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Resource Index > Regulatory Compliance

Regulatory Compliance

If you are involved in product development, sooner or later ISO 9000 certification will affect your organization. Your vendors or customers may demand it, or you may conclude that your organization will gain a competitive advantage from operating under a quality plan. There are many other regulations and quality certifications that could also affect your organization. The resources here help coordinate and manage certification work, compliance, and management. This is not a complete resource for ISO, SOX, or FDA compliance, but it should be helpful with understanding the pros and cons of quality plans, important criteria for determining your readiness, impacts on your project management processes, and more.

To get some fundamental information about ISO 9000, visit the International Standards Organization's web site.

How can we help you with your certification and compliance efforts?

Examples of Certification and Quality Plans in Action
ISO certification emphasizes documented processes and quality plans. These resources provide examples of what those documents and plans may look like in various contexts.

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  • Medical Product Risk Management Process
    Based on ISO 14971:2007 requirements, this document provides a model for medical product risk management processes, and an overview of what scrupulous risk management looks like in safety-critical environments.
  • System Hazard Analysis Method
    Medical products are required to perform risk management in compliance with ISO 14971:2007. This template provides a document outline based on that standard that your team can fill out and use as their official System Hazard Analysis document.
  • Software Quality Release Criteria
    A short document that captures the criteria with which the software's quality will be judged at various stages of the project.
  • Configuration Management Plan
    A Configuration Management Plan attempts to avoid lost time and expensive rework by documenting procedures the project team will use to control critical components of their project's "products" -- hardware, software, documentation, written products, etc.
  • Benefits Realization Plan
    A Benefits Realization Plan documents the expected benefits of the project, details how they will be measured, and captures those measurements for later assessment and use in lessons learned.
  • Requirements Measurement Plan
    Creating a plan to measure the requirements, in addition to the project work, insures you aren't handing off muddy requirements that will cause confusion and rework later in the project.
  • Recording Key Project Decisions
    This file provides several different formats for recording key decisions in various contexts, as well as tips for using features in common project management and collaboration tools to maintain this critical piece of project history.
Guidelines and Suggestions for Implementing Formal Quality Management
Implementing ISO-compliant quality management requires not just documentation, but actual processes that are useful and used by the organization. These resources explain how to start changing the company culture on quality.

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  • Release Decision Process Guidelines
    Use a process like this one near the end of a project, to systematically review open issues and determine which ones must be corrected before release.
  • Project Escalation Process Guidelines
    Scope issues, major tradeoff decisions, and serious resource conflicts are all examples of situations that can require escalation to higher management.
  • Lessons Learned Meeting Agenda
    A sample agenda for a lessons learned meeting, to capture what did or didn't go well on a project, how to replicate success, and what to do differently in the future.
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Other Options
  • Webinar: The First Five Traits of Risk Management Excellence
    In this compelling webinar, leading author, presenter, and risk management expert Carl Pritchard looks at what it takes to move your organization's risk management practice from good to excellent.
  • Webinar: The Second Five Traits of Risk Management Excellence
    Take the next step toward Risk Management excellence! In this follow-up webinar, leading author, presenter, and risk management expert Carl Pritchard walks you through 5 more risk management traits your organization should cultivate, and explains how to do it.
Typical Quality Management Issues and Answers to Common Questions
Can you invest too much in quality? Is there such a thing as too much documentation? These resources help you find your way through the trade-offs associated with implementing formal quality management processes.

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Burning Questions
What does good project documentation look like?

Who is responsible for prioritizing bug fixes?
Other Options
  • Bundle: Project Test Plans and Related Tools
    By testing pieces at each stage of development, then testing the system from the viewpoint of the how the customer will use it, teams can avoid painful and expensive end-game and post-deployment headaches.



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