ISO 9001 is a generic name given to a family of standards developed to provide a framework around which a quality management system can effectively be based.
The ISO 9001 family of standards was revised in December 2000. ISO 9001 family of standards can be implemented by any organization irrespective of size, nature or complexity of the business.
ISO 9001:2000, the requirement standard, includes the following main sections:
Measurement Analysis and Improvement
Better management of core business processes.
Increased awareness of quality among staff.
Improved productivity and quality.
Improved internal communications.
Reduced wastage and cost per unit / service.
Competitive Advantage : 72.3% of corporations with ISO 9001:2000 report a major competitive advantage. This means they are winning more business. (Source – Dun and Bradstreet Survey).
Improves Customer Demand : 33.4% of corporations with ISO 9001:2000 report improved customer demand. This means they are winning more business.(Source – Dun and Bradstreet Survey).
Protect Your Business : 69.3% of surveyed businesses that do not have ISO 9001:2000 say they have lost a customer bid or proposal to an ISO 9001:2000 certified competitor. Many of these companies said they didn’t know why they were losing the business until it was too late.
Your Competitors Are Doing It : In many industries, 35 to 40% of your competitors are ISO 9001:2000 Registered or in the process. The longer you wait to start, the greater is their competitive advantage.
Easy & Cost Effective : Getting ISO 9001:2000 is no longer the costly, time consuming proposition that it once was. Using our system to become ISO 9001:2000 compliant is very simple and inexpensive. It will put you way ahead of your competition and will enable you to improve your systems and operations.
Qualify for Government Contracts : The Department of Defense, Food and Drug Administration, Railways, Department of Energy and the General Services Administration have all approved the use of ISO 9001:2000 in contracts and bids.
Increased Credibility : You can generate a significant increase in business, as many corporations will only deal with ISO 9001:2000 Registered or Complaint companies.
The ISO 9001:2000 series of standards are based on eight dynamic Quality Management System Principles. These Principles are :
Involvement of People
Factual Approach to Decision Making
ISO 14001 was first published in 1996 and specifies the actual requirements for an environmental management system. It applies to those environmental aspects which the organization has control and over which it can be expected to have an influence.
ISO 14001 is often seen as the corner stone standard of the ISO 14000 series. However, it is not only the most well known, but is the only ISO 14000 standard against which it is currently possible to be certified by an external certification authority.
Having stated this, it does not itself state specific environmental performance criteria.
Implement, maintain and improve an environmental management system.
Assure itself of its conformance with its own stated environmental policy (those policy commitments of course must be made)
Ensure compliance with environmental laws and regulations
Seek certification of its environmental management system by an external third party organization
Make a self-determination of conformance
The ISO 14001 standard itself can be obtained either on its own, or as part of the Environmental Management Systems Electronic Book.
As an official BSI distributor, we can now offer purchase of both this kit and the standard online. Shipment is by UPS.
Worldwide (except UK, where first class mail is employed) direct from BSI headquarters.... and there are no shipping or packing fees!
ISO/TS 16949:2002 is an ISO Technical Specification which aligns existing US, German, French and Italian automotive quality system standards within the global automotive industry. ISO/TS 16949:2002 specifies the quality system requirements for the design/ development, production, installation and servicing of automotive-related products.
ISO/TS 16949 was written by the International Automotive Task Force (IATF). The IATF consists of an international group of vehicle manufacturers, BMW, DaimlerChrysler, Fiat, Ford Motor Company, General Motors (including Opel Vauxhall), PSA Peugeot-Citroen, Renault SA, Volkswagen and their respective trade associations - AIAG (U.S.), ANFIA (Italy), FIEV (France), SMMT (U.K.) and VDA (Germany).
Automotive Sector requirements, defining international automotive quality system requirements are contained in ISO/TS 16949, which is written around the format of ISO 9001:2000, in the case of ISO/TS 16949:2002.
Customer specific requirements are required by individual subscribing vehicle manufacturers and are provided separately.
ISO/TS 16949:2002 is relevant to automotive production and service part organizations only.
It is applicable only to sites where production or service parts are manufactured. (A site is
defined as: a location at which value added manufacturing processes occur. Manufacturing is
defined: as the process of making production materials, parts or assemblies, or heat treating,
painting, plating services.). Any tier within the supply chain can apply.
Any potential supplier can only be accepted for registration if they have a documented request
for quotation or is on a bid list of a subscribing customer.
ISO/TS 16949:2002 is also relevant to vehicle manufacturing plants: Jaguar, DaimlerChrysler, Land
Rover, Bentley are all working on quality systems to meet ISO/TS 16949:2002 requirements.
Some organizations that had been certified to QS-9000 were not eligible for ISO/TS 16949:2002
registration, for example: stockists and organizations who have no automotive customers.
Organizations which have automotive and non-automotive product will require separate
certification for these separate product groups. They would have ISO/TS 16949:2002 certification
for their automotive activities, and ISO 9001:2000 (or an alternative specified by their
non-automotive customers) for the non-automotive business.
Organizations wishing to break into the automotive market must wait until they are on an
automotive customer's potential supplier list before they can progress with registration.
Ford, GM, DaimlerChrysler, PSA Peugeot-Citroen, Renault, Fiat, BMW, Daimler Benz and Volkswagen all support ISO/TS 16949. DaimlerChrysler. Japanese and Korean manufacturers may also recognise ISO/TS 16949:2002 as a valid supplier approval mechanism in future.
Formal communications by Big 3 regarding their particular requirements have been made. Read our Vehicle Manufacturer Requirements section for more information.
Customer Specific Requirements: For subscribing members, these are to be made available via the IAOB website (Big 3 specifics are already referenced on this site) at www.iaob.org Note that some customer specifics may be incorporated into Purchasing agreements.
The ISO/TS 16949:2002 standard is the consensus of international quality requirements, which consists of policies and procedures that ensures worldwide consistence with the suppliers of parts, materials, or finishing services.
How do automotive manufacturers assure that the numerous parts that they receive from suppliers are of the highest quality? How do automobile manufactures assure that suppliers provide products that manufacturers can be responsible for and are worthy of the manufacturers name?
Automotive manufacturers assure quality by requiring registration to automotive quality standards that provide quality assurance. ISO/TS 16949:2002 is the latest automotive quality standard which was developed to be a new universally accepted quality standard for automobile suppliers. The ISO/TS 16949:2002 standard was developed to be an automotive standard for the customers’ of automotive manufacturers and it is aligned with the ISO-9001: 2002 standard. The purpose of ISO/TS 16949:2002 was to create standardization in the quality management standards for automobile suppliers throughout the world. ISO/TS 16949:2002 is a process approach quality standard, which places requirements that assure consistent quality, throughout organizations that supply automobile manufacturers. By requiring ISO/TS 16949:2002 certifications, automobile manufacturers can be assured that all of their suppliers are adhering to a consistent set of quality standards that are strict and intertwined throughout the supplier’s organization.
To know more about ISO / TS 16949:2002 and our deliverables through our unique process approach, click here or contact us for a Zero Cost discussion.
ISO 22000/ Hazard Analysis and Critical Central Point (HACCP) Food Safety Management System is a process control system designed to identify and prevent microbial and other hazards in food production and entire food chain. HACCP includes steps designed to prevent problems before they occur and to correct deviations through a systematic way as soon as they are detected.
Such preventive control systems with documentation and verification are widely recognized by scientific authorities and international organizations as the most effective approach available for producing safe food.
ISO 22000/ HACCP enables the producers, processors, distributors, exporters, etc, of food products to utilize technical resources efficiently and in a cost effective manner in assuring food safety.
The ISO 22000 standard outlines Food Safety Management System Requirements for any organization in the food chain, and is one of a family of standards focused at the development, implementation and improvement of a food safety management system.
Since ISO 22000 is a generic food safety management standard it can be used by any organization directly or indirectly involved in the food chain including- Farms, Fisheries and Dairies, Processors of Meats, Fish and Feed, including Manufacturers of soups, snacks, bread, cereal, beverages, canned and frozen food, etc as well as food service providers such as restaurants, fast food chains, hospitals and hotels.
Supporting services should not be forgotten and providers of food transportation storage and distribution, catering services as well as product suppliers for equipment, additives, raw materials, cleaning and sanitizing products, packaging. In short if your products touch the food industry or the food we eat, part or all of the ISO 22000 requirements will apply.
SA 8000 (Social Accountability 8000) is the first international certification on social responsibility. Its main objective is to guarantee workers' rights, in such a way that everyone involved wins: companies, workers, trade unions, government.
Lakshy Management Consultant Pvt. Ltd. is one of the leading SA 8000 compliance and certification consultants in India with clients in India, USA, UK, Saudi Arabia, Greece and Maldives.
The standard Requirements SA8000 was launched in 1997 by CEPAA - Council on Economics Priorities Accreditation Agency, an NGO, later renamed to SAI - Social Accountability International. Social Accountability 8000 (SA8000) is the first global standard for corporate social responsibility. SA8000 is based on both international human rights´ conventions (International Labour Organization, the International Declaration of Human Rights and the UN Convention on the Rights of the Child) and satisfying relevant local legislation. It aims to guarantee basic rights of workers involved in the production processes. SA 8000 Standard is composed of 9 requirements:
Forced labour is not permitted
Health and safety have to be assured
Freedom to organize and collective bargaining have to be guaranteed
Discrimination is not permitted
Disciplinary practices are not permitted
Working hours shall not exceed 48 hrs a week, with a maximum of 12 hrs overtime
Remuneration shall be sufficient
Management systems shall guarantee that the requirements are effectively satisfied
SA 8000 follows the structures of both the Quality Management Standards
ISO9000 and the Environment Management Standard ISO14000, and emphasizes the importance of an on-going
improvement process. Development and ongoing oversight of the standard is addressed by a multi-sector
Advisory Board with experts from business, trade unions, government and NGOs from around the world and
across industries. Facilities seeking certification of compliance to the standard must have robust
management systems in place and undergo an audit by an independent, accredited certification body. SAI
and its Advisory Board oversee the accreditation of certification bodies, which are required to
demonstrate extensive background in systems auditing, intensive training in SA8000, and the
institutional capacity to assure quality and responsiveness. There are currently nine accredited
certification bodies that have certified facilities in 30 countries. SAI regularly consults with
international experts on ways to strengthen certification audits and the SA8000 guidance documents.
Companies seeking to independently verify their social record.
Companies seeking to independently verify their own social record and that of their contractors.
Contractors that produce goods for U.S. and European companies and wish to demonstrate to companies and consumers that they are treating workers fairly.
Development or multilateral organizations seeking to ensure that they procure from companies that are not exploitative.
How companies can implement SA 8000 standard.
There are two options:
Certification to SA8000.
Involvement in the Corporate Involvement Program (CIP).
Companies that operate production facilities can seek to have individual facilities certified to SA8000 through audits by one of the accredited certification bodies. Since the SA8000 system became fully operational in 1998, there are certified facilities in 30 countries on five continents and across 22 industries.
Companies that focus on selling goods or that combine production and selling can join the SA8000 Corporate Involvement Program. The CIP is a two-level program that helps companies evaluate SA8000, implement the standard, and report publicly on implementation progress.
SA8000 Explorer (CIP Level One): Evaluate SA8000 as an ethical sourcing tool via pilot audits.
SA8000 Signatory (CIP Level Two):
Implement SA8000 over time in some or all of the supply chain through certification.
Communicate implementation progress to stakeholders via SAI-verified public reporting.
The CIP was launched in late 1999 and has attracted entities representing more than $100 billion in
annual revenue including Amana SA, Avon, Cutter & Buck, Dole, Eileen Fisher, Otto Versand, Tex Line,
Toys "R" Us, UNOPS, and Vögele Mode. Program benefits include training courses for managers, suppliers
and workers, technical assistance in implementing SA8000, access to a shared database of suppliers, and
the right to use the SAI and SA8000 logos to communicate with stakeholders.
Along with humane workplaces, the implementation of SA8000 offers more benefits to workers, companies
Enhanced opportunities to organize trade unions and bargain collectively.
A tool to educate workers about core labour rights.
Another opportunity to work directly with business on labour rights issues.
Public awareness of companies committed to assuring humane working conditions.
Putting company values into action.
Enhancing company and brand reputation.
Improving employee recruitment, retention and performance.
Better supply chain management and performance.
Clear and credible assurance for ethical purchasing decisions.
Identification of products made ethically and companies committed to ethical sourcing.
Broad coverage of product categories and production geography.
CE Marking is the symbol as shown on the top of this page. The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity". The term initially used was "EC Mark" and it was officially replaced by "CE Marking" in the Directive 93/68/EEC in 1993. "CE Marking" is now used in all EU official documents.
"CE Mark" is also in use, but it is NOT the official term. For instance, in the Directive 2007/47/ec, of 5 September 2007, amending the directives 90/385/eec, 93/42/eec & 98/8/ec, the term CE Marking appears 9 times whereas CE Mark appears nowhere in the entire 35-page document.
CE Marking on a product is a manufacturer's declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislation, in practice by many of the so-called Product Directives.*
*Product Directives contains the "essential requirements" and/or "performance levels" and "Harmonized Standards" to which the products must conform. Harmonized Standards are the technical specifications (European Standards or Harmonization Documents) which are established by several European standards agencies (CEN, CENELEC, etc).
CEN stands for European Committee for Standardization.
CENELEC stands for European Committee for Electrotechnical Standardization.
CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.
CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 28 countries), and
CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/vigilance authorities.
Along with more directives' becoming effective, more and more products are required to bear the CE Marking for gaining access to the EFTA & European Union market. However, many non-EU exporters are still unaware of or unsure about this fact and its impact on their business.
The CE marking shall be affixed only by the manufacturer or his authorised representative.
The CE marking shall be affixed only to products to which its affixing is provided for by specific Community harmonisation legislation, and shall not be affixed to any other product.
By affixing or having affixed the CE marking, the manufacturer indicates that he takes responsibility for the conformity of the product with all applicable requirements set out in the relevant Community harmonisation legislation providing for its affixing.
The CE marking shall be the only marking which attests the conformity of the product with the applicable requirements of the relevant Community harmonisation legislation providing for its affixing.
The affixing to a product of markings, signs or inscriptions which are likely to mislead third parties regarding the meaning or form of the CE marking shall be prohibited. Any other marking may be affixed to the product provided that the visibility, legibility and meaning of the CE marking is not thereby impaired.
Member States shall ensure the correct implementation of the regime governing the CE marking and take appropriate action in the event of improper use of the marking. Member States shall also provide for penalties for infringements, which may include criminal sanctions for serious infringements. Those penalties shall be proportionate to the seriousness of the offence and constitute an effective deterrent against improper use.
More important than the infrastructure, it is essential to know if the hospital has a documented process for its healthcare activities. Patient care not only involves the core clinical care, but also other support activities like requisition of tests, medicines, nurse doctor coordination, infection control practices, training, and so on. These need to run seamlessly in the background to provide the best experience to the patient and the relatives.
A quality-conscious hospital should define all such activities internally, document the same, and impart necessary training to the staff. These documented activities include detailed job responsibilities, work instructions, checklists and quality indicators for the staff to follow.
So how will the patient know about these processes? He is not expected to inquire with the hospital whether they have these processes laid down. And how many processes could he check even if allowed to?
Organisations like the Quality Council of India [QCI] and its National Accreditation Board for Hospitals and Healthcare providers [NABH] have designed an exhaustive healthcare standard for hospitals and healthcare providers. This standard consists of stringent 500 plus objective elements for the hospital to achieve in order to get the NABH accreditation.
To comply with these standard elements, the hospital will need to have a process-driven approach in all aspects of hospital activities – from registration, admission, pre-surgery, peri-surgery and post-surgery protocols, discharge from the hospital to follow-up with the hospital after discharge.
To give an idea what NABH standard comprises of, some of the 500-plus objective elements are listed here. The requirements have been grouped for easy understanding.
The patients and/or family members are explained about the proposed care.
The patients and/or family members are explained about the expected results.
The patients and/or family members are explained about the possible complications.
The patients and/or family members are explained about the expected costs.
Respect for personal dignity and privacy during examination, procedures and treatment.
Right to refusal of treatment.
Informed consent before anesthesia, blood and blood product transfusions and any invasive or high-risk procedures.
Information on how to voice a complaint.
Access to his / her clinical records.
Adequately qualified and trained personnel perform and/or supervise the lab investigations.
Policies and procedures guide collection, identification, handling, safe transportation and disposal of lab specimens.
Laboratory and imaging results are available within a defined time frame.
Critical results are intimated immediately to the concerned personnel.
The lab and imaging quality programme addresses verification and validation of test methods.
6. The lab and imaging quality programme includes periodic calibration and maintenance of all equipments.
The lab and imaging programme includes the documentation of corrective and preventive actions.
Surgical patients have a pre-operative assessment and a provisional diagnosis, documented prior to surgery.
Documented policies and procedures exist to prevent adverse events like wrong site, wrong patient and wrong surgery.
The operating surgeon documents the post-operative plan of care.
There is a documented policy and procedure for the administration of anaesthesia.
All patients for anaesthesia have a pre-anaesthesia assessment by a qualified individual.
During anaesthesia, monitoring includes regular and periodic recording of heart rate, cardiac rhythm, respiratory rate, blood pressure, oxygen saturation, airway security and level of anaesthesia.
Documented policies and procedures exist for prescription of medications.
The organisation defines a list of high-risk medication.
High-risk medication orders are verified prior to dispensing.
The hospital has an infection control team.
The hospital has designated and qualified infection control nurse[s] for this activity.
Hand-washing facilities in all patient care areas are accessible to health care providers.
Compliance regarding proper washing of hands is monitored regularly.
Isolation/ barrier nursing facilities are available.
Adequate gloves, masks, soaps, and disinfectants are available and used correctly.
The organisation’s environment and facilities operate to ensure safety of patients, staff and visitors.
There is a documented operational and maintenance [preventive and breakdown] plan.
Up-to-date drawings are maintained which detail the site layout, floor plans and fire escape routes.
The provision of space shall be in accordance with the available literature on good practices [Indian or International Standards] and directives from government agencies.
There are designated individuals responsible for the maintenance of all the facilities.
Maintenance staff is contactable round the clock for emergency repairs.
Response times are monitored from reporting to inspection and implementation of corrective actions.
Defined procedures for situation of bed shortages are followed.
Ambulance[s] is appropriately equipped.
Ambulance[s] is manned by trained personnel.
There is a checklist of all equipment and emergency medications in the ambulance.
In an NABH accredited hospital, there is a strong focus on the following:
Patient rights and benefits
Control and prevention of infections
Practicing good patient-care protocols e.g. special care for vulnerable groups, critically ill patients
Better and controlled clinical outcome.
NABH now is a member of the International Society for Quality in Health Care [ISQua] and thus NABH standard is at the threshold of being recognised globally.
So, if a hospital is NABH accredited, the patient can rest assured that the hospital follows stringent standards as laid down by the accreditation body for providing best in patient care comparable to any international hospital of repute.
The Value Methodology, also called Value Engineering (VE), Value Analysis (VA) or Value Management (VM), is a powerful problem-solving tool that can
reduce costs while maintaining or improving performance and quality requirements. VE is a technique directed towards analyzing the functions of an item or process to determine "best value," or the best relationship between worth and cost. RSD uses VE by being function-oriented, with a systematic team approach to provide value in a product from a design point of view.
The Value Methodology helps organizations compete more effectively in local, national and international markets to help increase market share by:
Reducing time to manufacture
RSD uses VE as an effective technique for reducing costs, increasing productivity, and improving quality. We can implement VE in all of the following aspects of the Product Development Process:
Production specifications and standards
Other acquisition program documentation
Facilities design and construction
VE can be successfully introduced at any point in the life cycle of products, systems, or procedures.
RSD can easily contribute savings of 30 percent of the estimated cost for designing and manufacturing a product through its VM services done offshore. The return on investment that public and private organizations derive from implementing VM programs averages 20 to 1. That is, for every dollar invested in a VM study - including participants' time and implementation costs - $20 in net savings results due to offshore engineering support.
Clarifying for itself the functionality of components as a part of gathering information on that component.
Using creative problem solving techniques to find better solutions (for example, structured Brainstorming).
Developing and presenting ideas generated during brainstorming exercises, and
Actually following through with the implementation of selected ideas.
We are providing training on…
ISO 9001 Training
ISO 14001 Training
ISO/TS 16949 Training
SA 8000 Training
APQP – Advance Product Quality Planning PAP – Part Approval Process FMEA – Failure Mode and Effect Analysis MSA – Measurement System Analysis SPC – Statistical Process Control 5S – House Keeping Problem Solving – 8D, Why-2, Cause and Effect Visual Controls Process / Productivity Improvement Poke Yoke Work Station Management