# Organization profile and standards (/docs/settings/organization)

This page is for the Org admin (Grace Ooi). Other roles with Settings access can read these screens, but only
the Org admin can change them.

Open **Settings > Organization**. The tab bar across the top of Settings has **Organization**, **Shifts &
schedule**, **Users & invitations**, **Roles & permissions**, **Entities & access** and **All master data**.

<GuideStep
  title="Organization settings on desktop"
  description="The company header, the On this page list and the numbered sections."
  src="/guide/organization/1.png"
  alt="Organization settings on desktop with the company header, the On this page list, Company details and Factories and working week"
  width={1440}
  height={1000}
  callouts={[
    { x: 30, y: 18, caption: "Settings tabs: Organization, Shifts & schedule, Users & invitations and more." },
    { x: 38, y: 28, caption: "Company header: name, registration, timezone and a badge for each standard that is on." },
    { x: 9, y: 46, caption: "On this page: choose a name to jump to that section." },
    { x: 95, y: 39, caption: "Edit opens the company form." },
    { x: 50, y: 52, caption: "Company details: a read-only list." },
    { x: 50, y: 79, caption: "Working week: a closed day has a dashed border." },
  ]}
/>

<GuideStep
  title="Organization settings on a phone"
  description="The same sections stacked in one column."
  src="/guide/organization/2.png"
  alt="Organization settings on mobile showing the company header, the section chips and Company details"
  width={375}
  height={812}
  callouts={[
    { x: 50, y: 22, caption: "Settings tabs scroll sideways." },
    { x: 50, y: 40, caption: "Company header with the standards that are on." },
    { x: 50, y: 62, caption: "On this page: a row of chips. Scroll it sideways." },
    { x: 20, y: 80, caption: "Edit." },
  ]}
/>

The page has five numbered sections. The **On this page** list at the left (a row of chips on a phone)
jumps to each one:

1. **Company details**
2. **Factories and working week**
3. **Standards you work to**
4. **Modules**: see [Modules and your package](/docs/settings/modules-and-package)
5. **Rules for signing and release**

At the top, the company header shows the initials, the legal name, the registration number and the
timezone. A badge shows each standard that is on and the number of people.

## Change the company details [#change-the-company-details]

These appear on certificates of conformance and device history records.

<Steps>
<Step>

Under **1 · Company details**, read the list: **Organization name**, **Company registration no.**,
**Slug**, **Address**, **Phone**, **Email**, **Timezone**, **Shop-floor languages**, **Management system**
and **OEE target (%)**. **Slug** is used in sign-in links and only Xentr support can change it.

</Step>
<Step>

Choose **Edit**. In the dialog, change the fields you need. **OEE target (%)** is a number up to 100.
**Management system** is free text, for example `ISO 13485:2016`.

</Step>
<Step>

Choose **Save changes**. The message `Organization saved` appears.

</Step>
</Steps>

## Set the letterhead and logo [#set-the-letterhead-and-logo]

The letterhead is the top and the foot of the documents that you print: certificates of
conformance, controlled copies of records, job travellers, device history records, first article
reports and the quality manual. Each organization has its own letterhead. Open **Sales > Settings > Document
layout**. A role with full access to Settings (by default the Org admin) can change it. Other roles
can only read it.

<Steps>
<Step>

Edit **Company name**, **Tagline / certifications**, **Address**, **Phone and email**,
**Registration and tax no.** and **Footer text**. The preview on the right shows a quotation with the
letterhead.

</Step>
<Step>

Under **Logo image**, choose **Upload logo** and pick a PNG, JPEG or WebP file. The app makes the
image smaller to fit the letterhead. To go back to the coloured badge with the **Logo initials**,
choose **Remove logo**.

<GuideStep
  title="Document layout with a logo image"
  description="The logo image replaces the badge in the preview and on every printed document."
  src="/guide/organization/letterhead-1440.png"
  alt="Document layout on desktop with the company fields, the logo image with Change logo and Remove logo, and the quotation preview"
  width={1440}
  height={900}
  callouts={[
    { x: 12, y: 78, caption: "Logo image with Change logo and Remove logo." },
    { x: 41, y: 21, caption: "The logo in the preview." },
    { x: 50, y: 52, caption: "Footer text and registration line." },
  ]}
/>

<GuideStep
  title="Document layout on a phone"
  description="The same screen at 375 px."
  src="/guide/organization/letterhead-375.png"
  alt="Document layout on a phone with the company fields"
  width={375}
  height={812}
  callouts={[{ x: 50, y: 30, caption: "Company fields." }]}
/>

</Step>
<Step>

Pick an **Accent colour** and choose whether to **Print a tracking QR on every document**. Choose
**Save**. The message `Document layout saved` appears, and the audit trail records the change. The
next print uses the new letterhead.

</Step>
</Steps>

<GuideStep
  title="A printed document with the letterhead"
  description="The certificate of conformance of DO-2026-0318 with the logo, the company details and the footer."
  src="/guide/organization/letterhead-print-1440.png"
  alt="Certificate of conformance on desktop with the logo image at the top and the footer text and registration line at the foot"
  width={1440}
  height={900}
  callouts={[
    { x: 30, y: 16, caption: "Logo and company details." },
    { x: 33, y: 70, caption: "Footer text and registration line." },
  ]}
/>

<Callout type="note">

A certificate of conformance shows the name of the legal entity that shipped the goods, when the
delivery order has one. The logo and the other details come from the letterhead.

</Callout>

## Set the operating hours [#set-the-operating-hours]

Under **2 · Factories and working week**, seven tiles show the days with their open hours. A closed day has
a dashed border. Below them, a line gives the number of factories, shifts and machines and the **OEE target**.
**Shifts & schedule** opens the [shifts screen](/docs/settings/shifts-and-calendar).

Choose **Edit hours**. In the dialog, switch each day **Open** or **Closed** and set **From** and **To**.
Planning, due dates and acknowledgement timers count against this time. Choose **Save changes**. The
message reads `Operating hours saved`. Details of shifts and planned downtime are in
[Shifts, working hours and planned downtime](/docs/settings/shifts-and-calendar).

## Switch management system standards [#switch-management-system-standards]

Under **3 · Standards you work to**, **ISO 9001:2015** is the base standard and is **Always on**. The other
three have a switch:

| Standard | What it adds |
|---|---|
| **ISO 13485:2016** | The medical device requirements, listed as features below it. |
| **ISO 14001:2015** | EHS environment: aspects and impacts, environmental monitoring, waste consignments. |
| **ISO 45001:2018** | EHS safety: hazard risk assessment, incidents and near misses, permits to work, inspections, worker consultation. |

While ISO 13485 is on, six tiles show what it adds: **Device history records**, **Advisory notices and
recalls**, **Complaint reportability**, **Software validation**, **Retention samples** and **Clause
references**. They are part of the standard. Each reads **On** while ISO 13485 is on, and they are hidden
when you switch ISO 13485 off. **Clause references** shows ISO 13485 numbers in the clause badges. When
ISO 13485 is off, clause badges show the ISO 9001 equivalent.

When you switch a standard off, the app asks `Switch off {name}?`. Confirming hides its pages, clause badges
and gates for everyone in the organization. Existing records are kept and come back when you switch it on
again. The change is written to the audit trail (ISO 13485 clause 4.1).

## Sign without a linked employee [#sign-without-a-linked-employee]

By default, each signed step needs a login with a linked, active employee who has current training
(ISO 13485 clause 6.2). A workspace that does not keep employee records can turn this check off. The Org
admin makes the change. It needs a reason and your e-signature.

<GuideStep
  title="Rules for signing and release"
  description="Each rule with its current value and a Change button."
  src="/guide/organization/3.png"
  alt="Section 4, Rules for signing and release, with the rows Who can sign, Before a product is released and Owner self-approval"
  width={1440}
  height={529}
  callouts={[
    { x: 82, y: 39, caption: "Who can sign: Linked employee required is on by default." },
    { x: 94, y: 39, caption: "Change opens a dialog. Only the Org admin can use it." },
    { x: 82, y: 57, caption: "Before a product is released: the set and how many items." },
    { x: 90, y: 83, caption: "Owner self-approval: its switch is in Purchasing settings." },
  ]}
/>

<Steps>
<Step>

Under **4 · Rules for signing and release**, find the row **Who can sign**. Its value reads **Linked employee required** while the check is on. Choose **Change**.

</Step>
<Step>

Read the dialog. If the workspace uses ISO 13485, a warning tells you that clause 6.2 requires trained
personnel to do and sign the work.

</Step>
<Step>

Type the **Reason for the change** (4 characters or more). Then choose **Sign · turn off**.

</Step>
</Steps>

<GuideStep
  title="Turn off the check"
  description="The reason, the ISO 13485 warning and your signature."
  src="/guide/organization/4.png"
  alt="Dialog Turn off the employee and training check with the ISO 13485 warning, the reason box and the signature box"
  width={1440}
  height={900}
  callouts={[
    { x: 50, y: 42, caption: "ISO 13485 warning: shown when the workspace uses ISO 13485." },
    { x: 50, y: 54, caption: "Reason for the change." },
    { x: 46, y: 65, caption: "Your signature." },
    { x: 61, y: 72, caption: "Sign · turn off." },
  ]}
/>

<GuideStep
  title="The same dialog on a phone"
  description="The dialog fills the width of the screen."
  src="/guide/organization/5.png"
  alt="Dialog Turn off the employee and training check on a phone"
  width={375}
  height={812}
  callouts={[
    { x: 50, y: 38, caption: "ISO 13485 warning." },
    { x: 74, y: 83, caption: "Sign · turn off." },
  ]}
/>

When the check is off:

- A signed step does not check the employee link or the training of the person who signs.
- Each login still needs a **Signs as** role, and the role must have the authority for the step.
- The "someone other than" rules stay. When a login has no employee, the system compares logins. For
  example, the login that reported an incident cannot close it.
- Each signature shows `training check off for this workspace` in the record history and the audit trail.
- You can link an employee to a login that has none, but you cannot remove or change a link. Turn the
  check on first.
- The other Org admins get a notification. The audit trail keeps the old and the new value, the reason and
  the signature.

<GuideStep
  title="The change in the audit trail"
  description="Each change of the rule, with the reason and the signature."
  src="/guide/organization/6.png"
  alt="Quality audit trail with the events Signing rule relaxed and Signing rule tightened"
  width={1440}
  height={900}
  callouts={[
    { x: 31, y: 43, caption: "Signing rule relaxed: on → off, with the reason." },
    { x: 60, y: 33, caption: "A signature taken while the check was off says so." },
  ]}
/>

You sign the change under the rule that applies at that time. To turn the check off, your own login must be
linked to an active employee with current training. If your login has no employee, link one first in
[Users & invitations](/docs/settings/users-and-invitations), or ask another Org admin. To turn the check on
again, choose the switch, type a reason and choose **Sign · turn on**.

## Set the product release requirements [#set-the-product-release-requirements]

The product release requirements tell the app what a product must have before you submit, approve or
release it. The app also checks the same items before you issue a manufacturing order for the product.
The Org admin makes the change. It needs a reason and your e-signature.

| Set | Required items |
| --- | --- |
| **Medical device** (default) | All items. Use this set for ISO 13485 work. |
| **General manufacturing** | **BOM**, **Released production method** and **At least one machine option**. |
| **Custom** | **BOM**, **Released production method**, **At least one machine option** and the other items that you turn on. |

The items are:

- **BOM**
- **Released production method**
- **At least one machine option**
- **Work instruction**
- **PFMEA with scored lines**
- **Inspection plan with a CTQ characteristic**
- **Process validation with an approved protocol**

An open High-priority PFMEA line always stops a release and a change, for all sets. Start its action
first. The sets change only whether a product must have a PFMEA.

<GuideStep
  title="The release row"
  description="The set in use and how many items each product needs."
  src="/guide/organization/7.png"
  alt="Row Before a product is released with the set Medical device, 7 of 7 items required and the Change button"
  width={1440}
  height={146}
  callouts={[
    { x: 82, y: 23, caption: "The set in use: Medical device by default, with the number of required items." },
    { x: 94, y: 23, caption: "Change. Only the Org admin can use it." },
    { x: 30, y: 85, caption: "An open High-priority PFMEA line always stops a release." },
  ]}
/>

<GuideStep
  title="The rules on a phone"
  description="The rows stack. Each value and its Change button sit under the text."
  src="/guide/organization/9.png"
  alt="Rules for signing and release on a phone with the Change buttons"
  width={375}
  height={812}
  callouts={[
    { x: 71, y: 32, caption: "Change for Who can sign." },
    { x: 42, y: 55, caption: "The set and how many items are required." },
    { x: 20, y: 61, caption: "Change for the release rules." },
  ]}
/>

<Steps>
<Step>

Under **4 · Rules for signing and release**, find the row **Before a product is released**. It shows the set and how many items are required. Choose **Change**.

</Step>
<Step>

Select the **Requirements set**. For **Custom**, turn on each other item that you require. The first
three items are always on.

</Step>
<Step>

Read the dialog. If the workspace uses ISO 13485 and you make an item optional, a warning tells you that
clause 7.3 controls design outputs and clause 7.5.6 requires validated processes.

</Step>
<Step>

Type the **Reason for the change** (4 characters or more). Then choose **Sign · save**.

</Step>
</Steps>

<GuideStep
  title="Change the requirements"
  description="The set, the items, the ISO 13485 warning, the reason and your signature."
  src="/guide/organization/8.png"
  alt="Dialog Change the product release requirements with the set General manufacturing, the ISO 13485 warning, the reason box and the signature box"
  width={1440}
  height={900}
  callouts={[
    { x: 50, y: 21, caption: "Requirements set." },
    { x: 64, y: 33, caption: "The first three items are always on." },
    { x: 64, y: 46, caption: "The other items. Turn them on for Custom." },
    { x: 50, y: 60, caption: "ISO 13485 warning: shown when an item becomes optional." },
    { x: 50, y: 73, caption: "Reason for the change." },
    { x: 63, y: 91, caption: "Sign · save." },
  ]}
/>

<GuideStep
  title="The same dialog on a phone"
  description="The dialog fills the width of the screen. Scroll down to sign."
  src="/guide/organization/10.png"
  alt="Dialog Change the product release requirements on a phone, scrolled to the warning, the reason and the Sign · save button"
  width={375}
  height={812}
  callouts={[
    { x: 50, y: 46, caption: "ISO 13485 warning." },
    { x: 50, y: 62, caption: "Reason for the change." },
    { x: 76, y: 92, caption: "Sign · save." },
  ]}
/>

When you change the requirements:

- The new items apply to the next submit, approval, release and order issue. Released products stay
  released.
- A refusal names only the items that the set requires. For example: `Product Prod Test 1 rev 1 cannot be
  submitted: its medical device file lacks BOM.`
- When a set does not require all items, the release event of a product names the set, for example
  `release requirements: General manufacturing (BOM, released production method, machine option)`.
- The other Org admins get a notification. The audit trail keeps the old and the new items, the reason and
  the signature (**Release requirements relaxed** or **Release requirements changed**).

You sign the change under the signing rule that applies at that time. If the rule requires a linked, trained
employee, your own login must have one.

## Set the process capability rule [#set-the-process-capability-rule]

Process capability (Cpk) is the PQ readings and the Min. Cpk of a process validation, and the Cp and Cpk on
the SPC charts. The row **Process capability (Cpk)** in **4 · Rules for signing and release** shows if
your workspace uses it, and how many lots and
readings a PQ needs. The Org admin makes the change. It needs a reason and your e-signature.

| Setting | Default | You can choose |
| --- | --- | --- |
| **Process capability** | On | On or off |
| **Lots per characteristic** | 3 | 1 to 5 |
| **Readings per lot** | 30 | 10 to 100 |

- **Off:** a process validation with PQ is judged on its results. The validation does not show the PQ
  readings or the Min. Cpk, and the approval does not ask for a Min. Cpk of 1.33. The SPC charts show the
  chart and the signals, but no Cp, Cpk or capability by lot.
- **Fewer than 3 lots or 30 readings:** type the **Rationale**, for example the procedure that sets the
  numbers: `QP-7.5-02: 1 lot of 15 readings for low-risk parts`. ISO 13485 7.5.6 asks for a rationale for
  each sample size. Each validation report shows the numbers and the rationale.
- Process capability is an add-on. If it is not part of your plan, the switch is off and you cannot turn it
  on. Contact VIGOR to add it.

<GuideStep
  title="The Process capability row"
  description="The rule in use and the rationale for numbers below the default."
  src="/guide/organization/11.png"
  alt="Process capability row in section 4 of the Organization settings page showing On, 1 lot of 15 readings, the Change button and the rationale"
  width={1440}
  height={900}
  callouts={[
    { x: 45, y: 85, caption: "What the setting does." },
    { x: 85, y: 83, caption: "The rule in use." },
    { x: 94, y: 83, caption: "Change: Org admin only." },
    { x: 35, y: 92, caption: "The rationale for numbers below 3 lots of 30." },
  ]}
/>

<GuideStep
  title="Change the rule"
  description="Choose Change. Set the switch and the numbers, type the rationale and the reason, then sign."
  src="/guide/organization/12.png"
  alt="Dialog Change the process capability rule with the switch on, 1 lot, 20 readings, the rationale, the reason and the signature"
  width={1440}
  height={900}
  callouts={[
    { x: 64, y: 27, caption: "Use process capability: on or off." },
    { x: 42, y: 36, caption: "Lots for each PQ, 1 to 5." },
    { x: 58, y: 36, caption: "Readings on each lot, 10 to 100." },
    { x: 50, y: 50, caption: "Rationale: needed below 3 lots or 30 readings." },
    { x: 50, y: 67, caption: "Reason for the change." },
    { x: 63, y: 85, caption: "Sign · save." },
  ]}
/>

When you change the rule:

- The new numbers apply to the next report and approval. Validated validations keep their Min. Cpk.
- The other Org admins get a notification. The audit trail keeps the old and the new rule, the reason and
  the signature (**Process capability relaxed** or **Process capability changed**).

## Set the line clearance rule [#set-the-line-clearance-rule]

A line clearance proves that the machine has no parts, labels or material from the last order
(ISO 13485 7.5.1 and 7.5.8). The row **Line clearance** in **4 · Rules for signing and release** shows when
an order needs one before setup or job start. The Org admin makes the change. It needs a reason and your
e-signature.

| Value | What the system does |
| --- | --- |
| **Every order** (default) | Each order needs a **Verified** line clearance for its machine. |
| **Only when the product changes** | An order needs a clearance unless it is a follow-on run. A follow-on run makes the same product and the same product revision as the last order that ran on that machine. |
| **Never** | The system does not ask for a clearance. |

- A clearance that someone already started for the order, **Open** or **Cleared**, is never ignored. Verify
  it before the order starts, whatever the value.
- Each machine records what last ran on it: the order, its product and the product revision at that
  moment. The system writes it when a setup starts, when a paused run resumes and when you move an order
  onto the machine, and when a traveller check-in scans the order in at a machine station. **Only when the product changes** compares the order with that record. A follow-on run
  needs another order of the same product at the same revision as the product has now. A new product
  revision, a different product or the same order again needs a clearance. Moving an order away does not
  clear the record of the machine it leaves. An order that already took the machine under this setting
  does not need a clearance again to start from the phone or to move back to it.
- The record is a change to the machine. If Maintenance edits a machine while a setup starts on it, the
  save can show that someone else changed the record. Reload the machine and make the edit again.
- A machine with no recorded run yet needs a clearance. This is the case for every machine until the next
  order is set up on it. If the system does not know the product revision, it asks for a
  clearance too.
- When the rule lets an order through, the **Setup started** and **Job started** events say why:
  `Line clearance not required: follow-on run of MO-2026-1128`, or `Line clearance not required: not required by organization setting`. An auditor sees the reason on the order.
- When the release set is **Medical device** and the value is not **Every order**, the row shows a warning.
  Medical device work normally needs a clearance for every order, and an auditor can raise a
  nonconformity.
- The other Org admins get a notification. The audit trail keeps the old and the new value, the reason and
  the signature (**Line clearance rule relaxed** or **Line clearance rule changed**).

## See the owner self-approval setting [#see-the-owner-self-approval-setting]

The row **Owner self-approval** shows if the Managing Director can approve a purchase requisition that they
raised. The value reads **On** or **Off**. The switch is not on this page. It is in **Purchasing >
Settings > Approvals**, because it belongs to the purchase approval levels. Choose **Open Purchasing
settings** to go there. Only the Org admin can change it. The system records each such approval as a
self-approval. Details are in [the approval ladder](/docs/purchasing/approval-ladder).

## Factories and legal entities [#factories-and-legal-entities]

Under **2 · Factories and working week**, the **Factories** list shows each factory. Each factory has a **Code** (assigned on save, for example `SITE-02`), **Factory** name, an
optional **Internal reference**, **Timezone**, **Location** and
**Status** (**Active** or **Inactive**). Each factory has its own timezone, shifts and machines, so add a
factory before assigning shifts to it.

**Entities & access** (`/config/tenancy`) shows the tenant and deployment, the **Legal entities** with
**ID**, **Name**, **Registration**, **Currency**, **Tax** and **Sites**, and the approval limits and
delegations (see [Invite people](/docs/settings/users-and-invitations)). Use **+ Legal entity** to add one.

## Run the setup wizard [#run-the-setup-wizard]

A new workspace opens the setup wizard at `/setup`: **Company** (registered name, registration number,
short name, address, phone, email), **Site** (standards and working hours) and **Team** (invite people by
email). Every answer can be changed later on the screens above.

## If the system refuses [#if-the-system-refuses]

Every message is in [Settings refusals](/docs/settings/refusals#organization).

| Message | What to do |
|---|---|
| `Only the Org admin can change the organization details.` | Ask the Org admin. |
| `Only the Org admin can change this setting.` | Standards, hours and permissions are Org admin only. |
| `Organization name is required.` | Fill in the name. |
| `OEE target must be a number up to 100.` | Enter a number between 0 and 100. |
| `Enter a valid email address.` | Fix the **Email**. |
| `... cannot take signed steps or steps that need training: the login is not linked to an employee.` | To turn the signing check off, link your login to an employee first, or ask another Org admin. |
| `This setting was changed meanwhile. Reload the page and try again.` | Another Org admin changed it. Reload the page. |

<NextSteps>

<NextStep href="/docs/settings/shifts-and-calendar" title="Shifts, working hours and planned downtime" description="Define when each factory runs." />

<NextStep href="/docs/settings/users-and-invitations" title="Invite people and link them to employees" description="Give people access." />

<NextStep href="/docs/settings/refusals" title="Settings refusals" description="Every message and the fix." />

</NextSteps>