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The ISO/TS16949 is an international standard aiming to the development of a Quality management

system that provides for continual improvement, emphasizing defect prevention and the reduction of
variation and waste in the supply chain.

TS16949 applies to the design/development, production and, when relevant, installation and servicing
of automotive-related products. It is based on ISO9001.

The requirements are intended to be applied throughout the supply chain. For the first time vehicle
assembly plants will be encouraged to seek ISO/TS16949 certification.

A quality management system (QMS) can be expressed as the organizational structure, procedures,
processes and resources needed to implement quality management.

Elements of a Quality Management System

1. Organizational Structure
2. Responsibilities
3. Methods
4. Data Management
5. Processes
6. Resources
7. Customer Satisfaction
8. Continuous Improvement
9. Monitoring
10. Product Quality.

Concept of quality - historical background
The concept of quality as we think of it now first emerged out of the Industrial Revolution. Previously
goods had been made from start to finish by the same person or team of people, with handcrafting and
tweaking the product to meet 'quality criteria'. Mass production brought huge teams of people together to
work on specific stages of production where one person would not necessarily complete a product from
start to finish. In the late 19th century pioneers such as Frederick Winslow Taylor and Henry
Ford recognized the limitations of the methods being used in mass production at the time and the
subsequent varying quality of output. Birland established Quality Departments to oversee the quality of
production and rectifying of errors, and Ford emphasized standardization of design and component

a statistician.S. The rule is promulgated at 21 CFR 820. and to establish methods and procedures to design. Likemedicine. quality has achieved status as a recognized profession[citation needed] Quality system for medical devices Quality System requirements for medical have been internationally recognized as a way to assure product safety and efficacy and customer satisfaction since at least 1983. Quality control activities were predominant in the 1940s. Food and Drug Administration (FDA) had documented design defects in medical devices that contributed to recalls from 1983 to 1989 that would have been prevented if Quality Systems had been in place. medical device manufacturers have the responsibility to use good judgment when developing their quality system and apply those sections of the FDA Quality System (QS) Regulation that are applicable to their specific products and operations. and were instituted as requirements in a final rule published on October 7. operating within this flexibility. and has evolved since then. These elements include: . produce. As with GMP. in Part 820 of the QS regulation. 1950s. and 1960s.standards to ensure a standard product was produced. 1996. According to current Good Manufacturing Practice (GMP). was introduced during the second-half of the 20th century. production and distribution. The FDA has identified in the QS regulation the essential elements that a quality system shall embody for design. Quality management systems are the outgrowth of work done by W. Over this period. Management of quality was the responsibility of the Quality department and was implemented by Inspection of product output to 'catch' defects. accounting. to engineering. Application of statistical control came later as a result of World War production methods. and engineering. The 1970s were an era of quality engineering and the 1990s saw quality systems as an emerging field. Quality. it is the responsibility of each manufacturer to establish requirements for each type or family of devices that will result in devices that are safe and effective. The quality profession grew from simple control. The U. as a profession and the managerial process associated with the quality function. Edwards Deming. and distribute devices that meet the quality system requirements. after whom the Deming Prize for quality is named. to systems engineering. few other disciplines have seen as many changes as the quality profession. without prescribing specific ways to establish these elements.

 defining and controlling inspection.  validating processes.  product acceptance. or extent of. measuring and test equipment. if it is impossible to mix up labels at a manufacturer because there .  handling. For example. storage.  instituting corrective and preventive action when errors occur. some quality elements and to develop and implement procedures tailored to their particular processes and devices.  product identification and traceability at all stages of production.  servicing.  controlling nonconforming product.  controlling purchasing.  statistical techniques. all overseen by Management Responsibility and Quality Audits.  controlling documentation. It is left to manufacturers to determine the necessity for.  labeling and packaging controls. Because the QS regulation covers a broad spectrum of devices and production processes.  controlling and defining production and process.  records.  controlling the product design. it allows some leeway in the details of quality system elements.Quality System  personnel training and qualification. distribution and installation.

Who is it relevant to? Environmental impact is becoming an increasingly important issue across the globe. process and the service industries. and specialist consultancies. including: • Single site to large multi-national companies • High risk companies to low risk service organizations • Manufacturing. Social pressures are also building up from the growing array of interested parties. with regular reviews for continual improvement. with pressure to minimize that impact coming from a number of sources: local and national governments. A perhaps would be expected. academia and neighbours. regulators. certification bodies. a number of older documents were used in the creation process. We can then periodically assess the system and. environmental and minority non-governmental organizations (NGOs). Drug manufactures are regulated under a different section of the Code of Federal Regulations: 21 CFR 211. The next step is to produce objectives for improvement and a management programme to achieve them. trade associations. if compliant. A main driver for this was to try to remove confusion in the workplace from the proliferation of certifiable OH&S. These included: . What’s in ISO 14001: • General requirements • Environmental policy • Planning implementation and operation • Checking and corrective action • Management review This means you can identify aspects of your business that impact on the environment and understand those environmental laws that are relevant to your situation. ISO 14001 is an internationally accepted standard that sets out how you can go about putting in place an effective Environmental Management System (EMS). with the commitment of your entire organization. employees and shareholders. specifications. such as consumer. So ISO 14001 is relevant to every organization. then there is no necessity for the manufacturer to comply with all of the GMP requirements under device labeling. the FDA has instituted new policies requiring QS for pharmaceuticals. including local governments • All industry sectors including public and private sectors • Original equipment manufacturers and their suppliers OHSAS 18001 MADE EASY OHSAS 18001 was created via the concerted effort from a number of the worlds leading national standards bodies. register your company or site to ISO 14001. it can enable you to achieve both objectives. only one label to each product. customers. The standard is designed to address the delicate balance between maintaining profitability and reducing environmental impact.

APPLICATION AND BENEFITS The OHSAS specification is applicable to any organisation that wishes to: • Establish an OH&S management system to eliminate or minimise risk to employees and other interested parties who may be exposed to OH&S risks associated with its activities • Implement. It does not state specific OH&S performance criteria. • BS8800:1996 Guide to occupational health and safety management systems • Technical Report NPR 5001: 1997 Guide to an occupational health and safety management system • SGS & ISMOL ISA 2000:1997 Requirements for Safety and Health Management Systems • BVQI SafetyCert: Occupational Safety and Health Management Standard • DNV Standard for Certification of Occupational Health and Safety Management Systems(OHSMS):1997 • Draft NSAI SR 320 Recommendation for an Occupational Health and Safety (OH and S) Management System • Draft AS/NZ 4801 Occupational health and safety management systems Specification with guidance for use • Draft BSI PAS 088 Occupational health and safety management systems • UNE 81900 series of pre-standards on the Prevention of occupational risks • Draft LRQA SMS 8800 Health & safety management systems assessment criteria It is worth noting that the certification bodies involved in creation hold about 80% of the world market for management system certification. COMPATIBILITIES OHSAS 18001 has been developed to be compatible with the ISO 9001 (Quality) and ISO 14001 (Environmental) management systems standards. to enable an organisation to control its OH&S risks and improve its performance. environmental and occupational health and safety management systems by organizations. maintain and continually improve an OH&S management system • Assure itself of its conformance with its stated OH&S policy • Demonstrate such conformance to others • Seek certification/registration of its OH&S management system by an external organisation . The (OHSAS) specification gives requirements for an occupational health and safety (OH&S) management system. should they wish to do so. nor does it give detailed specifications for the design of a management system. in order to facilitate the integration of quality.

OHSAS 18001 is an audit/certification specification. Gain OHSAS 18001 certification by completing our Free Quoteform. It is based on already published criteria such as BS 8800 and the Management Regulations 1992. Always bear in mind the need to conform to legislative requirements. maintain and improve the way in which you manage your Health and Safety system. then audit and review them.OHSAS 18001 . The setting of targets through the Health and Safety policy. Organisations registered to OHSAS 18001 can be more confident about meeting the requirements of Health and Safety legislation. a certificate of registration to OHSAS 18001 will be issued. Why seek certification to OHSAS 18001? Registration to OHSAS 18001 by an independent.Then identify the boundaries of your Health and Safety system and document your procedures for meeting the requirements of OHSAS 18001. OHSAS 18001 is one of the standards in the OHSAS 18000 family. This is followed at a later date by an audit to check that records are being kept and documented working practices are being followed. • Make a self-determination and declaration of conformance with this OHSAS specification. . internal audits are needed to ensure the system continues to be effective. not a legislative requirement or a guide to implementation. together with the ongoing measurement against it ensures a process of continual improvement. How do you start to implement OHSAS 18001? What is involved? Firstly.Occupational Health and Safety What is OHSAS 18001? OHSAS 18001 is the latest certification specification for Occupational Health and Safety Management Systems. it will review your documentation to ascertain that it meets all the requirements of OHSAS 18001. After a successful audit. certification body demonstrates a commitment to implement. Ensure these procedures are fully implemented. evaluate the Health and Safety needs of your staff and visitors. third party. There will then be continual surveillance visits (usually once a year) to ensure that the system is maintained and continues to be effective. Assessment to OHSAS 18001 Having chosen a third party certification body for your audit. Once developed.

This results in a practical. meaningful audit. it is difficult to produce a meaningful price list that is readily understood. by reducing duplication and providing a centralised document control system. What is the cost of assessment to OHSAS 18001? With Health and Safety impacting on different types and sizes of organisations quite differently. For specific costings. From that we provide you with a fixed. If you prefer. Auditors are also carefully allocated by their experience in the industry they are auditing. Audit of joint systems is available and may be the best method for some companies. ISO 9001 and ISO 14001 systems There are several common elements between these three systems. If you would like a copy.Why choose ISOQAR for your assessment? ISOQAR has an enviable record for customer satisfaction with its certification services. ISOQAR firmly believes that any audit should benefit the organisation that requests it. but may also offer cost benefits for your third-party us on +44 161 865 3699 Joint OHSAS 18001. written quotation. A friendly approach to audits and dislike of bureaucracy has led to unprecedented growth through referrals from contented clients. such as management review. carried out in an air of mutual understanding. We have produced an outline guidance price list to give you some idea of assessment fees. we ask you to complete a short on-line questionnaire telling us about your organisation. These can be integrated into a single. please get in touch. document control. joint system or a combination of any of the above. not be an intellectual exercise to 'please' the auditor. ISOQAR only employs auditors who have empathy with this approach. we will happily complete one for you over the telephone . Integrated systems not only help an organisations internally. . corrective action and the requirement for trained personnel.