International Quality Standards
The dictionary meaning of standard is “Something considered by an authority or by general consent as a basis of comparison; an approved model. What is an Standard ?
To bring a general agreement level, for making common reference while working in different condition e.g. Standard Measuring Units, Standard Operating Procedures, etc. Need for an standard
Contd.. • A Standard Specification • A Standard Test • A Standard Practice • A Standards Guide • A Standard Definition • A Standard Units • A Standard Operating Procedure
Predefined test, procedure, specification or may be a set of guidelines for commerce, trade, industry accepted across countries for uniform and equal applications in concerned area. International Standard
Contd.. • Process Standards: An approved manufacturing process, System, SOP, etc. e.g. ISO, USFDA, UKMCA, Kosher, etc • Product Standard: Product with predifned and approved features confirming the set requisites CE, Halal, ISI, etc.
Various National Authorities for Standard Development • BIS: Bureau of Indian Standards • ANSI: American National Standard Institute • BSI: British Standards Institute • CSA: Canadian Standards Association • DIN:(Deutsches Institufür Normung)German Institute for Standardization
ISO: International Organization for Standardization • The International Organization for Standardization (Organisation internationale de normalisation), widely known as ISO is an international-standard-setting body composed of representatives from various national standards organizations
Contd • Founded on 23 February 1947, the organization promulgates worldwide proprietary industrial and commercial standards. It has its headquarters in Geneva, Switzerland • ISO has members from 195 countries
ISO Standards • There are over 17500 ISO standards from ISO 1 to ISO 39999. Each standard may have one or more versions. • There is a range of standards for a particular area like for organizational systems, Environment and Safety, etc
Nomenclature • ISO (Standard):Version • e.g. ISO 9001:2000 • This means year 2000 version of ISO 9001 Standard. • ISO 22000:2001, ISO 14000:2005, etc.
ISO Certifications • An ISO certification means that the referred organization is following the set standards for process or system in the area where it has received the ISO certification. • Before being certified they are audited by independent auditors against the sent ISO Standard • The independent auditors are accredited by accreditation agencies • ISO NEVER GO FOR AUDIT AND CERTIFICATION OF ITS OWN.
Few ISO Certifying Agencies in India • TUV India • G – Cert • IQC – Integrated Quality Certification Pvt Ltd • Nemko AS Norway • Burea Varitas
Widely applied ISO Standards 1. ISO 9000 - Quality management system in production environments 2. ISO 14000- Environmental Management Standards in production environments 3. ISO 22000 Food safety management systems — Requirements for any organization in the food chain 4. ISO/IEC 20000:2005 IT Service Management System (based on BS15000) 5. ISO 20022 Financial Services — universal financial industry message scheme
ISO 9000: Quality Management Systems in Production Environment • ISO 9000 is a family of ISO Standards basically dealing in Quality Management System in Production Environment • Ensures that any organization engaged in the production of any goods or services deploys proper system, documents all activities and communicates to its employees its quality policy.
Summary of ISO 9000 • The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality policy is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards. • Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness. • Records should show how and where raw materials and products were processed, to allow products and problems to be traced to the source.
Contd.. You need to regularly review performance through internal audits and meetings. Determine whether the quality system is working and what improvements can be made. Deal with past problems and potential problems. Keep records of these activities and the resulting decisions, and monitor their effectiveness (note: you need a documented procedure for internal audits).
ISO 14000: Environmental Management Standards in production environments • Family of standards outlining the Green Manufacturing concept. • Environmental pollution, Carbon release, Human footprint, etc. are few areas around which the standards are oriented. • Collectively they cover Waste disposal from factory, Water recycling, Control of hazardous gas emissions, Extraction of raw material, etc.
Contd.. • ISO 14001 Environmental management systems—Requirements with guidance for use • ISO 14004 Environmental management systems—General guidelines on principles, systems and support techniques • ISO 14015 Environmental assessment of sites and organizations • ISO 14020 series (14020 to 14025) Environmental labels and declarations • ISO 14031 • ISO 14040 series (14040 to 14049), Life Cycle Assessment, LCA, discusses pre-production planning and environment goal setting. • ISO 14050 terms and definitions. • ISO 14062 discusses making improvements to environmental impact goals. • ISO 14063 Environmental communication—Guidelines and examples
ISO 22000: Food Safety Management Systems • Requirement for an organization in food chain. May be a manufacturer, a supplier or a distributor. • Covers HACCP: Hazard Analysis and Critical Control Point • Ensures Manufacturing and distribution of food material which is fit for human consumption.
ISO/IEC 20000:2005 IT Service Management System (based on BS15000) • ISO 20022 Financial Services — universal financial industry message scheme
ISO Certification Process Application Inspection Correction s Certificate Issue Final Inspection Implementation
ASTM: American Society for Material and Testing • ASTM International (ASTM), originally known as the American Society for Testing and Materials, is an international standards organization.
Contd. ASTM International (ASTM), originally known as the American Society for Testing and Materials, is an international standards organization that develops and publishes voluntary consensus technical standards for a wide range of : • materials • products • systems • services
Categories • The standards produced by ASTM International fall into six categories: • The Standard Specification, that defines the requirements to be satisfied by subject of the standard. • The Standard Test Method, that defines the way a test is performed. The result of the test may be used to assess compliance with a Specification. • The Standard Practice, that defines a sequence of operations that, unlike a test, does not produce a result.
Contd.. • The Standard Guide, that provides an organized collection of information or series of options that does not recommend a specific course of action. • The Standard Classification, that provides an arrangement or division of materials, products, systems, or services into groups based on similar characteristics such as origin, composition, properties, or use. • The Terminology Standard, that provides agreed definitions of terms used in the other standards.
ASTM Standards ASTM standards are categorised in various sections A/B/C/D/E/F/G are widely used in engineering e.g. • ASTM A36 Standard Specification for Carbon Structural Steel • ASTM B2-08 Standard Specification for Medium-Hard-Drawn Copper Wire
Non-governmental international standards organization that prepares and publishes International Standards for all electrical, electronic and related technologies – collectively known as "electrotechnology". IEC: International Electrotechnical Commission
IEC standards have numbers in the range 60000–79999. Their titles take a form such as IEC 60417: Graphical symbols for use on equipment IEC Standards
The CE marking (also known as CE mark) is a mandatory conformity mark on many products placed on the single market in the 1. European Economic Area (EEA) – 27 countries 2. European Free Trade Area (EFTA) – 4 countries (Iceland, Norway, Liechtenstein and Switzerland) 3. Turkey CE: Conformity European
The CE marking certifies that a product has met EU consumer safety, health or environmental requirements. Contd..
CE is a kind of self declaration done after standard process described by European Directives. Complete process is to be documented and should be produced to confirming authority when required. Technical Construction File (TCF) is the master file which is to be prepared as per the CE guidelines having technical details about the product. Contd.
Some National Authorities having global recognition • Underwriter Laboratories • USFDA – Food and Drugs Administration • UK MHRA – Medicine and Healthcare Products regulatory Agency • Australia TGA – Therapeutical Goods Association • BRC • Kosher
GMP: Good Manufacturing Practice Good manufacturing practice" or "GMP" refers to the quality control of manufacturing for foods, pharmaceutical products, and medical devices. GMPs are guidelines that outline the aspects of production that would affect the quality of a product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation.
WHO GMP The World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred countries worldwide, primarily in the developing world