3 X 3 Key Requirements of ISO/DIS 9001:2015

Transcription

1 3 X 3 Key Requirements of ISO/DIS 9001:2015 Jumpstart your QMS transition! 1

2 What is ISO/DIS 9001:2015?» ISO 9001 Quality Management System requirements standard» Demonstrate consistent good quality products/services meeting customer requirements» Over 1.1 million ISO 9001 certifications worldwide» DIS = Draft International Standard» 4 th Revision/review stage of the ISO 9001» Reflects proposed changes to ISO 9001» Provided for users/interested parties to offer comment and achieve consensus prior to adopting proposed changes 2

3 Why Revise ISO 9001?» 5 year standards review cycle» ISO management systems standards High Level Structure, (Annex SL)» Common management system standards structure/framework and requirements» Alignment and ease of implementation» NEW requirements mainly related to adoption of ISO High Level Structure 3

4 3 X 3 Key Requirements» 3 Core Concepts of ISO 9001:2015» 3 New Requirements to implement and audit» 3 External Audit/ Registrar discussion points 4

5 This session is for you if...» Your organization is currently certified to ISO 9001:2008 and you want to continue certification of your QMS in the future» You are responsible for implementing or maintaining your organization s QMS to ISO 9001 requirements» You conduct audits of QMS based on ISO 9001 requirements» You want to know what s new with ISO

6 Your Take-away?» Keep calm and breathe easy!» Ideas for updating your current QMS to address new requirements» Considerations for auditing new requirements» Actions you can take now to ease the transition to ISO 9001:2015» Resources to support you and your organization in updating your QMS 6

7 Your ISO 9001 QMS Expert: Cathy Fisher» Over 30 years industry experience» Worked with ISO 9001 for over 20 years» Hundreds of QMS implementations» Thousands of management systems audit days» A passion for Quality! 7

8 3 Core Concepts 1. Process approach 2. P-D-C-A, (Plan-Do-Check-Act) 3. Risk-based Thinking 8

9 Process Methods (instructions, etc.) Work Environment (facility, layout, etc.) Input Materials (requirements) Process steps Evaluation (gages, etc.) Output Product/Output (requirements) Equipment (selection, Maintenance, etc.) People (training, skills) 9

10 CUSTOMER INPUT Determination of Requirements Related to Product System ACTING of change IMPROVEMENT: (Management) b) maintain integrity of QMS in case 8.5 Improvement: continual improvement, corrective action, preventive action Strategic Planning/Improvement On-Going Improvement BUSINESS PLANNING: (Management) 4.1, 4.2.1, QMS planning & documentation requirements 5.1, 5.2, 5.3, 5.4 Management Responsibilities 6.1 Resource planning Continual Planning PRODUCT REALIZATION 7.1 Planning of Product Realization 7.2 Customer-related processes 7.3 Design & Development $$$ 7.4 Purchasing 7.5 Production & Service Provision including control, validation of processes, identification & traceability, customer property nad preservation of product RESOURCE PROVISION: (Management) 4.2.3, Document & Record Control 5.5 Responsibility, Authority & DOING Communication 6.2 Human Resources including competency, awareness & training 6.3, 6.4 Infrastructure & Work Environment 7.6 Control of Monitoring & Measurement Devices 5.6 Management Review Measures of Effectiveness EVALUATION: (Management) c) training effectiveness Verification of purchased product CHECKING Validation of processes 8.1 planning of monitoring/measurement, analysis & improvement Internal audit 8.2.3, Monitoring/Measurement of Processes & Product 8.3 Control of Nonconforming Product 8.4 Analysis of data Customer Feedback Customer Communication Customer Satisfaction Measures of Efficiency diagram 2: Managed Activities/Process System 10

11 Process Approach» Introduced in ISO 14001:1996 EMS standard» Adopted in ISO 9001:2000 QMS standard» Reflects how organizations do business» See ISO Guidance 544R3 11

12 PDCA Cycle ACT PLAN CHECK DO 12

13 PDCA» Plan-Do-Check-Act» Deming Improvement Cycle» Thinking behind Process Approach» How individual processes and overall system are managed» See ISO Guidance 544R3 13

14 PDCA Process Methods (instructions, etc.) ACT Work Environment (facility, layout, etc.) PLAN Evaluation (gages, etc.) Input Materials (requirements) Process steps Output Product/Output (requirements) CHECK Equipment (selection, Maintenance, etc.) DO People (training, skills) 14 14

15 CUSTOMER INPUT Determination of Requirements Related to Product System ACT ACTING of change IMPROVEMENT: (Management) b) maintain integrity of QMS in case 8.5 Improvement: continual improvement, corrective action, preventive action Strategic Planning/Improvement On-Going Improvement BUSINESS PLANNING: (Management) 4.1, 4.2.1, QMS planning & documentation requirements 5.1, 5.2, 5.3, 5.4 Management Responsibilities 6.1 Resource planning Continual Planning PRODUCT REALIZATION 7.1 Planning of Product Realization 7.2 Customer-related processes 7.3 Design & Development $$$ 7.4 Purchasing 7.5 Production & Service Provision including control, validation of processes, identification & traceability, customer property nad preservation of product PLAN RESOURCE PROVISION: (Management) 4.2.3, Document & Record Control 5.5 Responsibility, Authority & DOING Communication 6.2 Human Resources including competency, awareness & training 6.3, 6.4 Infrastructure & Work Environment 7.6 Control of Monitoring & Measurement Devices 5.6 Management Review Measures of Effectiveness CHECK EVALUATION: (Management) c) training effectiveness Verification of purchased product CHECKING Validation of processes 8.1 planning of monitoring/measurement, analysis & improvement Internal audit 8.2.3, Monitoring/Measurement of Processes & Product 8.3 Control of Nonconforming Product 8.4 Analysis of data Customer Feedback Customer Communication Customer Satisfaction Measures of Efficiency DO diagram 2: Managed Activities/Process System 15

16 Risk-based Thinking» Formerly Preventive Action, (8.5.3)» Also implied in QMS and product realization planning, change, management review, etc.» Risk = effect of uncertainty on an expected result» See ISO and ISO 31010» (more on this shortly!) 16

17 3 New Requirements 1. Context of Organization 2. Risk-based Thinking 3. Knowledge 17

18 Context of the Organization» Relates to 2 NEW requirements clauses 4.1 Understanding the organization and its context 4.2 Understanding the needs and expectations of interested parties» Determine internal & external issues and requirements that can impact on planning of the QMS» Scope of QMS remains the same: demonstrate ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements and aim to enhance customer satisfaction. 18

19 4.1 Understanding the organization and its context» Determine internal & external issues relevant to organization s purpose and strategic direction» Issues that affect ability to achieve intended results of QMS» Monitor and review information about these issues» Intent: integrate QMS into overall business planning, operations, etc.» Internal context: values, culture, knowledge, organization performance» External context: legal, technological, competitive, market, cultural, social, economic environments, (local, regional, national, international) 19

20 4.2 Understanding the needs and expectations of interested parties» Determine interested parties relevant to QMS» Requirements of these interested parties» Monitor and review information about interested parties and their relevant requirements» Intent: look beyond who you sell your products/ services to» Supply chain» Supporters» Influencers» Other? 20

21 A Business is a Network of Management Systems Quality Management System - customer Information Management System internal, etc. Environmental Management System neighbors, etc. Resource Management System suppliers, etc. Top Management Safety & Health Management System employees Other management systems Technology Management Systems competitors, industry Financial Management System - shareholders 21

22 What Context of the Organization may look like» Top leadership owns QMS, (no longer QMS as one-man show!)» QMS integrated into business planning» QMS-related business metrics» Organization-wide recognition of internal & external QMS stakeholders» Other?» (see Quistem s December & January Q- Revolution e-zines) 22

23 Risk-based Thinking» Woven throughout ISO 9001:2015 requirements» Relates to establishing, implementing, maintaining and improving QMS» Risk consideration is qualitative based on organization s context, processes, etc.» No requirement for formal risk management» No requirement for documented risk management process 23

24 Risk-based Thinking Requirements» 4.4 f) determine risks and opportunities and plan and implement appropriate actions to address them» b) top management ensure the risks and opportunities that can affect conformity of products and services and ability to enhance customer satisfaction are determined and addressed» 6.1 Actions to address risks and opportunities when planning QMS 24

25 Risk-based Thinking Requirements (cont.)» 6.3 consider consequences of change to QMS» validity of previous measurement results when measuring instrument found to be defective» 7.3 persons doing work under the organization s control shall be aware of implication of not conforming with QMS requirements 25

26 Risk-based Thinking Requirements (cont.)» 8.1 review consequences of unintended changes, taking action to mitigate any adverse effects» communicate with customers re: specific requirements for contingency actions» determine potential consequences of failure due to nature of products/services» review, control, identify changes... no adverse impact on conformity to requirements 26

27 Risk-based Thinking Requirements (cont.)» Type & extent of control of external provision» a) in determining extent of post-delivery activities required, organization shall consider risks associated with products/services» 8.7 take appropriate corrective action based on nature of nonconformity an impact on conformity of products/services» a) considerations when planning internal audits» 9.3 Management review 27

28 What Risk-based Thinking may look like» SWOT analysis in business planning» FMEA, FTA in product/process planning» Risk review of changes» Other? 28

29 7.1.6 Organizational Knowledge» Determine knowledge necessary for operation of processes and achieve conformity of products/services» Maintain and make knowledge available» Consider current knowledge and determine how to acquire/ access necessary additional knowledge when addressing changing needs and trends 29

30 Organizational Knowledge» Explicit = written down; available/accessible» Implicit = known but not yet captured» Tacit = 2 nd nature to us; not readily recognized; (unconscious competence)» Intellectual property» Lessons learned, (failures & successes)» Topical experts within organization» External: standards, conferences, customers, competition, academia, etc.) 30

31 What Organizational Knowledge may look like» Directory of SMEs» Lessons Learned database» FMEAs» SOPs» Design standards» Other? 31

32 3 External Audit/Registrar Discussion Points 1. Scope of QMS, (based on Context of Organization) 2. Design & Development requirement applicability 3. External provision of products/ services, (especially outsourced processes) 32

33 4.3 Determining the Scope of QMS» Determine boundaries and applicability of QMS» Consider internal and external issues, (4.1)» Requirements of relevant interested parties, (4.2)» Products and services of the organization» Scope available and maintained as documented information stating Products and services covered by QMS Justification for any instance where a requirement of ISO 9001 can t be applied 33

34 Applicability» Reference to permissible exclusions removed from standard» Apply any and all requirements which are part of the scope of your QMS» Determine which requirements are not applicable» Reflected via scope statement of QMS» Non-applicability of requirements can t result in failure to achieve conformity of products and services or to meet the aim of enhancing customer satisfaction. 34

35 8.3 Design & Development» Where detailed requirements of the organization s products and services are not already established or not defined by the customer or by other interested parties, such that they are adequate for subsequent production or service provision, the organization shall establish, implement and maintain a design and development process. 35

36 8.4 External Provision of Products & Services» The organization shall apply the specified requirements for the control of externally provided products and services when: Products and services are provided by external providers for incorporation into your organization s own products and services, Products and services are provided directly to the customer(s) by external providers on behalf of your organization, A process or part of a process is provided by an external provider as a result of a decision by your organization to Outsource a process or function 36

37 Control of externally provided products and services» Applies to all types of external provision, (products and services obtained from outside your organization)» Purchasing from suppliers» Arrangements with associate companies» Outsourcing processes/functions of the organization» Other?» Apply risk-based approach in determining type and extent of controls for external providers and externally provided products and services 37

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39 ISO 9001:2015 Timeline» 90% consensus achieved for DIS to move to FDIS in November, 2014» Currently preparing FDIS, (available soon!)» Comment period mid-2015» ISO 9001:2015 by end 2015» 3 year transition period following release 39

40 Other ISO Management Systems Standards» ISO currently DIS; tracking for release similar timing to ISO 9001:2015» ISO replaces OHSAS 18001; currently CD; final publication scheduled for late

41 » How do you feel about the information shared?» What information was most valuable for you?» What questions do you still have?» What are your next steps? 41

42 Thank You! Go to: for 1. A copy of this presentation 2. Detailed requirements map comparing ISO/DIS 9001:2015 with ISO 9001: Context of Organization information 42