Presentation on theme: "ISO 9001: Countdown to 2015 Presented by Ellen Diggs Ellen Diggs Consulting firstname.lastname@example.org February 11, 2015 It’s Not Just for Manufacturing Anymore!"— Presentation transcript:
1 ISO 9001: Countdown to Presented by Ellen Diggs Ellen Diggs Consulting February 11, 2015It’s Not Just for Manufacturing Anymore!This is presentation is part of a member meeting kit offered with assistance from the ASQ Knowledge Center. Find more information and resources here:The purpose is to involve local Sections and other ASQ member groups in discussions occurring across the Society on key topics in quality.The presentation will also point you to some of the content benefits you have access to with your membership through the Knowledge Center.The Knowledge Center is designed to be your front door to ASQ publications and other content resources. It contains editors picks that focus on new content, links to topics and types of publications, and a search function that allows you to search all ASQ publications by keyword.If you have questions or would like assistance before delivering this presentation, contact the ASQ Knowledge Center team atThank you for helping to deliver the key messages in this presentation!
2 ISO 9001 facts International standard for quality management systems Originally published in 1987Underwent major revision in 2000Implemented by more than one million organizations in over 170 countriesApplies to any organization regardless of size or industryStandards are “enablers for other major business processes” – The Boeing CompanyISO 9001 is one standard in the ISO 9000 series on quality management and quality assurance. The standards were developed to help companies effectively document the elements they need to maintain an efficient quality system. They are not specific to any one industry.The series includes ISO 9000:2005 (definitions), ISO 9001:2008 (requirements) and ISO 9004:2009 (continuous improvement).ISO 9001:2008 is the only standard in the ISO 9000 series to which organizations can certify.For more introductory information, visit
3 Reasons for 2015 revisionMaintain relevance for increasing diversity of users (industry, size, customer)Increase focus on effective process management to achieve desired resultsFacilitate integration with other management system standardsStandard structure, text, definitionsRecognition of supply chain complexityFormalize need for risk-based thinking within the context of the organizationAll ISO standards are periodically updated to maintain relevance.Regarding ISO 9001:2015, in particular, the revision will …- Respond to the increasing diversity of users, ensuring that needs of all user groups and industry sectors are met.- Allow for easier integration with other management system standards. The revision will use a common structure defined for management system standards such as environmental, health and safety, energy, and emergency preparedness.For a short video discussion, play an except (0:22 to 1:49) from this ASQ TV episode on standards and auditing:
4 Major Changes Structure – 10 clauses Understand organizational context Language – new terminologyProducts and servicesRisks and opportunitiesContext and interested partiesEffective resource managementSystematic control of changesBusiness strategy and QMS integrationFocus on process approach and effective process managementEmphasis on objectives, risks and opportunities within contextRisk and prevention in relation to context and interested parties.
5 Major Changes (continued) Language – new terminologyProducts and servicesRisks and opportunities (preventive action)Context and interested parties (customers)Documented information (documents and records)Relation with context and interested parties (as suitable)External providers of goods and services (suppliers)Effective resource managementSystematic control of changesDeletedQuality manualManagement representativeVerification and validationProduct realization
6 Quality Management Principles (QMPs) Customer focused organizationLeadershipInvolvement of peopleProcess approachSystem approachContinual improvementFactual approach to decision-makingMutually benefit supplier relationships7 QMPsCustomer focusLeadershipEngagement of peopleProcess approachImprovementEvidence based decision-makingRelationship management
8 Comparing the two… ISO 9001: 2008 ISO/DIS 9001:2015 4. General management systemControl of DocumentsControl of Records4. Quality management system (QMS)7.4 Documented information4.4. Process Approach5. Management ResponsibilityPlanningQuality objectivesQMS planningManagement representativeManagement review5. Leadership6. Planning for the QMS9.3 Management review6. Resource Management6.2 Human resources6.4 Work environment7.1 ResourcesCompetence7.1.4 Environment for the operation of processesPlanning for QMS includes identifying actions to address Risks and Opps and Change Management Planning4.1 relevant to strategic directionThings to consider :Changes and trends,Relations and Perceptions of relevant IP Governance, strategic priorities, Resources4.2 Understanding the needs - Understand and anticipate needs of and expectations of interested parties expectations affecting customer Requirements andcustomer satisfaction.Identifies relevant IP to be consideredNote on InnovationOpportunities
9 Comparing the two…(continued) ISO 9001: 2008ISO/DIS 9001:20157. Product realization7.1 Planning of product realization7.2 Customer-related processesDesign and developmentPurchasing7.4.3 Verification of purchased product7.5.2 Validation of processesControl of monitoring and measuring equipment8. Operations8.1 Operational planning and control8.2 Determine requirements for products and services8.3 Design and development of products and servicesControl of externally provided goods and services8.4.3 Release of products and services8.5.1 Control of product and services7.1.5 Monitoring and measurement resourcesPurchasing - Addresses all forms of external provision• Risk based approach to determine type and extent of control
10 Comparing the two…(continued) ISO 9001: 2008ISO/DIS 9001:2015Monitoring, analysis and improvementMonitoring of processMonitoring of productControl of nonconforming product8.4 Analysis of data8.5 Improvement8.5.2 Corrective Action8.5.3 Preventive Action9.1 Monitoring, measurement, analysis, and evaluationRelease of products and servicesControl of nonconforming process outputs, products and servicesAnalysis and evaluationImprovementNonconformities and corrective actionActions to address risks and opportunitiesMonitoring of process and product removed and covered by section 9.1 , Control of n/c product is now Control of nonconforming process outputs, products and services.
11 The text… Context of the organization (4) Leadership (5) Relevant to strategic directionUnderstand and anticipate customer needs and expectationsThe organization shall apply a process approachLeadership (5)With respect to the QMS and the customer (context)Shall be accountable for the effectiveness of the QMSAssign responsibility and authority
12 The text….(continued) Planning (6) Support (7) Consider context to identify risks and opportunities that need to be addressedIdentify the need and opportunity for changeTake change in a planned matterSupport (7)Resources (infrastructure, process environment, monitoring and measurement devices, and knowledge)Competence and awarenessCommunicationDocumented information
13 The text… (continued) Operations (8) Determination of market needs and interactions with customersOperational planning processControl of external provision of goods and servicesDevelopment of goods and servicesProduction of goods and servicesRelease of goods and servicesNonconforming goods and services
14 The text…(continued) Performance Evaluation (9) Improvement (10) Monitoring, measurement, analysis and evaluationInternal audit and Management ReviewAnalysis of data reinforced and clarifiedQMS performance indicatorsImprovement (10)Shall improve the QMS, processes, and goods and services, as appropriate, in response to:Results of analysis of dataChanges in organizational contextChanges in identified risk and new opportunitiesShall evaluate, prioritize and determine theimprovement to be implemented
15 Where’s the risk??Risk-based thinking…the organization is required to:4 (Context) Determine the risks to product or service conformity and customer satisfaction5 (Leadership) Commit to Clause 46 (Planning) Take action to identify risks and opportunities8 (Operation) Implement process to address risks and opportunities9 (Performance) Monitor, measure, analyze and evaluate risks and opportunities10 (Improvement) Respond to changes in riskDefinition of risk – the effect of uncertainty on an expected result (in this case, product or service conformity and customer satisfaction)
16 ISO 9001:2015 timelineJune 2013: Committee Draft (CD) Mid 2014: Expected publication of Draft International Standard (DIS) Mid 2015: Expected publication of Final Draft International Standard (FDIS) End 2015: Publication of International Standard as ISO 9001:2015 Currently, ISO 9001:2015 is in the committee draft stage.Countries participating in the development process are forming their national positions on the committee draft, which will result in the Draft International Standard (DIS).The DIS is expected to be released in mid 2014 and will be made available for public comment.
17 Currently certified to ISO 9001:2008? Transition period begins when new revision is publishedExpect to have three years before ISO 9001:2008 becomes out of dateCertify to ISO 9001:2015 before transition period ends (expected late 2018)
18 And members can always find more information about standards and ISO 9001 by visiting the Knowledge Center. From any page on the ASQ site, use the main menu bar to navigate to the Knowledge Center, and you’ll find a topic menu.For assistance finding ASQ content, contact the Knowledge Center team at