Quality Standards Application:
This presentation is the property of its rightful owner.
Sponsored Links
1 / 24

Quality Standards Application: Quality Management Certification and Accreditation PowerPoint PPT Presentation


  • 79 Views
  • Uploaded on
  • Presentation posted in: General

Quality Standards Application: Quality Management Certification and Accreditation Karl Heinrich Möller Gaertnerstr. 29 D-82194 Groebenzell Tel: +49(8142)570144 Fax: +49(8142)570145 Email: [email protected] Definitions History of the ISO 9000 Family

Download Presentation

Quality Standards Application: Quality Management Certification and Accreditation

An Image/Link below is provided (as is) to download presentation

Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author.While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server.


- - - - - - - - - - - - - - - - - - - - - - - - - - E N D - - - - - - - - - - - - - - - - - - - - - - - - - -

Presentation Transcript


Quality standards application quality management certification and accreditation

Quality Standards Application:

Quality Management Certification and Accreditation

Karl Heinrich Möller

Gaertnerstr. 29

D-82194 Groebenzell

Tel: +49(8142)570144

Fax: +49(8142)570145

Email: [email protected]


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

Topics


Definitions part 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)

DefinitionsPart 1


Definitions part 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

DefinitionsPart 2


Definitions part 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

DefinitionsPart 3


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.

Development of Quality Management Standards


Standards for management systems different groups of standards

Group1: 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)

Group2: 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)

Group3: Guidance Documents

Road haulage, warehouse management

Environmental Management Systems

Maintenance Management

Standards for Management SystemsDifferent Groups of Standards


Standards for management systems to 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.

Standards for Management SystemsTo Deal with Different Management Systems


Improve compatibility between quality management and environmental management

Improve compatibility betweenISO 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

Improve Compatibility between Quality Managementand Environmental Management


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

Common Requirements for all Management Standards

  • 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


Structure of iso 9001 and iso 9004 quality 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

Structure of ISO 9001 and ISO 9004Quality Elements versus Processes


Structure of iso 9001 2000 process definition

Input

Output

process

specifications,

requirements,

expectations

product,

fulfilment

of needs

value

adding

activities

Structure of ISO 9001:2000Process definition

Controlling processes

customer, market, society

customer

supporting processes

Improvement processes


Structure of iso 9001 2000 subdivision of processes

Process

Process

Process

Process

Process

Input

Output

Output

Input

Input

Output

Output

Input

Input

Output

value

adding

activities

value

adding

activities

value

adding

activities

value

adding

activities

value

adding

activities

product,

fulfilment

of needs

specifications,

requirements,

expectations

product,

fulfilment

of needs

specifications,

requirements,

expectations

specifications,

requirements,

expectations

product,

fulfilment

of needs

product,

fulfilment

of needs

specifications,

requirements,

expectations

product,

fulfilment

of needs

specifications,

requirements,

expectations

Structure of ISO 9001:2000Subdivision of processes


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.

Structure of ISO 9001:2000Examples for processes


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

ISO 9001 Family Product Line for the Year 2000


Iso 9001 2000 documentation 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

ISO 9001:2000Documentation Requirements 1


Iso 9001 2000 documentation 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)

ISO 9001:2000Documentation Requirements 2


Iso 9001 2000 records required by iso 9001 2000

ISO 9001:2000Records required by ISO 9001:2000

5.6.1 Management reviews

6.2.2 (e) Education, training, skills and experience

7.1 (d) Evidence that the realization processes and resulting product fulfil requirements

7.2.2 Results of the review of requirements related to the product and actions arising from the review

7.3.2 Design and development inputs relating to product requirements

7.3.4 Results of design and development reviews and any necessary actions

7.3.5 Results of design and development verification and any necessary actions

7.3.6 Results of design and development validation and any necessary actions

7.3.7 Results of the review of design and development changes and any necessary actions

7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations

7.5.2 (d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement


Iso 9001 2000 records required by iso 9001 20001

7.5.3 The unique identification of the product, where traceability is a requirement

7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use

7.6 (a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist

7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements

7.6 Results of calibration and verification of measuring equipment

8.2.2 Internal audit results and follow-up actions

8.2.4 Indication of the person(s) authorizing release of product.

8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained

8.5.2 Results of corrective action

8.5.3 Results of preventive action

ISO 9001:2000Records required by ISO 9001:2000


Conformity assessment and accreditation

certification body

Accredit.

supplier

supplier

supplier

certification body

Conformity Assessmentand Accreditation

Level of

assessment

without accreditation

with accreditation

mutual recognition

Accredit.

certification body

certif. body

certif. body

certif. body

supplier

supplier

supplier

same level

same level

Level of assessment always the same

- Requirements for certification body

- Requirements for supplier

Level of assessment differs

-Requirements for certification body

-Requirements for supplier


European co operation for accreditation ea multilateral agreement signatories until may 2001

Non signatories

European Co-operation for Accreditation (EA)Multilateral Agreement (Signatories until May 2001)

Calibration ; testing ; products quality systems and personnel certification

Calibration ; testing ; products and

quality systems certification

Calibration ; testing ; quality systems certification

Environnemental management systems certification

Calibration ; testing

Calibration ; testing ; products certification


Effort of conformity assessment several suppliers with an unique quality system

Effort of Conformity AssessmentSeveral Suppliers with an Unique Quality System


Effort of conformity assessments several suppliers with an unique quality system

number of suppliers random samplerandom sample

First and Re Auditannual

1 - 3 1 1

4 - 8 2 2

9 - 15 3 3

16 - 25 5 4

26 - 50 7 5

51 - 100 10 6

101 - 150 13 8

151 - 200 16 10

>200>20>12

Effort of Conformity AssessmentsSeveral Suppliers with an Unique Quality System


Iso 9001 2000 implementation questions

Management requirement

Structure of the documentation

Preparation of the documentation

Implementation of the documentation

Selection of the certification body

Agreement with the certification body

ISO 9001:2000 ImplementationQuestions


  • Login