Design & Development Gap Assessment — MSI

Free Gap Assessment

Design & Development
Process Assessment

Evaluate your organization's current state against ISO 9001:2015 and ISO 13485:2016 requirements. MSI will review your responses and provide personalized guidance.

New here? Read our ISO 9001 Design & Development guide first for context on what this assessment covers.

ISO 9001:2015 § 8.1 · 8.3 · 7.1 · 7.3 ISO 13485:2016 ~15 minutes

Step 1 of 7 — Contact Information 14%

Step 1 of 7

Contact Information

Tell us about your organization and the right person to follow up with.

1.Company Name *

4.Date of Assessment *

2.Primary Responsible Person for Design & Development

3.Email Contact for Follow-Up

Company WebsiteOptional — helps MSI research your organization before follow-up

Step 2 of 7

Preparation & Background

Help us understand your current readiness and prior ISO activity.

5.Responders' Preparation Plan

Met with other contributors Reviewed procedure(s) and manual, as applicable Reviewed questions in worksheet along with Overview Training Read the elements of the standard(s) Reviewed status of company's requirements-related objectives

6.Results of Previous ActionsFrom last ISO activity, as applicable

7.Major Concerns Needing AttentionOutstanding previous findings and company developments

Step 3 of 7

Current Process Overview

Describe how your organization currently manages D&D from start to finish.

8.How does the company currently address D&D requirements?Briefly from planning through release to manufacturing

9.Does your organization have documented procedures ensuring the D&D process is consistent?Not a direct ISO requirement but highly recommended. MSI can review your existing procedure.

10.How are Product/Service requirements made known throughout the process?

11.How are Design Projects planned out?

12.What are your Design & Development Process Stages?

13.Are Verification, Validation, and Design Transfer activities evident for each stage?

Step 4 of 7

Roles, Resources & Records

How responsibilities, resources, and documentation are managed.

14.Name by title the Responsibilities and Authorities for Design Projects

15.How is traceability of specification inputs and outputs managed?

16.How are Internal and External resources for D&D projects determined and allocated?Include necessary competence requirements

17.Where are Quality Objectives and product requirements noted during design?Especially Key Characteristics such as yield

18.How are records determined to provide evidence that D&D requirements and the resulting product meet requirements?

Step 5 of 7

Reviews, Risk & Interfaces

How your organization handles design reviews, risk, and stakeholder involvement.

19.Explain the Design & Development Review(s) process and especially approvals

20.How is the nature, duration and complexity of design activities determined? *

21.Are potential risk levels determined? *

Yes No In progress

22.How is it determined by title who participates in D&D Reviews?

23.What is needed to control interfaces between persons in the D&D process?Ex. communications methods, bug tracking

24.What customer/user involvement is needed in the D&D process?Ex. Customer buy-off, customer onsite testing

Step 6 of 7

Requirements & Change Controls

How statutory, regulatory, and downstream requirements are managed.

25.How are requirements for subsequent provision of products/services developed?Such as information for: procurement, operations, testing, configuration management, packaging and delivery

26.How are changes reviewed and controlled to ensure conformity with requirements?

27.How are statutory and regulatory requirements considered during D&D inputs?Ex. FCC, UL, CE — to ensure compatibility and known constraints

28.How is the D&D Process demonstrated to be controlled?

Step 7 of 7

Records, Evidence & Conclusion

Final documentation details and your overall assessment conclusion.

29.What documented information is maintained on:D&D changes · Results of reviews · Authorization of changes · Actions to prevent adverse impacts

30.What records describe results of change reviews, authorizing persons, and necessary actions?

31.Objective Evidence Reviewed (records)

32.Conclusion

33.Does the process currently comply with requirements?

Yes No

34.Identification of Supporting Records / Status of Records

35.Title of Primary / Secondary / Other Responsibilities

36.Owner

✓

Assessment Submitted

Thank you. An MSI consultant will review your responses and reach out within 1–2 business days to discuss findings and next steps.

What Happens Next

MSI reviews your assessment against ISO 9001:2015 Clause 8.3 requirements

A consultant contacts you to schedule a complimentary 20-minute discovery call

You receive a customized gap summary with recommended next steps

Your responses are confidential

MSI

ISO Consulting · 55+ Years Combined Experience

Design & Development Gap Assessment — MSI

Free Gap Assessment

Design & Development
Process Assessment

Evaluate your organization's current state against ISO 9001:2015 and ISO 13485:2016 requirements. MSI will review your responses and provide personalized guidance.

New here? Read our ISO 9001 Design & Development guide first for context on what this assessment covers.

ISO 9001:2015 § 8.1 · 8.3 · 7.1 · 7.3 ISO 13485:2016 ~15 minutes

Step 1 of 7 — Contact Information 14%

Step 1 of 7

Contact Information

Tell us about your organization and the right person to follow up with.

1.Company Name *

4.Date of Assessment *

2.Primary Responsible Person for Design & Development

3.Email Contact for Follow-Up

Company WebsiteOptional — helps MSI research your organization before follow-up

Step 2 of 7

Preparation & Background

Help us understand your current readiness and prior ISO activity.

5.Responders' Preparation Plan

6.Results of Previous ActionsFrom last ISO activity, as applicable

7.Major Concerns Needing AttentionOutstanding previous findings and company developments

Step 3 of 7

Current Process Overview

Describe how your organization currently manages D&D from start to finish.

8.How does the company currently address D&D requirements?Briefly from planning through release to manufacturing

9.Does your organization have documented procedures ensuring the D&D process is consistent?Not a direct ISO requirement but highly recommended. MSI can review your existing procedure.

10.How are Product/Service requirements made known throughout the process?

11.How are Design Projects planned out?

12.What are your Design & Development Process Stages?

13.Are Verification, Validation, and Design Transfer activities evident for each stage?

Step 4 of 7

Roles, Resources & Records

How responsibilities, resources, and documentation are managed.

14.Name by title the Responsibilities and Authorities for Design Projects

15.How is traceability of specification inputs and outputs managed?

16.How are Internal and External resources for D&D projects determined and allocated?Include necessary competence requirements

17.Where are Quality Objectives and product requirements noted during design?Especially Key Characteristics such as yield

18.How are records determined to provide evidence that D&D requirements and the resulting product meet requirements?

Step 5 of 7

Reviews, Risk & Interfaces

How your organization handles design reviews, risk, and stakeholder involvement.

19.Explain the Design & Development Review(s) process and especially approvals

20.How is the nature, duration and complexity of design activities determined? *

21.Are potential risk levels determined? *

Yes No In progress

22.How is it determined by title who participates in D&D Reviews?

23.What is needed to control interfaces between persons in the D&D process?Ex. communications methods, bug tracking

24.What customer/user involvement is needed in the D&D process?Ex. Customer buy-off, customer onsite testing

Step 6 of 7

Requirements & Change Controls

How statutory, regulatory, and downstream requirements are managed.

25.How are requirements for subsequent provision of products/services developed?Such as information for: procurement, operations, testing, configuration management, packaging and delivery

26.How are changes reviewed and controlled to ensure conformity with requirements?

27.How are statutory and regulatory requirements considered during D&D inputs?Ex. FCC, UL, CE — to ensure compatibility and known constraints

28.How is the D&D Process demonstrated to be controlled?

Step 7 of 7

Records, Evidence & Conclusion

Final documentation details and your overall assessment conclusion.

29.What documented information is maintained on:D&D changes · Results of reviews · Authorization of changes · Actions to prevent adverse impacts

30.What records describe results of change reviews, authorizing persons, and necessary actions?

31.Objective Evidence Reviewed (records)

32.Conclusion

33.Does the process currently comply with requirements?

Yes No

34.Identification of Supporting Records / Status of Records

35.Title of Primary / Secondary / Other Responsibilities

36.Owner

✓

Assessment Submitted

Thank you. An MSI consultant will review your responses and reach out within 1–2 business days to discuss findings and next steps.

What Happens Next

MSI reviews your assessment against ISO 9001:2015 Clause 8.3 requirements

A consultant contacts you to schedule a complimentary 20-minute discovery call

You receive a customized gap summary with recommended next steps

Your responses are confidential

MSI

ISO Consulting · 55+ Years Combined Experience

Design & DevelopmentProcess Assessment

Assessment Submitted

Design & DevelopmentProcess Assessment

Assessment Submitted

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Design & Development
Process Assessment

Design & Development
Process Assessment