Iso 13485 vs iso 9001 document control requirements

Listen to Podcast. See the Demo. Glossary ISO vs Medical device companies choosing between ISO vs for compliance need to understand the similarities and differences between the two quality management standards. This series of quality management standards originally included five main documents: ISO Quality Management Systems - Fundamentals and vocabulary ISO Model for quality assurance in design, development, production, installation, and servicing ISO Model for quality assurance in production, installation, and servicing ISO Model for quality assurance in final inspection and test ISO Model for quality management and quality system elements Over time, the original series of ISO standards changed form.

Here is a look at that timeline: In the year , ISO , and were combined into a single standard known as ISO ISO was published in Further revisions to ISO standards were made in ISO includes many sections and guidelines that are unique to medical devices, including: Medical device terminology Requirements for medical device clinical or performance evaluations in keeping with applicable regulatory requirements Separate document files for each medical device marketed or sold by the company Requirements for the documentation of purchasing procedures A documented procedure for collecting customer feedback and determining whether manufactured products have met customer requirements A requirement to include records of CAPA investigations in the quality system ISO Emphasizes Risk Management One of the most important trends in the world of medical device regulation is the regulatory shift towards risk management.

ISO Addresses Regulatory Requirements ISO can be applied broadly in companies and organizations across industries, some of which may be government regulated, but many of which are not. Are you interested in learning more about our Quality Management Software? View Related Pages. Read eBook. Related Links. So, when ISO was finally released with the new structure, was also already ready for release with the ISO structure.

The ISO organization decided to release with the old structure. In ISO , the manufacturer must show compliance with regulatory requirements in 58 places. After some information added in the introductory section that mainly tailors the text to the medical device industry, the first inclusions are in the terms and definitions.

There are 14 new terms used by the medical device industry. The differences between manufacturers, importers, distributors, and terms such as clinical evaluation and post-market surveillance are specifically explained. If your organization is at all involved in the medical device industry, ISO is the QMS standard you should look at for additional requirements above and beyond ISO Free white paper that provides guidelines for each clause of the ISO standard.

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Factor Quality has the experience you need for options you can rely on. Contact us Today! The aim of the standard is once your organization determines the need for a document i.

ISO does not handcuff organizations in dictating specific required procedures. Each organization is free to decide what documents need to be created and controlled. The expectation is that when you make the decision you ensure the document aligns with the nature of the business and any requirements that need to be met.

The ISO gives general rules for document control, that when used appropriately, do help businesses. Did you know ISO provides a general requirement for organizations, it does not tell you how many approvers certain documents need to have? Nor does it prescribe a document format or a document ID i.

These are misconceptions that have been circulating for a long time. All these requirements are self-imposed by each organization. The company defines the policy of how many approvers are needed for documents, what type of format is to be used and how to identify it. While ISO does not mandate specific formats, identifier or number of approvals, the documents created for the organization must meet a certain set of criteria to be considered as controlled effectively.

Remember — when you create a document you need to make sure the correct version is available to all in the business. The documents can be written, pictorials, flow charts, or a combination of these. Just remember it needs to make sense to your organization.

There is no need to have document numbers unless you believe these are needed and are helpful to your business.