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Quality Standards Application:
Quality Management Certification and Accreditation
Karl Heinrich MöllerGaertnerstr. 29
D-82194 GroebenzellTel: +49(8142)570144Fax: +49(8142)570145
Email: [email protected]
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Topics
• Definitions
• History of the ISO 9000 Family
• Compatibility of Management Standards (Quality, Environment, Safety, etc.)
• Process Orientation
• The 4 Main Standards of the Year 2000 Revision
• Documentation Requirements
• Accreditation
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DefinitionsPart 1
• Conformity (EN 45 020; 12.1):Fulfilment by a product, process or service of specified needs
• Conformity assessment (EN 45 020; 12.2):Any activity concerned with determining directly or indirectly that relevant requirements are fulfilled (see product and quality management certification, accreditation, etc.)
• Conformity evaluation (EN 45 020; 14.1):Systematic examination of the extent to which a product, process or service fulfils specified requirements (better, worse, see awards)
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DefinitionsPart 2
• Certificate of conformity (EN 45 020; 15.5):Document issued under the rules of a certification system, providing confidence that a duly identified product, process or service is in conformity with a specific standard or other normative document
• Suppliers declaration (EN 45 020; 15.1.1):Procedure by which a supplier gives written assurance (confidence) that a product, process or service conforms to specified requirements
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DefinitionsPart 3
• Certification (EN 45 020; 15.1.2):Procedure by which a third party gives written assurance (confidence) that a product, process or service conforms to specified requirements
• Accreditation (EN 45 020; 12.11):Procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks
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Development of Quality Management Standards
• First Release 1987 (ISO 9001,2,3 und 9004)– In the language to construct big Power Plants, Traffic Projects etc.
– Guidance Documents for Software (1991), Processed Material (1993) und Services (1991)
– First Standards for Tools (ISO 10011: Audits, ISO 10012: Measurement equipment)
• First Revision 1994 (development, software, services)– Standards for industry sectors (medical equipment, Automotive, etc.)
– Additional standards for tools
• Second Revision 2000 (all Industry sectors)– Applicable for hardware, software, processed material und services; small companies
– Process oriented
– Several guidance document no longer needed.
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Standards for Management SystemsDifferent Groups of Standards
• Group 1: Standards Derived from ISO 9001– Medical equipment– ISO TR 16 949 (based on ISO 9001:1994)– ISO TR 16 949 (based on ISO 9001:2000, in preparation)– QS-9000 (Chrysler, Ford und GM)– VDA 6.1 (Verband der Automobilindustrie) different structure– TL 9000 (Quality Excellence for Suppliers of Telecommunication Equipment– AS 9000 (Aviation Industry)
• Group 2: Different Management System Standards– Quality Management Systems (ISO/TC 176; ISO 9001)– Environmental Management Systems (ISO/TC 207; ISO 14001)– Security Management Systems (BS 7799)
• Group 3: Guidance Documents– Road haulage, warehouse management– Environmental Management Systems – Maintenance Management
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Standards for Management SystemsTo Deal with Different Management Systems
•How to bring the different management systems together
– One management system standard (rejected)– Compatible standards for Quality, Environment, safety, etc.
•Goal: Compatible standards – Identical structure– Common nucleus– Partly identical text – Special addenda's for Quality, Environment, safety, etc.
Quality StandardsMö/3.6.2002
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• Improve compatibility between ISO 9001 und ISO 14001, as well as ISO 9004 und ISO 14004
– Release of ISO 9001 und ISO 9004 in 2000
– Release ISO14001 und ISO 14004 not yet scheduled
• Combine the audit standards ISO 10011 und ISO 14 010 – 14 012 to a single Standard ISO 19 011
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Common Requirements for all Management Standards
• Management responsibility– Policy
– Management responsibility
• Objectives – Objectives and purpose of the
management system
– Planning
– Interfaces between quality, environment, etc.
• Management – Responsibilities
– Authorities
– Structure of the managementdocumentation
• Documentation and Communication – Description of the management system
– Documents
– Records
– Engagement of employees
• Control– Results (processes, products)
– Reviews/Audits
– Analysis
– Non conformities/corrections
• Process management– Process definitions
– Improvement processes
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Structure of ISO 9001 and ISO 9004Quality Elements versus Processes
•Structure follows quality elements – Quality management system documentation is only for quality
professionals
– Employees read procedure descriptions
•Structure follows Processes– Quality management system documentation is read by
employees
•New structure of the standard: Process oriented
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Structure of ISO 9001:2000Process definition
Controlling processes
supporting processes
cust
omerprocess
value addingactivities
Input
specifications, requirements,expectations
Output
product, fulfilment of needs
cust
omer
, m
arke
t, s
ocie
ty
Improvement processes
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Structure of ISO 9001:2000 Subdivision of processes
Input
specifications, requirements,expectations
Output
product, fulfilment of needs
Process
value addingactivities
Input
specifications, requirements,expectations
Output
product, fulfilment of needs
Process
value addingactivities
Input
specifications, requirements,expectations
Output
product, fulfilment of needs
Process
value addingactivities
Input
specifications, requirements,expectations
Output
product, fulfilment of needs
Process
value addingactivities
Input
specifications, requirements,expectations
Output
product, fulfilment of needs
Process
value addingactivities
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Structure of ISO 9001:2000 Examples for processes
• Controlling processes – Definition and improvement of policy
– Definition and improvement of objectives
– etc.
• Supporting processes – Performing internal audits
– Measuring and assessing of processes, inputs and outputs
– etc.
• Requirements of customers, markets and society– Definition and refinement of customer requirements
– Definition and refinement of market expectations
– etc.
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ISO 9001 Family Product Line for the Year 2000
• 9000:2000 (formerly ISO 8402)Concepts and Terminology
• 9001:2000 Quality Management Systems; Requirements In order to provide confidence as a result of demonstration...
• 9004:2000 Quality Management Systems; Guidance for performance
improvements Achieve benefits for all stakeholder groups
• 19011:2002Guidelines for quality and/or environmental management systems
auditing
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ISO 9001:2000Documentation Requirements 1
• ISO 9001:2000: The organization must have at least “documented procedures” for the following six activities:
– 4.2.3 Control of documents
– 4.2.4 Control of records
– 8.2.2 Internal audit
– 8.3 Control of nonconforming product
– 8.5.2 Corrective action
– 8.5.3 Preventive action
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ISO 9001:2000Documentation Requirements 2
• The only documents specifically mentioned in ISO 9001:2000 are:
– Quality policy (clause 4.2.1.a)
– Quality objectives (clause 4.2.1.a)
– Quality manual (clause 4.2.1.b)
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ISO 9001:2000Records required by ISO 9001:2000
5.6.1 Management reviews 6.2.2 (e) Education, training, skills and experience7.1 (d) Evidence that the realization processes and resulting product fulfil requirements7.2.2 Results of the review of requirements related to the product and actions
arising from the review7.3.2 Design and development inputs relating to product requirements7.3.4 Results of design and development reviews and any necessary actions7.3.5 Results of design and development verification and any necessary actions7.3.6 Results of design and development validation and any necessary actions7.3.7 Results of the review of design and development changes and any
necessary actions7.4.1 Results of supplier evaluations and any necessary actions arising from the
evaluations7.5.2 (d) As required by the organization to demonstrate the validation of processes
where the resulting output cannot be verified by subsequent monitoring or measurement
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ISO 9001:2000Records required by ISO 9001:2000
7.5.3 The unique identification of the product, where traceability is a requirement7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable
for use7.6 (a) Basis used for calibration or verification of measuring equipment where no
international or national measurement standards exist7.6 Validity of the previous measuring results when the measuring equipment is
found not to conform to requirements7.6 Results of calibration and verification of measuring equipment8.2.2 Internal audit results and follow-up actions8.2.4 Indication of the person(s) authorizing release of product. 8.3 Nature of the product nonconformities and any subsequent actions taken,
including concessions obtained8.5.2 Results of corrective action 8.5.3 Results of preventive action
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Conformity Assessmentand Accreditation
with accreditation
Level of assessment differs- Requirements for certification body- Requirements for supplier
Level of assessment always the same- Requirements for certification body- Requirements for supplier
certif. body certif. body certif. body
Accredit.
supplier same levelsame level
Accredit.
mutual recognition
Level of assessment
certification body
supplier supplier
certification body
without accreditation
certification body
supplier
supplier
supplier
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ICELEuropean Co-operation for Accreditation (EA)Multilateral Agreement (Signatories until May 2001)
Calibration ; testing ; products quality systems and personnel certification
Calibration ; testing ; products andquality systems certification
Calibration ; testing
Calibration ; testing ; quality systems certification
Calibration ; testing ; products certification
Non signatories
Environnemental management systems certification
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Effort of Conformity AssessmentSeveral Suppliers with an Unique Quality System
employees Initial assessment
auditor days
Initial assessment
auditor days
annual surveillance
auditor days
annual surveillance
auditor days
re-assessment
auditor days
re-assessment
auditor days
total on-site total on-site total on-site
less than 5 2 1 1 0.5 1.5 1
5 - 9 2.5 1.5 1 0.5 1.5 1
10 -19 3 2 1 1 2 1
20 -29 4 2.5 1.5 1 3 2
30 - 59 6 4.5 2 1 4 2.5
60 - 100 7 5 2 1.5 4 3
100 - 250 8 6 2.5 2 5 3
250 - 500 10 7 3 2 6 4.5
500 - 1000 12 9 4 3 8 5.5
1000 - 2000 15 12 5 4 10 6.5
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Effort of Conformity AssessmentsSeveral Suppliers with an Unique Quality System
number of suppliers random sample random sampleFirst and Re Audit annual
1 - 3 1 14 - 8 2 2
9 - 15 3 316 - 25 5 426 - 50 7 5
51 - 100 10 6101 - 150 13 8151 - 200 16 10
>200 >20 >12
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ISO 9001:2000 ImplementationQuestions
• Management requirement
• Structure of the documentation
• Preparation of the documentation
• Implementation of the documentation
• Selection of the certification body
• Agreement with the certification body
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