Executive Overview. Transitioning to ISO 9001:2015 Quality Management System. Biafore Associates Inc. Overview Objectives

Transcription

1 Executive Transitioning to ISO 9001:2015 Quality Management System Biafore Associates Inc. This guideline is for training purposes only; Not ISO controlled Objectives The overview objectives are as follows: -General QMS / ISO 9001:2015 Useful Terms -General: Why a need for Quality Management System? -ISO Supporting Standards -Process Approach QMS Systems Map -Plan-Do-Check (Study)-Act -Seven Quality Management Principles -Management System Standards (MSS) / / Annex SL -Risk Management -ISO 9001:2008 to ISO9001:2015 Transition Review -Understanding the Organization and it's Context -Understanding the Needs & Expectations of Interested Parties -Risk Management -Transition to the new Standard 2 Biafore Associate Inc. 1

2 ISO 9001:2015 Management System Useful Terms Stakeholder Context of the Organization Interested Party Risk Risk Management Top Management Policy Objective Documented Information Process Performance Outsource (verb) Monitoring 3 4 ISO Portfolio of Standards ISO Portfolio of Standards (ISO 9000, ISO 9004, ISO 9001) ISO 9001: The Requirements Standard This is the standard an organization is 3 rd party registered to ISO 9004: The Best Practice Standard Supports ISO 9001 Requirements standard Provides guidance for organizations that choose to progress beyond the requirements of the ISO 9001 Standard ISO 9000: Fundamentals and Vocabulary Supports ISO 9001 Requirements standard Provides an essential background for the proper understanding and implementation of the International Standard Biafore Associate Inc. 2

3 ISO Support Standards ISO Support Standards (ISO and ISO 31000, ISO Series) ISO 19011: The Auditing Standard Supports ISO 9001 Requirements standard Provides guidance and best practices on internal and external audits of Management Systems ISO 31000: The Risk Management Standard Supports ISO 9001 Requirements standard Provides guidance for organizations related to Risk Management methods including: identification, analysis, evaluation and mitigation ISO series of Standards are Referenced for additional support in the implementation of ISO 9001 ISO 10001/2/3/5/6/7/8/12/13/14/15/17/18/19 See ISO 9001:2015 for descriptions of each standard. 5 Why a need for Quality Management System? A robust quality management system can help an organization Prevent identified risks from occurring improve its overall performance The requirements of the International Standard are generic but the ways in which they are applied can differ from one organization to another. are complementary to requirements for products and services The intent of the ISO 9001 is not to: imply the need for uniformity in the structure of different quality management systems, Define uniformity of documentation to align to the clause structure of the International Standard, impose specific terminology to be used within the organization. 6 Biafore Associate Inc. 3

4 Why a need for Quality Management System? Along with the Organization s context the QMS design will be influenced with respect to: a) its specific objectives; b) the risks associated with its context and objectives; c) the needs and expectations of its customers and other relevant interested parties; d) the products and services it provides; e) the complexity of processes it employs and their interactions; f) the competence of persons within or working on behalf of the organization; g) its size and organizational structure. 7 Major changes in Terminology ISO 9001:2008 ISO 9001:2015 Products Exclusions Management representative Documentation, quality manual, documented procedures, records Work environment Monitoring and measuring equipment Purchased product Supplier Products and services Not used (The organization can only decide that a requirement is not applicable if its decision will not result in failure to achieve conformity of products and services) Not used (Similar responsibilities and authorities are assigned but no requirement for a single management representative) Documented information Environment for the operation of processes Monitoring and measuring resources Externally provided products and services External provider Biafore Associate Inc. 4

5 SYSTEMS MAP (PROCESS APPROACH) MODEL 4.1 Context / 4.3 QMS Scope 4.2 Interested Parties Customer & Stakeholder Requirements Product or Service Requirements INPUT A 6 Planning INPUT P 5 Leadership 10 Continual Improvement 4.4 Quality Management System + Processes 8 Operation 7 Support Processes C 9 Performance Evaluation D INPUT OUTPUT Customer & Stakeholder Product / Service Satisfaction Product or Service Delivery Plan-Do-Check-Act (PDCA) cycle ACT (Continually Improve) PLAN (extent depends on RISK) Other Processes INPUT (Requirements) PROCESS DO (Set of Activities) OUTPUT (Product) Other Processes CHECK (Monitor & Measure) 10 Biafore Associate Inc. 5

6 Quality Management Principles Current (2008) ISO 9K QMPs 1. Customer Focused 2. Leadership 3. Involvement of People 4. Process Approach 5. Systems Approach 6. Continual Improvement 7. Fact Based Decision Making 8. Mutually Beneficial Supplier Relationships New 2015 ISO9K QMPs 1. Customer Focused 2. Leadership 3. Engagement and Competence of People 4. Process Approach (Managing Processes as a System is Implied) 5. Improvement 6. Informed Decision Making 7. Relationship Management (as defined in Context of Organization) *Changes in Red 1.0 Scope 2.0 Normative Reference 3.0 Terms and Definitions 4.0 Quality Management System 5.0 Management Responsibility 6.0 Resource Management 7.0 Product Realization 8.0 Measurement, Analysis and Improvement 1.0 Scope 2.0 Normative Reference 3.0 Terms and Definitions 4.0 Context of the organization 5.0 Leadership 6.0 Planning 7.0 Support 8.0 Operation 9.0 Performance evaluation 10.0 Improvement 12 Biafore Associate Inc. 6

7 Management System Standards (MSS) Structure ISO 9001 QMS (Quality) Solves the problem of potential redundancy in basic structure for organizations wanting to adopt multiple standards ISO EMS (Environmental) Annex SL Joint Terminology, Structure and Other Content (Industry Specific Standards) IE. ISO/IEC (ISMS) One Management Team, One Management System! 13 Management System Standards (MSS) Structure MSS s adopting Annex SL (as of 2015): -ISO/IEC Info. Security Man. Systems -ISO Business Continuity -ISO Info. & Documentation -ISO 20121: Event Sustainability -ISO Road Traffic Safety / ISO Asset Management Next In-line (as of 3 rd QTR 2015): -ISO 9001 Quality Management -ISO Environmental Management -ISO Medical Device Under Review (expected in 2016): -ISO/TS Automotive -AS 9100/10/20 Aerospace -OHSAS Safety (or new ISO 45001) 14 Biafore Associate Inc. 7

8 4.0 Quality Management System 4.1 General Requirements Documentation General Quality Manual Control of Documents Control of Records 4.0 Context of the organization 4.1 Understanding the Org. and it s Context 4.2 Understanding the needs of inserted Parties 4.3 Determine scope of the QMS 4.4 QMS and it s Processes 7.0 Support 7.5 Documented Information General Creating & Updating (Documented Information) Control of Documented Information Understanding the Organization and it s Context Strategic Direction External Issues Customer Performance Supplier Performance State of the Economy Regulatory Requirements Determine & Monitor Issues Internal Issues Employee Perf. / Culture Performance to Objectives Capacity Constraints Intended Results Biafore Associate Inc. 8

9 4.2 Understanding the Needs & Expectations of Interested Parties Direct Parties Customer Suppliers Economics Regulatory Determine Relevant Interested Parties Indirect Parties Opposing Groups Competitor Society Determine Req. of Interested Parties Monitor Info. of Interested Parties 5.0 Management Responsibility 5.1 Management Commitment 5.2 Customer Focus 5.3 Quality Policy Quality Objectives Quality Management System Planning Responsibility and Authority Management Representative Internal Communications 5.6 Management Review Leadership Leadership and commitment for the quality management system Customer focus 5.2 Quality Policy 5.3 Organizational roles, responsibilities and authorities 6.0 Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes 7.0 Support 7.4 Communication 9. 0 Performance evaluation 9.3 Management review Biafore Associate Inc. 9

10 Risk Management Useful Terms (ref. ISO 31000) Risk Risk Management Risk Management Framework Risk Management Process Risk Assessment Risk Analysis (Quantitative / Qualitative) Risk Evaluation Risk Criteria Likelihood Level of Risk Risk Control 19 Risk Management Process Establish Context Risk Assessment Risk Identification Communication & Consultation A Risk Analysis Monitor & Review Risk Evaluation Risk Control Biafore Associate Inc. 10

11 6.0 Resource Management 6.1 Provision of Resources 6.2 Human resources Competence, Training & Awareness 6.3 Infrastructure 6.4 Work Environment 7.0 Support General People Infrastructure Environment for the operation of processes Monitoring and measuring resources Organizational knowledge 7.2 Competence Awareness 7.0 Product Realization 7.1 Planning of product realization Determination of requirements related to the product Review of requirements related to the product Customer communication 8.0 Operation 8.1 Operational planning and control Customer communication Determination of requirements related to products and services Review of requirements related to products and services 22 Biafore Associate Inc. 11

12 7.0 Product Realization 7.3 Design and development Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation 8.0 Operation 8.3 Design and development of products and services General Design and development planning Design and development Inputs Design and development controls Design and development outputs Design and development changes Control of design and development changes Product Realization 7.4 Purchasing Purchasing process Purchasing information Verification of purchased product 8.0 Operation 8.4 Control of externally provided products and services General Type and extent of control of external provision Information for external providers 24 Biafore Associate Inc. 12

13 7.0 Product Realization 7.5 Production and service provision Control of production and service provision Validation of processes for production and service provision Identification and traceability Customer property Preservation of product 7.6 Control of monitoring and measuring equipment 8.0 Operation Control of production and service provision Identification and traceability Property belonging to customers or external providers Preservation Post-delivery activities Control of changes Monitoring and measuring resources Measurement, Analysis and Improvement 8.1 General Customer satisfaction Internal audit Monitoring and measurement of processes 8.0 Operation 8.6 Release of products and services 8.7 Control of nonconforming process outputs, products and services 9. 0 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation Monitoring and measurement of product 8.3 Control of nonconforming product 8.4 Analysis of data Continual improvement Corrective action Preventive action General Customer satisfaction Analysis and evaluation 9.2 Internal audit Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement Biafore Associate Inc. 13

14 Transitioning to ISO 9001:2015 Clients currently registered to ISO 9001:2015 will have a 3 year migration to the 2015 version from the date of the release of the new standard. 3 rd Party Registrar s may have specific policies on transitioning or new registrations to the new standard. They range as follows: As soon as possible (adding.5 days for transition) Next Re-registration audit (adding.5 days for transition) new ISO 9001: 2008 certificates issued from now on must have an expiration date of September 23, 2018 new ISO 14001: 2004 certificates issued from now on must have an expiration date of September 15, 2018 last date we will be allowed to issue a NEW certificate for both ISO 9001: 2008 and ISO 14001: 2004, will be September 15, 2017 continue to allow clients to RE-CERTIFY to the older versions until December 31, 2017 Upgrades for ISO 9001: 2015 and ISO 14001: 2015 performed at surveillance will require a certification decision to be performed, but the new certificate will contain the current expiration date of the current cycle. Upgrades for ISO 9001: 2015 and ISO 14001: 2015 performed at re-certification will require a certification decision to be performed, and they will begin a new 3- year certification cycle. New Clients shall be registered to ISO 9001:2015 Refer to Registrar specific policies for direction. 27 Review of learning objectives of the overview: Session -General QMS / ISO 9001:2015 Useful Terms -General: Why a need for Quality Management System? -ISO Supporting Standards -Process Approach QMS Systems Map -Plan-Do-Check (Study)-Act -Seven Quality Management Principles - Management System Standards (MSS) / High Level Structure (HSL) / Annex SL -Risk Management -ISO 9001:2008 to ISO9001:2015 Transition Review -Understanding the Organization and it's Context -Understanding the Needs & Expectations of Interested Parties -Risk Management -Transition to the new Standard Contact and Follow-up Daniel Biafore Biafore Associates Inc. dbiafore@cogeco.ca Biafore Associate Inc. 14