| 4.1 |
Understanding the organization and its context: external and internal issues relevant to its purpose and strategic direction |
Context analysis procedure
PESTEL / SWOT matrix
Climate relevance assessment procedure
Climate position memo & action plan
|
| 4.2 |
Understanding the needs and expectations of interested parties |
Interested parties identification procedure
Needs and expectations matrix
Climate expectations grid
|
4.1 + 4.2 Amendment 1:2024 |
Amendment 1:2024 "Climate action": the organization shall determine whether climate change is a relevant issue (4.1) and interested parties may have requirements related to climate change (4.2 NOTE). Audited by IAF certification bodies since 2024. |
Climate relevance assessment procedure
Climate expectations grid
Climate position memo & action plan
|
| 4.3 |
Determination of the scope of the QMS (documented information maintained) |
QMS scope memo
|
| 4.4 |
QMS and its processes: sequence, interactions, criteria, resources, responsibilities, risks |
Process map
Process identity sheets
Sequence & interaction matrix
Process management procedure
|
| 5.1 |
Top management leadership and commitment + customer focus |
Top management commitment statement
Customer focus procedure
|
| 5.2 |
Quality policy: establishment + communication (documented information maintained) |
Quality policy
Policy communication procedure
Policy posting charter
|
| 5.3 |
Organizational roles, responsibilities, and authorities |
RACI matrix
Quality Manager job description
|
| 6.1 |
Actions to address risks and opportunities |
Risks & opportunities procedure
Risk rating matrix
R&O action plan
Process FMEA
|
| 6.2 |
Quality objectives and planning to achieve them (documented information maintained) |
Quality objectives procedure
SMART objectives table
|
| 6.3 |
Planning of changes to the QMS |
QMS change planning procedure
QMS change request form
|
| 7.1.1 — 7.1.4 |
Resources: general, personnel, infrastructure, process environment |
Resource management procedure
Personnel procedure
Infrastructure procedure
Process environment procedure
|
| 7.1.5 |
Monitoring and measuring resources + metrological traceability |
Measuring resources procedure
Metrological traceability procedure
Equipment register & calibration
|
| 7.1.6 |
Organizational knowledge (requirement introduced in the 2015 version) |
Organizational knowledge procedure
|
| 7.2 |
Competence (documented information retained as evidence) |
Competence management procedure
Competence assessment & skills matrix
Training plan & effectiveness
|
| 7.3 |
Personnel awareness of policy, objectives, and implications of nonconformity |
Awareness procedure
|
| 7.4 |
Internal and external communications relevant to the QMS |
Communication procedure (5W)
|
| 7.5 |
Documented information control (creation, update, control) |
Documented information control procedure
Master document list
Records management procedure
|
| 8.1 |
Operational planning and control + outsourced processes |
Operational planning procedure
Outsourced process control procedure
|
| 8.2 |
Requirements for products and services: customer communication, determination, review, changes |
Customer communication procedure
Contingency procedure (8.2.1.e)
Requirements determination procedure
Customer requirements review procedure
Requirement change procedure
|
| 8.3 |
Design and development: planning, inputs, controls, outputs, changes |
General D&D procedure
D&D planning procedure
D&D inputs form
D&D control procedure
Design review form
D&D outputs form
D&D change control procedure
|
| 8.4 |
Control of externally provided processes, products, and services (suppliers / external providers) |
External providers procedure
Supplier evaluation grid
Type and extent of control procedure
External requirements communication template
|
| 8.5 |
Production and service provision: control, identification, traceability, customer property, preservation, post-delivery, changes |
Production control procedure
Identification & traceability procedure
Customer / external provider property procedure
Preservation procedure
Post-delivery activities procedure
Production change procedure
|
| 8.6 |
Release of products and services (documented information retained) |
Release procedure
|
| 8.7 |
Control of nonconforming outputs |
Nonconforming outputs procedure
Nonconforming product record form
|
| 9.1 |
Monitoring, measurement, analysis, and evaluation + customer satisfaction + data analysis |
Monitoring & measurement procedure
KPI dashboard
Customer satisfaction procedure
Satisfaction questionnaire
Data analysis & evaluation procedure
|
| 9.2 |
Internal audit: program, criteria, objectivity, reporting |
Internal audit procedure
Multi-year audit program
Audit checklist clauses 4 to 10
Standard audit report
|
| 9.3 |
Management review: inputs (6 categories) and outputs |
Management review procedure
Standard review agenda
Standard review minutes
|
| 10.1 |
Improvement — selection of opportunities for improvement |
General improvement procedure
|
| 10.2 |
Nonconformity and corrective action (including complaints) |
NC treatment procedure
Nonconformity record form
Customer complaint procedure
Customer complaint register
Corrective action procedure (CAPA)
CAPA register
Root cause analysis grid
|
| 10.3 |
Continual improvement (PDCA applied continuously) |
Continual improvement procedure
PDCA approach
Improvement action tracking
|
| Cross-cutting |
System documentation and audit support — supporting all clauses: HLS quality manual, mapping matrices, certification audit kit, ISO 9000 glossary |
HLS Quality Manual
Clause-by-clause mapping matrix
Annex SL correspondence
Documented info maintain/retain matrix
Certification audit kit
ISO 9000 glossary
Global action plan tracking
Package user guide
QMS kick-off presentation
|
| Not included |
Documents specific to each organization, each trade, and each product/service — which must be written case by case by the company itself |
Trade work instructions (per activity)
Field work instructions (per workstation)
Product specifications (per reference)
Project quality plans (per project)
Internal technical specifications
Sector-specific regulatory documents (IATF, ISO 13485…)
Product certification dossiers (CE, FDA…)
|