38% of audit NCs are clause 10.2. Close them in 3 seconds.
IgeraIndustria helps Quality Managers prepare ISO 9001 audits, manage CAPA, control documented information and evaluate external suppliers under cl.8.4. The exact clause — and the evidence auditors will request — in 3 seconds.
Quality Managers spend days preparing audits they could prepare in hours
ISO 9001:2015 has 10 clauses and more than 30 points of documented information — mandatory and voluntary. Most Quality Managers spend weeks before each certification audit checking whether every piece of evidence is in order. IgeraIndustria makes every clause queryable in seconds.
38%
Of non-conformances in ISO 9001 renewal audits are related to cl.10.2 (non-conformances and corrective action). The most problematic clause.
cl.7.5
Documented information: mandatory vs voluntary distinction. An outdated document in use is an automatic non-conformance in audit.
cl.8.4
Supplier control: missing or outdated supplier evaluation records are one of the most common NCs in surveillance audits.
cl.9.3
Management review: missing mandatory inputs (9.3.2) result in major NCs. The agenda must include all required items with documented evidence.
The Quality Manager needs to know in 30 seconds whether the documented information for a given clause is mandatory or voluntary, what evidence the auditor will request and how to close a CAPA in a way that satisfies cl.10.2.2. IgeraIndustria provides all of that with the exact clause reference, so the quality team focuses on implementation rather than document search.
Instant ISO 9001 queries by clause, process or audit requirement
IgeraIndustria locates the exact clause that applies to any quality management question and returns the requirement, the mandatory documented information and the most common audit findings for that clause.
Clause-by-clause audit preparation
Query in natural language — “What evidence does the auditor need for cl.8.4 supplier control?” — and IgeraIndustria returns the mandatory documented information, the evaluation criteria requirements, the re-evaluation frequency and the most common NCs found in surveillance audits for this clause.
CAPA management (cl.10.2)
Full CAPA workflow: root cause analysis methods (5W, Ishikawa, 8D), corrective action definition, responsible person, deadline, effectiveness verification criteria and closure. IgeraIndustria also retrieves the mandatory documented information under cl.10.2.2 that auditors will request when reviewing closed CAPAs.
Documented information control (cl.7.5)
Distinction between “maintain” (procedures — 7.5.2) and “retain” (records — 7.5.3). Version control, access, distribution, storage and protection requirements. What makes an outdated document an automatic non-conformance. Full list of mandatory documented information by clause.
Supplier evaluation and re-evaluation (cl.8.4)
Criteria for initial supplier evaluation, monitoring during supply and periodic re-evaluation. What documented information must be retained. How to handle outsourced processes differently from product/service suppliers. The communication requirements to external providers under cl.8.4.3.
Internal audit programme (cl.9.2)
Audit programme design: criteria, scope, frequency, method and auditor selection (independence requirement). Reporting of results and retention of documented information. How internal audit findings feed into the management review (9.3.2c) and the corrective action process (10.2).
Management review (cl.9.3)
All mandatory inputs for cl.9.3.2: status of previous actions, external/internal changes, QMS performance data (customer satisfaction, objectives, process performance, NCs, audit results), resource adequacy, risk and opportunity actions, improvement opportunities. Output requirements (9.3.3) and the documented evidence auditors expect.
Complete ISO 9001 audit support — internal and external
For both internal audits and certification body visits, IgeraIndustria provides the Quality Manager with the support needed at every phase of the audit cycle — from programme design to NC closure.
Internal audit checklist by clause
For each ISO 9001:2015 clause, IgeraIndustria generates a verification checklist with the requirements, the documented information the internal auditor must request and the evidence that demonstrates conformance. Especially useful for auditors covering clauses outside their usual area of expertise.
Gap analysis vs ISO 9001:2015
Identifies which requirements are partially implemented or lack documentary evidence. Especially useful for companies that migrated from ISO 9001:2008, have had the system in place for years without updating it, or are preparing for initial certification.
Audit simulation with real auditor questions
IgeraIndustria can pose the questions that certification body auditors typically ask for each clause, allowing the Quality Manager to identify gaps before the actual audit visit and prepare the corresponding evidence.
Evidence management by clause
For each clause requiring documented information, IgeraIndustria specifies what type of document or record is valid as evidence, how it must be identified and controlled, and for how long it must be retained. Prevents the common error of retaining records in formats that auditors do not accept.
NC closure response to certification body
Support for the formal response to audit NCs: root cause analysis (5W, Ishikawa, 8D), corrective action definition, responsible person, reasonable deadline and how to draft the closure response to satisfy the certification body’s requirements. Includes templates for major and minor NC responses.
Action plans with deadline and responsible person
CAPA action plan structure that satisfies cl.10.2.2 requirements: action description, named responsible person, deadline, effectiveness verification criterion and follow-up status. Formatted to be submitted directly to the certification body as NC closure evidence.
The 4 ISO 9001 clauses that concentrate most audit NCs
These clauses account for the majority of non-conformances in ISO 9001 certification and surveillance audits. IgeraIndustria explains each one with the exact requirements, practical examples and the most frequent auditor findings.
cl.7.5 — Documented information
The clause that most confuses Quality Managers transitioning from ISO 9001:2008. “Documented information” replaces “documents and records”. Clauses requiring “maintain” = procedures (7.5.2: create, update and control). Clauses requiring “retain” = records (7.5.3: access, protection, retention period). The critical rule: if you voluntarily document something not required by the standard, you must control it under 7.5.2 — failure to do so is an automatic NC. IgeraIndustria lists all mandatory documented information by clause and distinguishes it from voluntary documentation.
cl.8.4 — Control of externally provided processes, products and services
One of the top sources of audit NCs. Requires defined criteria for evaluation, selection, monitoring and re-evaluation of external providers. Three categories: incorporated into the organisation’s output, provided directly to customers, and outsourced processes. Retained documented information must include evaluation results and actions arising from re-evaluations. Auditors routinely request the supplier evaluation register and find it outdated or incomplete. IgeraIndustria retrieves the complete cl.8.4 requirement and the documentation checklist in one query.
cl.10.2 — Nonconformity and corrective action
The clause generating 38% of NCs in renewal audits. Requires: react to the NC (correction), evaluate the need for action to eliminate the cause, implement corrective action if needed, review effectiveness and make changes to the QMS if necessary. Retained documented information (10.2.2): description of the NC, actions taken, results of the corrective action. The most common auditor finding: CAPA closed without documented effectiveness verification. IgeraIndustria provides the complete workflow and the evidence format for each step.
cl.9.3 — Management review
The management review is the most evidenced clause in certification audits — auditors always request the minutes. Mandatory inputs (9.3.2): status of previous actions, external/internal changes, QMS performance data (7 sub-items including customer satisfaction, objectives achievement, process performance, NCs, audit results), resource adequacy, risk/opportunity actions and improvement opportunities. Missing any mandatory input item is a major NC. IgeraIndustria generates the complete agenda checklist and the format that satisfies auditors.
How IgeraIndustria works for Quality Managers
Five steps from uploading your quality management system to receiving a response with the exact clause, mandatory documented information and audit evidence required.
Index your quality management system
Upload your quality procedures, NC records, CAPA logs, supplier evaluation registers, internal audit reports and management review minutes. IgeraIndustria processes them alongside ISO 9001:2015 within 24 hours and makes every clause and document queryable.
Connect the assistant to the quality team
Embed in your quality portal, Teams, Slack or deploy as a WhatsApp bot for auditors and process owners. One line of code. Compatible with any document management system or quality platform.
The Quality Manager queries in natural language
“What documented information is mandatory under ISO 9001:2015?”, “How do I close the auditor NC on cl.8.4?”, “What are the mandatory inputs for the management review?”, “What is the difference between major and minor NC?”
IgeraIndustria searches 2 layers of knowledge
First in your internal documentation (procedures, NC records, CAPA logs, supplier evaluations, audit reports), then in ISO 9001:2015 fully indexed with all clauses, documented information requirements and the evidence that auditors typically request.
Response with clause, requirements and mandatory documented information
The answer cites the applicable ISO 9001 clause, specifies whether the documented information is mandatory (“maintain” or “retain”) or voluntary, and highlights the most common audit findings for that specific clause or requirement.
IgeraIndustria in action — management review inputs cl.9.3.2
Complete list of mandatory inputs for the ISO 9001 management review resolved in under 3 seconds — with clause reference and the evidence format auditors expect.
Quality Manager
What are the mandatory inputs for the ISO 9001 management review under cl.9.3.2?
IgeraIndustria
ISO 9001:2015 — cl.9.3.2 Management review inputs (all mandatory)
- • (a) Status of actions from previous reviews
- • (b) Changes in external and internal issues relevant to the QMS
- • (c) QMS performance: customer satisfaction, quality objectives, process performance, NCs & CAPAs, monitoring results, audit results
- • (d) Adequacy of resources
- • (e) Effectiveness of actions addressing risks and opportunities
- • (f) Opportunities for improvement
OUTPUTS required (cl.9.3.3):
- • Decisions on improvement opportunities
- • Decisions on QMS changes needed
- • Resource decisions
⚠️ Missing any (c) sub-item is a major NC in certification audits — auditors always check the minutes agenda
✓ ISO 9001:2015 cl.9.3.2 & cl.9.3.3 · Confidence: 99.8%
180
employees, packaging company
0
major NCs in renewal audit
-34%
customer complaints in 12 months
We have been ISO 9001 certified for 8 years and every renewal audit involved two weeks of chaotic document preparation. Since deploying IgeraIndustria, the Quality Manager resolves in seconds what evidence each clause requires. Our most recent renewal was the first in our history with zero major non-conformances. And customer complaints fell 34% because we manage CAPAs much faster — the system retrieves the cl.10.2.2 requirements and the closure evidence format instantly.
*Representative testimonial based on results from real clients
Frequently asked questions — Quality Manager
What is the difference between mandatory and voluntary documented information in ISO 9001:2015?
ISO 9001:2015 uses two verbs to distinguish mandatory from voluntary documented information. Clauses that say “maintain documented information” require documents (procedures, instructions, plans) that describe how things are done — these are mandatory. Clauses that say “retain documented information” require records (evidence of activities performed) — also mandatory. Everything else is voluntary. The critical risk: if you voluntarily document a process not required by the standard, you must then control that document under cl.7.5.2, and failure to do so creates an automatic non-conformance in audit. IgeraIndustria distinguishes mandatory from voluntary documented information for every clause instantly.
What is the difference between a major and a minor non-conformance in an ISO 9001 audit?
ISO 9001 auditing practice distinguishes major non-conformances (also called “findings”) from minor ones (“observations” or “opportunities for improvement”). A major NC indicates the absence or systemic failure of a required element of the management system — for example, no evidence of internal audit programme (cl.9.2), or no documented non-conformance process (cl.10.2). A major NC can result in suspension or withdrawal of certification if not closed within the agreed timeframe. A minor NC indicates an isolated failure or partial implementation. IgeraIndustria helps Quality Managers prepare responses to both types and understand the closure evidence each requires.
What is the difference between CAPA and corrective action in ISO 9001:2015?
ISO 9001:2008 used the term “corrective and preventive action” (CAPA) explicitly. ISO 9001:2015 replaced preventive action with risk-based thinking (cl.6.1) and uses “corrective action” (cl.10.2) for actions taken in response to non-conformances. Strictly speaking, “CAPA” is no longer an ISO 9001:2015 term — but many industries (pharma, medical devices, aerospace) still use it in their quality management systems. IgeraIndustria answers questions about CAPA in both contexts: the ISO 9001:2015 corrective action requirement under cl.10.2 and the extended CAPA process used in regulated industries.
How does ISO 9001 cl.8.4 define supplier control requirements?
Clause 8.4 (Control of externally provided processes, products and services) requires the organisation to determine and apply criteria for the evaluation, selection, monitoring and re-evaluation of external providers. The extent of control depends on the impact of the externally provided output on the organisation’s ability to meet customer requirements. Three types of external provision are covered: products and services incorporated into the organisation’s output (8.4.1), products and services provided directly to customers on behalf of the organisation (8.4.1), and processes outsourced from the organisation (8.4.1). Documented information on evaluation results and any necessary actions arising from re-evaluations must be retained (8.4.1). IgeraIndustria retrieves the evaluation criteria requirements and the documentation that auditors will request.
What is the difference between an internal audit and an external certification audit?
An internal audit (cl.9.2) is performed by or on behalf of the organisation itself, using auditors who are not responsible for the area being audited (independence requirement). Its purpose is to verify that the QMS conforms to the organisation’s own requirements and to ISO 9001:2015, and is effectively implemented and maintained. An external certification audit is performed by an accredited certification body (AENOR, Bureau Veritas, TUV, DNV, etc.) to determine whether the QMS conforms to ISO 9001:2015 and to issue, maintain or renew certification. The results of internal audits are a mandatory input to the management review (cl.9.3.2c) and to the corrective action process (cl.10.2). IgeraIndustria supports both audit types with clause-by-clause checklists and evidence preparation.
What are the mandatory inputs for the ISO 9001 management review (cl.9.3.2)?
ISO 9001:2015 cl.9.3.2 specifies the mandatory inputs for the management review. These are: (a) the status of actions from previous reviews; (b) changes in external and internal issues relevant to the QMS; (c) information on the QMS performance and effectiveness, including trends in customer satisfaction, quality objectives, process performance, non-conformances and corrective actions, monitoring and measurement results, and audit results; (d) adequacy of resources; (e) effectiveness of actions taken to address risks and opportunities; (f) opportunities for improvement. The outputs (cl.9.3.3) must include decisions and actions related to improvement opportunities, resource needs and QMS changes. IgeraIndustria retrieves the full list of required inputs and the evidence format that satisfies auditors in 3 seconds.
IgeraIndustria plans — Quality Manager
No lock-in. Cancel anytime.
Starter
For ISO 9001 certified industrial SMEs that want to prepare audits without spending weeks searching for clause requirements and documentary evidence.
- ISO 9001:2015 pre-indexed
- Clause-by-clause queries
- Mandatory documented information checklist
- 1,000 queries/month
- Widget for Quality Manager
- Email support
Professional
For companies with an active quality system, regular audits and the need for continuous support for the quality team on CAPA, supplier control and management review.
- ISO 9001 + internal QMS documentation indexed
- CAPA management assisted (cl.10.2)
- Audit simulation by clause
- 5,000 queries/month
- Standard update alerts
- Priority support
Enterprise
For industrial groups with ISO 9001 integrated with ISO 14001 and ISO 45001, multiple sites and internal audit teams requiring multi-standard support.
- Multi-site and multi-standard
- ISO 9001 + 14001 + 45001 integrated
- Supplier evaluation management (cl.8.4)
- Unlimited queries
- SLA 99.9% uptime
- Dedicated customer success
Manage ISO 9001 clause by clause. Zero major NCs. Start today.
- Free 14-day trial — no credit card required
- ISO 9001:2015 fully indexed from day 1
- Upload your internal quality procedures, NC records and supplier evaluations
- Mandatory documented information checklist ready for audit preparation