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Quality and Safety Standards Save Lives and Reduce Financial Risk

ISO standards have made a significant contribution to improving our health and safety since the International Standards Organization was founded in 1947. Beyond bringing economic benefits, ISO standards protect the health of the planet and people in many facets of our daily lives.

Over the last 71 years, ISO has developed more than 1 300 standards that cover everything from the shoes we wear, to road safety, water and soil quality, secure medical packaging and medical devices.

Viewed through the lense of the World Health Organization (WHO), health is a human right, not a luxury. The WHO’s World Health Day campaign “Health For All” – marked on 7 April this year – calls on global leaders to commit to affording every person, everywhere, access to essential health services no matter their means.

ISO standards help governments and regulators support the WHO’s campaign for Universal Health Coverage, as standards assist in developing better policies and regulations and ensure that people receive quality health care.

In addition, ISO standards assist countries and organizations meet the United Nations (UN) Sustainable Development Goal 3, which aspires to: “ensure healthy lives and promote well-being for all at all ages”, as well as the principles contained in UN Agenda 21, which includes a section on protecting and promoting human health.

Standards also bring uniformity to healthcare organizations and help manufacturers understand people’s needs and develop products that serve markets better. The pharmaceutical sector and billions of consumers benefited when ISO released the Identification of Medicinal Products standards (IDMP) to help reduce global deaths caused by medication errors. Up until 2016 there was no means to identify medical substances on a global basis, which led to challenges when adverse reactions to medicinal products were reported in one country and needed to be interpreted by others.

A number of standards are currently in the pipeline to help healthcare facilities reduce global healthcare costs. Lee Webster, Secretary of ISO/TC 304, said: “A new series of standards will help to reduce waste, improve data transparency and improve interdisciplinary cooperation, resulting in better healthcare at lower costs. What’s more, recent research suggests patient satisfaction and outcomes are also improved in well-managed healthcare environments. So everyone wins.”

 

There is more to human health than meeting basic needs

Human health is not simply a matter of meeting basic needs, though. In 1986, the WHO redefined its definition of health as not just an “absence of disease or infirmity” but as “a resource for everyday life – health is a positive concept emphasizing social and personal resources, as well as physical capabilities”.

While ISO standards help with basic healthcare needs, they also take into account  ‘higher-level’ needs related to self-esteem, independence and happiness.

Face creams, soaps, perfumes and deodorants – products we take for granted in our daily lives and use to improve our self-esteem and happiness – can cause infections and severe allergic reactions in people with sensitivities. ISO 18416:2007, Cosmetics – Microbiology – Detection of Candida albicans, is an example of one ISO cosmetics standard that helps to reduce cases of infection from cosmetic products.

Depression and mental health conditions affect more than 300 million people across the world. Some of the causes of depression are related to living and working conditions. Implementing an Occupational Health and Safety Management system is a sound way organizations can reduce accidents and ill health.

Millions of people die each year from a work-related illness or injury; and thousands of people suffer from debilitating industrial diseases. The publication of ISO 45001 in March 2018, provides organizations with a single set of international requirements to help them protect workers from harm.

 

Companies ignore legislation, standards and quality systems at their peril

International standards mean that consumers can have confidence that the products they buy are safe, reliable and of good quality. Product liability claims are potentially one of the biggest threats to a company’s bottom line, and lack of attention to quality systems can result in hefty fines and indirect costs to companies.

The South African Consumer Protection Act (CPA) specifically caters for class-action suits. The CPA states: “a court can award damages against a supplier for collective injury to all or a class of consumers generally, to be paid on any conditions that the court considers just and equitable to achieve the purpose of the Act”.

Damages caused by defective products, including defective pharmaceutical products, defective toys and harmful food products could all find their way into court and manufacturers and suppliers in South Africa could be faced with mounting legal expenses defending these claims.

The South African gold miners’ silicosis lawsuit settlement is expected within a few weeks, and gold producers have set aside 5 billion rand ($420 million) in provision for the settlement.

Following what the WHO described as the world’s worst listeriosis outbreak on record — in which at least 190 died and many more were infected — human rights lawyer Richard Spoor launched a class- action against Tiger Brands and Enterprise Foods at the Johannesburg High Court on 29 March, 2018.

“Tiger Brands and Enterprise Foods have done terrible harm to the victims of the contaminated food they distributed from their Polokwane factory, to their reputation and to the Enterprise brand,” Spoor wrote on his Facebook page.

In what looks likely to be the biggest class-action in South African history, Spoor added that the  CPA allows for other affected parties to join the suit later.

Dr Selva Mudaly is quoted in a recent Business Day report as saying: “South Africa needs a better plan for food safety. We are not proactive. That’s the problem. We don’t pre-plan. Maybe the National Institute for Communicable Diseases (NICD) needs more laboratories to deal with this kind of thing.”

Across the waters in the United States, Abbott Laboratories, the global healthcare company, which is no stranger to class-action suits, was hit again last year with a nationwide $9.9 million class-action over defective cardiac defibrillators. It is alleged that St Jude Medical, a subsidiary of Abbott’s, knew about a battery-depletion defect in some of its cardiac defibrillators as early as 2011 but waited nearly 5 years before issuing a recall in October 2016.

Johnson & Johnson has met with similar woes in 2002 when the Lifescan unit of Johnsons agreed to pay $45 million to settle a class-action lawsuit brought by consumers who said that meters used to test diabetics’ blood-sugar levels were defective.

There can be no doubt that the costs of payouts in respect of claims can be crippling, and aside from reputational damage, could force a business to close its doors.

In order to properly reduce risk, suppliers and manufacturers are strongly advised to ensure that they have adequate standandards and monitoring measures in place to quickly become aware of any defect in their products and/or services.

Risk ZA offers training in a wide-range of medical, health and safety standards

Health, safe medical practices and quality of life are important to people everywhere. Customers expect products they buy and consume to be reliable and safe, that companies manage and reduce the negative effects their processes can have on the environment, and employees want workplaces that take their health and safety into consideration.

Risk ZA offers a wide-range of ISO related training, auditing and consulting solutions that help businesses to plan and implement internationally recognised standards that ensure products, services and working environments are safe and comply with legislation in order to protect a company’s reputation and reduce the risk of costly litigation.

We work intimately with a variety of standards but have courses running against the following standards through April to June:

  • ISO 9001:2015 – Quality Management
  • ISO 14001:2015 – Environmental Management
  • ISO 45001:2018 – Occupational Health and Safety Management

Visit our training course schedule for course details and booking information.

For more information or guidance on which ISO standard(s) and services would best suit the needs of your organisation, please email RISK ZA at: info@riskza.com or contact us on: 0861 Risk ZA / +27 (0) 31 569 5900

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