Six Sigma Quality International

EN 15085:2007  - with respect to the railway environment the standard series EN 15085:2007 specifies certification and quality requirements placed on the manufacturers that use welding in connection with the manufacturing of new structures and in connection with repairs. The standard series provides interconnection between output requirements specified for the structure, inevitability to have adequate quality of weldments in the course of the manufacturing process and the subsequent applications of the required types of quality control in production.

Railway application – welding railway vehicles and their parts - Part 2:  Requirements concerning quality and certification of the manufacturer in connection with welding. The series of standards apply to the welding of metal material in connection with the manufacturing and maintenance of railway vehicles and their parts, specify certification levels and requirements concerning manufacturers as regards welding, and describe verification procedures to be used by manufacturers in the welding processes. 
  
  

Kind of product in relation to the certification level  - four certification levels (CL) (levels 1 to 4) are specified for certification of the manufacturer. Particular certification levels further specify corresponding classes of weldment execution (CP A - CP D) of welded joints specified in EN 15085-3:2007.

Certification levels: 
- CL 1 - this level applies to the manufacturers that produce welded parts of railway vehicles or their welded parts with welded joints with the class of weldment execution CP A to CP D (certification level Cl 2 and CL 4 is involved). 
- CL 2 - this level applies to the manufacturers that produce welded parts of railway vehicles with welded joints with the class of weldment execution CP C2 to CP D (welded joints classified with the class of execution CP C1 are involved if these weldments are checked in accordance with the check class CT 1). 
- CL 3 - this level applies to the manufacturers that produce welded parts of railway vehicles with welded joints with the class of weldment execution CP D. 
- CL 4 - this level applies to the manufacturers that do not weld railway vehicles or their parts but that design or purchase railway vehicles and their sets or distribute them (certification for welding work is not required as regards certification level CL 3).
Class of weldment quality  – must be determined at the phase of the design depending on the safety category and the category of stress, practicability and feasibility of weldment is important. Welded joints are divided into six classes of weldment execution (CP A, CP B, CP C1, CP C2, CP C3, CP D), which are directly related to the class of we?dment testing and checking.

EN 15085:2008 as a profile of manufacturer

Marketing and management system of railway vehicle welding production  - marketing established requirements concerning the quality management system within welding processes. For that reason it is important to know what the client thinks of the quality of welding operations. There is a number of fields where the supplier can only meet the requirements made by product standards, however it is necessary to take into account that according to the client the quality is not only the utility properties of a product, however the client assesses also the quality of related logistic, production supporting and production processes as well as other ways of communication in connection with the final provision of the order. 

Six Sigma (1) a data-driven method for improving business and quality performance, has been published as a two-part ISO standard.

Six Sigma was originally developed by Motorola in 1986 to ameliorate manufacturing processes with the goal of 99.99966% (2) of products free of defects (i.e., 3.4 errors per million). Today, the methodology is applied in many sectors of activity by organizations large and small for all types of process and services to:

• Drive process improvement and make statistically based decisions
• Measure business results with a level of reliance
• Prepare for uncertainty
• Combine high returns and benefits in the short, medium and long-term
• Remove waste, defects and errors.

“Six Sigma can be used to effectively address serious chronic business issues,” says Dr. Michèle Boulanger, President of JISC-Statistics and co-chair of the subcommittee that developed the standard, “Organizations can deploy Six Sigma projects to increase customer satisfaction and become more competitive.”

“Although Six Sigma has existed for some time, bringing its best practice together under an ISO standard helps solidify and consolidate the methodology. The ISO brand is respected and recognized worldwide, and thus provides an added layer of confidence. Moreover, publication of Six Sigma methodology in an ISO standard will boost international uptake of the methodology in a coherent form, reduce fragmentation, and provide users with harmonized best practice,” concluded Dr. Boulanger.

Six Sigma projects follow a defined sequence of steps with quantified goals and financial targets (cost reduction and/or profit increase), and rely on statistical tools to deal with uncertainty. Implementation involves the establishment of an infrastructure with specific roles and responsibilities (e.g. black or green belts). The new standard, ISO 13053:2011, Quantitative methods in process improvement – Six Sigma, deals exclusively with the application of Six Sigma to ameliorate existing processes and is published in the following two parts:

• Part 1: DMAIC methodology, describes the five-phased methodology DMAIC (Define, Measure, Analyse, Improve and Control), and recommends best practice, including on the roles, expertise and training of personnel involved in such projects.
• Part 2: Tools and techniques, describes tools and techniques, illustrated by factsheets, to be used at each phase of the DMAIC approach.

Both documents can be applied to all sectors and organizations.

ISO 13053 Part 1 and Part 2 were compiled by technical committee ISO/TC 69, Applications of statistical methods, subcommittee SC 7, Application of statistical and related techniques for the implementation of Six Sigma.

ISO 13053-1:2011, Quantitative methods in process improvement – Six Sigma – Part 1: DMAIC methodology, and ISO 13053-2:2011, Quantitative methods in process improvement – Six Sigma – Part 2: Tools and techniques, is available from ISO national member institutes 

This document applies to the basic safety and essential performance of a ventilator in combination with its accessories, hereafter referred to as ME equipment:

—    intended for use in the home healthcare environment;

—    intended for use by a lay operator; and

—    intended for those patients who need differing levels of support from artificial ventilation including for ventilator-dependent patients.

This document is also applicable to those accessories intended by their manufacturer to be connected to a ventilator breathing system or to a ventilator where the characteristics of those accessories can affect the basic safety or essential performance of the ventilator.

Developed as a direct result of a partnership between ISO and the international oil and gas industry (led by the American Petroleum Institute - API), ISO 29001 specifically focuses on the oil and gas supply chain.

The ISO/TS 29001 standard is based on ISO 9001 and incorporates supplementary requirements emphasising defect prevention and the reduction of variation and waste from service providers.

These requirements have been developed separately to ensure that they are clear and auditable. They also provide global consistency and improved assurance in the supply quality of goods and services from providers. This is particularly important when the failure of goods or services have severe ramifications for the companies and industries involved. 

This standard is for all organizations working within the oil and gas industry supply chain. Certification to ISO/TS 29001 ensures standardization and improvement within the sector. 

Human resources are the people who make up the workforce of an organization, business sector, or economy. "Human capital" is sometimes used synonymously with "human resources", although human capital typically refers to a narrower effect (i.e., the knowledge the individuals embody and economic growth). Likewise, other terms sometimes used include manpower, talent, labour, personnel, or simply people.

A human-resources department (HR department) of an organization performs human resource management, overseeing various aspects of employment, such as compliance with labor law and employment standards, administration of employee benefits, organizing of employees files with the required documents for future reference, some aspects of recruitmen

SOAP Version 1.2 (SOAP) is a lightweight protocol intended for exchanging structured information in a decentralized, distributed environment. It uses XML technologies to define an extensible messaging framework providing a message construct that can be exchanged over a variety of underlying protocols. The framework has been designed to be independent of any particular programming model and other implementation specific semantics.

ISO/IEC 40210:2011 defines the SOAP messaging framework consisting of:

• the SOAP processing model defining the rules for processing a SOAP message;
• the SOAP Extensibility model defining the concepts of SOAP features and SOAP modules;
• the SOAP underlying protocol binding framework describing the rules for defining a binding to an underlying protocol that can be used for exchanging SOAP messages between SOAP nodes;

ISO 10002:2004 provides guidance on the process of complaints handling related to products within an organization, including planning, design, operation, maintenance and improvement. The complaints-handling process described is suitable for use as one of the processes of an overall quality management system. 

ISO 10002:2004 is not intended to change any rights or obligations provided by applicable statutory or regulatory requirements

ISO 10002:2004 is not applicable to disputes referred for resolution outside the organization or for employment-related disputes.
It is also intended for use by organizations of all sizes and in all sectors. Annex A provides guidance specifically for small businesses. 

ISO 10002:2004 addresses the following aspects of complaints handling: 

• enhancing customer satisfaction by creating a customer-focused environment that is open to feedback (including complaints), resolving any complaints received, and enhancing the organization''''''''s ability to improve its product and customer service  

• top management involvement and commitment through adequate acquisition and deployment of resources, including personnel training

• recognizing and addressing the needs and expectations of complainants 
  providing complainants with an open, effective and easy-to-use complaints process

•  analysing and evaluating complaints in order to improve the product and                          customer service quality auditing of the complaints-handling process  
• reviewing the effectiveness and efficiency of the complaints-handling proces   

ISO 10668:2010 specifies requirements for procedures and methods of monetary brand value measurement.

ISO 10668:2010 specifies a framework for brand valuation, including objectives, bases of valuation, approaches to valuation, methods of valuation and sourcing of quality data and assumptions. It also specifies methods for reporting the results of such valuation.

ISO 10668 is a specification by the International Organization for Standardization (ISO) for the procedures and methods of measuring the value of a brand.

In 2007 ISO set up a task force to draft an International Standard on monetary brand valuation. After 3 years the ISO 10668^[1] – Monetary Brand Valuation – was released in Autumn 2010. This sets out the principles which should be adopted when valuing any brand.

ISO 10668 applies to brand valuations commissioned for all purposes, including:

• Accounting and financial reporting
• Insolvency and liquidation
• Tax planning and compliance
• Litigation support and dispute resolution
• Corporate finance and fundraising
• Licensing and joint venture negotiation
• Internal management information and reporting
• Strategic planning and brand management

The last of these applications include:

• Brand and marketing budget determination
• Brand portfolio review
• Brand architecture analysis
• Brand extension planning

Under ISO 10668 the brand valuer must declare the purpose of the valuation as this affects the premise or basis of value, the valuation assumptions used and the ultimate valuation opinion, all of which need to be transparent to a user of the final brand valuation report.

A 5S (Five S) program is usually a part of, and the key component of establishing a Visual Workplace and are both a part of Kaizen - a system of continual improvement - which is a component of lean manufacturing.

• having visual order
• organization
• cleanliness
• standardization

The results you can expect from a 5S program are: improved profitability, efficiency, service and safety.

The principles underlying a 5S program at first appear to be simple, obvious common sense. And they are. But until the advent of 5S programs many businesses ignored these basic principles.

5S was developed in Japan and stands for the Japanese words seiri (tidiness), seiton (orderliness), seiso (cleanliness), seiketsu (standardization), and shitsuke (discipline). These words have been adopted to English to maintain "5S."

"Sorting" means to sort through everything in each work area. Keep only what is necessary. Materials, tools, equipment and supplies that are not frequently used should be moved to a separate, common storage area. Items that are not used should be discarded or recycled.

Don''''t keep things around just because they might be used, someday.

5S Sorting itself involves five steps:

1. Cleaning
2. Classifying
3. Ownership
4. Red Tagging
5. Recycling / Reassignment

The purpose of "sorting" is to identify unnecessary items and eliminate them from the workplace. To do this first requires cleaning up the workplace so you can see what you have. Clean up accumulations of dirt, debris, oil, grease, broken tools, excess materials, and scrap. As you do this you''''ll also be involved with the second step of 5S sorting.

As you are cleaning up you''''ll find tools, equipment, materials and supplies. As each item is found, classify it as to the type of object. Scrap metal might go directly to a recycling bin. An item classified as tool might go to a collection area for further identification.

In some cases, as items are found or classified their ownership may be obvious. For example, pallets might be collected in one area so they can be returned to the shipping department. It may be immediately obvious where a tool belongs and that tool can be directly returned to its correct storage location. In other cases determining ownership may require asking some questions or doing a little research.

5S Sorting - Red Tagging

If an item cannot be identified, or if it cannot be classified, or if ownership cannot be determined, then it should be red tagged. Red tagging involves marking items with a red tag so that each item can be evaluated and dealt with appropriately. Red tagged items are collected in an area that allows potential owners to examine them and determine what should be done with the items for which they are responsible.

The Food Standards Agency (FSA) are no longer sending out hard copies of any Safer food, better business documents to businesses within England, all the documents are now only available from their website. These can be found by following the links below for the Diary and the Catering, Retail, Cuisine specific and Childminder packs. The FSA have developed all these in printer friendly versions so you can print them off easily.

You are also now able to type / complete the Safe Method pages online, before printing them off. The website also allows you to save your typed input whilst working your way through the pack which means you do not need to complete all the Cooking, Cleaning, Chilling, Cross-contamination and Management sections in one go. We recommend however that you print off all your completed Safe Method pages and keep a paper copy in a file in your business.

If you require a Diary refill, these are available from the website in 4 week sections. These can be printed off or saved onto your computer to complete as an electronic record. Be aware that if you keep an electronic Diary you need to save each month so that they are readily accessible to staff who are responsible for completing them. They should be easy to access on your computer and in a way that you can easily identify the date e.g. ‘Sfbb Diary 3 Safer food, better business files, including the electronic Diary are accessible for inspection by your Local Authority Food Safety Officer and whenever your food business is trading these files must be readily available on site at all times.

DCS & LL-C (Certification) Europe provides for exams of welders, soldering and welding operators subject to the authorization by CWS ANB (CZECH WELDING SOCIETY AUTHORIZED NATIONAL BODY). The examiners have appropriate professional qualification based on their education (IWE, EWE), many years of experience in the field and they have valid letters of appointment issued by CWS ANB. The issued authorizations and certificates of welder exams are valid worldwide.

- Issuance of authorizations, certificates, welder´s certificates about welder exams, including their duplicates
- Organization of professional workshops for welding engineers from schools and companies - the trainees receive an Welding Engineer Authorization
- Final exams of metal welders, soldering and welding operators under the Czech standards SN 050705, SN EN 287-1, SN EN ISO 9606-2, SN EN 13133, SN EN 1418 a SN EN ISO 17660-1,2 at welding schools in the CWS ANB system or directly in the companies.

• Manufacturers
• Retailers
• Brand Managers
• Traders and Distributors.

• Enables organizations to demonstrate a commitment to food safety
• Conveys a degree of confidence required by consumers, retailers and buyers within the food industry
• Provides buyers, consumers, government enforcement and trade agencies with justified assurance that control systems are in place to assure the safe production of food
• It is based on the internationally-recognized Codex Alimentarius standards and guidelines and other national standards
• Regular assessments help you to continually monitor their food safety system.

BS 25999 was BSI''''s standard in the field of Business Continuity Management (BCM). It was withdrawn in 2012 (part 2) and 2013 (part 1) following the publication of the international standards ISO 22301 - ″Societal Security — Business continuity management systems — Requirements″ and ISO 22313 - ″Societal Security — Business continuity management systems — Guidance″

Upon its publication in 2007 BS 25999 replaced PAS 56, a Publicly Available Specification, published in 2003 on the same subject.

• For most vehicle manufacturers, certification is a mandatory requirement that is internationally recognized - helping  to do business worldwide.

• The specification is based on ISO 9001 and encourages a process approach. Understanding the inter-relationship of processes through the use of the standard can enable improved product and process quality and ultimately avoids variation in the supply chain.

• SO /TS 16949 is based on ISO 9001, making the process approach easy to adopt and integrate with other key management systems including ISO 14001 Environment and OHSAS 18001 Occupational Health and Safety. It also complements many existing business improvement tools, such as FMEA, PPAP and Six Sigma.

• Certification can provide additional confidence and consistency to all interested parties in global sourcing, enabling greater business opportunities and attracting more investment prospects.

• For suppliers to a number of different vehicle manufacturers, certification to ISO/TS 16949 avoids the need for multiple certificates, thereby eliminating duplication in preparation and documentation as well as second- and third-party audits.

There are a number of areas that ISO 5001 and BS EN 16001 differentiate themselves from one another;

• Energy Policy *Energy Procurement
• Energy Performance
• Metering systems
• Management Responsibility

The ISO standard is set up for more of a rigorous standard control on what is to be stipulated through the policy. The ISO standard requires commitment related to the purchase of energy efficient products and services. The British standard only requires the consideration of energy consumption when purchasing consuming equipment. The ISO standard also requires a commitment for the required resources to achieve objectives and targets.

ISO 50001 standard puts more emphasis on the actual procurement of energy services, products, equipment and energy by having its own section for it. Procurement was just broadly included within the BS EN 16001. There is a clearer emphasis on ISO 5001 for its energy supply as BS 16001 deals more with the energy efficiency. ISO 50001 focusses more on renewables and carbon intensity relating to energy supply and BS 16001 considers energy performance criteria in the purchase of equipment.

BS 16001 is much more focussed on particular sites and encourages energy efficiency within these sites, usually taken on a reduction based approach. ISO 50001 takes into consideration energy efficiency, energy production, and the design, modification and renovation of significant energy consuming facilities, equipment, systems and processes.

BS 16001 refers to an ‘energy management plan’ but ISO 50001 refers to an ‘energy measurement plan’. This would mean, subjectively speaking that BS 16001 is more heavily reliant on metering than its new counterpart. The scope of the energy performance indicators are also broadened to encompass more as stated before within the ‘Energy Procurement’.

ISO 50001 puts a much greater emphasis on the term ‘top management’ than BS 16001. There are actual requirements for the top management to abide by in order to adhere to ISO 5001. The management representative for ISO 50001 has a more focussed responsibility set out, this would be to ensure a more appropriate means to recognise the energy manager role within the organisation.

ISO 10004:2012 provides guidance in defining and implementing processes to monitor and measure customer satisfaction.

ISO 10004:2012 is intended for use by organizations regardless of type, size or product provided. The focus of ISO 10004:2012 is on customers external to the organization.

ISO 10004 provides guidance in defining and implementing processes to monitor and measure customer satisfaction.

In order to pursue this goal the organization should:

• identify customer expectations;
• gather customer satisfaction data;
• analyze customer satisfaction data;
• provide feedback for improvement of customer satisfaction;
• monitor customer satisfaction on-going.

The purpose and objectives influence what, when, how and from whom the data is gathered. They also influence how the data is analyzed and how the information is ultimately to be used.

For whom?

The international standard series ISO 10000 can be used by any organizations no matter what type, size or product. The focus is on customers outside of the organization, not suppliers or its personnel.

Benefits:

• obtain information on new expectation
• resolving complaints to the satisfaction of the complainant and the organization
• identify trends and therewith eliminate causes of complaints
• customer-focused approach to resolving complaints
• encourage personnel to improve their skills in working with customers
• basis for continual review and analysis of the complaints-handling process

ISO/TS 29001:2010 defines the quality management system for product and service supply organizations for the petroleum, petrochemical and natural gas industries.

Boxed text is original ISO 9001:2008 text unaltered and in its entirety. The petroleum, petrochemical, and natural gas industry sector-specific supplemental requirements are outside the boxes.

The 2003 edition incorporated the requirements of ISO 9001:2000 and supplemental, sector-specific requirements. ISO/TS 29001:2007 has edited and expanded these requirements, as well as, added new definitions. Further improvements and additions and well as an expansion of these definitions were included in this latest edition of ISO/TS 29001:2010. 

What is HALAL (Lawful) and HARAM (Prohibited)?

Muslims commonly use two terms to describe every subject as Halal or Haraam. Halal is a Arabic word which means permitted, lawful with respect to which no restriction exists, and the doing and consuming of which the Law-giver, Allah has allowed.
Haram means the opposite-unlawful or forbidden that which the Lawgiver absolutely prohibited; anyone who engages in it is liable to incur the punishment of Allah in the Hereafter as well as a legal punishment in this world.
Halal and haram are universal terms that apply to all facets of life. However, we use these terms only in relation to food products, meat products, cosmetics, personal care products, food ingredients, and food contact materials. There are some things which are not clear are considered questionable or suspect and more information is needed to categorize them as Halal or Haram. If a muslim consumes Haram foods and materials, he would be sinful.

Foods containing ingredients such as gelatin, enzymes, emulsifiers, etc. are often referred to as Mashbooh, (which means doubtful or questionable) because the origin of these ingredients are not known. Many of the foods are considered Halal except the following, which are Haram with out doubt.

Swine/pork and its by-products
Animals improperly slaughtered or dead before slaughtering
Animals killed in the name of anyone other than ALLAH (God)
Alcohol and intoxicants
Carnivorous animals, birds of prey and land animals without external ears
Blood and blood by-products
Foods contaminated with any of the above products are Haram.

• Customer retention: By adopting the management system,  organization''''s ability to retain the loyalty of customers will be enhanced.
• Brand reputation: Implementing and certifying complaints management system demonstrates to stakeholders that organizations has real commitment to manage customer care issues and have processes in place to handle, analyze and review complaints.
• Operational efficiency: Implementation and certification ensures a consistent approach to handling customer queries, enabling you to identify trends and eliminate the causes of complaints, as well as improves organization''''s operations.
• Improved internal communication and relation: It helps to adopt a customer-focused approach to resolving complaints and encourage personnel to improve their skills in working with customers.
• Continual improvement: It provides a basis for continual review and analysis of complaints-handling process, the resolution of complaints and where improvements can be made.

Understand and prioritize the threats to your business with the international standard for business continuity. ISO 22301 specifies the requirements for a management system to protect against, reduce the likelihood of, and ensure your business recovers from disruptive incidents

ISO 22301:2012 specifies requirements to plan, establish, implement, operate, monitor, review, maintain and continually improve a documented management system to protect against, reduce the likelihood of occurrence, prepare for, respond to, and recover from disruptive incidents when they arise.

The requirements specified in ISO 22301:2012 are generic and intended to be applicable to all organizations, or parts thereof, regardless of type, size and nature of the organization. The extent of application of these requirements depends on the organization''''s operating environment and complexity.

Sanitary-epidemiologic certificate confirms that the production meets Ukrainian hygienic norms and standards . That document is issued by Sanitary-epidemiological units, on a base of production expertise, documents and inspection reports. Sanitary-epidemiologic certificate is valid for 2 Years (depends on production type, production conditions, documentation and specialist who considers given case).

Sanitary epidemiological certificate confirms that proper Ukrainian Departments allowed on production or importation of certificated goods so they meet Ukrainian standards. That document officially confirms that products are not harmful to human health.

Sanitary epidemiological certificate as well as UKRSepro certificate is being checked by Ukrainian customs officer and commercial inspector. It is issued by Federal Service of Supervision of Consumer's Rights and Goods Protection.

SO 15189:2012 specifies requirements for quality and competence in medical laboratories.

ISO 15189:2012 can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.ISO 15189 Medical laboratories — Particular requirements for quality and competence specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardisations''s Technical Committee 212 (ISO/TC 212). ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories. This working group included provision of advice to users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab''s role in the education and training of health care staff.

While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.

Software solutions designed specifically for medical laboratories can aid in achieving ISO 15189 based accreditation. In particular, document control software can help by improving turnaround time (TAT) for document reviews, increasing efficiency of staff and improving overall quality.

ISO/TR 14969:2004 provides guidance for the application of the requirements for quality management systems contained in ISO 13485. It does not add to, or otherwise change, the requirements of ISO 13485. It does not include requirements to be used as the basis of regulatory inspection or certification assessment activities.

This guidance can be used to better understand the requirements of ISO 13485 and to illustrate some of the variety of methods and approaches available for meeting the requirements of ISO 13485.