Presentation on theme: "ISO 9001:2000 Documentation Requirements"— Presentation transcript:
1 ISO 9001:2000 Documentation Requirements Based on ISO/TC 176/SC 2March 2001ISO 9001:2000
2 Two of the Most Important Objectives in the Revision of the ISO 9000- Standard To develop a simplified set of standards that will be equally applicable to small as well as medium and large organizationsFor the amount and detail of documentation required to be more relevant to the desired results of the organization’s process activities
3 ISO 9001:2000 Significantly reduces documentation requirements Is much less prescriptiveAllows more flexibility in choice of documentation systemIt is stressed that ISO 9001 requires (and has always required) a “Documented quality management system”, and not a “system of documents”.
4 ISO 9001:2000Enables each organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its quality management system
5 What Is a Document? Communication of information Evidence of conformityKnowledge sharingMain objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS.
6 Communication of Information The type and extent of the documentation will depend on the nature of the organization’s products and processesThe degree of formality of communication systemsThe level of communication skillsThe organizational structure
7 Evidence of Conformity Provision of evidence that what was planned has actually been done.Say what you do, do what you say and prove it.
8 Knowledge SharingIn order to disseminate and preserve the organization’s experiences.Example: a technical specification, which can be used as a base for design and development of a new product.
9 Document Mediums Paper Magnetic Electronic Photographic Master Sample OtherUsers are also referred to ISO/TR “Guidelines for quality management systems documentation” for further guidance.
10 Clause 4.1, General Requirements Documented statements of quality policy and quality objectivesA quality manualDocumented procedures required by the international standardDocuments needed by the organization to ensure effective planning, operation and control of its processesRecords required by the international standardThe notes after Clause 4.2 make it clear that where the standard specifically requires a “documented procedure” the procedure has to be established, documented, implemented and maintained.
11 Documented Statements of Quality Policy (1 of 2) Defined in Clause 5.3Appropriate to the purpose of the organizationIncludes a commitment to comply with requirements and continually improve the effectiveness of the Quality Management SystemA framework for establishing and quality objectives
12 Documented Statements of Quality Policy (2 of 2) Defined in Clause 5.3Is communicated and understood within the organizationIs reviewed for continuing suitabilityQuality Policy must be measurable
13 Documented Statements of Quality Objectives Defined in Clause 5.4.1Includes those needed to meet requirements for product [Clause 7.1]Are established at relevant functions and levels within the organizationAre measurable and consistent with Quality Policy
14 Quality Manual Minimum content specified in Clause 4.2.2 Scope of the Quality Management System, including details of and justification for any exclusionsDocumented procedures established for the QMS, or references to themDescription of the interaction between processes of the QMS
15 Quality Manual-Structure Structure of the manual is a decision for the organization based on:Organization’s sizeOrganization’s complexityOrganization’s cultureControlled in accordance with the requirements of Clause 4.2.3
16 Documented Procedures Required by ISO 9001:2000Control of documents (Clause 4.2.3)Control of records (Clause 4.2.4)Internal Audit (Clause 8.2.2)Control of nonconforming product (Clause 8.3)Corrective action (Clause 8.5.2)Preventive Action (Clause 8.5.3)
17 Documents Needed by the Organization Specifically referenced in ISO 9001:2000Quality policy (Clause 4.2.1a)Quality objectives (Clause 4.2.1a)Quality Manual (Clause 4.2.1b)
18 Additional Documentation There are several requirements of ISO 9001:2000 where an organization could add value to its Quality Management System and demonstrate conformity by the preparation of other documents
19 Additional Documentation Process maps, process flow charts,and/or process descriptionsOrganization chartsSpecificationsWork and/or test instructionsProduction schedulesApproved suppliers listsTest and inspection plansQuality plans
20 Documented Procedures Controlled in accordance with Clause 4.2.3May combine the procedure for several activities into one documentMay require more than one document for a single procedureMay require additional procedures in order to implement an effective QMS
21 RecordsRequirements for control of records are different from those for other documentsAll records have to be controlled in accordance with the requirements of Clause 4.2.4Organization are free to develop records that may be needed to demonstrate conformity of their processes, products, and QMS
22 Required Records (1 0f 2) Management reviews (5.6.1) Education, training, skills and experience (6.2.2e)Evidence that the realization processes and resulting product fulfill requirements (7.1d)Design and development inputs (7.3.2)Results of design and development reviews (7.3.4)Results of design and development verificationResults of design and development validationResults of review of design and development changes (7.3.7)
23 Required Records (2 of 2) Results of supplier evaluations (7.4.1) To demonstrate process validity where output cannot be measured (7.5.2d)The unique identification of a product (7.5.3)Customer property (7.5.4)Basis for calibration of measuring equipment (7.6a)Results of calibration (7.6)Internal audits (8.2.2)Release of product (8.2.2)Nonconforming product (8.3)Results of corrective action (8.5.2)Results of preventive action (8.5.3)
24 Preparing to Implement a QMS Process approachIdentify the processes necessary for effective implementationUnderstand interactions between these processesDocument the processes to assure effective operation and control
26 Process AnalysisShould be driving force for defining amount of documentation, taking into account the requirements of ISO 9001:2000Should not be the documentation that drives the processes
27 Demonstrating Conformity With ISO 9001:2000 May not need extensive documentationMust be able to provide objective evidence of effectiveness of processes and quality management system
28 Objective EvidenceData supporting the existence or verity of something (Clause of ISO 9000:2000)May be obtained through observation, measurement, test or other meansDoes not necessarily depend on documented procedures, records or other documents except where specifically required by ISO 9001:2000
29 Objective EvidenceWhere the organization has no specific procedure for a particular activity, and this is not required by specification, it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2000Example: Internal and external audits
30 Terms and DefinitionsDocument - information and its supporting medium (ISO 9000:2000 Clause 3.7.2)Procedure – Specified way to carry out an activity (3.7.4)Quality Manual – Document specifying the quality management system of an organizationQuality Plan – document specifying which procedures and associated resources shall be applied, by whom and when to a specific project (3.7.5)Record – document stating results achieved or providing evidence of activities performed (3.7.6)Specification – document stating requirements
31 BibliographyGuidance on the Documentation Requirements of ISO 9001:2000ISO/TC 176/SC 2/N525RMarch 2001Quality Management Systems – RequirementsISO/FDIS 9001