Iso 13485 2003 Vs Iso 13485 2016

• Iso 13485 2003 Vs Iso 13485 2016 Design And Development
• Iso 13485:2003 Vs Iso 13485:2016
• Iso 13485 2003 Vs Iso 13485 2016 Changes Ppt
• Iso 13485 2003 Vs Iso 13485 2016 Certified

Since ISO 13485:2016 is based upon ISO 9001:2008, there are differences between the two standards. Some companies are interested in integrating both Quality Management Standards into their business and therefore it is important to compare ISO 9001:2015 and ISO 13485:2016.

ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.

There are many differences and similarities between ISO 9001 and ISO 13485 and many companies are curious what they are. Since these are the two biggest quality standards and many organizations have certification to both standards we wanted to thoroughly address the differences and similarities. ISO 9001:2015 changes to a new high level structure unlike ISO 13485:2016, making the two standards fork, going their own way. This divergence has caused a lot of organizations concerned on how to implement these two standards together. Understanding the differences and similarities make this process easier.

• If you are looking to become certified to ISO 9001:2015 and ISO 13485:2016 check out our product: ISO 9001:2015 / ISO 13485:2016 Combined QMS Package

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Compare ISO 9001:2015 and ISO 13485:2016 Quality Management Systems

Structure

Although there are obvious difference within the structure of the requirement, the overall requirements does not have as distinct of differences. The new structure was developed a common structure for ISO standards and to create terminology with simplified language. ISO 13485 decided not to follow the structure and was granted an exemption to help member countries.

Required Processes

ISO 13485 maintains the requirements to document key processes and related documentation in a quality manual. ISO 9001 has changed this requirement and is more flexible, allowing each organization to decide the documentation information that needs to be required to be maintained. Fullmetal alchemist conqueror of shamballa movie free.

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This document is a template for creating an Operations & Maintenance Manual for a given investment or project. The final document should be delivered in an electronically searchable format. The Operations & Maintenance Manual should stand on its own with all elements explained and acronyms spelled out for reader/reviewers, including reviewers. Preventative Maintenance (PM) Manual. As no two parishes or facilities are the same, this manual is not intended to be the final word on system(s) and/or building maintenance. It is to be used as a general guideline or roadmap so to speak. Each facility will. For example the U.S. Department of Defense requires the development of a Facility Electronic Operation and Maintenance Support Information (eOMSI) manual for a facility that houses engine test cells. Others may simply require that equipment vendor/manufacturer commercial manuals be organized by service or trade, and compiled in 3-ring binders. The Maintenance Handbook will be continually updated from the Corporate Office. It is the Property Supervisor’s responsibility to make the appropriate changes to keep the community’s Maintenance Handbook current. The Manager must make all employees aware of any new policy. Facility maintenance manuals manual. Maintenance manual template is absolutely indispensable. Every device needs maintenance and good maintenance can only be done when you have structured manual where guidelines are in an organized flow. That is why ready-made maintenance manual template can make this your job quick and easy with effective productivity.

Management Responsibilities

ISO 9001 allows top management to assign responsibilities without defining roles, ISO 13485 has made it a requirement to identify management representative.

Product Realization

ISO 13485:2016 emphasizes on design and development as a key process within product realization. ISO 9001:2015 shifted product realization onto the identification of operational processes to deliver products. ISO 9001:2015 is more focused on customer needs rather than the documentation of the design and development.

Continual Improvement

ISO 9001 focuses continual improvement on on customer satisfaction and the improvement of processes. ISO 13485 maintains the need to focus on improvement activities continuing suitability, adequacy and effectiveness of the quality management system and the safety and performance of the medical device.

Similarities between ISO 9001:2015 and ISO 13485:2016

Iso 13485 2003 Vs Iso 13485 2016 Design And Development

• Reason for using- both aim to achieve a quality management system
• Role of organization-Both make the organization define their role as an organization
• Customer focused- both focus on product realization and the need of the customer.
• Plan-Do-Check Act- both standards use this approach
• Risk Based- both standards advocate for risk assessments
• Competency- Both standards focus on competency of employees, making companies ensure that their employees are able to do the job they are assigned.
• Infrastructure- Both standards focus on determining that the organization has the infrastructure necessary for their processes.

Overall, as organizations seek to implement both ISO 9001 and ISO 13485 into their organization it is important to understand the differences between the two. Comparing ISO 9001:2015 and ISO 13485:2016 allows for an easier integration. Management should seek to fully understand these two standards in order to work integrate them into their organization and improve their QMS.

With the release of ISO 9001:2015 and ISO 13485:2016, it’s time to explore their alignment.

Decades ago, when I first started working with industry standards, the concept of alignment didn’t arise often. There were not enough widely adopted industry standards to worry about alignment. But today we are moving in the right direction with the widespread – often required – use of global standards. Now we need to consider alignment when we compare revised versions of standards against their predecessors or related standards.

What do we mean by alignment?

A traditional dictionary definition of alignment is “the proper positioning or state of adjustment of parts … in relation to each other” (Merriam-Webster). When we talk about the alignment between different quality system standards, the parts may include their intent, structure, and/or contents.

Are ISO 9001:2015 and ISO 13485:2016 aligned?

Short answer: No. Longer answer: From a high-level perspective, the standards now differ in intent, content, and structure.

A high-level look at the alignment between ISO 9001:2015 and ISO 13485:2016

Intent: Not fully aligned

The standards share one ultimate goal: Both ISO 9001:2015 and ISO 13485:2016 specify quality management system (QMS) requirements by which an organization must demonstrate that it can consistently provide products and services that meet customer and statutory/regulatory requirements.

ISO 9001, however, adds enhancing customer satisfaction and continual improvement as goals. As ISO 13485 has matured, it has moved way beyond ISO 9001. For the 2016 version, one objective of the working group that developed the new standard was to ensure ISO 13485 would better support the global alignment of regulatory requirements for medical devices.

Content: Not fully aligned

ISO 9001 specifies requirements that are generic so that any organization, regardless of the products or services it provides, can use the standard. ISO 13485 specifies requirements for organizations involved in one or more stages of the medical device life cycle. To a large extent, ISO 13485 keeps the fundamentals of quality management systems we see in ISO 9001, adding or subtracting, where appropriate, requirements that are/are not relevant to medical devices.

Both standards now feature more robust Introductions that clarify topics relevant to their respective users. As an example, ISO 9001 addresses the new risk-based approach to the QMS, while ISO 13485 notes factors that can influence the design and implementation of a QMS, such as an organization’s objectives or the products it provides. Of particular importance is the “Clarification of Concepts” section of the Introduction to ISO 13485. It includes a statement that says “when a requirement is qualified by the phrase ‘where appropriate,’ it is deemed to be appropriate unless the organization can justify otherwise.”

There are also more definitions in ISO 13485, which makes sense when you consider that ISO 13485 serves a distinct, high-risk industry: medical devices.

Structure: Somewhat aligned

While ISO 13485:2016 maintains the same structure of its prior version (based on ISO 9001:2008), the new structure of ISO 9001:2015 has an entirely fresh look and feel.

ISO 9001:2015 is based on Annex SL, which is intended to provide a uniform frame for writers to use when developing or revising standards. One goal of Annex SL is to support consistency in the writing of standards to make it easier to integrate multiple systems (e.g., quality, environmental, or safety).

The 2016 edition of 13485 does not follow the Annex SL structure, but it is possible that future editions of ISO 13485 may do so.

Below, a visual comparison between the two structures:

Source: Oriel STAT A MATRIX

The use of different structures eliminated the need to use italicized text in ISO 13485 to identify additional requirements beyond ISO 9001. The former “ISO 9001 + additional requirements” approach is replaced by a “stand-alone” approach. This independence is appropriate considering the difference in context between the two standards, as the 2016 edition of 13485 wants to facilitate the global alignment of regulatory requirements.

We maintain that ISO 9001:2015 and ISO 13485:2016 are not as aligned as you may have heard. Organizations holding certifications to both standards need to identify and address these differences as they upgrade to the most current versions of the standards.

Oriel STAT A MATRIX is available to assist organizations of all sizes in addressing the risk requirements, needed documentation, and regulatory compliance necessary for transitioning to ISO 13485:2016.

Related information on ISO 13485:2016 is available in our recent Market Update, Impacts and Opportunities Presented by the Major Changes in ISO 13485:2016 as well as a series of blog posts covering the revision.

Iso 13485:2003 Vs Iso 13485:2016

We are also offering three new courses to support your transition: Transition to ISO 13485:2016, Transition to ISO 9001:2015 and Risk Management for ISO 9001:2015.

Iso 13485 2003 Vs Iso 13485 2016 Changes Ppt

Contact us to learn more.

Iso 13485 2003 Vs Iso 13485 2016 Certified

About the author

Ernani Pires has helped organizations around the world improve performance and results for more than 40 years. Ernani oversees Oriel STAT A MATRIX’s Quality Management System and Performance Excellence practice areas. A certified Six Sigma Master Black Belt, Ernani uses the tools and techniques of Six Sigma, Lean, and data analysis methods to help organizations move beyond compliance and achieve sustainable performance excellence. Prior to joining Oriel STAT A MATRIX, Ernani was the first US President of SGS ICS – one of the largest Certification Bodies in the world.

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