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  Understanding ISO 9000:2000

Understanding ISO 9000:2000

 

 

Table of Contents

  Chapter


   Title


  Page


      1	   INTRODUCTION                                             1
	     Who and/or what is ISO?	                            1
	     What is a standard?	                            1
	     Who is responsible?	                            2
	     What is the ISO 9000 family of standards?	            2
	     What is ISO 9000?	                                    4
	     Why implement ISO 9000?	                            5
	     What are the benefits of ISO 9000?	                    5
	       Internal	                                            6
	       External	                                            6
	     What are the steps to registration?	            7

      2    QUALITY MANAGEMENT PRINCIPLES	                    8
	     What is a quality management principle?	            8
	     What were the major changes to the standard?           8
	     What are the eight quality management principles?      8
	       Customer Focus	                                    9
	       Leadership	                                   10
	       Involvement of People	                           10
	       Process Approach	                                   10
	       Systems Approach to Management	                   12
	       Continual Improvement	                           12
	         Six Classic Steps	                           13
	         Continuous Improvement Methodologies	           13
	            Benchmarking	                           14
	            Cause & Effect Diagrams	                   15
	            Nominal Group Technique	                   15
	            Quality Function Deployment	                   15
	            Pareto Charts	                           15
	            Statistical Process Control	                   16
	            Histograms	                                   16
		    Check Sheets	                           16
		    Input/Output Analysis	                   16
		    Scatter Diagram	                           16
		    Concurrent Engineering	                   16
		    Design of Experiments	                   16
		    Cost of Quality	                           17
		    Control Charts	                           17
		    Process Flow Analysis	                   17
		    PDCA or Shewhart Cycle	                   17
	         Factual Approach to Decision Making	           18
		 Mutually Beneficial Supplier Relationships        19

      3     DOCUMENTATION	                                   20
	      What documentation is necessary	                   20
	      What procedures are required	                   21
	      What records are required	                           22
	      What is the typical documentation structure          22
	      How do I develop ISO documentation	           23
	      What should be included in a quality manual          23
	      What format should be used for procedures	           24
	      How do I document a process/procedure	           25
	      What information does a controlled document 
		typically include	                           26

      4	    KEY TERMS AND DEFINITIONS	                           27
	      Audit	                                           27
	      Conformity	                                   27
	      Continual Improvement	                           27
	      Corrective Action                                    27
	      Customer Satisfaction	                           27
	      Document	                                           27
	      Preventive Action                                    27
	      Process	                                           27
	      Product	                                           27
	      Quality	                                           27
	      Quality Management System                            28
	      Quality Objective	                                   28
	      Quality Plan	                                   28
	      Quality Policy	                                   28
	      Record	                                           28
	      Top Management	                                   28
	      Validation	                                   28
	      Verification	                                   28

      5	    ISO 9001:2000 REQUIREMENTS	                           29
	      What is the scope of the ISO 9001 standard?          29
	      ISO 9001 requirements paraphrased	                   29

	      4 Quality Management System	                   29
	        4.1 General requirements	                   29
		4.2 Documentation requirements	                   30
		   4.2.1 General	                           30
		   4.2.2 Quality manual	                           30
		   4.2.3 Control of documents	                   30
		   4.2.4 Control of records	                   31

	      5 Management Responsibility	                   31
		5.1 Management commitment	                   31
		5.2 Customer focus	                           31
		5.3 Quality policy	                           31
                5.4 Planning	                                   32
		   5.4.1 Quality objectives	                   32
		   5.4.2 Quality management system planning	   32
		5.5 Responsibility, authority and communication	   32
		   5.5.1 Responsibility and authority	           32
		   5.5.2 Management representative	           32
		   5.5.3 Internal communication             	   32
		5.6 Management review	                           32
		   5.6.1 General	                           32
		   5.6.2 Review input	                           33
		   5.6.3 Review output	                           33

	      6 Resource Management	                           33
		6.1 Provision of Resources	                   33
	        6.2 Human Resources	                           33
		   6.2.1 General	                           33
		   6.2.2 Competence, Awareness & Training	   34
		6.3 Infrastructure	                           34
		6.4 Work Environment	                           34

	      7 Product Realization	                           34
		7.1 Planning of Product Realization	           34
		7.2 Customer Related Processes	                   35
		   7.2.1 Determination of Product Requirements	   35
		   7.2.2 Review of Product Requirements 	   35
		   7.2.3 Customer Communication	                   35
		7.3 Design and Development	                   35
		   7.3.1 Design & Development Planning	           35
		   7.3.2 Design & Development Inputs	           36
		   7.3.3 Design & Development Outputs	           36
		   7.3.4 Design & Development Review	           36
		   7.3.5 Design & Development Verification	   37
		   7.3.6 Design & Development Validation	   37
		   7.3.7 Control of Design & Dev. Changes	   37
	        7.4 Purchasing	                                   37
		   7.4.1 Purchasing Process                        37
		   7.4.2 Purchasing Information	                   38
		   7.4.3 Verification of Purchased Product	   38
	        7.5 Production & Service Provision (P&S)	   38
		   7.5.1 Control of P & S Provision	           38
		   7.5.2 Validation of Process for P & S Provision 38
		   7.5.3 Identification and Traceability	   39
		   7.5.4 Customer Property	                   39
		   7.5.5 Preservation of Product	           39
	        7.6 Control of Monitoring & Measuring Devices	   40

	      8 Measurement, Analysis & Improvement	           40
	        8.1 General	                                   40
	        8.2 Monitoring & Measurement	                   40
		   8.2.1 Customer Satisfaction	                   40
		   8.2.2 Internal Audit 	                   41
		   8.2.3 Monitoring & Measurement of Processes	   41
		   8.2.4 Monitoring & Measurement of Product	   41
	        8.3 Control of Non-conforming Product	           42
	        8.4 Analysis of Data	                           42
	        8.5 Improvement	                                   42
		   8.5.1. Continuous Improvement	           42
		   8.5.2 Corrective Action	                   43
		   8.5.3 Preventive Action	                   43
                     5   Key Areas	                           43

      6     ISO COMPARISON MATRIX	                           44
               1994 : 2000	                                   44
	       2000 : 1994	                                   45

      7     ISO 9000:2000 FINDINGS	                           46
	       Top 5 Areas of Non-Conformance	                   46
	       Perceived Benefits	                           46
	       Bottom Line Improvements	                            4


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