--- url: https://www.qualityweb360.com/iso-9001-quality-manual/ title: "ISO 9001 quality manual: do you still need one? (with an example)" language: en kind: post generated: 2026-10-20T17:24:36Z source: https://www.qualityweb360.com/ --- # ISO 9001 quality manual: do you still need one? (with an example) - [Home](https://www.qualityweb360.com) - [Quality Management 360](https://www.qualityweb360.com/quality-management-360/) - ISO 9001 quality manual: do you still need one? (with an example) # ISO 9001 quality manual: do you still need one? (with an example) Some companies still keep an 80-page quality manual in a binder nobody has opened since the last audit. Others are just starting with ISO 9001 and wonder whether they need to write one from scratch before calling a certification body. The short answer surprises many people: **ISO 9001 no longer requires a quality manual**. It stopped asking for one in the 2015 edition. What it does require is that certain information is documented and controlled. The manual went from mandatory to optional, and in some cases it is still a good idea to have one. This guide covers what a quality manual is, what replaced it in the standard, when it is still worth having, what it should include, and a complete **quality manual example** in a short version you can adapt to your company. **In short:** a quality manual is the document that describes how your quality management system (QMS) works. ISO 9001 has not required it since 2015, but it does require you to document the scope of the system, the quality policy, the quality objectives and any information your company needs to run its processes under control. If a customer or a contract asks for a manual, or if it helps you explain the system, keep one. If not, do not write it out of habit. Table of Contents - [What is a quality manual?](#What_is_a_quality_manual) - [Does ISO 9001 still require a quality manual?](#Does_ISO_9001_still_require_a_quality_manual) - [What replaced the manual: the documented information ISO 9001 requires](#What_replaced_the_manual_the_documented_information_ISO_9001_requires) - [When a quality manual is still worth having](#When_a_quality_manual_is_still_worth_having) - [What a quality manual should include](#What_a_quality_manual_should_include) - [Quality manual example (short version)](#Quality_manual_example_short_version) - [How to write a quality manual in 5 steps](#How_to_write_a_quality_manual_in_5_steps) - [Common quality manual mistakes](#Common_quality_manual_mistakes) - [Manual in Word, a shared folder or software](#Manual_in_Word_a_shared_folder_or_software) - [Quality manual FAQ](#Quality_manual_FAQ) - [Is a quality manual mandatory under ISO 9001?](#Is_a_quality_manual_mandatory_under_ISO_9001) - [What is a company quality manual?](#What_is_a_company_quality_manual) - [What should a quality manual contain?](#What_should_a_quality_manual_contain) - [How long should a quality manual be?](#How_long_should_a_quality_manual_be) - [Can an auditor ask for my quality manual?](#Can_an_auditor_ask_for_my_quality_manual) - [What is the difference between a quality manual and procedures?](#What_is_the_difference_between_a_quality_manual_and_procedures) ## What is a quality manual? A quality manual is the document that presents a company’s quality management system: what it covers, how it is organized, which processes make it up and where the rest of the documentation lives. Think of it as the cover page of the QMS: a newcomer (an employee, a customer, an auditor) can read it and understand in ten minutes how the company manages quality. For years it was the central document of any ISO 9001 system. The problem is that many companies turned it into a copy of the standard with their logo on it: chapter by chapter, restating the requirements without saying how they are met. That kind of manual helps nobody, and it is one of the reasons the standard stopped requiring it. ## Does ISO 9001 still require a quality manual? No. Since the 2015 edition, ISO 9001 does not list the quality manual as a required document, and it does not require a fixed number of written procedures either. Instead it talks about **documented information**: the information the company must control and maintain, in whatever format it chooses (paper, digital files or software). The practical consequence: **an auditor cannot raise a nonconformity just because you do not have a manual**. What they will check is that the information the standard requires, and the information you decided you need, exists and is controlled. If you do have a manual, it gets audited like any other document: current, approved and true to the way you actually work. There is one important exception. If a customer, a contract or an industry standard asks for a quality manual, then it is a requirement for you. This is common for suppliers in automotive, aerospace and medical devices, and in some public tenders. ## What replaced the manual: the documented information ISO 9001 requires The general requirement sits in [ISO 9001 clause 7](https://www.qualityweb360.com/iso-9001-clause-7-support/) (section 7.5, documented information). Several other clauses then ask for specific information. These are the items auditors check most: Documented informationClauseWhat it is forScope of the QMS4.3States which products, services and sites the system covers, and which requirements do not apply and whyInformation to operate processes4.4What the processes need to run as planned (procedures, work instructions, process maps)Quality policy5.2Top management’s commitment and the framework for objectivesQuality objectives6.2What you want to achieve, how it is measured and who is accountableEvidence of competence7.2That each person is qualified for their roleOperational records8.2 to 8.7Review of customer requirements, supplier evaluation, traceability, release and nonconforming outputsMonitoring, internal audit and management review9.1, 9.2 and 9.3Measurement results, audit programme and results, and management decisionsNonconformities and corrective actions10.2What happened, what was done and whether it workedNotice that the scope (4.3) and a description of how processes interact (4.4) are exactly what used to fill the first pages of the manual. That is why many companies keep one: it gathers in a single document what the standard asks you to have separately. We cover this in depth in our [ISO 9001 document control guide](https://www.qualityweb360.com/assuring-quality-through-document-control/), along with the difference between a document and a record. ## When a quality manual is still worth having Not mandatory does not mean useless. These are the cases where it pays off: - **A customer or contract asks for it.** If it is in the contract, it is no longer optional. Check your main customers’ requirements before deciding. - **You have several sites or high turnover.** A short manual helps everyone understand the system the same way and speeds up onboarding. - **You want a map of the system.** One document that says “this is what the QMS covers, these are the processes, and here is where everything is” saves time in audits and in the management review. - **You already have one and it is up to date.** If your manual describes how you really work, do not throw it away: update it and make it shorter. And these are the cases where you should skip it: when you would write it only because “it has always been done”, when nobody will keep it current, or when it would repeat what your procedures already say. An outdated manual is worse than no manual, because the auditor finds contradictions between what it says and what they see. ## What a quality manual should include If you decide to have one, keep it short: 5 to 15 pages for a small or mid-sized business. A good quality manual includes: 1. **Company overview:** what you do, for whom and where. 2. **QMS scope:** products, services and sites covered, plus any requirements that do not apply and why. 3. **Quality policy:** the current one, as signed by top management (here are [6 quality policy examples](https://www.qualityweb360.com/quality-policy-objectives-iso-9001/) by industry). 4. **Process map:** strategic, operational and support processes, and how they connect. 5. **Organization and responsibilities:** who is accountable for what within the system. 6. **How each part of the standard is met:** a sentence or a paragraph per clause, pointing to the document or record that holds the detail. No copying the standard. 7. **List of system documents:** or a reference to the master document list. 8. **Control of the manual itself:** version, date, approver and what changed. ## Quality manual example (short version) Here is a quality manual example for a fictitious company: **Ribera Packaging**, a manufacturer of plastic food containers with 60 employees and a single plant. Use it as a guide for tone and length; the data is made up. SectionExample content1. The companyRibera Packaging makes injection- and blow-moulded plastic containers and caps for the food and beverage industry. It serves 40 industrial customers from one plant running two shifts.2. Scope“Design, manufacture and sale of plastic containers for food and beverages, at the company’s plant.” Control of customer property for moulds does not apply, because all moulds are company-owned.3. Quality policy“We deliver containers that meet the customer’s specification right first time and on time. To do that we inspect every batch, meet food-contact legal requirements and review every month what to improve.” Signed by the general manager, version 3.4. ProcessesStrategic: planning and management review. Operational: sales, container design, purchasing, production, inspection and delivery. Support: maintenance, people, document control and metrology. See process map MP-01.5. ResponsibilitiesThe general manager approves the policy and objectives. The quality lead coordinates the system, internal audits and corrective actions. Each department head owns the KPIs of their process.6. How we meet the standardContext and interested parties: annual SWOT analysis (RE-01). Risks: risk matrix by process (RE-02). Objectives: monthly KPI dashboard (RE-05). Suppliers: twice-yearly evaluation (PR-04). Nonconforming product: red tag and record (PR-07). Internal audit: annual programme (PR-09). Corrective actions: root cause analysis with 5 Whys (PR-10).7. System documentsThe full list is in master document list LM-01, with the current version and owner of each document.8. Control of this manualVersion 4 · approved by the general manager · change: process map updated after adding the blow-moulding line.Notice three things: it does not copy a single requirement from the standard, every section points to the document that holds the detail, and it fits on two or three pages. That is what makes a manual readable and maintainable. ## How to write a quality manual in 5 steps 1. **Decide whether you need one.** Check contracts and customer requirements. If nobody asks for it and it will not serve as a map of the system, skip it. 2. **Gather what you already have.** Scope, policy, process map and document list. The manual is assembled from these, not invented. 3. **Write one section per block, in your own words.** What you do and where the evidence is. If a sentence could appear in any company’s manual, delete it. 4. **Approve it and put it under document control.** With version, date and owner, like any other QMS document. 5. **Review it whenever the system changes.** New site, new process or a change of scope: update the manual the same month. Put it on the management review agenda. If you are implementing ISO 9001 from scratch, the manual belongs to the documentation phase. To see how long that phase and the rest of the project will take, try the [ISO 9001 Timeline Generator](https://www.qualityweb360.com/tools/iso-9001-timeline/). ## Common quality manual mistakes - **Copying the standard.** A manual that restates the requirements does not say how you meet them, which is exactly what the auditor is looking for. - **Making it huge.** The longer it is, the faster it goes out of date. Detail belongs in procedures and work instructions. - **Promising what does not exist.** If the manual mentions a procedure nobody uses, the auditor will ask to see it. - **Keeping two versions.** A printed one in the binder and a different one on the quality lead’s laptop. There must be a single current version. - **Forgetting it after certification.** If the system changed and the manual did not, it no longer describes your company. ## Manual in Word, a shared folder or software The format is up to you: the standard only asks that the document is controlled. In practice, manuals fail for the same reasons as every other document: duplicate versions, nobody knows which one is current, and changes are not recorded. Quality management software such as QualityWeb 360 handles this with version control, an approval workflow and a single place where the current document lives. If you still work with Word and folders, the [Simple Document Builder™](https://www.qualityweb360.com/guides/simple-document-builder/) guide gives you the structure to organize the manual and the rest of your documentation. ## Quality manual FAQ ### Is a quality manual mandatory under ISO 9001? No. Since the 2015 edition, ISO 9001 does not require a quality manual. It requires documented information: the scope of the system, the quality policy, the objectives and the information the company needs to operate its processes. It is only mandatory if a customer, a contract or an industry standard asks for it. ### What is a company quality manual? It is the document that describes the company’s quality management system: what it covers, its policy, the processes that make it up, who is accountable for what and where the rest of the documentation is. ### What should a quality manual contain? A company overview, the QMS scope, the quality policy, a process map, responsibilities, how each part of the standard is met with references to the supporting documents, the list of system documents and version control of the manual itself. ### How long should a quality manual be? There is no fixed length. For a small or mid-sized business, 5 to 15 pages is enough. If it goes past 30, it is probably copying the standard or repeating what the procedures already say. ### Can an auditor ask for my quality manual? They can ask whether you have one, but they cannot raise a nonconformity just because it does not exist. If you have one, it is audited like any document: current, approved and consistent with what the company actually does. ### What is the difference between a quality manual and procedures? The manual gives the overview of the system; procedures explain how a specific process is done, step by step. The manual points to the procedures, it does not replace them. Want to organize your manual and the rest of your documentation without starting from scratch? Download the [Simple Document Builder™](https://www.qualityweb360.com/guides/simple-document-builder/) guide: the structure to create and control your QMS documents. ### Share your love ) ) %20-%20https%3A%2F%2Fwww.qualityweb360.com%2Fiso-9001-quality-manual%2F) ) ### About The Author [#### Gabriel Salles ](https://www.qualityweb360.com/author/gsalles/)Founder and CEO of QualityWeb 360. With over 15 years managing, auditing, and implementing ISO 9001 Quality Management Systems across industries, he built QualityWeb 360 so any organization can run their QMS simply — no spreadsheets, no chaos. [← Previous Post](https://www.qualityweb360.com/iso-9001-auditor-accept-qms-software/ "Will your ISO 9001 auditor accept QMS software? 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