ISO Certification

Quick Navigation: Overview • Challenges • Typical Engagement • Our Approach • Client Profile

Service Overview

ISO certification in life sciences requires building genuine operational capability rather than documentation theater. We design certification programs that create systematic operational improvements while satisfying audit requirements, focusing on quality management (ISO 9001), information security (ISO 27001), and medical device standards (ISO 13485) that support long-term business objectives and regulatory readiness.

Common Challenges

Organizations struggle with ISO programs that create administrative overhead without improving performance, certification audits that expose gaps between documented processes and actual operations, and compliance frameworks that don’t address real business risks or operational inefficiencies. Specific situations requiring strategic ISO implementation include:

ISO 27001 information security programs where supplier risk management becomes bureaucratic nightmare, requiring continuous vendor assessment and monitoring that overwhelms compliance teams while missing actual security vulnerabilities. ISO 9001 quality management implementations where process documentation becomes disconnected from daily operations, creating compliance theater that satisfies auditors but doesn’t improve product quality or operational efficiency.

ISO 13485 medical device quality systems that must integrate with existing GxP compliance frameworks without creating redundant documentation or conflicting process requirements across different regulatory domains. Multi-site ISO harmonization where different facilities operate under different maturity levels and must achieve consistent certification without disrupting existing operations.

Digital transformation initiatives requiring ISO frameworks to accommodate cloud systems, automated processes, and AI-assisted decision-making while maintaining traditional audit trail and control requirements. Merger and acquisition integrations where different ISO approaches and documentation standards must be unified across organizations with different risk tolerances and operational cultures.

Surveillance audit preparation that shouldn’t require organizational fire drills or temporary process changes to demonstrate ongoing compliance and continuous improvement.

Most ISO failures occur because organizations focus on satisfying audit checklists rather than building operational systems that naturally generate the evidence auditors want to see.

Recent Engagements

• Biotech company implementing ISO 27001 across cloud infrastructure while maintaining GxP data integrity requirements and avoiding operational disruption
• Medical device manufacturer achieving ISO 13485 certification for new product line while harmonizing with existing FDA quality system requirements
• Pharmaceutical CDMO establishing integrated ISO 9001/GxP framework across multiple client programs with different quality requirements

Typical Engagement

Duration: 6-12 months for initial certification, ongoing for surveillance and continuous improvement programs

Deliverables: Gap analysis, implementation roadmap, process documentation, control frameworks, internal audit programs, certification readiness assessment

Client involvement: Executive sponsorship essential, cross-functional implementation teams, process owner interviews, management review participation

Engagement model: Project-based for certification achievement, retainer-based for ongoing compliance program management

Our ISO Approach

1. Operational Reality First We document how work actually gets done before designing ISO-compliant processes. This prevents the common problem of creating parallel documentation systems that don’t reflect operational reality.

2. Risk-Based Implementation We focus ISO controls on actual business risks rather than generic standard requirements, ensuring certification efforts address real operational vulnerabilities that could impact business outcomes.

3. Integration with Existing Systems We design ISO frameworks that complement existing GxP, FDA, and other regulatory requirements rather than creating competing compliance systems that burden operations.

4. Continuous Evidence Generation We build processes that naturally create audit evidence through normal operations rather than requiring special documentation efforts for surveillance audits.

5. Scalable Framework Design We create ISO systems that can grow with organizational complexity without requiring complete process redesign or documentation overhaul.

Integration Points

ISO certification connects with all other compliance functions - GxP systems must align with ISO quality management requirements, validation activities must satisfy ISO documentation and control standards, and information security frameworks must integrate with both regulatory and business continuity requirements.

Change management programs ensure ISO process adoption beyond initial certification, while risk management frameworks guide ISO control selection and implementation priorities to focus resources on actual operational vulnerabilities.

Client Profile

Organizations seeking certification that supports business objectives rather than just regulatory compliance checkboxes. Particularly valuable for companies facing complex multi-standard requirements, managing rapid growth or technology transformation, or needing to demonstrate operational maturity to customers, investors, or regulatory agencies.

Ready to discuss your ISO certification needs? Contact us to explore how systematic ISO implementation can build operational capability while achieving certification.

Connect with Kevin Shea on LinkedIn for ongoing insights on life sciences technology and compliance.