2 ISO 9000There are 5 Standards in the basic ISO 9000 series: conformance models or guides.A conformance model is a Standard to which your organisation must conform in order to be certified.A guide is a set of recommendations concerning the establishment of an effective quality system in order to be certified in one of the conformance models.
3 ISO 9000 Guides ISO 9000 ISO 9004 Conformance Models ISO 9001 ISO 9002
4 GuidesISO 9000Guidelines for selection and use of the standards on quality management, quality system elements, and quality assurance.ISO 9004Guidelines for quality management and quality system elements.
5 Conformance models ISO 9001 ISO 9002 ISO 9003 Quality assurance in design/development, production, installation, and servicing.ISO 9002Quality assurance in production, installation, and servicing.ISO 9003Quality assurance in final inspection and test.
6 Quality systemA quality system is the organisational structure, responsibilities, procedures, processes, and resources needed to implement quality management. It should only be as comprehensive as needed to meet quality objectives.
7 What is certified?Your quality system must conform to the ISO 9000 Standard that your organisation selects.It is the quality system that becomes certified (registered) during the certification process.
8 Terms Product: The material or service provided. Applies in the Standard toIncoming material/serviceIn-process product/serviceFinished product/serviceSupplier: Your organisationSubcontractor: Your supplierCustomer: The organisation that receives your product/service.
10 Quality AuditsAn audit is an evaluation of your quality system and documentation.Your organisation may undergo several types of audits:First-party auditsSecond-party auditsThird-party audits
11 Third-party auditsThe third-party audit is a quality system audit performed by an auditor on the supplier in order to achieve certification for one of the ISO 9000 Standards. The third-party auditor must be independent of both the customer and the supplier.Third-party audits cannot be performed by the customer or the supplier.
12 What is looked for?Do your documents conform to the requirements of the Standard?Do your operations conform to the documents?Do your records show past conformance to your documents?
13 9 stages to certification Strategic planningGap analysisCorrective actionDocumentation and recordsImplementationPre-certification auditRegistrar documentation reviewSite preparationCertification audit
14 Strategic planning Management: Displays strong commitment to the certification effortSelects a registrarSelects a conformance model for which organisation may seek certificationForms a project teamEstablishes a timelineAssesses training needs regarding ISO 9000 and organisational background.
15 Gap analysis Corrective action teams: Evaluate the existing quality system against the selected conformance modelEvaluate the documentation against the quality system and the selected conformance model.
16 Corrective actionCorrective action teams institute changes in quality system as identified in stage 2.
17 Documentation and records Corrective action teams:Implement a document structure and control systemInstitute a control of quality records processRevise documents as necessaryProvide training about changes, additions, and other topics as identified in stage 1.
18 Implementation Management: Implements and monitors all changes in the quality systemEnsures all gaps identified in stage 2 are closedMaintains records of all changes.
19 Pre-certification audit Pre-assessment auditor ensures that all operations and documentation are according to the selected conformance model.
20 Registrar documentation review Registrar reviews quality manual (and any other requested documents) as advance organiser to the organisation and the supporting documentation.
21 Site preparationManagement prepares organisation for the registrar and certification audit.
22 Certification auditRegistrar reviews quality system and documentation to determine if quality system meets the selected conformance model and can be certified as such.
23 Time taken depends on: Typically 12 to 18 months The amount of existing documentationThe complexity and size of the organisationThe ISO 9000 conformance model chosen for certificationThe commitment of managementThe documentation skills of the project teamsThe project management skills of the project teamsThe availability of certification auditors.Typically 12 to 18 months
24 The 20 Sections of ISO 9001ISO 9001 Standard contains 20 sections (known as 4.1 – 4.20.)ISO 9002 Standard contains 19 of the 20.ISO 9003 Standard contains 16 of the 20.
25 Management responsibility “Your organisation’s management shall provide forA quality policyAssignment of responsibility and authority to personnelResources for identification and verificationAppointment of a management representativeA management review for the suitability and effectiveness of your quality system.”
26 Quality system “Your organisation shall Plan, establish, maintain, and document your quality system to ensure that your product and/or service conforms to specified requirementsProvide an outline of the documentation structure and reference to immediate supporting documents in a quality manualProvide quality plans.”
27 Contract review“Your organisation shall review each contract or accepted order with your customer to ensure thatCustomer requirements are adequately definedYour organisation has the capability to meet these needs.”
28 Design control“Your organisation shall control and verify the design of its product to ensure that it meets specified requirements.”Not 9002Not 9003
29 Document and data control “Your organisation shall control all your quality system documents and data to ensure availability of documented information to those requiring it.”
30 Purchasing“Your organisation shall ensure that purchased product conforms to specified requirements.”Not 9003
31 Control of customer-supplied product “Your organisation shall provide for verification, storage, and maintenance of customer-supplied product provided for incorporation into your product.”
32 Product identification and traceability “Your organisation shall provide any necessary identification and traceability of incoming materials, in-process product, and finished product.”
33 Process control“Your production, installation, and servicing processes are operated under controlled conditions.”Not 9003
34 Inspection and testing “Your organisation shall ensure thatIncoming product is verified for conformance to specified requirementsIn-process product is inspected and tested as necessaryFinished product is verified as conforming to specified requirements prior to release.”
35 Control of inspection, measuring, and test equipment “Your organisation shallcontrol, calibrate, and maintain inspection, measuring, and test equipment and software used in your quality system to demonstrate the conformance of product to specified requirementsensure that measurement uncertainty is known and consistent with the required measurement capability.”
36 Inspection and test status “Your organisation shall ensure identification of inspection and test status of product throughout production, installation, and servicing.”
37 Control of non-conforming product “Your organisation shall ensure that non-conforming product is prevented from unintended use or installation.”
38 Corrective and preventive action “Your organisation shallInvestigate the cause of non-conforming product and consider corrective action needed to prevent recurrenceAnalyse your quality system to detect and eliminate potential causes of non-conforming product.”
39 Handling, storage, packaging, preservation, and delivery “Your organisation shall provide adequate handling, storage, preservation, packaging, and delivery of your product to ensure that it meets specified requirements.”
40 Control of quality records “Your organisation’s control of quality records process shall ensure that your quality records demonstrate that:Your quality system operates effectivelyRequired product quality is achieved.”
41 Internal quality audits Your organisation’s internal quality audit plan shall verify that your quality activities and related results meet requirements, and determine the effectiveness of your quality system.”
42 Training“Your organisation shall identify training needs and train personnel to meet these needs.”
43 Servicing“When servicing is a specified requirement in the contract, your organisation shall control that servicing and verify that it meets specified requirements.”Not 9003
44 Statistical techniques “Your organisation shall identify and use appropriate statistical techniques as necessary to verify the acceptability of process capability, product characteristics, and service.”
45 The Certification Audit The registrar visits your site(s) to:Meet with upper management to provide an overview of what will occur while they are there and answer any of management’s questionsDetermine whether or not your quality system is implemented according to the selected conformance model and the quality system documentation. To assess your quality system, the registrar asks your employees questions and observes employees performing their jobs.
46 The outcome. You cannot fail certification The outcome? You cannot fail certification. The worst that can happen is that you quit!