# Nonconformance and Corrective Action Standards Clause Map

> Source: https://netray.co/tools/nonconformance-corrective-action-standards-clause-map
> Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems.
> Section: Free Tools

## Short answer

A lookup of clause numbers that cover nonconforming outputs, corrective action and related controls in ISO 9001, AS9100D, IATF 16949 and ISO 13485.

## Category

compliance-legal

## Audience

- Quality manager
- Internal auditor
- Compliance lead

## Tool

**Kind:** worksheet

**Mode:** reference

**Columns:**

#### Standard

**Key:** standard

**Type:** text

#### Clause

**Key:** clause

**Type:** text

#### Clause title

**Key:** title

**Type:** text

#### What it covers (summary)

**Key:** topic

**Type:** text

#### Typical audit evidence

**Key:** evidence

**Type:** text

**Rows:**

#### Control of nonconforming outputs

**Standard:** ISO 9001:2015

**Clause:** 8.7

**Topic:** Identify and control outputs that do not meet requirements to prevent unintended use or delivery

**Evidence:** NCR procedure, quarantine records, disposition records

#### Actions on nonconforming outputs

**Standard:** ISO 9001:2015

**Clause:** 8.7.1

**Topic:** Correction, segregation, return, suspension, informing the customer, authorization to accept by concession

**Evidence:** Disposition and concession records

#### Documented information on nonconformity

**Standard:** ISO 9001:2015

**Clause:** 8.7.2

**Topic:** Retain records describing the nonconformity, actions taken, concessions and who decided

**Evidence:** Completed NCR with authority sign-off

#### Nonconformity and corrective action

**Standard:** ISO 9001:2015

**Clause:** 10.2

**Topic:** React to nonconformity, evaluate need for action to eliminate causes, implement and review effectiveness

**Evidence:** CAPA records, effectiveness reviews

#### Retained evidence of corrective action

**Standard:** ISO 9001:2015

**Clause:** 10.2.2

**Topic:** Keep records of the nature of nonconformities, actions taken and results

**Evidence:** CAPA log with results

#### Release of products and services

**Standard:** ISO 9001:2015

**Clause:** 8.6

**Topic:** Planned verification before release, evidence of conformity and person authorizing release

**Evidence:** Final inspection and release records

#### Identification and traceability

**Standard:** ISO 9001:2015

**Clause:** 8.5.2

**Topic:** Identify outputs and status, and control unique identification where traceability is a requirement

**Evidence:** Lot and serial records, status tags

#### Analysis and evaluation

**Standard:** ISO 9001:2015

**Clause:** 9.1.3

**Topic:** Analyse data including product conformity, supplier performance and effectiveness of actions

**Evidence:** Trend reports, management review inputs

#### Type and extent of control (external providers)

**Standard:** ISO 9001:2015

**Clause:** 8.4.2

**Topic:** Ensure externally provided processes and products do not adversely affect conforming delivery

**Evidence:** Supplier requirements, incoming inspection

#### Control of nonconforming outputs

**Standard:** AS9100D

**Clause:** 8.7.1

**Topic:** Adds requirements such as authority for disposition, customer approval for use-as-is or repair where required, and marking of scrap

**Evidence:** Disposition procedure, customer approvals

#### Nonconformity and corrective action

**Standard:** AS9100D

**Clause:** 10.2.1

**Topic:** Includes corrective action flow down to suppliers, and determining whether other nonconformities exist or could occur

**Evidence:** Supplier corrective action records

#### Prevention of counterfeit parts

**Standard:** AS9100D

**Clause:** 8.1.4

**Topic:** Planning and controls to prevent use of counterfeit or suspect parts

**Evidence:** Counterfeit prevention procedure

#### Information for external providers

**Standard:** AS9100D

**Clause:** 8.4.3

**Topic:** Communicate requirements including corrective action flow down to suppliers

**Evidence:** Purchase order flow-down clauses

#### Customer authorization for concession

**Standard:** IATF 16949:2016

**Clause:** 8.7.1.1

**Topic:** Obtain customer authorization before processing when product or process differs from the approved one

**Evidence:** Customer concession records

#### Control of reworked product

**Standard:** IATF 16949:2016

**Clause:** 8.7.1.4

**Topic:** Rework instructions and reinspection before shipment

**Evidence:** Rework instructions, reinspection records

#### Control of repaired product

**Standard:** IATF 16949:2016

**Clause:** 8.7.1.5

**Topic:** Repair instructions and customer authorization where required

**Evidence:** Repair instructions and approvals

#### Problem solving

**Standard:** IATF 16949:2016

**Clause:** 10.2.3

**Topic:** Documented problem solving process including containment, root cause analysis, systemic corrective action and verification

**Evidence:** Problem solving procedure, 8D records

#### Error-proofing

**Standard:** IATF 16949:2016

**Clause:** 10.2.4

**Topic:** Determine error-proofing methods in the PFMEA and test their failure modes

**Evidence:** Error-proofing verification records

#### Warranty management systems

**Standard:** IATF 16949:2016

**Clause:** 10.2.5

**Topic:** Process to minimize warranty failures and handle warranty parts analysis

**Evidence:** Warranty analysis records

#### Customer complaints and field failure test analysis

**Standard:** IATF 16949:2016

**Clause:** 10.2.6

**Topic:** Analyse customer complaints and field failures and communicate results

**Evidence:** Complaint and field failure analysis

#### Control of nonconforming product

**Standard:** ISO 13485:2016

**Clause:** 8.3

**Topic:** Identify and control nonconforming product, with evaluation for investigation and notification of external parties

**Evidence:** Nonconforming product procedure and records

#### Rework

**Standard:** ISO 13485:2016

**Clause:** 8.3.4

**Topic:** Documented rework procedures that consider adverse effects of rework

**Evidence:** Rework procedures and reverification records

#### Corrective action

**Standard:** ISO 13485:2016

**Clause:** 8.5.2

**Topic:** Action without undue delay to eliminate causes of nonconformities, with review of effectiveness

**Evidence:** Corrective action records

#### Preventive action

**Standard:** ISO 13485:2016

**Clause:** 8.5.3

**Topic:** Determine action to eliminate causes of potential nonconformities

**Evidence:** Preventive action records

**Notes:** This is a navigation aid with short summaries in our own words. Clause numbering follows the published editions named in the table. Always read the current standard text and your certification body's interpretation before relying on it in an audit.

## Content

**Intro:** When an auditor asks where your system addresses nonconforming product, you need the clause number fast. This map lists the clauses across four common quality standards and the evidence auditors usually look for.

**Sections:**

#### How to use the clause map

**Body:** Filter by standard or search for words such as concession, rework or complaint. Each row shows the clause, a short summary and typical audit evidence. Use it when writing an NCR or CAPA procedure so each requirement is traceable to a clause, when preparing for a surveillance audit, or when building an internal audit checklist. Export to Excel and add a column for the document or record that satisfies each clause in your own system.

#### Where the standards differ

**Body:** ISO 9001 sets the base: control nonconforming outputs, keep records, fix causes and check effectiveness. AS9100D adds disposition authority, customer approval for use-as-is and repair, and supplier flow down. IATF 16949 adds a defined problem solving process, error-proofing and customer authorization for concessions. ISO 13485 adds notification of external parties and consideration of adverse effects of rework. Know which applies to each customer you serve.

**Bullets:**

- AS9100D: customer approval for use-as-is and repair where required
- IATF 16949: documented problem solving and error-proofing
- ISO 13485: rework and notification of external parties

#### Common audit findings

**Body:** Frequent findings include dispositions made by someone without defined authority, missing effectiveness reviews on closed corrective actions, rework with no reinspection record, and supplier corrective action requests that never reach the supplier. Map each clause to a named record in your ERP or quality system so an auditor can sample it. If the record is a spreadsheet or email, expect questions about control and retention.

**Cta:** If auditors keep asking for evidence that sits in several systems, we can help build a read-only report over your ERP that produces it on request.

**Faq:**

#### Which ISO 9001 clause covers corrective action?

**Answer:** Clause 10.2 covers nonconformity and corrective action. It requires reacting to the nonconformity, evaluating whether to eliminate the cause, implementing action, reviewing effectiveness, updating risks if needed and keeping documented information.

#### Is this the same for ISO 9001 and AS9100D?

**Answer:** AS9100D is built on the ISO 9001 structure, so clause numbers align, but it adds aerospace requirements such as disposition authority, customer approval for certain dispositions, and flow down of corrective action to suppliers.

#### Does IATF 16949 require 8D?

**Answer:** IATF 16949 requires a documented problem solving process in clause 10.2.3 but does not mandate a specific format. Many customers specify 8D in their customer-specific requirements, so check each customer.

#### Can I quote these summaries in an audit?

**Answer:** Use them to find the right clause, then cite the clause number and your own procedure. Summaries here are paraphrases, not standard text, so refer to the purchased standard for exact wording.

## Search terms

iso 9001 8.7 nonconforming outputs, iso 9001 10.2 corrective action, as9100d nonconforming product clause, iatf 16949 10.2.3 problem solving, iso 13485 8.3 nonconforming product, ncr capa clause reference, quality standard clause map, internal audit nonconformance clauses

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