ISO 9001: 2015 BUSINESS PROCESS IMPLEMENTATION GENERAL AWARENESS ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION Business today? - External Major contracts required ISO 9001 Supply chain assessed against ISO 9001 Purchasers rely on ISO 9001 certification Expected integrity of supply and continuous improvement ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION Business today? - Internal Customer and contract focused Require competitive advantage Must be forward planning and pro-active Risk assessment and loss prevention activities Due diligence and self assessment ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION Management System Design Discussed and reviewed the existing systems Plot the department / functions Identify the key in-puts / out-puts (forms used) The internal customer / supplier (records) Collate / agree the documentation (format) Completed the draft “business system manual” ISO 9001 Made Easy by Dr.Bassam Salama

The Eight Quality Management Principles Applied to ISO 9001: 2015 Customer Focus Leadership Involving People Process Approach System Approach Continual Improvement Factual Decision Making Mutually Beneficial Supplier Relationships Risk Assessment ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION Quality Policy & Objectives Policy : Commitment to requirements and continual improvement Quality Objectives : Measurable and defined, consistent with the Policy ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION Emphasis on Legal Requirements Customer contract needs and expectations this must include: Regulatory and legal requirements Product and business integrity … as expected by any customer. ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION Training & Competence Induction training Equipment training Product training Evaluation of the effectiveness (appraisals) Employee awareness of their importance ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION Processes (System & Product Realisation) Identify the processes Determine the sequence and correctness Methods for operational control (forms) System monitoring and measurement (records) Information needed to support the effective management (business decisions). ISO 9001 Made Easy by Dr.Bassam Salama

Process Based Systems (Inspection) ISO 9001 & BUSINESS PROCESS Process Based Systems (Inspection) Managing a Process (scope of operation) INPUT PROCESS OUTPUT SITE-VISIT INSPECTION DATA REPORT SPECIFICATION METHOD RECORDS FILES SCOPE DATA ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION Internal Audits Programme based on importance / status. Evaluation of system against ISO 9001: 2015 Proof of auditor independence How this is achieved Who decides what to audit? ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION SESSION 2 ISO 9001: 2015 - THE STANDARD ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION 1. SCOPE The Scope of the Quality Management System Those parts of the business that are included within the system for certification (inspection services, product being inspected, report, etc.) ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION 2. NORMATIVE REFERENCES Make references to: ISO 9001:2015 Applicable: Standards, PAS, Directives, Codes, etc. appropriate to the Scope ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION 3. TERMS & DEFINITIONS The business terms defined within the trade As understood by the organisation ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION 4. QUALITY MANAGEMENT SYSTEM (4.1 General) (4.2 Documentation) The structures, resources, commitment, principles and policy towards supporting effective QMS implementation ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION 5. MANAGEMENT RESPONSIBILITY (5.1 Commitment) Leadership Change Management Improvement Communication ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION 5. MANAGEMENT RESPONSIBILITY (5.2 Customer) Customer focus Customer requirements Customer expectations Customer satisfaction ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION 6. RESOURCE MANAGEMENT (6.1 Provision of resources) Determine and provide resources For the quality management system For meeting customer requirements ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION 6. RESOURCE MANAGEMENT (6.2 Human resources) Determine and provide resources for Personnel requirements Quality system awareness training Training and experience records Evaluation and induction ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION 6. RESOURCE MANAGEMENT (6.3 Infrastructure) Computer system and information technology Materials, plant and equipment Environment Transport and communication ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION 6. RESOURCE MANAGEMENT (6.4 Work environment) Personnel Building Workspace Process Equipment To achieve product conformity ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION 7. PRODUCT REALISATION Planning of product (production control) Customer related processes Review of requirements Customer communication ISO 9001 Made Easy by Dr.Bassam Salama

ISO 9001 & BUSINESS PROCESS IMPLEMENTATION 8. MEASUREMENT, ANALYSIS AND IMPROVEMENT Monitoring and measurement of: Customer satisfaction Internal (quality system) auditing Process performance / improvement Product conformity / non-conformance ISO 9001 Made Easy by Dr.Bassam Salama