ISO Management Systems
Built to hold at audit.
A management system must withstand scrutiny. We build the infrastructure, develop the documentation, and prepare your team for the audit.
No certification guarantee. Independent technical readiness assessment and implementation support.
Self-assessment
How ready is your organisation for ISO certification?
Six questions assessing your quality management system, leadership commitment, and certification readiness. A structured diagnostic before booking any external assessment.
We collect your email at the halfway point. Privacy policy.
Methodology
Built on real audit experience.
Based on ISO 9001:2015 and related management system standards. Clear's consultants hold ISO 9001:2015 certification through QS Quality Services Italia (ESYD-accredited under ISO/IEC 17021) and support organisations through initial certification and surveillance cycles across Europe.
Sample
The questions that matter.
“Is leadership actively engaged in defining quality objectives and reviewing system performance?”
“Do you have documented procedures covering your core operational processes and their interactions?”
“Have you conducted a risk assessment identifying the key risks and opportunities for your management system?”
5 archetypes
Where you stand. What you can do.
First stages of the compliance journey. Basic systems and documentation not yet formally in place.
Compliance frameworks in progress, with partial implementation. Gap analysis and prioritisation are the main focus.
Mature systems with specific gaps remaining. Targeted remediation to close priority observations.
Near full compliance with refinement needs. Audit readiness and continuous improvement as the next horizon.
Next steps
A report, then options.
Right after submission
- ✓Your 3-page PDF report delivered to your email
- ✓Archetype classification with detailed reasoning
- ✓Concrete next steps tailored to your position
If you want to discuss
- ✓Optional 30-minute call with a Clear consultant
- ✓No commitment, no sales follow-up unless requested
- ✓Schedule directly via Zoom Scheduler
You are in the right place if...
We hear this every week.
"We have the documents. But when an auditor asks for evidence, we cannot find it."
"The certificate was obtained three years ago. Since then, nothing has been updated."
"We have a Stage 1 in 6 weeks. I do not know what state the system is in."
"The quality manager left. The system went with them."
"Our biggest customer is asking for ISO 27001. We have never done this before."
"We received a major finding. The certification body wants a corrective action in 30 days."
"We operate across five sites. Nothing is consistent between them."
"The internal audit found no issues. Then the external auditor found sixteen."
8
ISO standards covered
12+
Countries
100+
Audits supported
Accredited
CB network
The gap
Most operations have documentation. Few have a functioning system.
Certification bodies certify objective evidence rather than documents. The gap between having a procedure and demonstrating compliance with it is where most organisations lose certification audits.
Eight standards
Which standard fits your operation?
Core standards
Broadly applicable across sectors
ISO 9001
Quality Management
For whom
Any organisation needing to demonstrate consistent quality to customers, buyers, or regulators.
Primary driver
Customer complaints, inconsistent process outcomes, failed supplier audits, lost tenders.
ISO 14001
Environmental Management
For whom
Manufacturing, production, logistics, construction, and any sector with a material environmental footprint.
Primary driver
Environmental liability exposure, procurement requirements from large customers, regulatory compliance gaps.
ISO 45001
Occupational Health and Safety
For whom
Any employer with meaningful physical or operational risk. Replaces OHSAS 18001.
Primary driver
Incident exposure, regulatory enforcement risk, insurance requirements, tendering prerequisites.
ISO 27001
Information Security Management
For whom
IT service providers, SaaS companies, data processors, and any organisation handling sensitive client data.
Primary driver
Enterprise client RFP requirements, cyber risk exposure, GDPR enforcement risk, contractual obligations.
Specialised standards
Sector or scope-specific
ISO 50001
Energy Management
For whom
Energy-intensive manufacturers, facilities managers, and organisations with formal ESG energy commitments.
Primary driver
Rising energy costs, regulatory requirements, investor ESG reporting, carbon reduction commitments.
ISO 13485
Medical Devices Quality Management
For whom
Medical device manufacturers, component suppliers, and distributors under EU MDR or FDA requirements.
Primary driver
Regulatory approval pathways, notified body audit requirements, EU MDR compliance, market access barriers.
ISO 14064
GHG Quantification and Reporting
For whom
Organisations with investor-grade ESG commitments, carbon disclosure obligations, or supply chain pressure.
Primary driver
Scope 1/2/3 reporting accuracy, inconsistent inventory methodology, investor and customer reporting demands.
ISO 14065
GHG Validation and Verification
For whom
Organisations seeking external validation of carbon claims or preparing for formal GHG statement assurance.
Primary driver
Credibility of published carbon commitments, regulatory acceptance of GHG statements, investor trust.
How it works
How an engagement works.
Every engagement follows the same rigorous sequence across three phases. The scope and timelines vary, the methodology stays consistent.
Phase 1: Discovery and diagnosis
Intake and scope definition
We define the scope of the management system, the applicable standard requirements, and the legal and regulatory context relevant to your operations.
Document and context review
Remote review of existing documentation, procedures, and records. We identify what exists, what is missing, and what contradicts current operations.
On-site gap assessment
Structured interviews with process owners and operational staff. We map actual practice against ISO requirements at each clause level.
Gap report and nonconformity register
Written report scoring each clause. Findings classified as major nonconformities, minor nonconformities, or opportunities for improvement.
Phase 2: Build and implement
Remediation roadmap
Prioritised action plan with ownership, sequencing, and realistic timelines. Built around your operational capacity, beyond a standard template.
Management system design
System structure: processes, interactions, performance indicators, and governance framework designed before a single document is written.
Documentation development
Policy, procedures, work instructions, forms, and records developed to reflect how your organisation actually operates.
Staff training and competence verification
Role-specific training on system requirements and individual responsibilities. Competence records established and maintained.
Phase 3: Certify and sustain
Internal audit
Full-scope internal audit conducted at lead auditor grade. Findings formally recorded. The internal audit report becomes a certification-grade artefact.
Certification audit support
On-site support during Stage 1 document review and Stage 2 certification audit. Document request management and technical responses to auditor questions.
Post-audit follow-up
Management of audit findings through root cause analysis, corrective action, and closure evidence submitted to the certification body.
Services
What we deliver.
ISO gap assessment
Deliverable
Scored clause-by-clause report, classified findings, remediation roadmap.
When needed
Starting point for any engagement. Suitable for new and existing systems.
Management system design
Deliverable
Process map, system architecture, performance indicator framework, governance structure.
When needed
First-time certification or full system rebuild.
Documentation development
Deliverable
Policy, procedures, work instructions, forms, and records templates.
When needed
Documentation is absent, outdated, or disconnected from actual operations.
Risk and opportunity register
Deliverable
Clause 6.1-compliant risk register with assessment criteria, mitigation actions, and monitoring cadence.
When needed
ISO 9001, 14001, 45001, 27001, or 50001 engagements.
Legal and regulatory compliance register
Deliverable
Applicable legislation mapped to system requirements. Compliance status documented.
When needed
ISO 14001, ISO 45001, and any regulated sector engagement.
Internal audit
Deliverable
Full-scope audit report, nonconformity register, corrective action tracking.
When needed
Surveillance cycle, pre-certification, or when internal audit capability is absent.
Training and competence programs
Deliverable
Role-specific training materials, delivery, and competence records.
When needed
Staff onboarding, system implementation, and surveillance readiness.
Certification body selection and liaison
Deliverable
Certification body recommendation, application management, Stage 1 scheduling.
When needed
First-time certification or change of certification body.
Certification audit support
Deliverable
On-site support during Stage 1 and Stage 2. Document request management and real-time technical guidance.
When needed
Any organisation without in-house certification audit management experience.
Nonconformity management and CAPA
Deliverable
Root cause analysis, corrective action plan, objective evidence package, closure submission.
When needed
Following any major or minor finding at internal or external audit.
Integrated Management System design
Deliverable
Single-framework IMS covering two or more standards. Common documentation structure and audit programme.
When needed
Organisations pursuing ISO 9001 + 14001 + 45001 or any multi-standard combination.
Typical findings
What auditors find at the first audit.
These are the five most common finding categories at first-time ISO certification audits. None of them are surprising. All of them are preventable.
Who it's for
Built for your situation.
You lost a tender that required ISO 9001 certification.
The buyer's supplier questionnaire requires certification. The deadline is real.
Gap assessment in week one. Remediation roadmap with fixed milestones. Certification audit supported from document review to close-out.
Your quality manager left. The system left with them.
The certificate exists. No one knows what it covers, where the documents are, or when the next surveillance audit is.
System recovery assessment. Documentation inventory. Interim quality management support through the next surveillance cycle.
A Stage 2 audit is 8 weeks away and the gaps are still unknown.
The certification body confirmed the date. The team needs clarity about the current state of the system.
Accelerated internal audit. Prioritised remediation of critical findings. On-site support on audit day.
An enterprise client is asking for ISO 27001.
The RFP requires ISO 27001 certification. You are an IT company with no formal information security management system in place.
Scope definition. Asset and risk register. Statement of Applicability across 93 controls. Structured path to Stage 2.
You received a major nonconformity at audit.
The certification body issued a major finding. You have 30 days to submit a corrective action with objective evidence.
Root cause analysis. Corrective action plan. Implementation tracking. Evidence package for certification body submission.
You need ISO 13485 for the EU MDR pathway.
The medical device regulatory pathway requires ISO 13485. Your current QMS sits below the standard.
ISO 13485-specific gap assessment. Documentation rebuilt and aligned with EU MDR technical file requirements.
You operate across multiple sites with inconsistent systems.
Four sites. Different procedures, different forms, different practices. A single certificate scope requires a unified system.
Multi-site IMS design. Central framework with site-specific annexes. Sampling approach for the certification audit.
Selected engagements
How it plays out in practice.
Integrated management system from scratch to certification in 14 weeks.
A mid-size manufacturing group needed ISO 9001 and ISO 14001 simultaneously for a major customer tender. Starting with no formal system, we designed an integrated management system, developed 34 procedures and 112 record templates, conducted a full internal audit, and supported the Stage 2 audit through to certification recommendation.
Result
Zero major nonconformities at Stage 2. Three minor findings closed within 10 days.
ISO 27001:2022 certification in response to an enterprise RFP.
A SaaS company received an enterprise RFP requiring ISO 27001 certification within 6 months. Starting from an informal security posture, we built the ISMS, completed a risk assessment covering 89 assets, developed the Statement of Applicability across 93 controls, and managed the Stage 1 and Stage 2 audit process.
Result
Certification issued on time. Deal closed.
Unified integrated management system across 6 sites.
A multi-site industrial group operated with inconsistent procedures across six facilities. We designed a single integrated management system under one certificate scope with a common framework at each site and site-specific annexes. One internal audit programme replaced six separate ones.
Result
One certificate. Six sites. Surveillance cycle manageable with in-house team.
Free resource
ISO readiness scorecard
A practical self-assessment tool covering the 12 most common gap areas found at first-time ISO certification audits. Use it to benchmark your current state before engaging a consultant or scheduling a gap assessment.
Leadership commitment and policy
Objectives and measurable targets
Risk and opportunity register
Documented information control
Internal audit independence
Management review completeness
Competence records
Nonconformity management and CAPA
Supplier and external provider control
Performance monitoring and KPIs
Legal and regulatory compliance tracking
Surveillance and recertification readiness
Why Clear
CB neutral
We hold zero commercial arrangements with certification bodies. Our recommendation is based purely on fit.
Lead auditor grade
Internal audits are conducted at lead auditor standard. The audit report is a certification-grade artefact.
Accredited network
We connect you to accredited certification bodies aligned with your sector, size, and geographic scope.
Common questions
Questions about ISO consultancy.
Ready to build a system that holds at audit?
Gap assessment first. Everything else follows from what we find.