# ISO 13485 Required Procedures: Mandatory Documents Register

> Source: https://netray.co/tools/iso-13485-required-procedures-and-document-register
> Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems.
> Section: Free Tools

## Short answer

Editable register of the documented procedures ISO 13485:2016 expects, with clause, trigger, typical record, owner and status, plus guidance on the quality manual, technical file and NCR.

## Category

quality

## Industry

Medical Devices

## Audience

- Quality manager
- Regulatory affairs
- Document controller

## Tool

**Kind:** worksheet

**Mode:** editable

**Columns:**

#### Clause

**Key:** clause

**Type:** text

#### Documented procedure or document

**Key:** procedure

**Type:** text

#### Applies when

**Key:** applies

**Type:** text

#### Typical record

**Key:** record

**Type:** text

#### Status

**Key:** status

**Type:** select

**Options:**

- Not started
- Drafted
- Approved
- Not applicable

#### Owner

**Key:** owner

**Type:** text

#### Document number

**Key:** docno

**Type:** text

**Rows:**

**Clause:** 4.2.2

**Procedure:** Quality manual

**Applies:** Always

**Record:** Scope, justified exclusions, procedure references

**Status:** Not started

**Owner:** Quality manager

**Docno:** QM-01

**Clause:** 4.2.3

**Procedure:** Medical device file (technical file)

**Applies:** Each device type or family

**Record:** Description, specifications, labeling, manufacturing and servicing procedures, risk file

**Status:** Not started

**Owner:** Regulatory affairs

**Docno:** MDF-xx

**Clause:** 4.2.4

**Procedure:** Control of documents

**Applies:** Always

**Record:** Document list, change records, approval history

**Status:** Not started

**Owner:** Document controller

**Docno:** QP-01

**Clause:** 4.2.5

**Procedure:** Control of records

**Applies:** Always

**Record:** Record retention schedule

**Status:** Not started

**Owner:** Document controller

**Docno:** QP-02

**Clause:** 4.1.6

**Procedure:** Validation of software used in the QMS

**Applies:** Software used in quality system

**Record:** Validation plan, test evidence

**Status:** Not started

**Owner:** IT and quality

**Docno:** QP-03

**Clause:** 6.2

**Procedure:** Competence, training and awareness

**Applies:** Always

**Record:** Training records, competence evaluation

**Status:** Not started

**Owner:** HR and quality

**Docno:** QP-04

**Clause:** 6.4

**Procedure:** Work environment and contamination control

**Applies:** If environment affects product quality

**Record:** Monitoring logs, cleanroom records

**Status:** Not started

**Owner:** Production manager

**Docno:** QP-05

**Clause:** 7.1

**Procedure:** Risk management process

**Applies:** Product realization

**Record:** Risk management file

**Status:** Not started

**Owner:** Design and quality

**Docno:** QP-06

**Clause:** 7.2

**Procedure:** Customer-related processes and communication

**Applies:** Always

**Record:** Contract review, customer feedback

**Status:** Not started

**Owner:** Sales

**Docno:** QP-07

**Clause:** 7.3

**Procedure:** Design and development

**Applies:** If you design products

**Record:** Design plan, inputs, outputs, reviews, verification, validation, transfer

**Status:** Not started

**Owner:** R&D manager

**Docno:** QP-08

**Clause:** 7.4

**Procedure:** Purchasing and supplier evaluation

**Applies:** Always

**Record:** Approved supplier list, evaluations, purchasing data

**Status:** Not started

**Owner:** Purchasing

**Docno:** QP-09

**Clause:** 7.5.1

**Procedure:** Production and service provision control

**Applies:** Always

**Record:** Batch or device history records

**Status:** Not started

**Owner:** Production manager

**Docno:** QP-10

**Clause:** 7.5.2

**Procedure:** Cleanliness of product

**Applies:** If cleanliness is a requirement

**Record:** Cleaning records

**Status:** Not started

**Owner:** Production manager

**Docno:** QP-11

**Clause:** 7.5.3

**Procedure:** Installation activities

**Applies:** If you install devices

**Record:** Installation and verification records

**Status:** Not started

**Owner:** Service manager

**Docno:** QP-12

**Clause:** 7.5.4

**Procedure:** Servicing activities

**Applies:** If servicing is required

**Record:** Service reports, analysis of service data

**Status:** Not started

**Owner:** Service manager

**Docno:** QP-13

**Clause:** 7.5.5

**Procedure:** Sterile medical devices

**Applies:** Sterile devices only

**Record:** Sterilization process parameters per batch

**Status:** Not started

**Owner:** Production manager

**Docno:** QP-14

**Clause:** 7.5.6

**Procedure:** Process validation

**Applies:** Where output cannot be fully verified

**Record:** IQ, OQ, PQ records

**Status:** Not started

**Owner:** Validation engineer

**Docno:** QP-15

**Clause:** 7.5.8

**Procedure:** Identification of product

**Applies:** Always

**Record:** Labels, status identification

**Status:** Not started

**Owner:** Production manager

**Docno:** QP-16

**Clause:** 7.5.9

**Procedure:** Traceability

**Applies:** Always, extent per regulation

**Record:** Lot or serial traceability records

**Status:** Not started

**Owner:** Quality manager

**Docno:** QP-17

**Clause:** 7.5.11

**Procedure:** Preservation of product

**Applies:** Always

**Record:** Storage and handling records

**Status:** Not started

**Owner:** Warehouse

**Docno:** QP-18

**Clause:** 7.6

**Procedure:** Control of monitoring and measuring equipment

**Applies:** Always

**Record:** Calibration records

**Status:** Not started

**Owner:** Metrology

**Docno:** QP-19

**Clause:** 8.2.1

**Procedure:** Feedback process

**Applies:** Always

**Record:** Feedback and post-market information

**Status:** Not started

**Owner:** Quality manager

**Docno:** QP-20

**Clause:** 8.2.2

**Procedure:** Complaint handling

**Applies:** Always

**Record:** Complaint file and investigation

**Status:** Not started

**Owner:** Quality manager

**Docno:** QP-21

**Clause:** 8.2.3

**Procedure:** Reporting to regulatory authorities

**Applies:** Always

**Record:** Reports and decision logs

**Status:** Not started

**Owner:** Regulatory affairs

**Docno:** QP-22

**Clause:** 8.2.4

**Procedure:** Internal audit

**Applies:** Always

**Record:** Audit program, reports

**Status:** Not started

**Owner:** Quality manager

**Docno:** QP-23

**Clause:** 8.3

**Procedure:** Control of nonconforming product

**Applies:** Always

**Record:** Nonconformity report and disposition

**Status:** Not started

**Owner:** Quality manager

**Docno:** QP-24

**Clause:** 8.3.3

**Procedure:** Issuing advisory notices

**Applies:** If product already delivered

**Record:** Advisory notice and distribution records

**Status:** Not started

**Owner:** Regulatory affairs

**Docno:** QP-25

**Clause:** 8.3.4

**Procedure:** Rework

**Applies:** If rework is done

**Record:** Rework instruction, re-verification

**Status:** Not started

**Owner:** Production manager

**Docno:** QP-26

**Clause:** 8.4

**Procedure:** Analysis of data

**Applies:** Always

**Record:** Trend reports, management review input

**Status:** Not started

**Owner:** Quality manager

**Docno:** QP-27

**Clause:** 8.5.2

**Procedure:** Corrective action

**Applies:** Always

**Record:** CAPA records

**Status:** Not started

**Owner:** Quality manager

**Docno:** QP-28

**Clause:** 8.5.3

**Procedure:** Preventive action

**Applies:** Always

**Record:** Preventive action records

**Status:** Not started

**Owner:** Quality manager

**Docno:** QP-29

**Totals:**

#### Items in register

**Key:** clause

**Agg:** count

**Notes:** Use this as a starting checklist, not a substitute for the standard. Confirm applicability with your regulatory strategy and notified body. Mark a row Not applicable and record the reason if an exclusion is justified.

## Content

**Intro:** ISO 13485:2016 asks for many documented procedures, but only where the clause says so and where your activities make it relevant. This register lists the common ones with clause, trigger and typical record, so you can plan your document set, assign owners and track status, then export it to Excel.

**Sections:**

#### How to use the register

**Body:** Go through the list and mark each row Applicable or Not applicable. Not applicable is acceptable only for activities you do not perform, such as installation or sterile devices, and the reason belongs in the quality manual. Assign an owner and document number to every remaining row, track status from drafted to approved, and export the sheet as your master document index. Review it at each management review and whenever the scope changes.

**Bullets:**

- Exclusions allowed only in clause 7 and only where justified
- One procedure may cover several clauses if it is clear
- Procedures describe how, records prove it happened
- Regulatory requirements can add documents beyond the standard

#### Quality manual and technical file

**Body:** The quality manual states the scope, justifies exclusions, references the procedures and describes how processes interact. A free-form template is easy to write, but keep it short and specific to your company. The medical device file (often called the technical file) holds the product description, specifications, labeling, manufacturing and servicing information, and the risk management file. Regulations such as EU MDR and FDA rules define additional content, so use ISO 13485 as the frame and add market requirements.

#### Nonconformity, installation and servicing

**Body:** A nonconformity report in ISO 13485 identifies the product, the problem, the evaluation of the need for investigation, the disposition and who authorized it. Release of nonconforming product by concession requires documented justification and regulatory compliance. Installation and servicing procedures are required only when the device needs them, and must cover acceptance criteria, verification of installation and records of service activities. Feed service data into complaint handling and data analysis.

**Cta:** Netray can help you keep document status and CAPA data searchable on your own network with a private AI layer, so audits and management reviews draw from live records.

**Faq:**

#### What documented procedures does ISO 13485 require?

**Answer:** Required documented procedures include control of documents and records, software validation, training, risk management, design and development, purchasing, production control, process validation, traceability, calibration, complaint handling, internal audit, nonconforming product, corrective action and preventive action. Others apply only where relevant.

#### Does ISO 13485 require a quality manual?

**Answer:** Yes. The standard requires a quality manual that includes the scope, justified exclusions or non-applications, references to documented procedures and a description of the interaction between processes. There is no required length or format.

#### What is a medical device file?

**Answer:** It is the collection of documents for each device type or family, covering description, intended use, specifications, labeling, manufacturing and servicing procedures, and the risk file. Markets use the term technical file or technical documentation with specific content rules.

#### Can I use free ISO 13485 templates?

**Answer:** Yes, as a starting structure. Adapt them to your processes and regulations, remove clauses that do not apply, and make sure staff can actually follow them. A copied template that does not match practice will fail an audit.

## Search terms

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