ISOISO

What is a standard?What is a standard?

Standards are written guidelines which Standards are written guidelines which help to do things, or make things, more help to do things, or make things, more efficiently or more safely. efficiently or more safely.

They are written through a formal They are written through a formal prescribed process which involves prescribed process which involves consultation with relevant bodies and consultation with relevant bodies and reaching consensus across all interested reaching consensus across all interested parties so that the final document meets parties so that the final document meets the needs of business and society. the needs of business and society.

All standards take the form of either: All standards take the form of either: specifications, methods, vocabularies, specifications, methods, vocabularies, codes of practice or guides.codes of practice or guides.

What is ISO?What is ISO?

International Organization for International Organization for Standardization.Standardization.

An International-Standard setting body.An International-Standard setting body. Founded on 23 February 1947.Founded on 23 February 1947. promulgates worldwide proprietary promulgates worldwide proprietary

industrial and commercial standards.industrial and commercial standards. headquarters in Geneva, Switzerland.headquarters in Geneva, Switzerland. non-governmental organization.non-governmental organization. two official languages, English and two official languages, English and

French.French. ISO has 158 (of 195) national members.ISO has 158 (of 195) national members.

About…About… Name and abbreviation.Name and abbreviation. main products are the International Standards.main products are the International Standards. ISO also publishes Technical Reports, ISO also publishes Technical Reports,

Technical Specifications, Publicly Available Technical Specifications, Publicly Available Specifications, Technical Corrigenda, and Specifications, Technical Corrigenda, and Guides Guides

International StandardsInternational Standards are identified in the are identified in the format format ISO[/IEC][/ASTM] [IS] nnnnn[:yyyy] ISO[/IEC][/ASTM] [IS] nnnnn[:yyyy] TitleTitle

((IECIEC for for International Electrotechnical International Electrotechnical Commission)Commission)

- the std. is a work of ISO/IEC JTC1 (the ISO/IEC - the std. is a work of ISO/IEC JTC1 (the ISO/IEC Joint Technical Committee). Joint Technical Committee).

ISO documents are copyrighted. ISO documents are copyrighted. Not Open source.Not Open source.

About…About…

List of some ISO StandardsList of some ISO Standards ISO 1ISO 1 Standard reference temperature for Standard reference temperature for

geometrical product specification and geometrical product specification and verification verification

ISO 1000ISO 1000 SISI units and recommendations for the units and recommendations for the use of their multiples and of certain other units use of their multiples and of certain other units

ISO 9000ISO 9000 Quality management system in Quality management system in production environments production environments

ISO 9001ISO 9001 Quality management Quality management ISO 10006ISO 10006 Quality management — Guidelines to Quality management — Guidelines to

quality in project managementquality in project management ISO 14001 Environmental management ISO 14001 Environmental management

standards standards ISO/IEC 20000:2005ISO/IEC 20000:2005 IT Service Management IT Service Management

System (based on BS15000)System (based on BS15000) ISO 31000ISO 31000 — Risk Management — Risk Management ISO/IEC 80000ISO/IEC 80000 — Quantities and Units — Quantities and Units

ISO 9000ISO 9000

ISO 9000ISO 9000 is a is a familyfamily of standards of standards for quality management systems.for quality management systems.

maintained by ISO.maintained by ISO. administered by accreditation and administered by accreditation and

certification bodies.certification bodies. Companies are "ISO 9001 certified" Companies are "ISO 9001 certified"

or "ISO 9001 registered". or "ISO 9001 registered".

ISO 9000 series of standardsISO 9000 series of standards includes:-includes:- ISO 9001:2008 Quality management systems ISO 9001:2008 Quality management systems

– Requirements (also – 9000 series like 9002, – Requirements (also – 9000 series like 9002, 9003)9003)

ISO 9004:2000 Quality management systems ISO 9004:2000 Quality management systems - Guidelines for performance improvements - Guidelines for performance improvements

ISO 9001: Version includes – ISO 9001: Version includes – 19871987 19941994 20002000 20082008

ISO 9001:2000ISO 9001:2000 combines the three standards combines the three standards 9001, 9002, and 9003 into one, called 90019001, 9002, and 9003 into one, called 9001

ISO 9001:2008 Quality management ISO 9001:2008 Quality management

systems — Requirementssystems — Requirements Page iv: Page iv: ForewordForeword Pages v to vii: Section 0 Pages v to vii: Section 0 IntroductionIntroduction Pages 1 to 14: Pages 1 to 14: RequirementsRequirements

Section 1: Section 1: ScopeScope Section 2: Section 2: Normative ReferenceNormative Reference Section 3: Section 3: Terms and definitionsTerms and definitions (specific (specific

to ISO 9001, not specified in ISO 9000)to ISO 9001, not specified in ISO 9000) Pages 2 to 14 Pages 2 to 14

Section 4: Section 4: Quality Management SystemQuality Management System Section 5: Section 5: Management ResponsibilityManagement Responsibility Section 6: Section 6: Resource ManagementResource Management Section 7: Section 7: Product RealizationProduct Realization Section 8: Section 8: Measurement, analysis and Measurement, analysis and

improvementimprovement

ISO 9001:2008 Quality management ISO 9001:2008 Quality management systems — Requirementssystems — Requirements

The standard specifies six compulsory The standard specifies six compulsory documents:documents:

Control of Documents (4.2.3) Control of Documents (4.2.3) Control of Records (4.2.4) Control of Records (4.2.4) Internal Audits (8.2.2) Internal Audits (8.2.2) Control of Nonconforming Product / Control of Nonconforming Product /

Service (8.3) Service (8.3) Corrective Action (8.5.2) Corrective Action (8.5.2) Preventive Action (8.5.3) Preventive Action (8.5.3)

Also, Quality Policy & Quality Manual Also, Quality Policy & Quality Manual

Summary of ISO 9001:2008 in Summary of ISO 9001:2008 in

informal languageinformal language

See also,See also, http://www.praxiom.com/iso-9001.hthttp://www.praxiom.com/iso-9001.ht

mm

Elements of QMSElements of QMS

Organizational structure Organizational structure Responsibilities Responsibilities Procedures Procedures Processes Processes ResourcesResources

Auditing Auditing

Two types of auditing: Two types of auditing:

Internal Audits & External AuditsInternal Audits & External Audits

"compliance auditing" "compliance auditing"

Tell me what you do Tell me what you do (describe the (describe the business process)business process)

Show me where it says that Show me where it says that (reference (reference the procedure manuals)the procedure manuals)

Prove that that is what happened Prove that that is what happened (exhibit evidence in documented (exhibit evidence in documented records)records)

Non-ComplianceNon-Compliance

Corrective Action Preventive Corrective Action Preventive

ActionAction CAPA is part of the overall quality CAPA is part of the overall quality

management system (QMS). management system (QMS). CAPA focuses on the systematic CAPA focuses on the systematic

investigation of discrepancies (failures investigation of discrepancies (failures and/or deviations) in an attempt to and/or deviations) in an attempt to prevent their recurrence (for prevent their recurrence (for corrective action) or prevent from corrective action) or prevent from occurrence (for preventive action). occurrence (for preventive action).

Both fit into the Plan Do Check Act Both fit into the Plan Do Check Act philosophy philosophy

PDCAPDCA

PDCAPDCA (" ("Plan-Do-Check-ActPlan-Do-Check-Act") is an ") is an iterative four-step problem-solving iterative four-step problem-solving process typically used in business process typically used in business process improvement. It is also process improvement. It is also known as the known as the Deming CycleDeming Cycle, , Shewhart cycleShewhart cycle, , Deming WheelDeming Wheel, , or or Plan-Do-Study-ActPlan-Do-Study-Act. .

The PDCA CycleThe PDCA Cycle

ExampleExample

Questions?Questions?