Brief Introduction to the ISO 9001:2000 and Quality Principles

Transcription

1 Vilmos Berényi H2509 H2509 Esztergom-Kertváros, Hőtáv Hőtávu. u Hungary Hungary , fax: fax: Brief Introduction to the ISO 9001:2000 and Quality Principles 11

2 Objective Introduce Introduce myself myselfand andthis thisproject Discussion about aboutquality qualityand andmanagement definitions Introduce Introduce the the concept concept of of ISO ISO Standard Standard Highlight Highlight important important tasks tasksand and changes changes due duetotothe theiso ISO Standard Briefly Briefly introduce introduce the the system system requirements of of the the ISO ISO Standard 22

3 International standards ISO 9000:2005, Fundamentals and Vocabulary, describes the fundamentals of a QMS and specifies the terminology for a QMS. ISO 9004: 2000 Quality management systems - Guidelines for performance improvements, QMS, Guidelines for performance improvement ISO 14001:2004 Environmental management systems. Requirements with guidance for use ISO OHS Standard ISO ISMS Standard ISO 17025: General requirements for the competence of testing and calibration laboratories. GMP, GLP, validation and qualification 33

4 ISO 9001: 2000 Quality management systems - Requirements specifies requirements for a QMS where an organization needs to demonstrate its ability to provide products that meet customer requirements and applicable regulatory requirements and aims to enhance customer satisfaction. 44

5 Definitions Product The result of a process. Service An intangible product that is the result of at least one activity performed at the interface between the supplier and the customer. Management System The set of interrelated or interacting elements to establish policy and objectives and to achieve those objectives. Nonconformity The nonfulfillment of a requirement. Requirement A need or expectation that is stated, generally implied, or obligatory. Process A set of interrelated or interacting activities which transform inputs into outputs. 55

6 Definitions Quality The degree to which a set of inherent characteristics fulfills requirements. Quality Manual A document specifying the quality management system of an organization. They vary in detail and format to suit the size and complexity of an individual organization. Documentation Written material defining the process to be followed (e.g. test procedure, quality manual, operation sheets). Record A document stating results achieved or providing evidence of activities performed. 66

7 Quality Policy Definitions The overall intentions and direction of an organization related to quality as formally expressed by top management. Quality Objective Something sought, or aimed for, related to quality. The objectives are generally based on the quality policy of an organization and specified for relevant functions and levels in the organization. Scope The scope of registration defines the company sites, product lines, and operations covered by an ISO 9001 certificate. 77

8 ISO 9001:2000 Model Continual Improvement of the Quality Management System 5.Management Responsibility CUSTOMERS Requirements 6. Resource Management Quality Management System 7. Product Realization 8. Measurement Analysis and Improvement Product Satisfaction CUSTOMERS Consumption 88

9 Principles of new standard Customer Customer focus focus Leadership Leadership Mutual Mutual beneficial beneficial supplier supplier relationship relationship Based Based on on eight eight quality quality Factual management Factual approach principles approach to to decision decision making making Continual Continual System System improvement improvement approach approach to to Management Management Involvement Involvement of of people people Process Process approach approach 99

10 Principles of new standard Customer focus Organization depends customers Understand current & future customer needs. Meet / exceed customer expectations Leadership Leaders establish purpose & direction of the organization Should create & maintain environment to achieve organization s objectives Involvement of People People of all levels are essence of an organization Their full involvement for organization s benefit Process approach Desired results are achieved more efficiently when activities and resources are managed as process 10

11 Principles of new standard System approach to Management Identifying, understanding and managing interrelated process as a system contributes to the organization s effectiveness & efficiency Continual improvements Continual improvement of the organization s overall performance should be a permanent objective of the organization Factual approach to decision making Effective decisions are based on the analysis of data and information Mutually beneficial supplier relationships An organization & its suppliers are interdependent Mutually beneficial relationship enhances the ability of both to create value 11

12 Expectations of the ISO 9001 Standard Avoid Avoid the the application of of systems that that are are separate from from the the organization s business process Enable the the development of of a Quality system that that is is fully fully integrated into into the the normal operations of of organization s business Enable Continual improvements of of the the system for for enhanced customer satisfaction Enable compliance to to statutory & regulatory requirements Avoid Avoidinconsistency and andredundant documentation Create documentation system extent correlated to tocompany size size 12

13 INPUT ACTIVITY OUTPUT RESOURCES 13

14 Process approach Process definition Set Set of of interrelated or or interacting activities which transforms inputs into into outputs Identify Identify the the processes Identify Identify the the Inputs Inputs & outputs outputs Identify Identify the the Interactions to to other other processes Establish Establish measuring criteria criteria Ensure Ensure continual continual improvements improvements Do it it for all all value adding processes 14

15 Process approach Continual improvements of Process Understandings & meeting requirements PLAN Processes in terms Of Added Value DO PDCA Cycle Continual improvements of Processes based on objective measurements ACTION Measure results of process Performance and effectiveness - Objective Measurements CHECK 15

16 PLAN: establish the objectives and processes necessary to deliver results in accordance with customer requirements and organizational policies DO: implement the processes ACT: take actions to continually improve process performance. CHECK: monitor and measure processes and product against policies, objectives and requirements 16

17 E.g. - Purchasing Process Inputs Required item item // quantity // date date Applicable specs specs Supplier source source Suppliers capability to to meet meet our our requirements Purchasing Procedure Interactions to to Storage Inspection and and Testing Manufacturing Finance Outputs Receipt of of Material on on right right condition Right Right Quality Right Right Quantity Right Right Time Time Performance Measurements Delivery status On-time, On On spec, NCP NCP etc etc Supplier evaluation 17

18 System Requirements / Structure of the Standard 4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realization 8 Measurement Analysis & improvement General requirements Management Commitment Provision of resources Planning General Documentation Requirements Customer focus Human resources Customer related processes Monitoring & measurement Quality policy Planning Infrastructures Work environment Design & development Purchasing Control of NCP Analysis of data Responsibility, authority & communication Production & service provision Improvements Management Reviews 18

19 4 - Quality management system Continual improvements Identification of processes required Monitoring and Measuring of processes 4.1 General requirements Availability of information & resources for operation & control Criteria and methods to ensure Operation & control 19

20 4 - Quality management system 4.2 Document requirements Quality Policy Quality Objectives Quality Manual Procedures required by the Standard Procedures required for planning, operation & control of Organization activities Records 20

21 DOCUMENTATION SYSTEM STRUCTURE Quality policy Quality objectives Quality manual Procedures Instructions, standards, regulations Records 21

22 5 - Management Responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.6 Responsibility authority & communicate 5.7 Management Review Quality objectives QMS planning Responsibility & authority Management representative General Review inputs Internal communication Review outputs 22

23 6 - Resource Management Resources required to to Implementing, monitoring monitoring & continual continual improvements Enhance Enhance Customer Customer satisfaction by by meeting meeting customer customer requirements Human Resources Resource Management Infrastructures Infrastructures needed needed to to achieve achieve product product conformity conformity Work Work environment Work Work environment needed needed to to achieve achieve product product conformity conformity 23

24 6 - Human Resources Competent on on the the basis basis of of appropriate education, education, skill skill and and experience Define Define competencies for for people people performing performing work work affecting affecting product product quality quality Human Resources Provide Provide training training or or actions actions Evaluate Evaluate effectiveness of of the the training training // actions actions Employees should should aware aware importance of of the the activity activity being being performed performed 24

25 7 - Product Realization Planning of product realization Customer related processes Design and development Purchasing Production & service provision Control of monitoring measuring devices Identification of customer requirement Review of customer requirement Customer communication Design planning Design inputs Design outputs Design review Design verification Purchasing process Purchasing information Verification of purchased products Control Validation of processes Identification & traceability Customer property Design validation Preservation of product Design Changes 25

26 7 - Product Realization Customer related processes (Sales) Identification of of Customer Customer // Market Market requirements Specified Specified by by customer customer Requirements Requirements taken taken for for granted granted Statutory Statutory/ / Regulatory Regulatory requirements requirements Review Review of of requirements related related product product prior prior to to acceptance // commitment to to customers customers --ability ability to to meet meet customer customer requirements Effective Effective communication with with customer customer in in relation relation to to Product Product information information Sales Sales order order handling handling Customer Customer feedback feedback Customer Customer complaints complaints 26

27 7 - Product Realization Purchasing Purchasing is is done done in in controlled controlled manner manner to to ensure ensure that that purchased purchased products products conforms conforms to to specific specific requirements Degree Degree of of control control depends depends on on effects effects of of subsequent processes processes and and effect effect on on final final product product Supplier Supplier evaluation evaluation Verification of of purchased purchased product product Inspection Inspection and and testing testing 27

28 7 - Product Realization Product Product characteristics (Specs) (Specs) Procedures and and work work instructions Production and and service service provision provision Manufacturing // service service provision provision under under controlled controlled condition condition to to ensure ensure conformity conformity of of product product Suitable Suitable equipments to to manufacture. Monitoring Monitoring and and inspection inspection & testing testing Product Product release, release, delivery delivery and and post post delivery delivery Process Process validation validation Identification and and traceability Customers property property Material Material supplied supplied by by customers customers e.g.. e.g.. 3 rd rd party party blending blending 28

29 7 - Product Realization Control of of monitoring and and measuring devices Control Control and and Calibration of of equipments used used for for monitoring, inspection inspection and and testing testing --Also AlsoReference Referencematerials --Legal Legalrequirements --GMP-GLP GMP-GLP requirements (IQ-OQ-PQ) 29

30 8 - Measurement, analysis and improvement 8.1 General 8.2 Monitoring & measurements 8.3 Control of non conforming product 8.4 Analysis of data 8.5 Improvement Customer satisfaction Continual improvements Internal audits Corrective action Measurement of processes Preventive action Measurement of product 30

31 To To demonstrate - -To demonstrate 8 - Measurement, analysis and improvement Conformity Conformity of of the the product product Conformity Conformity to to QMS QMS requirements requirements Continually Continually improvements improvements and and the the effectiveness effectiveness of of the the system system Monitoring and and Measurements Customer Customer satisfaction satisfaction // perception perception Internal Internal audits audits --conformity conformity planned planned arrangements arrangements of of QMS QMS and and ISO9001 ISO9001 Monitoring Monitoring and and measurements measurements of of processes processes to to determine determine / / demonstrate demonstrate ability ability of of processes processes to to achieve achieve required required results results Monitoring Monitoring and and measurements measurements of of product product Conformity Conformity to to product product requirements requirements Control of of NCP NCP To To assure assure that that NCP NCP products products are are identified identified and and controlled to to prevent prevent unintended use use // delivery delivery 31

32 8 - Measurement, analysis and improvement Improvements Continual Improvements QMS QMS needed needed to to be be continually improved improved Corrective action Actions Actions to to prevent prevent recurrence of of NCP, NCP, NCR NCR etc etc Includes Includes reviews, reviews, determination of of causes, causes, need need of of action, action, implementation of of action, action, review review of of action action and and maintenance of of relevant relevant records records Preventive action Actions Actions against against potential potential non non conformities to to avoid avoid their their occurrence Includes Includes identification of of potential potential non non conformities, cause, cause, need need for for action, action, implementation of of action, action, review review of of action action and and maintenance of of records records 32

33 business businessoriented. Less Less procedure procedure oriented oriented Customer Customer focus focus than than product product focus focus Company Company wide wide involvement involvement Less Less emphasis emphasis on on documentation documentation Continual Continual improvements improvements Mutual Mutual benefit benefit to to all all interested interested parties parties 33

34 ISO 9001 PROJECT Interview and information gathering with all colleagues to be involved Preparation of Quality Policy, Quality Manual and annual Quality Plan Defining and documentation of Operational Procedures Quality Programs Trainings for the management and operational staff Internal audit Management review Certification audit 34

35 ISO 9001 PROJECT Quality Programs Supplier or sub-contractors evaluation Claim and Nonconformity handling Justification of activities done (phone calling, e- mail and oral messages Calibration and maintenance of measuring devices Job descriptions an work instructions Record keeping and identification Competence and other specification 35

36 ISO 9001:2000 The Short Version: Writing down what you do. Doing what you write down. Provide visible evidence that you are doing what you wrote down (quality records). Identify errors in the process and opportunities to improve process. Use a preventive action method to identify additional essential processes. 36