ISO 9001 · the quality manual
The quality manual, written from a few answers
The standard stopped asking for a quality manual in 2015 and customers, tender desks and auditors kept asking for one, because a short document that says what the company delivers, what the system covers, which processes run it and where each clause's evidence lives is the fastest way to read a quality system; this page writes that document from a few answers, with a clause map over the whole standard in your language.
The manual
Ten sections, the clause map last; an empty entry is written as a gap to fill, not skipped.
# Quality manual: [company] Owner: [the quality system owner] · Approved by: [top management] Written on with the free page on getstandardos.com against the clauses of ISO 9001:2015. The clause titles are StandardOS's own descriptions, not the standard's text. ## 1. Purpose of this manual This manual describes the quality management system of [company]: what the company delivers, what the system covers, the processes that run it, who is responsible, and where the evidence for each clause of the standard lives. It is the entry point for a customer, an auditor or a new colleague; the documents and records it points to are the system itself. ## 2. The company and what it delivers [company] delivers [what the company delivers, to be completed]. The quality management system exists so that what customers receive matches what they were promised, and so that the company learns from every case where it did not. ## 3. Scope and exclusions The scope of the quality management system: [the scope statement, to be completed: the products or services, the sites and the activities the system covers] Every requirement of the standard is applied; there are no exclusions. ## 4. The processes and how they interact The system is run as a set of processes. Each has an owner, inputs and outputs, and at least one measure that shows whether it performs: [The processes are to be completed: the ones that produce what customers buy and the ones that keep them running.] The processes hand over to each other in the order a customer experiences them: a requirement enters through sales, is delivered through the operating processes, and is supported and improved through the evaluation processes; the supporting processes provide people, infrastructure, suppliers and documented information to all of them. A process map showing these hand-overs is kept with this manual. ## 5. Leadership and roles [top management] sets the quality policy, approves this manual, provides the resources the system needs and chairs the management review. [the quality system owner] owns the system day to day: keeps this manual and the documented information current, runs the internal audit programme, tracks the objectives and the corrective actions, and reports to the management review. Every process owner is responsible for the performance of their process and for its measure. ## 6. Planning: risks, opportunities and objectives The company records the internal and external issues that affect the system and the interested parties that matter to it, and from them the risks and opportunities the system has to address, with an action and an owner for each. The quality objectives are set from the policy, measurable, with an owner, a date and a way of measuring them, and are reported at the management review. A change to the system is planned before it is made, with its purpose, its consequences and who is responsible. ## 7. Support: people, infrastructure and documented information The company decides the competence each role needs, keeps evidence of it, and closes gaps by training or hiring. The infrastructure and the working environment the processes need are provided and maintained. Documented information is controlled: each document has an owner, a version and an approval, is available where it is used, and is protected from unintended change; records are kept for the period the company sets. [the quality system owner] keeps the register of documents and records. ## 8. Operation: from requirement to delivery Customer requirements are established and reviewed before the company commits to them, and changes are handled the same way. Delivery runs under controlled conditions with the documented information, the resources and the checks each process needs. External providers are chosen, evaluated and monitored according to their effect on what customers receive. Products and services are released only when the planned checks have passed, and outputs that do not conform are identified, controlled and dealt with, with a record of what was done. ## 9. Evaluation and improvement The company decides what it monitors and measures, including customer satisfaction, and analyses the results. Internal audits are run to a programme that covers every clause and process at least once a year. The management review considers the inputs the standard lists and decides on improvements, on changes to the system and on resources. A nonconformity is corrected, its cause found, and the correction checked, and the records of all of this feed the next review. ## 10. Clause map: where the evidence lives Every clause of the standard, in the order of the standard, with the document or record that answers it. A blank is filled by the company with its own document or record. ### 4: Context of the organization - 4.1 The issues, internal and external, that affect the quality system: [document or record to be named] - 4.2 Interested parties and what they require of you: [document or record to be named] - 4.3 The scope of the quality management system, documented: section 3 of this manual - 4.4 The processes of the system, their sequence, criteria and interaction: section 4 of this manual and the process map ### 5: Leadership - 5.1.1 Top management demonstrating commitment to the system: [document or record to be named] - 5.1.2 Customer focus: meeting customer and legal requirements: [document or record to be named] - 5.2 A quality policy, documented, communicated and available: the quality policy - 5.3 Roles, responsibilities and authorities, assigned and communicated: section 5 of this manual ### 6: Planning - 6.1 Actions to address the risks and opportunities that matter: [document or record to be named] - 6.2 Quality objectives, measurable, monitored and planned for: the quality objectives, reported at the management review - 6.3 Changes to the system, planned rather than improvised: [document or record to be named] ### 7: Support - 7.1.1 Resources determined and provided: [document or record to be named] - 7.1.2 People needed to run the system: [document or record to be named] - 7.1.3 Infrastructure for the operation of processes: [document or record to be named] - 7.1.4 The environment in which processes are operated: [document or record to be named] - 7.1.5 Monitoring and measuring resources, and their traceability: [document or record to be named] - 7.1.6 The knowledge the organization needs, maintained and available: [document or record to be named] - 7.2 Competence, evidenced rather than assumed: [document or record to be named] - 7.3 Awareness of the policy, the objectives and one's own contribution: [document or record to be named] - 7.4 Internal and external communication about the system: [document or record to be named] - 7.5 Documented information, controlled and versioned: section 7 of this manual and the register of documents and records ### 8: Operation - 8.1 Planning and controlling the processes that deliver the product: [document or record to be named] - 8.2 Customer requirements: communication, determination, review and change: [document or record to be named] - 8.3 Design and development, from planning through to changes: [document or record to be named] - 8.4 Externally provided processes, products and services: [document or record to be named] - 8.5 Production and service provision, identification, traceability, preservation: [document or record to be named] - 8.6 Release of products and services against planned arrangements: [document or record to be named] - 8.7 Control of nonconforming outputs: [document or record to be named] ### 9: Performance evaluation - 9.1.1 What is monitored and measured, by what methods, and when: [document or record to be named] - 9.1.2 Customer satisfaction, monitored as a perception: [document or record to be named] - 9.1.3 Analysis and evaluation of the resulting data: [document or record to be named] - 9.2 Internal audit on a planned programme: the internal audit programme and the audit reports - 9.3 Management review, with the inputs and outputs the clause lists: the management review minutes ### 10: Improvement - 10.1 Determining and selecting opportunities for improvement: [document or record to be named] - 10.2 Nonconformity and corrective action, through to effectiveness: the corrective action records - 10.3 Continual improvement of the system's suitability and adequacy: [document or record to be named] Approved by [top management] on [date]; owned by [the quality system owner]; reviewed at least once a year and whenever the scope, the processes or the roles change. This manual is written from the answers given. It is not certification advice; the certification body reads the manual for the shape of the system and then samples the documents and records it points to, and the evidence it accepts is what the company keeps.
In StandardOS the clause map is live
StandardOS holds the scope, the policy, the objectives, the processes and the records against the clauses of ISO 9001, so the map in this manual is the coverage page the auditor reads, kept current as records are added, instead of a table someone retypes before each audit.
The quality policyThe internal audit programmeThe management review minutesEvery template