What is an SOP, and how do you write one people actually follow?
Written by PolicyDrafters. Published , updated .
A standard operating procedure (SOP) is a numbered set of steps for one process, naming each step's owner, system and record. To write one people follow, walk the process with whoever does it, write one action per step, say what happens if a step fails, test it on a newcomer, and control it as ISO 9001:2015 clause 7.5 describes.
What is an SOP?
A standard operating procedure (SOP) is a written, numbered set of steps for carrying out one process. Each step names the role that performs it, the system or form it uses and the record it leaves. It lets a trained person do the task the same way each time and show that it was done.
An SOP sits between two other documents. The policy above it says what must be true. The SOP says how that is made true. A work instruction below it details a single step, such as how to complete a form.
A typical SOP carries these parts:
- a header with the document ID, version, owner, approver, effective date and review date
- the purpose and scope
- the roles
- the numbered steps
- the decision points
- the records
- a revision block
An SOP library is every such procedure in an organisation written to one template, so that a reader who has learned one knows the layout of all.
The word "standard" carries two meanings and both matter. The procedure is the standard way of doing the task, so that two people doing it on different days produce the same result and the same record. And the document is written to a standard template, so that the header, the numbering and the revision block are in the same place on every procedure. Procedures that are followed tend to have both. Procedures that are ignored usually have neither. The policy and procedure guide draws the line between the two kinds of document in more detail.
Why are most SOPs not followed?
An SOP is ignored for one of four reasons, and none of them is that staff are careless:
- It was written by someone who does not do the task, so it describes the process as management imagines it rather than as it runs.
- It has no owner per step, so when a step is skipped nobody is the person who skipped it.
- It says nothing about what to do when a step fails, so the first exception sends the reader back to asking a colleague, and the document is never opened again.
- It was written once, the tool changed, and the document now describes a screen that no longer exists.
Each of those failures has a fix that is part of writing the document, not part of enforcing it. The method below is those fixes in order.
Pick one process with one owner
Start with one process, bounded at both ends: a trigger that starts it and a result that ends it. Onboarding a new starter begins when the offer is accepted and ends when the person has access, equipment and a signed acknowledgement. Handling a records request begins when the request arrives and ends when the response is sent and logged. A process with no clear end is two processes, and a procedure that tries to cover both will be followed for neither.
Give the process one owner, named by role. The owner is the person who runs the process most days, not the most senior person in the department. The owner walks the process with you, approves the draft and opens the review when something changes. If two people claim ownership, the procedure will be reviewed by neither.
Walk it with the person who does it
Sit with the person who does the task and watch them do it, or have them talk through it with the screens open. Write down what they actually do, in the order they do it, including the step they describe as just checking the spreadsheet, because that step is a step. Ask at each point what they need to have in hand before they can start, where they have to decide something, and who they ask when they are unsure. The answers to the last question are the decision points and the escalation route, and they are the part of the procedure most often missing.
This walk is the intake, one per process, and it is where the document gets its accuracy. A procedure written from a meeting about the process rather than from the process itself reads like management's view and is treated as such.
Number the steps and name the owner, the system and the record
Write one action per step, numbered, in the order the actions happen. Each step names the role that performs it, the system or form it uses and the record it leaves. "Create the user account in the identity system and record the account name on the onboarding checklist" is one step with one owner, one system and one record. "Set up the new starter" is a heading, not a step.
The record is the part people leave out and the part an auditor reads. A step that leaves no record cannot be shown to have happened. A step that leaves a record in a named place can be sampled. If a step genuinely leaves no record, say so, and ask whether it should.
Decision points get their own line. Where the person doing the task has to choose, the procedure names the options, the criterion, and who decides if the criterion does not settle it. Most procedures fall apart at the step where judgement is needed, written as if there were none.
Write what happens when a step fails
Every step can fail: the system is down, the approver is away, the document the step needs has not arrived. For each step that can fail in a way that stops the process, say what the person should do: wait and retry, use the named alternative, or escalate to the named role. This is the section that keeps the document open after the first exception. Without it the reader learns that the procedure covers the easy case only, and stops consulting it.
Keep it on one template with a document ID and revision block
Every procedure in the organisation goes on the same template:
- a header with the document ID, the version, the owner, the approver, the effective date and the review date
- a purpose and scope paragraph
- the roles
- the inputs
- the numbered steps
- the decision points
- the records and where they are kept
- the related documents
- the revision block that records each change
A reader who has used one procedure then knows where to look in all of them. A register of procedures can be kept because every document carries the same fields.
ISO 9001:2015 is a useful reference here even for an organisation that is not certified to it, because its clause 7.5 says what a controlled document looks like. The requirements sit in clauses 7.5.2 and 7.5.3 [1].
Clause 7.5.2 asks that documented information be:
- identified and described, by a title, date, author or reference number
- in a suitable format and medium
- reviewed and approved for suitability and adequacy when it is created and when it is updated
Clause 7.5.3 asks that it be available where and when it is needed, adequately protected, and changed under control, with version control as the example the standard gives.
ISO has since withdrawn the 2015 edition and replaced it with ISO 9001:2026. The clauses cited here are from the 2015 text. A template that carries those fields is structured the way auditors expect to read a controlled document, whichever standard they work to.
Test it with someone who has never done the process
Give the draft to a person who has never done the task and ask them to do it, or to walk through it, using only the document. Every point at which they stop and ask a question is a gap in the procedure, and most gaps are a missing input, an unnamed system or an undescribed decision. Fix the gap in the document rather than in the explanation, then test again. A procedure that a newcomer can follow is a procedure that the experienced person will also follow, because it matches what they do.
Review it when the tool or the team changes
A procedure describes tools and people, and both change faster than rules do. Set a review date on the header, a year out by convention. Open a review earlier whenever:
- the tool changes
- the team is reorganised
- a step fails in a way the document did not cover
- an auditor asks a question the document cannot answer
Each review adds a row to the revision block: the date, the reviewer, what changed.
A library needs a change-control procedure of its own, so that a change to one procedure is proposed, approved and issued the same way every time, and the register shows which version is current. The review cycles that the main standards and rules expect are set out in the policy review guide.
What do the steps of an SOP look like?
The table shows the numbered steps of an SOP for onboarding a new starter, not the whole procedure. A full version adds the inputs, the decision points and the failure route for each step.
Scroll sideways for the other columns
| Step | Owner | System or form | Record |
|---|---|---|---|
| 1. Confirm the start date and role with the hiring manager | HR lead | Offer letter | Start date entered in the HR system |
| 2. Create the personnel file and request identity documents | HR lead | HR system, right-to-work checklist | Checklist filed, documents stored in the personnel file |
| 3. Order equipment | Office manager | Equipment request form | Request number on the onboarding checklist |
| 4. Create accounts and assign access by role | IT administrator | Identity system, access matrix | Account names and access level on the onboarding checklist |
| 5. Send the handbook and collect the acknowledgement | HR lead | Handbook, acknowledgement form | Signed acknowledgement in the personnel file |
| 6. Book the training due in the first thirty days | Line manager | Training calendar | Training dates on the onboarding checklist |
| 7. Review the checklist and sign it off | HR lead | Onboarding checklist | Signed checklist filed, start of probation recorded |
Step four's failure route reads: if the access matrix has no entry for the role, the IT administrator asks the line manager to confirm the nearest listed role and records the decision on the checklist. Step five's reads: if the acknowledgement is not returned within five working days, the HR lead reminds the line manager and records the date. Two sentences, and the procedure survives its first two exceptions.
Which rules require written procedures?
Some sectors do not leave it to convention. In healthcare administration, the HIPAA Security Rule at 45 CFR 164.316 requires covered entities and business associates to keep the policies and procedures that implement the rule in written form, which may be electronic. Paragraph (b)(2) of the section then sets three requirements for that documentation [2]:
- retain it for six years from the date it was created or the date it was last in effect, whichever is later
- make it available to the people responsible for carrying out the procedures
- review it periodically, updating it in response to environmental or operational changes that affect the security of electronic protected health information
That is a description of a controlled SOP library, written as a rule.
Healthcare organisations write procedures for access requests, workforce access, incident handling and records retention to this requirement. Clinical procedures and clinical SOPs are a different discipline and are out of scope for this guide and for our work.
Financial services has the same kind of rule. In the United States, FinCEN's customer due diligence rule at 31 CFR 1010.230(a) requires covered financial institutions to establish and maintain written procedures reasonably designed to identify and verify the beneficial owners of legal entity customers, and to include those procedures in their anti-money-laundering programme [3].
Procedures of that kind are the operational half of an AML/KYC manual: customer due diligence, enhanced due diligence, monitoring and reporting. Each is written step by step with the record it leaves, because the examiner samples the records.
Where no rule names the procedures, the business decides which to write first. A small business usually starts with the HR procedures that sit under its handbook, such as leave requests, grievances and onboarding, because those are the ones a new manager asks for first.
How do you turn processes nobody has written down into an SOP library?
In a growing organisation many processes are held only in the heads of the people who run them. They are unavailable whenever those people are. Getting them on paper follows the method above, run across the whole organisation.
First list the processes, each with its trigger, its result and its owner. Keep that list as the register: the document that shows every procedure, its ID, its current version and its next review date.
Then walk each process with its owner, because the steps that matter most are the ones the owner no longer notices doing, and a walk at the screen catches them where an interview does not.
Write each procedure on the one template and test it on someone new. Issue it through change control, so that the next change to it is proposed, approved and recorded in the register the same way as the first.
Order the list by who is waiting. A process a customer or auditor has asked to see goes first, then the ones only one person can do, then the rest. Our SOP library is that project done for you, five to twelve procedures at a time.
What changes when you write a library rather than one procedure?
One procedure can be written in an afternoon by its owner, following the method above. A library of five to twelve is a project, because the template has to be agreed first, the register and change control set up, and every procedure walked with its owner.
That is the shape of our SOP library service:
- one template agreed with you
- each procedure drafted from an intake with the person who runs it
- a register and a change-control procedure
- review of the set by our legal team
- the review dates kept moving under the maintenance plan
Whether you draft the library yourself or have it drafted, the test is the same. Hand a procedure to someone who has never done the task and see whether they can.
Questions
- How long should an SOP be?
- An SOP should be as long as its steps need and no longer. Most administrative procedures run two to four pages: a header, a paragraph of purpose and scope, the roles, the numbered steps with an owner and a record for each, the decision points, the records and the revision block.
- Who should write an SOP?
- An SOP should be written by the person who does the task, or by someone who has walked the task with them, and approved by the process owner. A procedure written from a meeting rather than from the process tends to describe what management imagines, and staff treat it accordingly.
- What is the difference between an SOP and a work instruction?
- An SOP covers one process end to end with its owners, decisions and records. A work instruction covers one step of it in detail, such as how to complete a form. Most organisations need SOPs first and add work instructions where a step is hard to do.
- How often should an SOP be reviewed?
- An SOP should carry a review date on its header, a year out by convention, and be reviewed earlier whenever the tool, the team or the process changes, a step fails in a way the document did not cover, or an auditor asks a question it cannot answer. Each review adds a row to the revision block with the date, the reviewer and what changed.
- Does PolicyDrafters write clinical SOPs?
- PolicyDrafters does not write clinical SOPs. It writes administrative and operational procedures, including the ones healthcare organisations keep for access requests, incidents and records; clinical procedures and clinical SOPs are out of scope.
The documents this guide is about
SOP library
An SOP library is a set of standard operating procedures (SOPs) written to one template, listed in one register and changed under one change-control procedure.
$1,200 to $2,500
12 working days
AML/KYC manual
An AML/KYC manual is the document that sets out how a firm assesses its money laundering and terrorist financing risk, identifies and verifies its customers, monitors their activity, reports suspicion and proves that all of it happened.
$3,000 to $5,000
15 working days