Rules that require a procedure in writing
12 US and UK rules that require a company to write a procedure down, each quoted from the regulation or the regulator page, read 28 October 2026.
Who the rule binds
What it requires
The rule in its own words
All the answers, rule by rule
Each row is one rule. Click an answer to see the sentence behind it, quoted from the text with the date we read it. Where it says "not stated", the text we read is silent on that question.
| Rule | Who the rule binds | What it requires | The rule in its own words |
|---|---|---|---|
| Drug batch record retention, US | drug manufacturers | the procedure must be written and kept or reviewed | All records required under this part, or copies of such records, shall be readily… |
| Drug production and process control procedures, US | drug manufacturers | the procedure must be written and kept or reviewed | Any deviation from the written procedures shall be recorded and justified. |
| Emergency procedures for hazardous substances, UK | employers using hazardous substances | the procedure must be written down | procedures, including the provision of appropriate first-aid facilities and relevant… |
| Energy control procedures, US | employers servicing machines | the procedure must be written down | Procedures shall be developed, documented and utilized for the control of potentially… |
| HACCP procedures, UK | food businesses | the procedure must be written and kept or reviewed | Food business operators shall put in place, implement and maintain a permanent procedure… |
| Medical device complaint records, US | medical device makers | the procedure must be written and kept or reviewed | In addition to Clause 8.2.2 in ISO 13485, Complaint Handling, the manufacturer shall… |
| Oil spill plan inspection procedures, US | facilities storing oil | the procedure must be written and kept or reviewed | You must keep these written procedures and a record of the inspections and tests, signed… |
| Process safety operating procedures, US | sites handling highly hazardous chemicals | the procedure must be written down | The employer shall develop and implement written operating procedures that provide clear… |
| Recorded safety arrangements, UK | employers generally | a written procedure is required above a stated threshold | Where the employer employs five or more employees, he shall record the arrangements… |
| Writing the policy down, UK guidance | employers generally | a written procedure is required above a stated threshold | If you have fewer than five employees you do not have to write anything down, but it is… |
| Written food safety plan, US | food businesses | the procedure must be written down | You must prepare, or have prepared, and implement a written food safety plan. |
| Written health and safety policy, UK | employers generally | the procedure must be written and kept or reviewed | it shall be the duty of every employer to prepare and as often as may be appropriate… |
Quoted wording for all 36 answers
- Drug batch record retention, US, 21 CFR 211.180, read 2026-10-08, Who the rule binds:
Any production, control, or distribution record that is required to be maintained in compliance with this part and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch
- Drug batch record retention, US, 21 CFR 211.180, read 2026-10-08, What it requires:
shall be retained for at least 1 year after the expiration date of the batch
- Drug batch record retention, US, 21 CFR 211.180, read 2026-10-08, The rule in its own words:
All records required under this part, or copies of such records, shall be readily available for authorized inspection during the retention period at the establishment where the activities described in such records occurred.
- Drug production and process control procedures, US, 21 CFR 211.100, read 2026-10-24, Who the rule binds:
There shall be written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
- Drug production and process control procedures, US, 21 CFR 211.100, read 2026-10-24, What it requires:
These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit.
- Drug production and process control procedures, US, 21 CFR 211.100, read 2026-10-24, The rule in its own words:
Any deviation from the written procedures shall be recorded and justified.
- Emergency procedures for hazardous substances, UK, COSHH Regulations 2002 reg 13, read 2026-10-28, Who the rule binds:
in order to protect the health of his employees from an accident, incident or emergency related to the presence of a substance hazardous to health at the workplace
- Emergency procedures for hazardous substances, UK, COSHH Regulations 2002 reg 13, read 2026-10-28, What it requires:
procedures, including the provision of appropriate first-aid facilities and relevant safety drills (which shall be tested at regular intervals), have been prepared
- Emergency procedures for hazardous substances, UK, COSHH Regulations 2002 reg 13, read 2026-10-28, The rule in its own words:
procedures, including the provision of appropriate first-aid facilities and relevant safety drills (which shall be tested at regular intervals), have been prepared which can be put into effect when such an event occurs;
- Energy control procedures, US, 29 CFR 1910.147, read 2026-10-03, Who the rule binds:
Procedures shall be developed, documented and utilized for the control of potentially hazardous energy when employees are engaged in the activities covered by this section.
- Energy control procedures, US, 29 CFR 1910.147, read 2026-10-03, What it requires:
Procedures shall be developed, documented and utilized for the control of potentially hazardous energy
- Energy control procedures, US, 29 CFR 1910.147, read 2026-10-03, The rule in its own words:
Procedures shall be developed, documented and utilized for the control of potentially hazardous energy when employees are engaged in the activities covered by this section.
- HACCP procedures, UK, Regulation (EC) 852/2004 art 5, read 2026-10-24, Who the rule binds:
Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.
- HACCP procedures, UK, Regulation (EC) 852/2004 art 5, read 2026-10-24, What it requires:
establishing documents and records commensurate with the nature and size of the food business
- HACCP procedures, UK, Regulation (EC) 852/2004 art 5, read 2026-10-24, The rule in its own words:
Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.
- Medical device complaint records, US, 21 CFR 820 (QMSR), read 2026-10-03, Who the rule binds:
the manufacturer shall maintain records of the review, evaluation, and investigation for any complaints involving the possible failure of a device
- Medical device complaint records, US, 21 CFR 820 (QMSR), read 2026-10-03, What it requires:
the manufacturer shall maintain records of the review, evaluation, and investigation for any complaints involving the possible failure of a device
- Medical device complaint records, US, 21 CFR 820 (QMSR), read 2026-10-03, The rule in its own words:
In addition to Clause 8.2.2 in ISO 13485, Complaint Handling, the manufacturer shall maintain records of the review, evaluation, and investigation for any complaints involving the possible failure of a device, labeling, or packaging to meet any of its specifications.
- Oil spill plan inspection procedures, US, 40 CFR 112.7, read 2026-10-28, Who the rule binds:
Conduct inspections and tests required by this part in accordance with written procedures that you or the certifying engineer develop for the facility.
- Oil spill plan inspection procedures, US, 40 CFR 112.7, read 2026-10-28, What it requires:
You must keep these written procedures and a record of the inspections and tests, signed by the appropriate supervisor or inspector, with the SPCC Plan for a period of three years.
- Oil spill plan inspection procedures, US, 40 CFR 112.7, read 2026-10-28, The rule in its own words:
You must keep these written procedures and a record of the inspections and tests, signed by the appropriate supervisor or inspector, with the SPCC Plan for a period of three years.
- Process safety operating procedures, US, 29 CFR 1910.119, read 2026-10-23, Who the rule binds:
The employer shall develop and implement written operating procedures that provide clear instructions for safely conducting activities involved in each covered process
- Process safety operating procedures, US, 29 CFR 1910.119, read 2026-10-23, What it requires:
The employer shall develop and implement written operating procedures that provide clear instructions for safely conducting activities involved in each covered process
- Process safety operating procedures, US, 29 CFR 1910.119, read 2026-10-23, The rule in its own words:
The employer shall develop and implement written operating procedures that provide clear instructions for safely conducting activities involved in each covered process consistent with the process safety information
- Recorded safety arrangements, UK, Management of Health and Safety at Work Regulations 1999 reg 5, read 2026-10-28, Who the rule binds:
Every employer shall make and give effect to such arrangements as are appropriate
- Recorded safety arrangements, UK, Management of Health and Safety at Work Regulations 1999 reg 5, read 2026-10-28, What it requires:
Where the employer employs five or more employees, he shall record the arrangements referred to in paragraph (1).
- Recorded safety arrangements, UK, Management of Health and Safety at Work Regulations 1999 reg 5, read 2026-10-28, The rule in its own words:
Where the employer employs five or more employees, he shall record the arrangements referred to in paragraph (1).
- Writing the policy down, UK guidance, HSE guidance on health and safety policies, read 2026-10-24, Who the rule binds:
It explains how you, as an employer, will manage health and safety in your business.
- Writing the policy down, UK guidance, HSE guidance on health and safety policies, read 2026-10-24, What it requires:
If you have five or more employees, you must write your policy down.
- Writing the policy down, UK guidance, HSE guidance on health and safety policies, read 2026-10-24, The rule in its own words:
If you have fewer than five employees you do not have to write anything down, but it is useful to do so.
- Written food safety plan, US, 21 CFR 117.126, read 2026-10-28, Who the rule binds:
You must prepare, or have prepared, and implement a written food safety plan.
- Written food safety plan, US, 21 CFR 117.126, read 2026-10-28, What it requires:
You must prepare, or have prepared, and implement a written food safety plan.
- Written food safety plan, US, 21 CFR 117.126, read 2026-10-28, The rule in its own words:
You must prepare, or have prepared, and implement a written food safety plan.
- Written health and safety policy, UK, Health and Safety at Work etc. Act 1974 s2(3), read 2026-10-24, Who the rule binds:
it shall be the duty of every employer to prepare and as often as may be appropriate revise a written statement of his general policy
- Written health and safety policy, UK, Health and Safety at Work etc. Act 1974 s2(3), read 2026-10-24, What it requires:
it shall be the duty of every employer to prepare and as often as may be appropriate revise a written statement of his general policy
- Written health and safety policy, UK, Health and Safety at Work etc. Act 1974 s2(3), read 2026-10-24, The rule in its own words:
it shall be the duty of every employer to prepare and as often as may be appropriate revise a written statement of his general policy with respect to the health and safety at work of his employees
Not counted on this board
2 named documents were read and left out because they are not what this board covers; each reason is below. They are counted, never answered.
How this was built
Each rule's own regulation texts and regulator guidance that require procedures in writing were read through estate-fetch and stored whole (sha256 on every row).
For every text, three questions were answered from its own words: who the rule binds, what it requires, the rule in its own words.
Every stated answer carries the sentence it rests on, checked against the stored text; 'not stated' means the text read does not address the question.
A rule with several texts reads 'varies' where they disagree.
12 rules, 12 texts.
Where we looked (14)
- eCFR (quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing)
- eCFR (quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing)
- eCFR (quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing)
- eCFR (quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing)
- eCFR (quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing)
- OSHA (read, set aside)
- eCFR (quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing)
- legislation.gov.uk (quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing)
- eCFR (quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing)
- legislation.gov.uk (quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing)
- HSE (quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing)
- GOV.UK (read, set aside)
- legislation.gov.uk (quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing)
- legislation.gov.uk (quoted for reporting from the publisher's regulation texts and regulator guidance that require procedures in writing)
Use this figure
12 US and UK rules that require a company to write a procedure down, each quoted from the regulation or the regulator page, read 28 October 2026.
Who the rule binds, by rule: employers generally 3 of 12, drug manufacturers 2 of 12, food businesses 2 of 12, employers servicing machines 1 of 12, employers using hazardous substances 1 of 12, medical device makers 1 of 12, facilities storing oil 1 of 12, sites handling highly hazardous chemicals 1 of 12 (12 rules, read 28 October 2026).
What it requires, by rule: the procedure must be written and kept or reviewed 6 of 12, the procedure must be written down 4 of 12, a written procedure is required above a stated threshold 2 of 12 (12 rules, read 28 October 2026).
The rule in its own words, by rule: stated 12 of 12 (12 rules, read 28 October 2026).
To cite: "Rules that require a procedure in writing", updated 2026-10-28, https://sellsopstoai.com/datasets/sop-written-procedure-rules/.
Get the CSV (36 answers, updated 2026-10-28)