Learning objectives1. ISO 9001:2008 Clause 4.2 Documentation requirements2. What is a document?3. What is a record?4. What are the required documents?5. What are the required records?Target audience1. QMS implementers2. Internal auditors3. Relevant interested parties
ISO 9001:2008 Documentation requirements• Clause 4.2.1 General• The quality management system documentation shallincludea) documented statements of a quality policy andquality objectives,b) a quality manual,c) documented procedures and records required bythis International Standard, andd) documents, including records, determined by theorganization to be necessary to ensure the effectiveplanning, operation and control of its processes.
Your QMS Documentation• You need specificdocuments, includingdocumented proceduresand records as requiredby ISO 9001• You need specificdocuments, includingrecords as required byyour organization toensure the effectiveplanning, operation andcontrol of your QMS• The extent of the qualitymanagement systemdocumentation can differ fromone organization to another dueto1. the size of organization andtype of activities,2. the complexity of processesand their interactions, and3. the competence ofpersonnel.• The documentation can be in anyform or type of medium.
What’s a document?• ISO 9000:2005 definitions:1. A document is information and its supportingmedium2. The medium can be paper, magnetic,electronic or optical computer disc,photograph or master sample, or acombination thereof3. A set of documents, for example specificationsand records, is frequently called“documentation”
Documented procedure• The term “documented procedure” means that theprocedure is established, documented, implementedand maintained.• A single document may address the requirements forone or more procedures.• A requirement for a documented procedure may becovered by more than one document.
What’s a record?ISO 9001:2005 definitions• A record is a document stating results achieved orproviding evidence of activities performed• Records can be used, for example, to documenttraceability and to provide evidence ofverification, preventive action and correctiveaction.• Generally records need not be under revisioncontrol.
Clause 5.3 Quality Policy• Overall intentions and direction of anorganization related to quality as formallyexpressed by top management• Top management person or group ofpeople who directs and controls anorganization at the highest level
Clause 5.4.1 Quality objectives• A quality objective is something that is sought,or aimed for, related to quality• Select your process KPI’s and set their targets• Create a Quality Objectives Register to recordall quality objectives as set/approved by topmanagement
Clause 4.2.2 Quality Manual• A document specifying the qualitymanagement system of an organization• The manual mirrors the ISO 9001 standard• The manual is your response to ISO 9001requirements
Clause 7.1 Quality Plan• A document specifying which procedures andassociated resources shall be applied by whom andwhen to a specific project, product, process orcontract• These procedures generally include those referringto quality management processes and to productrealization processes.• A quality plan often makes reference to parts of thequality manual or to procedure documents.• A quality plan is generally one of the results ofquality planning
Clause 5.5.1 Organization chart• A chart that defines the arrangement of anorganization’s structure in terms responsibilities,authorities and relationships between people• The arrangement is generally orderly• A formal expression of the organizational structure isoften provided in a quality manual or a quality planfor a project• The scope of an organizational structure can includerelevant interfaces to external organizations
Clause 4.2.3 Control of Documents ProcedureGeneratenewdocumentApprovedocumentDistributedocumentReviewdocumentRe-approvedocumentDispose obsoletedocumentMark as obsolete ifretainedRegister externaldocumentDistributeexternaldocumentUpdate externaldocument
Clause 4.2.4 Control of Records ProcedureIdentify recordrequirementsCreate forms ifnecessaryRegister record,location &retentionLabel recordstorage medium& locationPreserve recordDispose record1. Ensure that records remain legible, readily identifiableand retrievable2. Create a Records Register3. Ensure that handwriting on forms is legible
Clause 8.2.2 Internal Audit ProcedureEstablish annualaudit scheduleGenerate anddistribute AuditPlanConduct OpeningMeetingCarry out auditPrepare andpresent AuditReport in ClosingMeetingFollow-up actions
Clause 8.3 Control of Nonconforming ProductProcedureDetect NCPEliminate, correct,release underconcession ormodify NCPRe-verify NCPagainstrequirementsMaintain NCPrecords
Quality records• Records provide evidence of implementationand conformity to requirements.• Forms function like a work instruction as itcontrols the activity being performed. Filledup forms become quality records.• To meet ISO 9001 requirements, createsuitable forms to record your activities.
Clause 5.5.1 Responsibility and authority• Top management shall ensure thatresponsibilities and authorities are definedand communicated within the organization.• Maintain your Organization Chart• Maintain employee job descriptions• Note: Quality Manual and SOP’s containinformation on responsibilities
Clause 5.5.2 Management representative• Top management shall appoint a member of the organizationsmanagement who, irrespective of other responsibilities, shall haveresponsibility and authority that includesa) ensuring that processes needed for the quality managementsystem are established, implemented and maintained,b) reporting to top management on the performance of thequality management system and any need for improvement,andc) ensuring the promotion of awareness of customerrequirements throughout the organization.• Specify the appointment of your Management Representative inthe Organization Chart
Clause 5.5.3 Internal communication• Top management shall ensure thatappropriate communication processes areestablished within the organization and thatcommunication takes place regarding theeffectiveness of the quality managementsystem.• Record your meetings in the Quality MeetingMinutes format
Management review• The output from the management review shallinclude any decisions and actions related toa) improvement of the effectiveness of the qualitymanagement system and its processes,b) improvement of product related to customerrequirements, andc) resource needs.• Record the management review in theManagement Review Meeting Minutes
Clause 6.2.2 Competence, training & awareness• Maintain records of employee qualifications,training, competence• Create and maintain employees’ job descriptions• Maintain performance appraisal records(measure gaps in competency)• Maintain training records (training or othernecessary actions can fill gaps)• Orientate employee on Quality Policy, QMS, theirKPI and quality objectives and maintain thoserecords
Clause 6.3 Infrastructure• Includes facilities, equipment and servicesneeded for the operation of an organization• Maintain preventive maintenance records
Clause 7.1 Quality planning• Your Quality Plan is evidence of your qualityplanning
Clause 7.2.1 Determination of customerrequirements• The records will depend on how yourcustomer requirements are determined inyour business– Customer’s RFQ– Tender documents– Market surveys– Etc.
Clause 7.2.2 Review of customer requirements• Records pertaining to your acceptance of yourcustomers’ sales orders• Quotations• Tender submission documents• Contracts
Clause 7.2.3 Customer communication• Website• Brochures• Written and email correspondence• Customer complaints and handling records
Clause 7.3 Design and development• If your organization engage in product design,maintain all records of the product and designprocess.• Create a Design & Development Plan, similarto the Quality Plan• Maintain all records related to design inputs,outputs, including review, verification andvalidation activities
Clause 7.4 Purchasing• Maintain the following records:1. RFQ’s2. Supplier quotations3. Purchase orders4. Delivery orders and inspection records5. Suppliers’ performance evaluation
Clause 7.5.1 Control of production and serviceprovision• Maintain production and/or service plans todemonstrate control activity and relateddocuments such as forms/work instructions,flowcharts, etc.• Maintain records as specified within theproduction and/or service plans
7.5.2 Validation of processes for production andservice provision• Maintain a Process Validation Plan, if applicable to yourorganization, to specify the following:1. defined criteria for review and approval of theprocesses,2. approval of equipment and qualification ofpersonnel,3. use of specific methods and procedures,4. requirements for records (see 4.2.4), and5. revalidation.• Maintain records of the above
7.5.3 Identification and traceability• If product traceability is a requirement, uniqueidentification records shall be maintained.
7.5.4 Customer property• Maintain records of customer property,including all damage/loss reports
7.5.5 Preservation of product• Maintain suitable warehousing or storagerecords for your products
Clause 7.6 Control of monitoring and measuringequipment• Maintain the following:1. Equipment calibration records2. Equipment verification records3. Equipment calibration status tags4. Records of verification of measurements madeby faulty equipment
Clause 8.2.1 Customer satisfaction• Implement suitable customer satisfactionsurvey• Maintain those survey records
Clause 8.2.3 Monitoring and measurement ofprocesses• Maintain all process monitoring recordspertaining to your KPI’s , production and/orservice operations
Clause 8.2.4 Monitoring and measurement ofproduct• Maintain all records pertaining to QCinspections as per your product requirements• Service companies shall operate suitable QCactivities and maintain such records• Records shall indicate person who authorizedthe product release• Note: In ISO 9001 lingo, product also equalsservice.
Clause 8.4 Analysis of data• Maintain all records pertaining to the analysis of datathat you have collected, such as1. customer satisfaction (see 8.2.1),2. conformity to product requirements (see 8.2.4),3. characteristics and trends of processes andproducts, including opportunities for preventiveaction (see 8.2.3 and 8.2.4), and4. suppliers (see 7.4).• It can be in any suitable format
Clause 8.5.2 Corrective action• Maintain all Corrective Action Requests andrelated corrective action records• Maintain your CAPA Register
Clause 8.5.3 Preventive action• Maintain all Preventive Action Requests andrelated preventive action records• Maintain your CAPA Register
Using ISO 9001 documentation templates• If you decide to use documentation templates,you will need to customize them to suit yourQMS needs• Templates are available athttp://www.iso9001consultant.org/p/documents-store.html