Commit af676f32 authored by Luka Trbojevic's avatar Luka Trbojevic

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......@@ -11,11 +11,9 @@ Using GitLab's portfolio and project management (PPM) tools, you may be able to
### Can GitLab be used as part of an ISO 13485:2016 QMS?
While every organization has its own unique needs and every application used as part of its QMS must be evaluated based on those needs, GitLab offers many features and controls that can make it a useful tool in an ISO 13485:2016 QMS.
GitLab offers many features and controls that may be useful as part of an ISO 13485:2016 QMS. Because GitLab isn’t a compliance tool and makes no guarantees about compliance, every application used as part of your QMS must be evaluated based on your unique requirements and needs.
GitLab can be used as both an application within the QMS and a functional tool to enable faster development and deployment. By merging PPM under the same roof as development and deployment, you can better centralize and simplify your QMS while increasing collaboration between teams and reducing silos.
Because GitLab is not a compliance tool and makes no guarantees about compliance, every usage of GitLab to meet compliance requirements has to be evaluated by your organization in the context of your its unique needs.
GitLab can be used as both an application within the QMS and as a functional tool to enable faster development and deployment. By merging PPM under the same roof as development and deployment, you can better centralize and simplify your QMS while increasing collaboration between teams and reducing silos.
### Creating and managing documentation
......@@ -39,27 +37,28 @@ As part of your QMS you may have process enforcement requirements. GitLab offers
* In the future, the [Requirements Management](https://gitlab.com/groups/gitlab-org/-/epics/670) product category will allow for a more complete and structured way to granularly enforce and audit compliance with complex requirements.
### ISO 13485:2016 software validation with GitLab
A challenging new requirement in ISO 13485:2016 is QMS software validation. It requires organizations create procedures to evaluate software used in its QMS, evaluate the software before use and, as appropriate, as changes are made to the software.
A challenging new requirement in ISO 13485:2016 is QMS software validation. It requires organizations to create procedures to evaluate software used in its QMS, to evaluate the software before use and, as appropriate, as changes are made to the software.
One solution to creating validation procedures are [description templates](https://docs.gitlab.com/ee/user/project/description_templates.html):
* With description templates, you can create procedures in the form of an [issue](https://docs.gitlab.com/ee/user/project/issues/). Within a description template, you can upload or link to forms and other files, create task lists, and more. This means you can create a comprehensive, easy-to-follow validation process where work can be tracked and file can referenced or uploaded. All actions in an issue, such as when the description is edited or a comment is made, are logged, making it easy to maintain a comprehensive record of all actions taken in the issue.
* With description templates, you can create procedures in the form of an [issue](https://docs.gitlab.com/ee/user/project/issues/). Within a description template, you can upload or link to forms and other files, create task lists, and more. This means you can create a comprehensive, easy-to-follow validation process where work can be tracked and files can be referenced or uploaded. All actions in an issue, such as when the description is edited or a comment is made, are logged--making it easy to maintain a comprehensive record of all actions taken in the issue.
* Because of how easy description templates are to use, anybody on your team can initiate the validation process by simply creating an issue and selecting the appropriate template.
* Because of the ease with which description templates are used, anybody on your team can initiate the validation process by simply creating an issue and selecting the appropriate template.
* Issues can be further organized using [issue boards](https://about.gitlab.com/product/issueboard/).
Another is to use the [wiki](https://docs.gitlab.com/ee/user/project/wiki/):
Another solution to creating validation procedures is the [wiki](https://docs.gitlab.com/ee/user/project/wiki/):
* Because the wiki is a more familiar interface, it may be best suited to store the validation procedure. Using a wiki may also be more accessible to non-technical staff compared to description templates.
* Because the wiki is a more familiar interface, it may be better suited to store the validation procedure. Using a wiki may also be more accessible to non-technical staff, as compared to description templates.
* You can also incorporate description templates into your validation procedure hosted on the wiki. When [creating](https://docs.gitlab.com/ee/user/project/issues/create_new_issue.html) a new issue, you can add the `?issuable_template=Template Name` parameter to the end of the new issue page URL. When people visit the link, it will take them to the new issue page with the appropriate description template already selected, removing the need for staff to manually find and select the correct template.
* In addition, you can incorporate description templates into your validation procedure hosted on the wiki. When [creating](https://docs.gitlab.com/ee/user/project/issues/create_new_issue.html) a new issue, you can add the `?issuable_template=Template Name` parameter to the end of the new issue page URL. When people visit the link, it will take them to the new issue page with the appropriate description template already selected, removing the need for staff to manually find and select the correct template.
### Learn more about GitLab PPM
To learn more about GitLab PPM, [watch GitLab product manager Victor Wu](https://www.youtube.com/watch?v=ME9VwseXMuo) show how GitLab itself is created using GitLab PPM.
To learn more about GitLab PPM, watch GitLab product manager Victor Wu show how GitLab itself is created using GitLab PPM:
[![IMAGE ALT TEXT HERE](https://img.youtube.com/vi/ME9VwseXMuo/0.jpg)](https://www.youtube.com/watch?v=ME9VwseXMuo)
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