Welcome ISO9001:2015 /ISO14001:2015

Transcription

1 Welcome ISO9001:2015 /ISO14001:2015 DQS 2017 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. 1

2 Presenters Joe Mansour ISO9001:2015 Program Manager Candace Orbaugh ISO14001:2015 Program Manager DQS Inc.

3 ISO14001:2015 ISO9001:2015 Issued 9/15/2015 ANAB Accredited DQS Inc.

4 Previous Webinars 1. Scope 2. Normative reference 3. Terms and definitions 4. Context of the organization 5. Leadership March 25, Planning 7. Support April 29, Operation 9. Performance evaluation May 26, Improvement IS Webinar on July 29,

5 ISO9001:2015/ISO14001: ISO 9001:2015 ISO14001:2015 DQS Inc.

6 ISO9001:2008 vs. IS09001:2015 ISO 9001:2008 ISO 9001:2015 ISO 9001:2008 ISO 9001:2015 ISO 9001:2008 ISO 9001:2015 ISO 9001:2008 ISO 9001: , 8.3.1, , 7.5.1, , , , , , , , 6.1, , , Clause removed see 6.1 6

7 Notable Changes Quality Manual Preventive Action Management Representative DQS Inc.

8 Notable Changes DQS Inc.

9 Notable Changes P-D-C-A ISO9001:2008 Preventive Action INPUT PROCESS OUTPUT DQS Inc.

10 Notable Changes P-D-C-A ISO9001:2015 Risk Based Thinking INPUT PROCESS OUTPUT DQS Inc.

11 ISO 9000:2015 Terms & Definitions PROCESS Set of interrelated or interacting activities which transforms inputs into outputs. 11

12 Section 4 - Context Of The Organization 4.1 Understanding the Organization and Its Context 4.2 Understanding The Needs And Expectations Of Interested Parties 4.3 Determining The Scope of The Quality Management System 4.4 Quality Management System And Its Processes 12

13 Benefits of Process Approach Benefits of the process approach are: Integration and alignment of processes to enable achievement of desired outcomes Ability to focus effort on process effectiveness and efficiency. Provision of confidence to customers, and other interested parties, about the consistent performance of the organization. Transparency of operations within the organization. Lower costs and creation of shorter cycle times, through the effective use of resources. Improved, consistent and predictable results. DQS Inc.

14 QMS and its Processes

15 4.4 QMS - and its Processes - Service 15

16 4.4 - QMS and its Processes The organization shall identify the processes and shall determine: The risks and opportunities The inputs required and the outputs expected The assign of the responsibilities and authorities The sequence and interaction of these processes The resources needed The criteria, methods, including performance indicators 16

17 4.4 STAMPING Process Quality Objectives For The Stamping Process OBJECTIVE ACTUAL GOAL ACTION PPM Continue to Monitor Machine Up Time 82 % 95% Increase PM, have spare parts available, staffing Parts Per Hour Continue to Monitor Cost of Rework $496 <$500 per month Continue to Monitor/consider risk

18 4.4 STAMPING Process Map Quality Objectives For Support Process Sales HR Cal Maint Revenue/Employee % Won # of hires # of training hours # overdue # out of tolerance % On Time, MTTF Repair Time, Uptime

19 PDCA Cycle Act Plan INPUT PROCESS (DO) OUTPUT Check 19

20 RISK Effect of uncertainty on an expected result. The effect can be positive or negative consequence - Risk is characterized by potential events and consequences. 20

21 Section 6 Planning for QMS Risk is the effect of uncertainty on an expected result. a) Incorporated in requirements for the establishment, implementation, maintenance and continual improvement of the QMS. b) May Use ISO but not required. c) Not all processes represent the same level of risk. d) Considering Risk qualitatively to define the QMS, processes and activities. 21

22 6.1 Actions Risks & Opportunities Addressing Risks/Opportunities Manage QMS Change Determine Risks and Opportunities per sections 4.1 and 4.2 Establish Quality Objectives Actions to Address Risks 22

23 Section 6 23

24 Section 6 7 R s of Risk Management Recognition of Risks Ranking or Evaluation of Risks Responding to Significant Risks Resourcing Controls Reaction Planning Reporting and Monitoring Reviewing Framework 24

25 Responding To Significant Risks Section 6 4 T s of Risk Management Tolerate Treat Transfer Terminate 25

26 Section 6 Planning for QMS Identify The Risks Analyze & Prioritize Plan Actions to address Take Action Check Effectiveness Learn & Improve 26

27 FMEA - RPN SEVERITY 1 No relevant effect 2 Very Minor, no damage 3 Minor, low damage 4 Moderate 5 Critical (loss of primary function) 6 Catastrophic Risk Priority Number (RPN) = Severity * Occurance * Detection OCCURANCE 1 Extremely Unlikely 2 Remote 3 Occasionally 4 Reasonably Possible 5 Frequent DETECTION 1 Certain 2 Almost Certain 3 High 4 Moderate 5 Low 6 Undetectable 27

28 Section 6 Failure-Mode-And-Effect (FMEA) RPN= Severity * Occurrence * Detection RPN= Risk Priority Number 28

29 Section 6 - Risk Register 29

30 Candace Orbaugh ISO14001:2015 Program Manager ISO14001:2015 DQS Inc.

31 ISO-14001:2015 Key Changes ISO-14001:2015 ISO-14001:2004 Key changes Introduction Introduction Background, Aim of Environmental system, Success Factors, PDCA 1 Scope 1 Scope No significant change 2 Normative References 2 Normative Reference No significant change 3 Terms and Definitions 3 Terms and Definitions Definitions of a few new terms including documented information, life cycle perspective DQS Group May 12,

32 Life cycle life cycle consecutive and interlinked stages of a product (or service) system, from raw material acquisition or generation from natural resources to final disposal. Note 1 to entry: The life cycle stages include acquisition of raw materials, design, production, transportation/ delivery, use, end-of-life treatment and final disposal

33 ISO 14001:2015 requires taking a life cycle perspective. In Annex A6.1.2, a life cycle perspective is explained as follows: This does not require a detailed life cycle assessment; thinking carefully about the life cycle stages that can be controlled or influenced by the organization is sufficient. The life cycle stages of a product (or service) include acquisition of raw materials, design, production, transportation/delivery, use, end-of life treatment and final disposal (3.3.3). In Clause 6.1.2, ISO 14001:2015 requires the organization to consider these life cycle stages when determining the environmental aspects that it can control or can influence. DQS Group May 12,

34 ISO-14001:2015 ISO-14001:2004 Key changes 4 Context of the organization 4.1 Understanding the organization and its context 4.2 Understanding the needs & expectations of interested parties New requirement for the organization to determine external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcomes of its environmental management system. Interested parties is now a requirement of the new standard 4.3 Determining the scope 4.1 General Requirements Similar, but with added detail and includes interested parties DQS Group May 12,

35 Context of organisaton Determining the scope of the environmental management system (4.3) The organization shall determine the boundaries and applicability of the environmental management system to establish its scope. (functional unit, boundaries, remote locations, temp. Sites..) DQS Group May 12,

36 How will the organization demonstrate that they have considered life cycle when determining aspects (6.1.2) and when planning and controlling operations, including design through end of life? DQS Group May 12,

37 ISO-14001:2015 ISO-14001:2004 Key changes 4.4 Environmental Management System 4.1 General Requirements In addition to previous requirements, new requirement to consider context and achieving intended outcomes DQS Group May 12,

38 ISO-14001:2015 ISO-14001:2004 Key changes 5.1 Leadership and Commitment New clause with expanded requirements for top management. 5.1 Leadership and commitment Top management shall demonstrate leadership and commitment with respect to the environmental management system by: taking accountability for the effectiveness of the environmental management system; ensuring that the resources needed for the environmental management system are available; ensuring that the environmental management system achieves its intended outcomes; supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility; DQS Group May 12,

39 ISO-14001:2015 ISO-14001:2004 Key changes 5.1 Leadership and Commitment New clause with expanded requirements for top management top management person or group of people who directs and controls an organization (3.1.4) at the highest level Note 1 to entry: Top management has the power to delegate authority and provide resources within theorganization. Note 2 to entry: If the scope of the management system (3.1.1) covers only part of an organization, then top management refers to those who direct and control that part of the organization. Section A51 in Annex A of guidance To demonstrate leadership and commitment, there are specific responsibilities related to the environmental management system in which top management should be personally involved or which top management should direct. Top management may delegate responsibility for these actions to others, but it retains accountability for ensuring the actions are performed. DQS Group May 12,

40 ISO-14001:2015 ISO-14001:2004 Key changes 5.2 Environmental Policy 5.2 Environmental Policy Same basic requirements 5.3 Organizational roles, responsibilities, and authorities Resources, Roles, responsibility, and authority New clause to split out resources. DQS Group May 12,

41 risks and opportunities ISO-14001:2015 ISO-14001:2004 Key changes 6.1 Actions to address risks and opportunities 6.1 General Environmental aspects New requirement relating to risk Risks and opportunities are defined as potential adverse effects (threats) or beneficial effects (opportunities), which may result from environmental aspects, compliance obligations, or from other issues and requirements identified as part of the context of the organization. The intent is for the organization to determine which risks or opportunities it considers to be important to address within its EMS, in order to achieve the intended outcomes of its EMS and support continual improvement. DQS Group May 12,

42 Risks and Opportunities Actions to address risks and opportunities 4.1 external and internal issues 4.2 interested parties Compliance obligations 4.3 scope of the environmental management system determine risks and opportunities Environmental aspects 42

43 ISO-14001:2015 ISO-14001:2004 Key changes Compliance obligations Legal and Other Requirements Basically the same requirement, new clause number Planning Action Specifically requires the organization to take action with regards to significant environmental aspects and compliance obligations. DQS Group May 12,

44 ISO-14001:2015 ISO-14001:2004 Key changes 6.2 Environmental objectives and planning Objectives, targets, and programs 7.1 Resources Resources, Roles, responsibility, and authority 7.2 Competence Competence, training, and awareness 7.3 Awareness Competence, training, and awareness Requirements are the same, but additional detail added Same requirements, but a separate clause Same requirement, highlighted by separating the clauses Same requirement, highlighted by separating the clauses DQS Group May 12,

45 ISO-14001:2015 ISO-14001:2004 Key changes 7.4 Communication General Internal communication External Communication 7.5 Documented information Documentation Control of documents Control of records Communication Same basic requirements. Internal and external communications separated out to demonstrate equal importance Documents and records included in same clause. Basic requirements of both remain the same DQS Group May 12,

46 ISO-14001:2015 ISO-14001:2004 Key changes 8.1 Operational planning and control Operational control Includes a few additional items, including control of outsourced processes, change management, lifecycle during purchasing and design. DQS Group May 12,

47 ISO 14001:2015 defines outsource as make an arrangement where an external organization performs part of an organization s function or process. A process or service obtained from an external provider is not necessarily an outsourced process. Outsourced processes can be viewed as a subset of these externally provided processes or services. Criteria that an organization can use to distinguish outsourced processes from other processes and services are described in Annex A.8.1, which states that an outsourced process is one that fulfils all of the following: it is within the scope of the environmental management system; it is integral to the organization s functioning; it is needed for the environmental management system to achieve its intended outcome; liability for conforming to requirements is retained by the organization; the organization and the external provider have a relationship where the process is perceived by interested parties as being carried out by the organization. DQS Group May 12,

48 ISO-14001:2015 ISO-14001:2004 Key changes 8.2 Emergency Preparedness & response Emergency Preparedness & response Same basic requirements DQS Group May 12,

49 ISO-14001:2015 ISO-14001:2004 Key changes 9.1 Monitoring, measurement, analysis & evaluation General Evaluation of compliance Evaluation of compliance Includes requirements for monitoring and measurement related to aspects, compliance obligations, operational controls, etc Same requirements 9.2 Internal Audit Internal Audits Same basic requirements DQS Group May 12,

50 ISO-14001:2015 ISO-14001:2004 Key changes 9.3 Management Review 4.6 Management Review Same input requirements. Output must include opportunities to improve integration of the EMS with other business processes and any implications for the strategic direction of the organization Improvement Organization must determine opportunities for improvement 10.2 Nonconformity and Corrective action Nonconformity, corrective action and preventive action Basically equivalent, the specific term preventive action was removed DQS Group May 12,

51 ISO-14001:2015 ISO-14001:2004 Key changes 10.3 Continual Improvement The organization shall continually improve the suitability, adequacy and effectiveness of the environmental management system to enhance environmental performance. DQS Group May 12,

52 TOP 10 #1 Context of the organization requires an understanding of the external and internal factors that could impact the organization s ability to meet its objectives. #2 Identification of Stakeholders and Interested Parties Although self-evident, the revised standards enlarge the group of stakeholders and interested parties beyond customers and owners / shareholders of the organization. DQS Inc.

53 TOP 10 #3 Risk-based Thinking An added dimension to decision making at all levels within the organization and encourages the consideration of risks and opportunities with achieving the desired objectives. #4 Process Approach A challenge even before the 2015 revisions. Organizations continue to address their management systems on the obsolete clause basis and are in the journey of thinking along business processes. DQS Inc.

54 TOP 10 #5 #6 Out-sourced Processes The applicability of these requirements has not changed and yet the type of control to be exercised over outsourced processes includes consideration of the environmental aspects and impacts over the life cycle of the product or service. Leadership and Commitment The requirement to demonstrate commitment DQS Inc.

55 TOP 10 #7 Multi-Site Coordination Larger organizations have an increased level of complexity with multiple locations and assuring consistent roll-out of business processes across the locations. #8 Timing In many large organizations, the timing decision on planning and implementing upgrades to the 2015 revision is made at a corporate or divisional level. While global or corporate processes are more conducive for changes with a short lead-time, DQS Inc.

56 TOP 10 #9 Terminology The revised standards indeed include new terminology for business concepts currently in place #10 Outcomes and Performance One of the significant changes is the focus on output matters and performance. DQS Inc.

57 Upgrade Audits QM08 to QM15 UM to UM15 Options

58 Transition Plan September 2015: Published International Standard September 2015: Start of 3 years transition period to September 2018

59 Upgrade Audits Available on under ISO9001:2015 Informational Sessions

60 Transition Plan An Organization may be upgraded to ISO9001:2015 or ISO14001:2015 During a scheduled Recertification Audit; with minimal additional days, if needed In a Planned Manner During A Surveillance Audit as Stage 2 Upgrade Assessment /Days same as TRI In a Planned Manner During A Surveillance Audit with additional Days as Surveillance Upgrade Assessment Through a Special Transition Audit with performing a Stage 2 Upgrade Assessment. DQS Inc.

61 Upgrade during a normal recert audit During a scheduled Recertification Audit; with minimal additional days, if needed Stage 2 Upgrade Assessment Stage 1 Stage 2 number of days for a recertification audit, with no reductions New Certificate Issued. New Certification cycle. Good for 3 years. DQS Inc.

62 Stage 2 upgrade during a surveillance In a Planned Manner During A Surveillance Audit as Stage 2 Upgrade Assessment /Days same as TRI Stage 1 Stage 2 number of days for a recertification audit, with no reductions New Certificate Issued. New Certification cycle. Good for 3 years. DQS Inc.

63 Surveillance Upgrade Assessment In a Planned Manner During A Surveillance Audit with additional Days as Surveillance Upgrade Assessment. Stage 1 Stage 2 number of days for Surveillance audit, with additional days (~35%) for a Surveillance Upgrade Assessment. New Certificate Issued. Does not reset the certification cycle. No change in certificate expiration date. DQS Inc.

64 Stage 2 upgrade audit at Special visit Through a Special Transition Audit with performing a Stage 2 Upgrade Assessment. Stage 1 Stage 2 number of days for a recertification audit, with no reductions New Certificate Issued. New Certification cycle. Good for 3 years. DQS Inc.

65 For Upgrades 2008 to 2015 Transition All Upgrade Options Require Stage 1. Stage 1 upgrade assessment Stage 2 upgrade assessment DQS Inc.

66 2008 to 2015 Transition Identification of Interested Parties and their requirements. Identification of Gaps and actions needed Identification of Risks and Opportunities Identification of Processes Context of the Organization and Leadership Requirements 66

67 2008 to 2015 Transition Develop the Stage 2/Upgrade Assessment agenda Review of one round of process-based Internal Audits to ISO9001:2015 At least one management review after the completion of the audits. Ensure Understanding of the Requirements Deployment of Process-based Management System Stage 1 to be done about 2-3 months prior to Stage 2. Review of QF / confirmation of Stage 2 Assessment days 67

68 DQS Inc.

69 ISO9001/14001:2015 Available Services ISO9001/ISO14001:2015 Transition Process and Requirements Availability of Gap Assessments 69

70 2008 to 2015 Transition Please let your Customer Service Representative know should be interested in these services and your Upgrade Plans. 70

71 Please send your questions to: DQS Inc.