of quality management system for medical devices, (learn about the differences here). While it remains a stand-alone document, the latest version aligns with ISO 9001:2008 (Yes, 2008, not 2015). Meaning that 13485 does not follow the high level structure (Annex SL) of the latest version, ISO 9001:2015. (See ISO 9001:2015+13485:2016 QMS) There are some additional clauses as well as the removal of some requirements.

• Read compare ISO 13485:2016 and ISO 13485:2003
• Read compare ISO 13485:2016 and ISO 9001:2015

This global standard is mandatory in some countries and in April of 2019, ISO 13485 became the FDA’s mandatory QMS for Medical Devices. Third party registrars (CB’s) conduct audits to ensure conformance.

• Learn more about the relationship between FDA-QSR 21 CFR 820 and ISO 13485:2016

There are many different stages of medical device development from design and development to distribution and servicing, and this standard was developed to be used in organizations no matter what their role in the life-cycle.

For more information, please see our tutorial:

• What is ISO 13485?
• Why become ISO 13485 Registered?
• What are the requirements of the Standard?
• What are the steps to certification?
• And more…

To learn more about the Medical Device terminology, please view: Definitions which covers the various classifications of medical devices across the globe.

Who is ISO 13485:2016 for?

ISO 13485:2016 is beneficial for many organizations, and can be used by suppliers and external parties that are involved with providing medical device products.

Requirements of the standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, they apply equally to associated services as supplied by the organization. The requirements may vary based upon the class of medical device – from a wheelchair to a pacemaker.

The processes required by the standard are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to the standard reflect any exclusion of design and development controls.

If any requirement in Clauses 6, 7 or 8 are not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2. Today, the standard has become more harmonized internationally, and will replace the U.S.’s FDA’s regulatory requirements documentation 21 CFR 820 in 2019.

If you are certified to the QMS standard, learn how to advertise your certification.

Changes from ISO 13485:2003 to ISO 13485:2016

There are several key changes between the 2016 requirements and 2003 requirements, we will discuss the 11 key changes here, which were changed to align with the FDA.

Clause 4.1 General Requirements

The first big change is the application of a risk based approach in establishing and maintaining a QMS.

4.2 General Requirements

Within 4.2, there are two major changes. First, there is a change regarding confidential health information, and second a large change is how to deal with deterioration and the loss of documents.

6.2 Human Resources

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The newest version of the standard expands upon the 2003 version, requiring more processes to identify that individuals are competent, that they are provided with any necessary training, and make sure that personnel, and their roles are documented.

7.2 Customer-related processes

Several new terms in regards to communicating with regulatory authorities relating to product information, customer feedback, and advisory notes.

7.3 Design and Development

The 2016 version of 13485 has better aligned with the FDA.

7.3.8-Design and Development Transfer

Another big change, is that this new revision has specific requirements for the transfer of products and design.

7.3.10 Design and Development Files

The old standard had no criteria regarding the requirements for maintaining documentation regarding design and development, in the new revision, these requirements are defined

7.4 Purchasing

There are several new requirements as it relates to purchasing. New requirements address the following:

• Monitoring and re-evaluating suppliers
• Actions to be taken when purchasing requirements are not met
• Notifying of any change in regards to purchased products
• Purchasing verification

7.4.8 Identification

The new standard now requires that procedures are documented as it relates to production identification and status.

8.2.2 Complaint handling

In the previous standard there was no clause addressing complaints. This has changed with the new 2016 standard.

8.2.3 Reporting to regulatory authorities

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There are now requirements for reporting to regulatory authorities, unlike the old version of the standard.

Historic Medical Device Quality Management Systems

EN ISO 1SO 13485:2012

EN ISO 1SO 13485:2012 was a revision based off of ISO 13485:2003 established by the European Union. The EU has two standard organizations, the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC). When the CEN issues a standard based off of an ISO standard, you will see a prefix “EN” and the year will be adjusted accordingly.

The standard includes parts of ISO 9001, and was a revision of ISO 13485:2003. It was created to be compliant with CE-marking requirements. The standard’s requirements remain unchanged and the updated revision was created only for manufacturers placing devices on the market throughout Europe. ISO 13485:2003 remained the applicable standard for all other international markets, including the U.S

ISO 13485:2003/Cor 1:2009

ISO 13485:2003/Cor 1:2009 = ISO 9001:2008 + Medical Device Requirements

Technical Corrigendum 1 to ISO 13485:2003 was prepared by the ISO/TC 210 technical committee and published on January 8, 2009. It is a very brief document where the standard is aligned with ISO 9001:2000 and ISO 9001 is replaced with ISO 9001:2000 in pages v and vi at sub-clauses 0.3 and 0.4; in page 1 at sub-clause 1.1: and in page 25 at first paragraph of Annex B.

This document was published after the 2007 release of ISO 9001, making only minor adjustments. At the time, there were not enough adjustments to justify a new revision of the standard, but in 2016 ISO released a new revised standard ISO 13485:2016.

ISO 13485:2003

ISO 13485:2003 = ISO 9001:2000 + Medical Device Requirements

ISO 13485:2003 Medical Devices- Quality Management System requirements for regulatory purposes is an ISO standard, originally published in 1996. This standard incorporated aspects of ISO 9001:2000 Quality Management System, but is specific to the global medical device industry.

ISO 9001 is the international standard for a quality management system (“QMS”). In order to be certified to the ISO 9001 standard, a company must follow the requirements set forth in the ISO 9001 Standard. The standard is used by organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements and to demonstrate continuous improvement.

There are several different documents in the ISO 9000 family of standards, but ISO 9001 is the only standard in the 9000 series that requires certification. Typically, an entire organization will seek certification, but the scope of the QMS can be tailored to improve performance at a particular facility or department. The current version is ISO 9001:2015, which was published in September of 2015 (thus the: 2015).

• It does NOT matter what size your organization is: 1 person or 1 million people
• It does NOT matter what industry you are in (service or manufacturing) – it can be a restaurant, consultancy, manufacturing company, government entity, etc. There are other standards based upon ISO 9001 for a few specific industries.
• It is NOT a standard for products. It does not define product quality. This is a process-based standard: you use it to control your processes, then your end product should meet the desired results.
• It is NOT a personal Standard – a person cannot get certified to ISO 9001, instead an organization or company becomes certified. Individuals, however, CAN become an ISO 9001 Certified Lead Auditor after a 5 day training course. This then allows them to audit other companies.
• There is no such thing as “ISO Certification” or “ISO 9000 Certification”, only ISO 9001 certification.
• It is NOT a membership group – An organization cannot “join” ISO 9001. To become ISO 9001 certified, your organization must
  • Follow the steps to implement an ISO 9001 quality management system.
  • Then a Certification Body (CB or Registrar) audits the performance of your organization against the latest version of the ISO 9001 Requirements. If you pass this audit, the Registrar issues an ISO 9001 Certificate demonstrating that your organization is Registered to ISO 9001 for a three year period. (See Who is able to grant certification)
  • Finally, the organization must be re-certified every three years in order to maintain their ISO 9001 certification status.

A great way to understand how ISO 9001 works is to apply it to an example. Here is an easy example of ISO 9001 applied to making cookies.

The Definition of ISO 9001 Certification

“ISO 9001 Certified” means an organization has met the requirements in ISO 9001, which defines an ISO 9001 Quality Management System (QMS). ISO 9001 evaluates whether your Quality Management System is appropriate and effective, while forcing you to identify and implement improvements.

Continuous improvement assures your customers benefit by receiving products/services that meet their requirement, and that you deliver consistent performance. Internally, the organization will profit from increased job satisfaction, improved morale, and improved operational results (reduced scrap and increased efficiency).

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• Estimate the Cost of ISO 9001 Certification
• What is a Quality Management System?
• Learn the Steps to ISO 9001:2015 Certification
• Learn about the ISO 9001:2015 Requirements
• Learn about the entire ISO 9000 Family
• ISO 9001:2015 Training reviews all the clauses of ISO
• ISO 9001 is based upon the 7 principles of quality management which form the basic characteristics of quality management
• Learn about the Benefits of ISO 9001:2015

What is the resource impact of ISO 9001 on my company?

As with most business processes, the more you do yourself, the less the cost, but the more time it may require. No matter how many external resources are utilized, there will need to be involvement by your employees and staff to varying degree. While there is no total “do it yourself” solution, you can go a long way on ISO 9001’s basic requirements by using pre-formatted materials for documentation and training. (Check out our materials here!) While the procedures and methods in these must be tailored to your situation, they are typically created with the goal of minimizing the changes required and maximizing the ability for others to use and comprehend them. The goal of any quality management system should not be to add unnecessary paperwork, but to make all references clear and highly usable.

ISO 9001:2015 (Current Version)

ISO 9001:2015 is the current version of the ISO 9001 standard which outlines the requirements an organization must maintain in their quality system for ISO 9001:2015 certification. ISO 9001 is explained in detail above.It is the most recent version of the standard which included several changes from ISO 9001:2008 including:

• Adaption/adoption of the new ISO structure (Annex SL) to align with other standards including ISO 14001, ISO 45001, etc.
• Enlarging the relationship between organizations and quality management systems
• ISO 9001:2015 promotes a process approach in order to produce the sought after quality outcomes
• Presents requirements for quality performance in the organization’s strategic planning
• Greater emphasis on top level management for ownership of the QMS
• Less prescriptive requirements compared to previous versions
• The main focus is on customer satisfaction
• Straightforward terminology throughout the standard

For more detailed information, please see below:

ISO 9001:2008

ISO 9001:2008 became obsolete effective September 2018 and is replaced by ISO 9001:2015. 9001:2008 is the standard that outlines the requirements an organization must maintain in their quality system for ISO 9001:2008 certification. There are several different documents in the ISO 9000 family of standards, but ISO 9001 is the only ISO standard that requires certification.

Learn more about ISO 9001:2008 – Changes from 9001:2000

ISO 9001:2000

The revision allowed exceptions to design and development procedures if a company does in fact NOT engage in the creation of new products, as well as introducing a few concepts:

• Process approach, replacing an inspection mentality.
• A focus on Management Commitment instead of only relying upon quality personnel.

Changes from 1994 to 2000

The text has been reworded for easier adaptation to a wider range of organizations. Some definitions have been changed.

• “Subcontractor” was changed to “supplier”.
• “Organization” now refers to the main organization seeking certification.
• “Customer” remains unchanged.

The standard has a process-oriented structure. It includes a process model based on the Plan-Do-Check-Act cycle, which outlines the product and/or service cycle and the management control cycle.

The 20-point format was replaced. The text of the standard is now organized into four major processes:

• Section 5. Management Responsibility
• Section 6. Resource Management
• Section 7. Product Realization
• Section 8. Measurement, Analysis, and Improvement

Documentation requirements are less-prescriptive, and allow greater flexibility.

ISO 9001:1994

ISO 9000:1994 emphasized quality assurance via preventive actions, instead of final product inspection, requiring evidence of compliance with documented procedures. This version also included ISO 9002 and ISO 9003 as in the 1997 versions.

ISO 9001:1987

ISO 9001:1987 was based on BS 5750, with three quality management systems depending on the activities of the organization:

• ISO 9001:1987 Model for quality assurance in design, development, production, installation, and servicing was for companies and organizations whose activities included the creation of new products.
• ISO 9002:1987 Model for quality assurance in production, installation, and servicing had basically the same material as ISO 9001 but without covering the creation of new products.
• ISO 9003:1987 Model for quality assurance in final inspection and test covered only the final inspection of finished product, with no concern for how the product was produced.
• ISO 9000:1987 was also influenced by existing U.S. and other Defense Standards (“MIL SPECS”), and was better suited to manufacturing.