Gap analysis
We review your current system against the DIS/FDIS of ISO 9001:2026 and identify exactly which clauses, procedures and records require updating. We deliver a gap report prioritised by impact and effort.
ISO 9001 is being revised in 2026 with changes to organisational context, leadership and risk management. If you already hold an ISO 9001:2015 certificate, you have until 2029 to migrate — the earlier you start, the less disruption your management system absorbs.
The sixth edition of ISO 9001 brings two structural changes that affect every certified organisation. First, the context analysis (clause 4) now explicitly requires companies to determine whether climate change is a risk or an opportunity for their quality management system. Second, digitalisation — automation, artificial intelligence, cybersecurity — is formally integrated as an environmental variable that top management must consider when defining the quality strategy. This is not about adding documents: it is about revisiting the logic by which the organisation identifies what affects it.
In clause 5, leadership carries greater weight: the standard requires management to demonstrate verifiably how the management system is aligned with business strategy, how resources are allocated with clear rationale, and how cultural barriers to continuous improvement are removed. Clause 6 draws a sharper distinction between risks and opportunities, directing analysis towards data-driven decision-making. These changes do not require rebuilding the system from scratch, but they do require reviewing key procedures, updating the quality policy, and ensuring that records support what the standard now explicitly demands.
At Summum Calidad we guide the transition process from the initial diagnosis through to the recertification audit with the certification body (AENOR, Bureau Veritas, SGS, TÜV or any other ENAC-accredited entity). Our experience supporting close to 200 ISO certifications in SMEs allows us to shorten adaptation timelines and anticipate the most common audit observations, so that your team invests the minimum effort needed to keep the certificate current.
We review your current system against the DIS/FDIS of ISO 9001:2026 and identify exactly which clauses, procedures and records require updating. We deliver a gap report prioritised by impact and effort.
We adapt the Quality Manual (if applicable), the policy, the affected procedures and the risk-and-opportunity matrices to incorporate the requirements of the new edition: climate context, digitalisation and reinforced leadership.
We train quality managers and top management on the normative changes. We support practical implementation through context workshops, objective reviews and verification of the records that underpin the new approach.
We conduct a transition internal audit before the certification body visits. We coordinate timelines with your certification body and support you throughout the surveillance or recertification audit until the renewed certificate is obtained.
The operational detail: what we deliver as part of the work and what we keep alive afterwards.
ISO 9001:2026 gap report
Document mapping each new or modified requirement against the current state of your QMS, with compliance level and action plan.
Quality policy and objectives update
Review and drafting of the quality policy to reflect the active leadership and strategic alignment required by the new clause 5.
Extended context matrix
Tool integrating SWOT analysis with the new factors: climate risks, digitalisation and stakeholder impact.
Updated procedures and records
Review and adaptation of procedures covering clauses 4, 5, 6 and 9, with the evidence records the external auditor will verify.
Training sessions for the management team
Dedicated workshop for top management on the leadership obligations in the new edition: how to demonstrate active involvement in management reviews and data-driven decisions.
Transition internal audit
Internal audit against ISO 9001:2026 criteria before the certification body visit, with a report on potential non-conformities and corrective actions.
The ISO 9001:2026 transition touches digital context and sustainability: when you also need to adapt your ERP systems or automate quality processes, Summum Sistemas and Summum Consultoría come into play.
ISO 14001 is also being revised in 2026 on the same timeline: if you hold both certificates, an integrated transition saves documentary and audit effort.
View service → consultoríaThe new climate context requirements of ISO 9001:2026 align with the ESG strategy and CSRD reporting managed by Summum Consultoría.
View service → sistemasAutomating quality control workflows with Power Platform makes it easier to generate the evidence records the new standard requires more explicitly.
View service →Official publication of ISO 9001:2026 is scheduled for September 2026. From that date, a three-year transition period opens, meaning ISO 9001:2015 certificates will remain valid until approximately September 2029. Organisations that begin the transition early can synchronise it with their next scheduled surveillance or recertification audit at no additional cost.
The most significant changes affect three areas. First, context analysis (clause 4) explicitly incorporates climate change and digital transformation as factors the organisation must evaluate. Second, leadership (clause 5) requires top management to demonstrate verifiable involvement in aligning the management system with strategy. Third, planning (clause 6) sharpens the distinction between risks and opportunities and directs decision-making towards data. The High Level Structure (HLS) of the standard is retained, so the entire system does not need to be restructured.
No. Most existing documentation remains valid. What needs to be reviewed and updated are the procedures and records that directly relate to the amended clauses: context analysis, quality policy, objectives and the risk matrix. Depending on the maturity level of your current system, the update effort ranges from a few weeks to two or three months of work.
No. Summum Calidad is a consultancy, not a certification body. We support your organisation in meeting the requirements of the standard and being ready for the external audit. Certification is issued by a body accredited by ENAC (AENOR, Bureau Veritas, SGS, TÜV Rheinland, etc.). This separation ensures the independence of the process and the international validity of the certificate.
Yes, and it is the most efficient option if you have both integrated systems. The ISO 14001 revision calendar runs in parallel with ISO 9001, with publication also expected in 2026 and the same three-year transition period. An integrated transition project shares the diagnosis, context update and internal audit stages, reducing the time and resources required.