Quality Management Systems ISO 9001 : 2000 Quality Management Systems 4-SYSTEM REQUIREMENTS Ships in Service Training Material A-M CHAUVEL

Quality Management Systems Q M S REQUIREMENTS 1- The organization shall define and manage the processes necessary to ensure that product and/or service conforms to customer requirement. Quality Management Systems ISO 9001 2- The organization shall establish a quality management system covering all the requirements of the ISO 9001 Standard. Ships in Service Training Material A-M CHAUVEL 400

Quality Management Systems Q M S REQUIREMENTS 3- The organization shall prepare quality management procedures that describe the processes required to implement the quality system. Quality Management Systems ISO 9001 The system procedures depend upon : 1- Size and type of organization 2- Complexity and interaction of the processes 3- Methods used and skills and training of the personnel involved in performing the work Ships in Service Training Material A-M CHAUVEL 400

Quality Management Systems Q M S REQUIREMENTS The system procedures shall include : 1- System level procedures that describe the activities required to implement the QMS. 2- Procedures that describe the sequence and interactive nature of the processes necessary to ensure the conformity of the product and/or service 3- Instructions that describe the operating practice and control of process activities Quality Management Systems ISO 9001 Ships in Service Training Material A-M CHAUVEL 400

Quality Management Systems From Supplier to Organisation ISO 9001 - 1994 ISO 9000 - 2000 Subcontractor Supplier Quality Management Systems ISO 9001 Organisation Supplier Client Client Ships in Service Training Material A-M CHAUVEL

Quality Management Systems Q M S REQUIREMENTS Define and manage the processes Quality Management Systems ISO 9001 Establish a quality management system Organization Prepare system procedures Ships in Service Training Material A-M CHAUVEL 400

Quality Management Systems ISO 9001 Quality Management Systems 5-MANAGEMENT RESPONSIBILITY Ships in Service Training Material A-M CHAUVEL

Quality Management Systems MANAGEMENT RESPONSIBILITY 5.1 General requirements 5.2 Customer requirements 5.3 Legal requirements 5.4 Policy 5.5 Planning 5.6 Quality management system 5.7 Management review Quality Management Systems ISO 9001 Ships in Service Training Material A-M CHAUVEL 500

Quality Management Systems MANAGEMENT RESPONSIBILITY General requirements Customer requirements Legal Quality Management Systems ISO 9001 Quality management system Planning System Management review Ships in Service Training Material A-M CHAUVEL 500

Quality Management Systems GENERAL REQUIREMENTS Top management shall demonstrate its commitment to : - Creating and maintaining awareness of the importance to fulfil customer requirements - Establishing the quality policy and the quality objectives and planning - Establishing a quality management system - Performing management review - Ensuring the availability of resources Quality Management Systems ISO 9001 Ships in Service Training Material A-M CHAUVEL 501

Quality Management Systems CUSTOMER REQUIREMENTS Customer needs Customer expectations Quality Management Systems ISO 9001 Customer requirements Understood Met 721 Ships in Service Training Material A-M CHAUVEL 520

Quality Management Systems LEGAL REQUIREMENTS Establish Maintain Quality Management Systems ISO 9001 Procedure Identify and have access to legal requirements applicable to quality aspects of its products and/or services Ships in Service Training Material A-M CHAUVEL 530

Quality Management Systems Organisation needs Customer Appropriate Meeting requirements Continual improvement Commitment Continuing suitability Review Quality Management Systems ISO 9001 POLICY Establishing objectives Reviewing Framework Understood Implemented Communicated Organisation Ships in Service Training Material A-M CHAUVEL 540

Quality Management Systems OBJECTIVES Policy Quality Management Systems ISO 9001 Coherence Requirements for products and services Commitment for continual improvement Ships in Service Training Material A-M CHAUVEL 551

Quality Management Systems QUALITY PLANNING Planing shall covers : Process required Realisation processes Resources needed Quality Characteristics Verification activities Criteria for acceptability Quality records Quality Management Systems ISO 9001 TO REACH THE OBJECTIVE Ships in Service Training Material A-M CHAUVEL 552

The company shall establish a : Quality Management Systems representative Internal communication Responsibility and authority Quality Management Systems ISO 9001 QUALITY MANAGEMENT SYSTEM Control of documents Control of records Quality manual Ships in Service Training Material A-M CHAUVEL 560

Quality Management Systems RESPONSIBILITY AND AUTHORITY Function Quality Management Systems ISO 9001 Responsibility Authority Degree of freedom Ships in Service Training Material A-M CHAUVEL 562

Quality Management Systems MANAGEMENT REPRESENTATIVE Top management shall appoint a member of the management who shall have defined authority that includes : - ensuring that the system is implemented and maintain Quality Management Systems ISO 9001 - reporting to top management on the performance of the system including needs for improvement - ensuring awareness of customer requirements throughout the organization Ships in Service Training Material A-M CHAUVEL 563

Quality Management Systems INTERNAL COMMUNICATION LEVELS AND FUNCTIONS Quality Management Systems ISO 9001 EFFECTIVENESS Ships in Service Training Material A-M CHAUVEL 564

QUALITY MANUAL The organization shall prepare a quality manual which include : - description of the elements of the system - interaction of the elements of the system - any reduction in the scope of the standard Quality Management Systems ISO 9001 - system level procedures or reference thereto The quality manual need not be a stand-alone document Ships in Service Training Material A-M CHAUVEL 565

Quality Management Systems CONTROL OF DOCUMENTS Master list revision status Relevant Adequacy Approved Quality Management Systems ISO 9001 Release Available Obsolete documents Revision Retained for legal purposes Ships in Service Training Material A-M CHAUVEL 566

Quality Management Systems CONTROL OF RECORDS Conservation Evidence Conformance to requirements Effective operation of the system Quality Management Systems ISO 9001 Identification, storage, retrieval, protection, retention time and disposition Ships in Service Training Material A-M CHAUVEL 567

Quality Management Systems MANAGEMENT REVIEW Management reviews actions follow-up Customer feedback Results of audits Quality Management Systems ISO 9001 Processes & product analysis Preventive & corrective action Changing circumstances Resource needs Quality management system improvement Ships in Service Training Material A-M CHAUVEL 570

Quality Management Systems ISO 9001 Quality Management Systems 6-RESSOURCE MANAGEMENT Ships in Service Training Material A-M CHAUVEL

Quality Management Systems RESOURCE MANAGEMENT The organisation shall determine and provide in a timely manner, the resources needed to establish and maintain the quality management system. Quality Management Systems ISO 9001 600 Ships in Service Training Material A-M CHAUVEL

Quality Management Systems RESOURCE MANAGEMENT Human resources Information Quality Management Systems ISO 9001 Infrastructure Work environment 600 Ships in Service Training Material A-M CHAUVEL

Education Training Skills Experience ASSIGNMENT OF PERSONNEL Personnel shall be competent on the basis of : Education Training Quality Management Systems ISO 9001 Skills Experience 621 Ships in Service Training Material A-M CHAUVEL

Quality Management Systems COMPETENCE TRAINING QUALIFICATION AND AWARENESS Identify training needs Quality Management Systems ISO 9001 Maintain records Provide training AWARENESS Evaluate effectiveness 622 Ships in Service Training Material A-M CHAUVEL

COMPETENCE TRAINING QUALIFICATION AND AWARENESS The organization shall establish and maintain procedures to make employees aware of : - Importance of conformance with the quality policy Quality Management Systems ISO 9001 - Significant impacts of their work activities on quality - The benefits of improved personal performance 622 Ships in Service Training Material A-M CHAUVEL

COMPETENCE TRAINING QUALIFICATION AND AWARENESS The organization shall establish and maintain procedures to make employees aware of : - Their roles and responsibilities in achieving conformance with quality policy Quality Management Systems ISO 9001 - Potential consequences of departure from specified operating procedures 622 Ships in Service Training Material A-M CHAUVEL

Quality Management Systems INFORMATION ? The organization shall determine Control of processes Ensure conformity Necessary to Access Protection To ensure Quality Management Systems ISO 9001 630 Ships in Service Training Material A-M CHAUVEL

INFRASTRUCTURE The organization shall define, provide and maintain the infrastructure needed to achieve the conformity of the product and/or service Workspace Associated facilities Quality Management Systems ISO 9001 Equipment Hardware Software Maintenance Supporting Services Ships in Service Training Material A-M CHAUVEL

Quality Management Systems WORK ENVIRONMENT The organization shall define and implement those human and physical factors needed to achieve conformity of the product and/or service Health and safety conditions Work methods Quality Management Systems ISO 9001 Work ethics Ambient working conditions 650 Ships in Service Training Material A-M CHAUVEL

Quality Management Systems ISO 9001 Quality Management Systems 7-PRODUCT / SERVICE REALIZATION Ships in Service Training Material A-M CHAUVEL

552 PRODUCT / SERVICE REALISATION Methods Processes Practices implemented Sequences Interactions Quality Management Systems ISO 9001 Determined 552 Elements output Planned Results shall be maintain as quality records 710 710 Ships in Service Training Material A-M CHAUVEL

Quality Management Systems PRODUCT / SERVICE REALISATION 7.2 Clients C1 C2 C3 Input Output Understand 7.3 Design D1 D2 D3 Input Output Conceive 7.4 Purchasing A1 A2 A3 Input Output Buy Quality Management Systems ISO 9001 7.5 Production P1 P2 P3 Input Output Do 7.6 Measurement M1 M2 M3 Input Output Control 710 Ships in Service Training Material A-M CHAUVEL

PRODUCT / SERVICE REALISATION The organization shall determinate how each process affects the ability to meet product and/or service with customer requirements : Methods Practices Criteria Quality Management Systems ISO 9001 Verify that processes can be operated to achieve product / service conformance Implement arrangements for measurement, monitoring, and follow-up actions Make available information and data necessary Keep the results of process control measurement 710 Ships in Service Training Material A-M CHAUVEL

Quality Management Systems To meet the customer requirements CUSTOMER-RELATED PROCESSES Identification of the customer requirements Review of the customer requirements Quality Management Systems ISO 9001 To meet the customer requirements Customer communication 720 Ships in Service Training Material A-M CHAUVEL A-M CHAUVEL - BUREAU VERITAS - DNS / DCO

IDENTIFICATION OF CUSTOMER REQUIREMENTS The organization shall establish a process to determine : The customer requirements Completeness of the customer product / service requirements Quality Management Systems ISO 9001 Requirements not specified but necessary for fitness for purpose Obligations related to product / service legal and regulatory requirements Requirements for availability, delivery and support of product / service Ships in Service Training Material A-M CHAUVEL 721

REVIEW OF CUSTOMER REQUIREMENTS The customer requirements, including any requested changes, shall be reviewed : Before a commitment to supply product / service Requirements clearly defined Quality Management Systems ISO 9001 Requirements confirmed before acceptance Requirements differing from those previously expressed Organisation ability to meet the customer requirements Ships in Service Training Material A-M CHAUVEL 722

CUSTOMER COMMUNICATION The organization shall implement arrangements for communication with customers : With the aim of meeting customer requirements Product / service information Quality Management Systems ISO 9001 Enquiry and order handling including amendments Customer complaints and actions relating to non conforming product / service Customer responses relating to performance of the product / service 723 Ships in Service Training Material A-M CHAUVEL

Quality Management Systems DESIGN AND DEVELOPMENT - Responsibilities and authorities - Input - Output - Review - Verification - Validation - Control of changes Quality Management Systems ISO 9001 730 Ships in Service Training Material A-M CHAUVEL

Interfaces between groups DESIGN AND DEVELOPMENT Plans Activities Interfaces between groups Review Control of changes Verification Validation Quality Management Systems ISO 9001 Inputs Outputs 731 Ships in Service Training Material A-M CHAUVEL

DESIGN AND DEVELOPMENT INPUTS Defined, review and recorded Performances requirements Regulatory and legal requirements Quality Management Systems ISO 9001 Environmental requirements Requirements from previous similar designs Other essential requirements Ships in Service Training Material A-M CHAUVEL 732

DESIGN AND DEVELOPMENT OUTPUTS Approved before released Meet the design input requirements Quality Management Systems ISO 9001 Contain or make reference to product/service acceptance criteria  Define the essential characteristics for safe and proper use of the product / service Ships in Service Training Material A-M CHAUVEL 733

At suitable stages systematic reviews Quality Management Systems DESIGN AND DEVELOPMENT REVIEW At suitable stages systematic reviews shall be conducted to : Propose solutions Quality Management Systems ISO 9001 Evaluate capability to fulfil requirements Identify (if any) problems Ships in Service Training Material A-M CHAUVEL 734

Quality Management Systems DESIGN AND DEVELOPMENT VERIFICATION Planned performed & Quality Management Systems ISO 9001 Elements Requirements Inputs Outputs Meet Results must be recorded Ships in Service Training Material A-M CHAUVEL 735

to DESIGN AND DEVELOPMENT VALIDATION Performed Confirm Capability of the Product / Service in meeting the particular requirements for a specific intended customer use. Quality Management Systems ISO 9001 Prior its delivery or implementation Results must be recorded Ships in Service Training Material A-M CHAUVEL 736

Before and interaction CONTROL OF CHANGES Approved Implementation To determine the effect of changes on the: Elements of the design and development Quality Management Systems ISO 9001 Component parts of the product / service and interaction Existing experience on upon post delivery Need for carrying out re-verification or re-validation Results must be recorded Ships in Service Training Material A-M CHAUVEL 737

Quality Management Systems PURCHASING The organization shall : Control its purchased product and/or service In accordance with its requirements Actions shall be recorded Evaluate and select suppliers on their ability to supply product and/or service Quality Management Systems ISO 9001 741 Ships in Service Training Material A-M CHAUVEL

PURCHASING INFORMATION Purchasing documents shall contain requirements for approval or qualification of : Including any management system requirements Prior to release - Product - Service - Procedures - Processes - Equipment and - Personnel Quality Management Systems ISO 9001 742 Ships in Service Training Material A-M CHAUVEL

? VERIFICATION OF PURCHASED P and/or S The organization shall determine and implement the arrangements for verification of purchased product and/or service Arrangements necessary for the verification When the organisation or the client proposes to perform verification activities at the supplier’s premises ? Quality Management Systems ISO 9001 Method of product / service release Shall be specified in the purchasing documents 743 Ships in Service Training Material A-M CHAUVEL

PRODUCTION AND SERVICE OPERATIONS Identification and traceability Validation of processes Quality Management Systems ISO 9001 Handling, packaging, storage, preservation and delivery Customer property 750 Ships in Service Training Material A-M CHAUVEL

The organization shall PRODUCTION AND SERVICE OPERATIONS The organization shall Production and service operations including those undertaken after initial delivery Plan and control Quality Management Systems ISO 9001 751 Ships in Service Training Material A-M CHAUVEL

Quality Management Systems PRODUCTION AND SERVICE OPERATIONS Through : Specifications Product Service Instructions Equipment Production Maintenance Installation Quality Management Systems ISO 9001 Methods Release Installation Delivery Activity Measuring Monitoring Verification Work environment 751 Ships in Service Training Material A-M CHAUVEL

throughout all processes IDENTIFICATION AND TRACEABILITY The organization shall make provision for identifying : Status product / service Suitable means throughout all processes With respect to required measurements and verification activities Any effect on the conformity with requirements And to component parts if Quality Management Systems ISO 9001 752 Ships in Service Training Material A-M CHAUVEL

The organization shall IDENTIFICATION AND TRACEABILITY The organization shall Control and record the unique identification of the product / service Throughout all processes ISO 9001 ISO 14001 ISM B.V When required Quality Management Systems ISO 9001 Supply - Production - Distribution 752 Ships in Service Training Material A-M CHAUVEL

CLIENT PROPRIETY intellectual propriety CUSTOMER PROPERTY The organization shall exercise care with: Product - Material - Equipment Identification Storage Quality Management Systems ISO 9001 CLIENT PROPRIETY Verification Maintenance intellectual propriety 753

Documentation available and approved Quality Management Systems HANDLING TO DELIVERY To final destination. From internal operation Handling Storage Documentation available and approved Quality Management Systems ISO 9001 Packaging Preservation Delivery 754 Ships in Service Training Material A-M CHAUVEL

HANDLING TO DELIVERY Product release and/or service delivery shall not proceed until all the specified activities... Quality Management Systems ISO 9001 … have been satisfactorily completed and the related documentation is available and authorized 754 Ships in Service Training Material A-M CHAUVEL

VALIDATION OF PROCESSES When the resulting output cannot be readily or economical verified by subsequent monitoring inspection and/or testing Re-validation Specific records procedures Quality Management Systems ISO 9001 Qualification of equipment of personnel Effectiveness Acceptability Processes qualified prior use Ships in Service Training Material A-M CHAUVEL 755

Quality Management Systems CONTROL OF MEASURING AND MONITORING DEVICES Devices Control Calibration Maintenance Methods Handling Preservation Storage Quality Management Systems ISO 9001 Software Validated prior to use Ships in Service Training Material A-M CHAUVEL 760

CONTROL OF MEASURING AND MONITORING DEVICES Uncertainty Accuracy Precision Specified Intervals Calibration Adjustment International National Quality Management Systems ISO 9001 Methods for calibration Results of calibration Environmental conditions Identification status Safeguard again invalidated calibration Validation of previous inspection and test results 760 a-g Ships in Service Training Material A-M CHAUVEL

Quality Management Systems ISO 9001 Quality Management Systems 8-MEASUREMENT ANALYSE IMPROVEMENT Ships in Service Training Material A-M CHAUVEL

Quality Management Systems MEASUREMENT, ANALYSIS AND IMPROVEMENT Measurement and monitoring System improvement Quality Management Systems ISO 9001 Control of nonconformity Analysis of data Ships in Service Training Material A-M CHAUVEL 800

Quality Management Systems MEASUREMENT AND MONITORING OF Customer satisfaction System performance Quality Management Systems ISO 9001 Processes Product / service Internal audit Ships in Service Training Material A-M CHAUVEL 820

CONTROL OF NONCONFORMITY The organization shall ensure that product and/or service that does not conform to requirements is controlled to prevent unintended use or delivery Hold Area Quality Management Systems ISO 9001 Ships in Service Training Material A-M CHAUVEL 832

NONCONFORMITY REVIEW AND DISPOSITION The organization shall review nonconformities and determine the action to be taken Corrected or adjusted Re-assigned for alternatives Quality Management Systems ISO 9001 Responsibility and authority for the review and resolving of nonconformities shall be defined Accepted under condition Rejected unsuitable Ships in Service Training Material A-M CHAUVEL 832

Quality Management Systems ANALYSIS OF DATA FOR IMPROVEMENT Dissatisfaction Satisfaction Client Characteristics Product / service Conformance Requirements Quality Management Systems ISO 9001 Pertinence Effectiveness Adequacy System Trends Characteristics Processes 840 Ships in Service Training Material A-M CHAUVEL

Identification of a nonconformity Quality Management Systems IMPROVEMENT Identification of a nonconformity Review of the action effectiveness Determination of the causes Quality Management Systems ISO 9001 Corrective action Evaluation of the need for action Recording of the action taken Implementation of the action determined Ships in Service Training Material A-M CHAUVEL 852

Identification of a potential nonconformity Quality Management Systems IMPROVEMENT Identification of a potential nonconformity Review of the action effectiveness Determination of the causes Quality Management Systems ISO 9001 Preventive action Determination of the preventive action Recording of the action taken Implementation of the preventive action Ships in Service Training Material A-M CHAUVEL 853