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Global Manager Group has designed awareness training presentation on ISO 9001:2015 to helps organization and consultants with information about update ISO/DIS 9001:2015 revision.
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C118 Awareness Training on ISO 9001:2015 PART – 2
Timeline to ISO 9001:2015 Revision Release and Client Transition 201320142015 2015 2018 June 2013 CD(Committee Draft) April 2014 DIS(Draft International Standard) July 2015 FDIS(Final Draft International Standard) September 2015 (Published International Standard) start of 3 years transition period to September 2018
Seven principle of ISO/DIS 9001:2015
ISO/DIS 9001: 2015 Standard Overview 0 Introduction Scope Normative references Terms and definitions Context of organization Leadership Planning of QMS Support Operations Performance evaluation Improvement
Main Changes • Risk-based thinking throughout the standard supersedes a single clause on preventive action • The term ‘documented information’ replaces ‘documents and records’ • The term ‘outsourcing’ is replaced by ‘external provision’ • Increased leadership requirements • No requirement for a management representative
Documented Information Required by ISO/DIS 9001 : 2015 List of Documented Information • Scope of the Quality management system(4.3 ) • Quality policy (5.2) • Quality Objectives (6.2) • Evidence of fitness of monitoring and measuring devices or instrument calibration and maintenance records (7.1.4) • Competence records for employee experience, qualification, skill or certification etc (7.2d) • Necessary information for effectiveness of QMS-Objectives monitoring sheet (7.5.1b) • Change control and version control- change control sheet (7.5.3c) • External origin documents necessary for planning and execution of QMS (7.5.3) • Establish confidence on processes - Process monitoring sheet and monitoring records (Process execution ,monitoring against planning) (8.1c) • Contract review results against requirements and amendments (8.2.3) • Processes of the QMS and resources( Quality Plan) (8.3) • Results of evaluation of external providers - External providers selection and evaluation records (8.4.2)
Clause 4.2 Understanding the needs & expectations of interested parties Interested parties: The organization shall consider the following relevant interested parties: Direct customers End users; Suppliers, distributors, retailers or others involved in the supply chain Regulators Any other relevant interested parties.
Areas to considered in risk and opportunity identification • Corporate Requirement • Business Requirement • Contractual Requirement • Client/customer Requirement • Process and product requirements • Legislative Requirement • Regulatory Requirement • Statutory Requirements
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