Design and Development of Products and Services

ISO 9001:2015 – Section 8.3

Our consultancy approach ensures organizations establish a structured, documented, and controlled design and development process. This helps ensure that outputs consistently meet customer, statutory, and regulatory requirements while supporting innovation, risk management, and continual improvement.

Scope of Work

1. Design and Development Planning

  • • Define stages, reviews, responsibilities, and resources for design and development activities.

    • Establish timelines, milestones, and approval checkpoints.

    • Integrate risk-based thinking into planning to mitigate potential failures.

2. Design and Development Inputs

  • • Gather and document customer, statutory, and regulatory requirements.

    • Define functional, performance, and safety requirements.

    • Capture lessons learned from previous projects and best practices.

3. Design and Development Controls

  • • Conduct reviews at planned stages to ensure alignment with requirements.

    • Implement verification and validation activities.

    • Apply configuration control and document version management.

4. Design and Development Outputs

  • • Produce specifications, drawings, prototypes, and process documents.

    • Ensure outputs are clear, measurable, and meet intended requirements.

    • Provide acceptance criteria and references for production/service delivery.

5. Design and Development Changes

  • • Establish procedures for identifying, reviewing, and approving changes.

    • Analyze the impact of changes on requirements, resources, and risks.

    • Maintain records of all design and development modifications.

6. Cross-functional Collaboration

  • • Engage stakeholders including engineering, operations, quality, and customers.

    • Ensure effective communication across functions to prevent misinterpretation.

    • Integrate customer feedback into design iterations.

Deliverables

  • • Documented design and development procedure.

    • Design and development plan with milestones.

    • Requirements input register and validation records.

    • Approved design and development outputs (specifications, prototypes, reports).

    • Change log and control records.

    • Verification and validation reports.

Pricing & Timeline

  • • Fee: $3,150.00/month per facility (6-month engagement)

    • Estimated Duration: 180 business days

    Completion timeline may vary based on client responsiveness and documentation turnaround.

Sample Milestone Plan

Phase Key Activities Core Deliverables
Month 1 – Planning Kick-off, scope definition, project charter ✓ Implementation Plan
✓ Scope Statement & Team Roles
Months 1–2 – Design FSMS drafting, PRP setup, document control systems ✓ SOPs, PRPs
✓ Controlled Document Framework
Months 2–3 – Execution Competency training, system rollout, records logging ✓ Training Logs
✓ First Cycle Recordkeeping Evidence
Months 3–6 – Validation Internal audits, reviews, performance monitoring ✓ Internal Audit Reports
✓ CAPA Logs
✓ Management Review
Month 6 – Readiness Final system check, CB coordination, mock audit ✓ Pre-Audit Summary
✓ Final CAPA Log
✓ Audit-Day Prep

Certification Audit Support

  • • On-site or remote audit-day presence

    • Real-time response to auditor inquiries

    • Post-audit support and non-conformance response drafting

Deliverables:

  • ✓ Audit Representation

    ✓ NC Response Support

    ✓ Audit Day Documentation

Project Closure

  • • Final FSMS documentation handover

    • Executive summary outlining system status and sustainability plan

    • Option to transition into maintenance & continuous improvement support

Deliverables:

  • ✓ Final Document Handover

    ✓ Close-Out Report

    ✓ Maintenance Plan Proposal

Additional Compliance Support Options

Service Description Fee
Design & Development Framework Package Complete methodology, templates, and tools for ISO-compliant design processes. $2,500/project
Prototype Validation Support Assistance with product/service testing, validation, and compliance documentation. $1,800/system
Change Control & Configuration Toolkit Procedures, forms, and registers for controlled handling of design changes. $1,200/project
Innovation & Risk Integration Workshop Training on embedding risk-based thinking and innovation into design. $950/session
Digital Design Documentation Templates Ready-to-use ISO 9001 documentation tools for design and development processes. Starting at $120/month

  • • Context Analysis Workshop – $1,500/session

    Facilitate an interactive session to identify internal/external issues and stakeholder expectations.

    • Interested Parties Mapping & Register Setup – $1,200/project

    Create a structured register of interested parties, their requirements, and review protocols.

    • Risk & Opportunity Assessment Package – $2,800/system

    Comprehensive risk-based thinking integration aligned with ISO 9001 clauses 4.1 & 6.1.

    • Management Review Toolkit – $950

    Includes templates, KPIs, and guidance for effective leadership reviews.

    • Digital Compliance Templates Bundle – Starting at $99/month

    Ready-to-use ISO 9001 documentation templates with version control.

Your Compliance Journey Starts Here

  • Book a Free Consultation and Design & Development Process Review
"Strong design processes create strong outcomes—let’s align your development practices for compliance and innovation."

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