How to Ensure Traceable and Efficient Standards Management in Medical Device Development
“Why should I care about standards management? Reading through standards is painful enough, let me focus on the exciting parts of design!”
This could be a thought when the topic of standards management arises. However, an efficient and robust standards management process can save your business from wasting many hours and costly mistakes.
With so many moving parts in a modern quality management system, it’s easy for standards management (especially standards version control) to fall through the cracks. Without an effective management system, your company risks both costly last-minute redesigns and, if you are a certified institution, laborious audit non-conformances.
Whatever your feelings are towards standards, they are a vital part of ensuring the safety, quality and reliability of products and services. As an ISO 13485 certified product design consultancy, medical products and services developed by IDC must adhere to all the relevant standards.
This article takes you through common pitfalls and provides a blueprint for implementing standards management best practices in your workplace without creating a documentation burden.
Common Pitfalls with Standards Management in Medical Device Development
Fear of the size of the task.
Your company might be running several projects which require adherence to a number of standards; leading those projects are multiple project managers who are referencing different standards, permeating numerous project documents. All the while new projects are kicking off, others are closing, and standards are reviewed every five years; interspersed with occasional amendments. Therefore, an understandable misconception about standards management is it will be labour intensive to keep up to date with the volume of documentation which needs reviewing and updating when a standard is amended or revised.
Leaving no stone unturned.
When undertaking such an ostensibly large task, a reviewer can remain uncertain they have updated all instances of a standard reference across all documents, which may lead to yet a longer process. Plus, should they fail in their task, the reference to an out-of-date standard will remain in the documentation for a diligent auditor to find.
Ambiguous ownership.
As a consultancy, it is not always necessary for IDC to own every standard being used in projects. In fact, it will often make sense for the client to own some (or all) of the standards, depending on the client’s level of specialism and previous experience in the area. However, without a very clear definition of responsibility for each standard, both parties can easily assume that the other is responsible.
With these pitfalls in mind, consider the following questions:
- Can your company demonstrate that the latest standards being used across all your projects are owned or available and up to date? Is it clear which standards are owned by your clients?
- Are your project managers aware of standard updates?
- Does all project documentation reference the correct version of the standard? Can you be sure that none have been missed during an update?
- When standards are updated or a new standard is added to a project, is it simple to update relevant project documentation?
If the answer to any of these is no, it may be time to implement a new system of standards management.
What does an Efficient and Robust Standards Management System Need to do?
A robust system creates an audit trail that allows you to know:
- Which projects are standards compliant.
- Which of those standards are your company’s responsibility to manage.
- That all standards you are responsible for are available or owned and up to date.
- That all documents in those projects, referencing those standards, refer to the correct version.
In addition, an efficient system must allow you to quickly:
- Add and subtract from the list of compliant projects and owned standards.
- Perform routine checks to ensure that all owned standards are up to date.
- Update project documentation to reflect changes in standard versions.
How to Implement a Traceable, Low Maintenance Management System
Part 1: The Right Documentation
As counter intuitive as it may sound as an article promising less documentation - the first step to a reduced workload is more documentation. But once these documents are in place, the benefits will quickly become apparent.
The standards management infrastructure at IDC consists of three documents: a company standards library, a project standards manager template and a company standards matrix.
The flow chart below shows who is responsible for these documents and how they feed into one another.
1. Project Standards Managers (PSMs) are populated using standards in the Standards Library.
2. The Standards Matrix captures all standards captured in the PSMs.
3. The PSM is updated when a Standards Matrix review identifies an out-of-date standard.
4. The Standards Library is updated when a new or amended version of a standard is purchased and project managers are notified of an update needing review.
The Standards Library is a searchable document containing all standards which are or have been owned by the company; for each standard, the file location and details of any archived version are listed. This results in a simply searched document which clearly shows which standards are owned.
The Project Standards Manager (PSM) template is used to create a central reference document for any standards compliant project. It records all standards used in a project and indicates a responsible party for each. This document is used as a reference, when standards are relevant, throughout project documentation. It allows the revisions of standards not to be referenced in any other project documents, thereby reducing the number of documents which require updating to reflect standards updates. If the standards revision must be referenced (i.e., when providing a quote), the template records where references to standard revisions have been made outside of the Standards Manager, which ensures no document updates are missed.
The Standards Matrix captures all standards used in all live projects across the company. This matrix is routinely checked and updated by a designated Standards Supervisor to ensure that it captures all live projects, and that the latest version of all relevant standards are being used. Efficient standards checks and communication of updates to all relevant projects can be made using this centralised management document. Additionally, the matrix lists all live projects (exported from company operations software) and clearly identifies which projects are standards compliant to ensure comprehensive, traceable management.
Part 2: Running the system
When a new standards compliant project is started, a list of all the relevant standards and directives should be agreed with your client, in addition to who will be responsible for each. This is recorded in a PSM.
The only remaining task is a regular check of the Standards Matrix by the Standards Supervisor to ensure that all standards remain up to date and that only current projects are being captured. (Note: Given the nature of standards amendments and the release of new versions, a bi-annual check is sufficient).
Conclusion: Simplifying Standards Management
Standards management can be a daunting task and it can lead to a host of problems if poorly implemented. However, with the right infrastructure and a clear definition of responsibilities within your team, traceable and efficient standards management can simply become standard procedure.
About the author
Björn Bloomquist is a Design Engineer at IDC. Since graduating from The University of Bath with a Master’s Degree in Integrated Mechanical & Electrical Engineering, Björn has worked extensively in medical device development while also being a core member of IDC’s quality management team, having successfully navigated multiple BSI audits.
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Standards Management FAQs
What is standards management in medical device development?
Standards management is the controlled way you identify, access, maintain, and apply the correct standards across a project and the wider organisation, so that teams can demonstrate they are working to the right requirements, using the correct versions with clear ownership and traceability.
What’s the difference between standards management and document control?
Document control focuses on managing your internal documents (templates, procedures, records). Standards management focuses on managing external requirements (standards and their versions) and ensuring your internal documents reference and reflect them correctly. They overlap, but they are not the same.
How do you prove standards management is working during an audit?
Auditors typically want evidence of version control, access/availability, defined responsibility, and traceability: which standards apply to which projects, who owns them, how updates are detected, and how impacted documentation/projects are reviewed and updated. A standards library + project-level manager + cross-project matrix creates that evidence trail.
How often should you review standards as part of standards management?
A scheduled review (such as bi-annual) is often practical, but your standards management approach should also include event-driven updates, for example, responding when notified of revisions/amendments or when project scope changes introduce new applicable standards.
Who should own standards management in a consultancy-client setup?
Ownership should be explicit per standard. In many cases, clients own domain-specific standards while a consultancy manages standards that are central to delivery or quality processes. The key is that standards management responsibility must be named, recorded, and operationalised, otherwise both parties can assume coverage that doesn’t exist.