Quality Systems (ISO 9001)
We deploy a full ISO 9001 2015 quality management system built on the Annex SL structure, the process approach and certification preparation
Quality Systems
(ISO 9001)
Quality Systems to ISO 9001 builds your quality management system from end to end on the 2015 edition of the standard. Our team works through the Annex SL high level structure, which runs from the context of clause four to the improvement of clause ten, and embeds the process approach, risk based thinking and proper control of documented information. We design a system that holds up under both Stage 1 and Stage 2 third party audit and the everyday reality of the operating floor.
Our implementation model
A practical, phased delivery approach that runs from gap assessment through operational embedding and is built around your regulatory context.
Assess current quality management against ISO 9001 2015 Annex SL requirements, identify Cl.4 to 10 gaps.
Design QMS, context, leadership, planning, support, operation, performance evaluation, improvement processes.
Implement process approach, process mapping, inputs/outputs, interactions, performance criteria, risks/opportunities.
Develop required documented information, policy, objectives, procedures, records, per Cl.7.5 control discipline.
Internal audit programme per ISO 19011, management review per Cl.9.3, corrective action and continual improvement.
Third party Stage 1 / Stage 2 certification audit, ongoing surveillance audit cycle (annual / triennial).
Quality Systems in full scope
Value of Quality Systems (ISO 9001)
- Process discipline brings variation down
- Risk based thinking brings hazards into view
- Documented work removes the need to improvise
- Management review puts the focus where it belongs
- You earn ISO 9001 certification
- You can show customers a sound quality system on request
- You qualify for tenders and requests for proposal
- You gain recognition in regulated fields such as aviation and medical
- Customers grow more satisfied
- Clearer processes mean less rework
- Your records hold up under examination with full traceability
- Continuous improvement becomes part of how you work
- The cost of poor quality is avoided
- Customers you might have lost are kept
- Tender qualification opens new revenue
- Insurers and lenders recognise the system
Codes & standards we work to
Triggers that signal the need
Where Quality Systems (ISO 9001) applies
Wellheads, separators, gas compression, FPSO topsides, produced water systems.
Distillation columns, reactors, heat exchangers, storage spheres, LPG handling.
Cryogenic exchangers, liquefaction trains, BOG compressors, storage and sendout.
Reactive systems, batch reactors, solvent handling, runaway reaction scenarios.
Boilers, HRSGs, steam headers, hydrogen systems, ammonia SCR units.
Sterile vessels, CIP/SIP, pressure fermenters, solvent recovery, spray dryers.
Tangible deliverables
- An ISO 9001 gap report
- A quality system architecture with process maps
- A complete set of documented information
- An internal audit programme
- A management review pack
- A certification readiness report
Ready to start your project?
Speak with our team to scope an engagement tailored to your facility, regulatory context, and lifecycle stage.