Customer & regulatory requirements
Identify applicable customer, statutory, regulatory and sector-specific requirements before proposing a solution.
Compare general, sector-specific and complementary management systems by what they change in customer-facing commercial work.
| System or standard | Primary scope | Relationship to ISO 9001 | Commercial relevance | Use status |
|---|---|---|---|---|
| ISO 9001 | General quality management | Reference baseline | Customer requirements, controlled commitments, performance and improvement | Certifiable |
| IATF 16949 | Automotive quality management | ISO 9001 plus automotive requirements | Customer-specific requirements, feasibility, product launch and supply-chain controls | Certifiable scheme |
| IAQG 9100 / AS9100 / EN 9100 | Aviation, space and defence | ISO 9001 plus aerospace requirements | Contract review, configuration, product safety, risk and counterfeit-part prevention | Certifiable scheme |
| ISO 13485 | Medical-device QMS | Separate sector QMS with shared foundations | Regulatory requirements, risk, traceability, validation and controlled communication | Certifiable |
| ISO 22163 | Railway quality management | ISO 9001 plus railway requirements | Project, supply-chain, safety and defect-prevention expectations | Certifiable |
| ISO 29001 | Oil and gas sector QMS | ISO 9001 plus sector requirements | Contract, supplier, risk and product/service conformity controls | Certifiable |
| ISO 22000 | Food-safety management | Harmonised management-system structure | Food-chain communication, hazards, emergency response and operational control | Certifiable |
| ISO/IEC 27001 | Information-security management | Complementary management system | Security claims, customer information, risk treatment and supplier assurance | Certifiable |
| ISO 14001 | Environmental management | Complementary management system | Environmental requirements, claims, life-cycle perspective and obligations | Certifiable |
| ISO 45001 | Occupational health and safety | Complementary management system | Commitments affecting worker safety, contractors and operational risk | Certifiable |
| ISO 22301 | Business continuity management | Complementary management system | Resilience claims, recovery expectations and continuity commitments | Certifiable |
| ISO 10002 | Complaint handling guidance | Supports ISO 9001 customer focus | Accessible complaint handling, analysis and learning | Guidance |
| ISO 10004 | Customer-satisfaction monitoring | Supports ISO 9001 evaluation | Customer perception, measurement design and interpretation | Guidance |
| ISO 19011 | Management-system auditing | Supports multiple management systems | Risk-based audit, competence, evidence and programme governance | Guidance |
| EFQM Model | Organisational excellence model | Broader performance framework | Stakeholder value, transformation, performance and organisational maturity | Assessment model |
| Lean and Six Sigma | Improvement disciplines | Complementary improvement methods | Flow, variation, defects, root cause and verified improvement | Method family |
Use ISO 9001 as the general quality baseline, then add only the applicable sector, regulatory, security, environmental, safety and resilience controls.
Identify applicable customer, statutory, regulatory and sector-specific requirements before proposing a solution.
Review capability, capacity, design, supply chain, safety, security and continuity before commitment.
Make scope, claims, configuration, acceptance, exceptions and authority unambiguous.
Transfer the accepted baseline, changes, records and open risks into delivery.
Monitor customer perception, complaints, conformity, failure cost and realised outcomes.
Use evidence, root cause and effectiveness checks across the integrated system.
ISO 9001:2015 remains the current published edition while its successor is under publication. Every guide identifies its source and must be reviewed when a relevant standard or scheme changes.
SaleQMS does not reproduce protected requirements or determine certification conformity. Use authorised standards, applicable regulations, customer-specific requirements and competent advice. These pages provide independent commercial-process guidance.
A customer promise may be affected by general quality, sector, regulatory and complementary management-system obligations at the same time.
The applicable combination depends on customers, products, services, jurisdictions, contracts and organisational context.