USING ATLASSIAN JIRA + LINKS EXPLORER TO IMPLEMENT ISO-9001 DESIGN & DEVELOPMENT CLAUSES

In this article, we will cover

• The impact of the gaps in design and development processes
• How ISO-9001 addresses these gaps
• And how we can implement these ISO quality management system using JIRA and Links Explorer Traceability & Hierarchy

IMPACT OF GAPS IN DESIGN AND DEVELOPMENT PROCESSES

Organizations trying to invent or innovate products, often tend to miss important aspects of product design and development with proper ISO certificate. Typically developers and engineers get so immersed in the process of “design and release” that they sometimes neglect the critical aspects of the path from A to B. This requires organizations to introduce a comprehensive design system or process implementing ISO 9001. Overlooking these processes can lead to

• extended timelines and a large number of development iterations
• product recalls which cost companies tens of millions, destroys brand reputation and erodes customer’s trust.

ISO 9001 clauses address these gaps by providing guidelines to organizations.

COVERAGE OF ISO-9001 DESIGN AND DEVELOPMENT CLAUSES

ISO 9001 contains various clauses that help companies achieve Total Quality through their Quality Management Systems. One such ISO 9001 clause focuses on the Design & development of products and services.

ISO 9001 Design & Development defines seven steps to implement the product development life cycle.

IMPLEMENT DESIGN & DEVELOPMENT PROCESS USING ATLASSIAN JIRA + LINKS EXPLORER

Managing the process for the design & development keeping in mind the quality management systems of products manually or using Excel spreadsheet is not only complicated but also prone to multiple errors. Here’s how we can simplify this process using Jira and Links Explorer.

We have categorized the seven steps of design & development into:

• Planning
  • Design Planning
• Engineering
  • Design Input & Output
  • Design Review
  • Design Verification & Validation
  • Design Control

Planning

Create Jira issues to plan the activities to be executed. Jira is capable of creating Jira issues of multiple types e.g. Requirements, Epics, Stories, Task, subtask, etc.

• These Jira issues can be linked with one another as required and assigned to respective users for execution with set deadlines.

• Use Links Explorer’s Unified tree view for periodic review & update of the design plan.
• The Unified Tree View displays a complete hierarchy of linked Jira issues in a tree structure.

Engineering

• We can create JIRA issues as placeholders for documents like user requirements, legal & regulatory requirements, etc.
• And we can create documentation for each Design Input and Design Output implementing 9001 ISO in any system capable of version control.
• Confluence can be one choice and we can store the reference of Confluence Document in the corresponding Jira issue.

• Design reviews can be performed by an authorized user using Jira and Links Explorer’s Unified Tree View. We can easily navigate from tree view to Jira issues detail page to determine whether all design requirements are captured correctly.

• Design verification activities can be planned using JIRA issues and the comments/observations can also be logged as JIRA issues.
• For Design Validation one can create Test cases, Test Plans and Test execution cycles within Jira. Jira also supports additional Test case management apps.

If a change request arrives, the impact of changes in constituent parts can be assessed using the Traceability Report of Links Explorer. This ensures that the changes will not impact the intended use of the The Design & Development process applies to every industry taking care of the quality management system. Making Jira + Links Explorer a part of your QMS will streamline the process and help ease the path to compliance.