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
standards to ensure a standard product was produced. Management of quality was the responsibility of
the Quality department and was implemented by Inspection of product output to 'catch' defects.

Application of statistical control came later as a result of World War production methods. Quality
management systems are the outgrowth of work done by W. Edwards Deming, a statistician, after whom
the Deming Prize for quality is named.

Quality, as a profession and the managerial process associated with the quality function, was introduced
during the second-half of the 20th century, and has evolved since then. Over this period, few other
disciplines have seen as many changes as the quality profession.

The quality profession grew from simple control, to engineering, to systems engineering. Quality
control activities were predominant in the 1940s, 1950s, and 1960s. The 1970s were an era of quality
engineering and the 1990s saw quality systems as an emerging field. Likemedicine, accounting,
and engineering, 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, and were instituted as requirements in
a final rule published on October 7, 1996. The U.S. 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. The rule is promulgated at 21 CFR 820.

According to current Good Manufacturing Practice (GMP), 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, in Part
820 of the QS regulation. As with GMP, operating within this flexibility, 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, and to establish methods and procedures to design, produce, and distribute
devices that meet the quality system requirements.

The FDA has identified in the QS regulation the essential elements that a quality system shall embody for
design, production and distribution, without prescribing specific ways to establish these elements. These
elements include:
Quality System

 personnel training and qualification;

 controlling the product design;
 controlling documentation;
 controlling purchasing;
 product identification and traceability at all stages of production;
 controlling and defining production and process;
 defining and controlling inspection, measuring and test equipment;
 validating processes;
 product acceptance;
 controlling nonconforming product;
 instituting corrective and preventive action when errors occur;
 labeling and packaging controls;
 handling, storage, distribution and installation;
 records;
 servicing;
 statistical techniques;

all overseen by Management Responsibility and Quality Audits.

Because the QS regulation covers a broad spectrum of devices and production processes, it allows some
leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for,
or extent of, some quality elements and to develop and implement procedures tailored to their particular
processes and devices. For example, if it is impossible to mix up labels at a manufacturer because there
is only one label to each product, then there is no necessity for the manufacturer to comply with all of the
GMP requirements under device labeling.

Drug manufactures are regulated under a different section of the Code of Federal Regulations: 21 CFR
211. However, the FDA has instituted new policies requiring QS for pharmaceuticals.

ISO 14001 is an internationally accepted standard that sets out how you can go about putting in place an
effective Environmental Management System (EMS). The standard is designed to address the delicate
balance between maintaining profitability and reducing environmental impact; with the commitment of
your entire organization, it can enable you to achieve both objectives.

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. The next step is to produce objectives for
improvement and a management programme to achieve them, with regular reviews for continual
improvement. We can then periodically assess the system and, if compliant, register your company or
site to ISO 14001.

Who is it relevant to?

Environmental impact is becoming an increasingly important issue across the globe, with pressure to
minimize that impact coming from a number of sources: local and national governments, regulators, trade
associations, customers, employees and shareholders. Social pressures are also building up from the
growing array of interested parties, such as consumer, environmental and minority non-governmental
organizations (NGOs), academia and neighbours.

So ISO 14001 is relevant to every organization, including:

• Single site to large multi-national companies

• High risk companies to low risk service organizations
• Manufacturing, process and the service industries; 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, certification bodies, and specialist consultancies. A main driver for this was to try to
remove confusion in the workplace from the proliferation of certifiable OH&S. specifications.

A perhaps would be expected, a number of older documents were used in the creation process. These
included:
 • 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, in order to facilitate the integration of quality,
environmental and occupational health and safety management systems by organizations, should they
wish to do so.

The (OHSAS) specification gives requirements for an occupational health and safety (OH&S)
management system, to enable an organisation to control its OH&S risks and improve its performance. It
does not state specific OH&S performance criteria, nor does it give detailed specifications for the design
of a management system.

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, 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
 • Make a self-determination and declaration of conformance with this OHSAS specification.OHSAS

18001 - Occupational Health and Safety

What is OHSAS 18001?

OHSAS 18001 is the latest certification specification for Occupational Health and Safety Management
Systems. It is based on already published criteria such as BS 8800 and the Management Regulations
1992. OHSAS 18001 is an audit/certification specification, not a legislative requirement or a guide to
implementation.
OHSAS 18001 is one of the standards in the OHSAS 18000 family.
Why seek certification to OHSAS 18001?
Registration to OHSAS 18001 by an independent, third party, certification body demonstrates a
commitment to implement, maintain and improve the way in which you manage your Health and Safety
system.
Organisations registered to OHSAS 18001 can be more confident about meeting the requirements of
Health and Safety legislation. The setting of targets through the Health and Safety policy, 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, evaluate the Health and Safety needs of your staff and visitors. Gain OHSAS 18001 certification
by completing our Free Quoteform.Then identify the boundaries of your Health and Safety system and
document your procedures for meeting the requirements of OHSAS 18001. Ensure these procedures are
fully implemented, then audit and review them.
Once developed, internal audits are needed to ensure the system continues to be effective. Always
bear in mind the need to conform to legislative requirements.
Assessment to OHSAS 18001
Having chosen a third party certification body for your audit, it will review your documentation to
ascertain that it meets all the requirements of OHSAS 18001. This is followed at a later date by an
audit to check that records are being kept and documented working practices are being followed.
After a successful audit, a certificate of registration to OHSAS 18001 will be issued. There will then be
continual surveillance visits (usually once a year) to ensure that the system is maintained and continues
to be effective.
Why choose ISOQAR for your assessment?
ISOQAR has an enviable record for customer satisfaction with its certification services. A friendly
approach to audits and dislike of bureaucracy has led to unprecedented growth through referrals from
contented clients. ISOQAR only employs auditors who have empathy with this approach. Auditors are
also carefully allocated by their experience in the industry they are auditing. This results in a practical,
meaningful audit, carried out in an air of mutual understanding. ISOQAR firmly believes that any audit
should benefit the organisation that requests it, not be an intellectual exercise to 'please' the auditor.
What is the cost of assessment to OHSAS 18001?
With Health and Safety impacting on different types and sizes of organisations quite differently, it is
difficult to produce a meaningful price list that is readily understood. We have produced an outline
guidance price list to give you some idea of assessment fees. If you would like a copy, please get in
touch. For specific costings, we ask you to complete a short on-line questionnaire telling us about your
organisation. From that we provide you with a fixed, written quotation. If you prefer, we will happily
complete one for you over the telephone - call us on +44 161 865 3699
Joint OHSAS 18001, ISO 9001 and ISO 14001 systems
There are several common elements between these three systems, such as management review,
document control, corrective action and the requirement for trained personnel. These can be
integrated into a single, joint system or a combination of any of the above. Audit of joint systems is
available and may be the best method for some companies.
Integrated systems not only help an organisations internally, by reducing duplication and providing a
centralised document control system, but may also offer cost benefits for your third-party audit.