Understanding the importance and benefits of auditing Quality Management Systems

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Auditing Quality Management Systems is a core requirement for ensuring that Quality Management Systems – defined as “…a set of policies, processes and procedures required for planning and execution” in the core business area of an organization, meaning those that impact the ability of the organization to meet customer requirements – are updated and kept in compliance with regulatory requirements. The ISO 9001 set of standards is a step towards helping organizations achieve this end.

The ISO 9001 series, aimed at facilitating and ensuring that organizations of various kinds audit their Quality Management Systems in tune with regulatory requirements set out in this standard; was first implemented in the 1980’s. Today, across the globe, over a million organizations have been certified for complying with its requirements. The ISO 9001 is a tool for auditing Quality Management Systems across all kinds of organizations: big, small or medium to one stop providers to multinational organizations that operate in various geographies.

Why is auditing of Quality Management important?

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ISO standards have been arrived at after years of practice, observation and trial and error endeavors. These standards have evolved over continuous implementation of many best practices that are suited to particular organizations based on the size of their operations and the nature of their business.

An organization that has been in the practice of auditing Quality Management Systems is said to be implementing a better way of dealing with risk management. It is also considered an organization that enjoys enhanced stakeholder and customer confidence, as well as an improved, efficient and effective management and operational systems.

More than anything else, auditing Quality Management Systems are the surest means to ensuring that products and services from an organization meet certain prescribed processes and standards. An auditing Quality Management System officially certifies that the organization task a risk-based, process oriented, streamlined approach to ensure the safety, reliability and consistency of its products and services. A company that puts auditing Quality Management Systems in place is said to be more conscious of meeting customer expectations and makes continuous efforts and improvements into its products and services and complies with the law.

Certification is proof that the organization is auditing its Quality Management Systems

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Certification is like the proof of the pudding in Quality Management Systems audits. A company may claim to be implementing quality standards, but how does the world come to know about it? It is only through auditing Quality Management Systems certification that this happens. For a company to earn auditing Quality Management Systems certification; it has to be audited by the ISO. Upon careful scrutiny of its practices, the ISO awards the organization the 9001 Quality Management Certification.

What are the benefits of auditing Quality Management Systems certification?Certification from the world’s leading Quality Management Systems auditing certifying body gives such an audited and certified company a host of credentials and benefits. These are some of them:

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Good Manufacturing Practices are essential for ensuring quality

Good Manufacturing Practices (GMPs) constitute one of the core components that go into the manufacture and distribution of foods, drugs and other pharmaceutical products. Good Manufacturing Practices are prescribed by regulatory agencies from around the world, the FDA and the EMA being among them.

The guidelines set out by these regulatory agencies are aimed at bringing about standardization in the process of manufacture of these products and to ensure their quality. The utmost diligence of organizations that manufacture these products is called for.

goodManufacturingPracticesThe FDA attaches the highest importance to quality, since drugs and pharmaceuticals are consumed by millions of Americans for a variety of diseases and conditions. Keeping this in mind, the FDA has formulated guidelines with which manufacturing maintains set quality standards across a range of products ranging from foods to pharmaceuticals. The whole set of guidelines for manufacturing products in a variety of industries and activities is clubbed under the collective term, “Good Manufacturing Practices (GMP)”. The FDA attaches the highest importance to quality, since drugs and pharmaceuticals are consumed by millions of Americans for a variety of diseases and conditions. Keeping this in mind, the FDA has formulated guidelines with which manufacturing maintains set quality standards across a range of products ranging from foods to pharmaceuticals. The whole set of guidelines for manufacturing products in a variety of industries and activities is clubbed under the collective term, “Good Manufacturing Practices (GMP)”.

Since these best practices keep changing from time to time and the latest developments overshadow the existent ones; the FDA expects manufacturers to keep abreast of the latest regulations it passes, called cGMP, meaning “current” Good Manufacturing Practice.

No single set of standardsgoodManufacturingPracticesGMPs and cGMPs are not a single, rigid and monolithic set of standards or rules that everyone is expected to implement in their manufacturing systems. The regulatory agencies prescribe a broad set of general principles, from which a manufacturer from particular industries have to implement at a minimum level of quality requirements, the ones appropriate to it. Further, these guidelines offer options on the ways by which those regulations that are relevant to it can be accomplished. The organization needs to determine the one that suits it best for implementing that system.

Purpose of Good Manufacturing PracticesgoodManufacturingPracticesWhy the regulatory agencies take this task upon themselves is because the consumer is not in a position to identify a spurious product or one that has not been through all these scientifically designated processes. The fundamental purpose for which the regulatory agencies require adherence to the CGMP regulations is that compliance to these guidelines is a means to assuring the following:

goodManufacturingPracticesIn order to achieve this, drug manufacturers have to take all the steps needed to control the manufacturing operations. This includes establishing strong Quality Management Systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.

The FDA believes that putting all these steps and processes in place through this formal system of controls by a pharmaceutical company is a means to prevent mix-ups, contamination failures, deviations and errors. In addition to ensuring that drug products that go through these processes meet their quality standards; the cGMPs help to put in place systems with which proper design, monitoring, and control of manufacturing processes and facilities are assured.

Highlights of GMPs/cGMPsThe nature and role of current Good Manufacturing Practices can be summarized into the following:

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The GMP regulatory requirements in the EU

The EMA, being the regulatory agency for the EU; oversees the implementation of cGMP guidelines. The EMA’s guidelines apply to all the Member States of the European Union. The purpose for which these guidelines are set out by the EU is more or less the same as that for which other agencies such as the FDA lay out these rules. The essential reason for which this is done is to ensure that the pharmaceutical or any other regulated products:

goodManufacturingPracticesThe EU’s directives on GMP are listed out in its important legal frameworks and guidelines. These include:

  • Regulation No. 1252/2014 and Directive 2003/94/EC, which are for active substances and medicines for human use
  • Directive 91/412/EEC, which relates to medicines for veterinary use
  • Directive 2001/83/EC and Directive 2001/82/EC, which prescribe related provisions.

 

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Regulations in the US and EU Dealing with Combination Products

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Registering and maintaining combination products in the US and the EU is a bit tricky, because these are disparate markets that are governed by different sets of regulations which are independent of each other. So, any business that wants to market combination products into the US or the EU must be completely aware of the nature and meaning of all the regulations. Such businesses need to understand the nuances of the regulatory expectations and do what it takes to meet these.

Professionals and organizations that work in these areas must familiarize themselves with the existing regulations and their latest updates. This is the foundation to ensuring that their products comply with regulatory requirements and meet quality standards, which ensures that the consumer consumes products that are of the set scientific standards.

The regulations in the two markets have evolved differently. The fact that the regulatory agencies in the two markets, namely the US FDA and the European Medicines Agency (EMA) work to ensure the quality of drugs and thus the wellbeing of their consumers is the commonality between the two.

While the US FDA is a centralized agency that regulates food and medicinal products across the vast US market; the EMA, synchronizes the regulations of the 28 countries that are members of the European Union. While the FDA was primarily created to be a consumer protection agency; the regulations from the EMA came about to harmonize the commercial and technological interests of the Member States.

The EU’s new update

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In September 2016, the EU, through its two major legislative organs -the European Commission and the European Council, reached a compromise on a major area concerning combination products. Reached four years after a deal was made; the compromise relates to medical devices and invitro diagnostic (IVD) devices.

High risk combination devices, such as implants, will from now be assessed and authorized by the EMA. Brought in to replace the existing EU legislation on medical devices and in-vitro diagnostics; the new regulation seeks to make these products more consistent and uniform in terms of their assessment and approval process across the EU.

Thorough and sound learning of the US and EU regulations on combination products

This is the case of just one regulation in the EU concerning combination products. When the regulations and their updates from both the US and the EU are taken together, a regulatory professional or anyone in manufacturing is up against a mountain. It is to help gain clarity on this wide array of topics that GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance, will be organizing a two-day seminar.

This seminar, which is aimed at giving professionals who work in areas concerning regulation in the combination products area, will have Salma Michor, founder and CEO of Michor Consulting Schweiz GmbH, as the Director.

Please visit Regulations in the US and EU Dealing with Combination Products to register for this seminar. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Clarity about combination products

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Over two days of intense learning, Salma will offer a thorough understanding of the complexities involved in the regulations about combination products in the EU and the US. She will offer in-depth explanation of all the relevant regulations and guidelines. She will reinforce this learning by offering real life examples of how to register and maintain various types of combination products.

Salma will also help participants explore Interfaces, at which Change Management and LCM will be taken up for explanation. Other important aspects relating to the subject of combination products, namely compliant safety reporting for combination products and documentation requirements and interfacing, will be described in detail at this session.

Over the two days of intense learning, Salma will cover the following areas:

Documentation requirements and interfacing

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  • Documentation requirements for combination products EU
  • Documentation requirements for combination products US
  • Interfacing, development, quality, regulatory
  • Managing third parties and document control.

This seminar is of high value to professionals whose work is related in one or another way to combination products, such as Regulatory Affairs, Medical Officers, and Clinical Trial Managers.

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Forward brings its personalized healthcare service to Los Angeles

Forward, the San Francisco-based startup that’s looking to refashion healthcare services in Apple’s image, is expanding with its first location in Los Angeles.

Weaving together a number of Silicon Valley’s favorite healthcare trends, the company’s services combine proprietary, purpose-built medical devices with algorithmically enabled diagnostic tools, and the latest in gene, bacteria and blood tests to provide a holistic view of its patients’ health.

These technologies and services include: unlimited access to its medical staff; baseline screening; blood and genetic testing; wellness and nutrition counseling; and ongoing monitoring from wearable sensors provided at the clinic. Support and access to its AI and 24/7 access to medical staff through the app are available exclusively to anyone who’s willing to pay the $149 per month fee.

At its launch, Adrian Aoun told us about 15 percent of its early users come from underserved communities and had received free membership. Members also get their first month of prescription medicine free through Forward’s onsite pharmacy, which also offers vitamins and supplements.

Forward also plans to offer vitamins and other supplements and wearables through the onsite store, and Aoun said he would like to offer other alternatives, such as acupuncture, in the future.

Opening in a small office on the first floor of the Westfield Century City mall, Forward’s Los Angeles office will contain all of the bells and whistles that brought it so much attention when it opened its first San Francisco location in January.

There are custom-built exam rooms kitted up with interactive, touch-screen displays — part of what the company touts as an integrated, paperless system for new electronic health records.

The centerpiece of the company’s facility is a purpose-built body scanner that collects basic vital signs like temperature, pulse and arterial health, which are then sent to the company’s staff doctors.

Those aren’t the only diagnostic tools. The company also has an app and is rolling out services around fertility and sleep tracking, as well as dermatological and optometry services in its two offices.

 

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Rural health care centers provide low-cost care

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Providing health care services in rural areas is vital to addressing health disparity needs in the United States, said Candice King, the ACORN clinic’s executive director.

To get dental services she can afford, 73-year-old Juanita Jenkins has one of her sons drive her 16 miles from her home in the Duval neighborhood in northeast Gainesville to the Alachua County Organization for Rural Needs (ACORN) Clinic in Brooker. The 32-mile round trip is worth it, she says.

Jenkins is one of thousands of people in Alachua County and surrounding counties who need the inexpensive services provided by nonprofit organizations, such as ACORN, which was established in 1974 to serve area migrant workers.

“I started coming here last year and I’ve been here to the dentist about four or five times,” said Jenkins, after getting fitted for dentures. “They take good care of you here, and I would recommend their services to anybody.”

Thursday is National Rural Health Day, created to recognize rural health workers for their efforts and their collaborations that address the unique challenges faced in rural communities.

Providing health care services in rural areas is vital to addressing health disparity needs in the United States, said Candice King, the ACORN clinic’s executive director.

ACORN has grown from a singlewide trailer on a sandy lot of land to several modular buildings that house dental, medical and administrative offices at 23320 N. State Road 235 in Brooker.

The clinic provides a range of medical, dental and mental health care services, referrals to other health services and social services and professional education and training, King said.

Like ACORN, Archer Family Healthcare, an arm of the University of Florida College of Nursing, started out in a small building before moving into a larger building to better serve its patients. According to Joan Newell-Walker, manager of the clinic, retired Dr. Dee Williams lobbied to establish the clinic after being urged to do so by Archer residents. Williams’ efforts led to the clinic opening in 2001, and it has grown from an approximately 1,000-square-foot, two-story bungalow to a more than 5,000-square-foot facility composed of six modular buildings that were built in downtown Archer in 2007.

“We have grown to accommodate approximately 5,000 patient visits annually,” Newell-Walker said.

Patients visit the Archer clinic for a variety of reasons, including chronic diseases like diabetes, hypertension, chronic obstructive pulmonary disease, as well as prenatal care, medication consultations, health education and disease prevention, immunizations, physical exams and more, Newell-Walker said.

The clinic in Archer was established to meet the needs of residents who live in the rural community in southwest Alachua County who didn’t have a health care facility before the clinic opened. But it’s grown to serve patients from throughout North Central Florida, Newell-Walker said.

The clinic’s funding comes from local, state and federal sources, and it’s run by advanced registered nurse practitioners, Newell-Walker said.

The nurse practitioners provide expert care for patients and are supported by other health care professionals, including a case manager, community health nurses and a consulting physician, Newell-Walker said.

At ACORN, a wide variety of dental, medical and mental health care services are provided, including disease management education, general medical care, reduced cost X-rays, women’s health care, dental exams and X-rays, extractions, orthodontics, root canals and more.

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Innovation in education looks to cure doctor shortage

Business News | 20 hours ago |

Arizona has a serious doctor shortage. The state is a “Designated Health Professional Shortage Area” and according to the latest numbers from the Health Resources & Services Administration, the department that makes these designations, slightly less than half of Arizona’s primary care health professional needs are met.

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Since only 49 percent of the state’s needs are met, Arizona residents, particularly those in the rural parts of the state, are subject to long wait times for regular checkups because of the doctor shortage.

Arizona needs to add 520 physicians in order to lose its “shortage” designation. These doctors won’t appear out of thin air, but Arizona does have a great pool to reel new doctors from — its growing medical schools.

Midwestern University’s Arizona campus in Glendale sees an estimated 40 percent of its graduates residing and practicing in Arizona, says Dr. Kathleen H. Goeppinger, president and CEO of Midwestern University.

The University of Arizona College of Medicine in Phoenix offers a pipeline to local communities. The efforts include Saturday Scrubs and Summer Scrubs, where those interested in the medical field are welcomed into simulation labs to watch students care for mannequins — or faux patients. The hope is the program will spark the interest in those considering a career in the medical field.

And Mayo Clinic welcomed its first class of about 50 students to the Valley this year, making Arizona the third state to receive a Mayo Medical school, behind Minnesota and Florida.

The Mayo Clinic School of Medicine has created a curriculum that is designed to not only teach students how to do certain medical procedures, but also teach them the ins and outs of the healthcare delivery system.

“We want to prepare physicians to meet the needs and challenges of the healthcare system,” says Michele Halyard, MD, dean of the Mayo Clinic School of Medicine’s Arizona campus. “We are hoping that many of the students will wind up staying in Arizona for their residency and ultimately becoming a physician within the Arizona community.”

Class act

In late September, several medical groups in the state formed an alliance that will work to increase the number of doctors and healthcare professionals in Arizona and ease the doctor shortage.

Maricopa Integrated Health System, Creighton University School of Medicine, Dignity Health’s St. Joseph’s Hospital and Medical Center and District Medical Group will work together as the Creighton University Arizona Health Education Alliance to expand Arizona’s offerings of healthcare education programs.

“With this alliance, we have the opportunity to continue to strengthen Arizona’s reputation as the home of some of the best medicine in the nation,” says Patty White, president and CEO of St. Joseph’s. “The affiliation will enable us to increase the numbers of doctors and other healthcare professionals who will want to make Arizona their home.”

Arizona is also on the cutting edge of medical education, training and creating doctors who will be prepared to deliver care in a modern healthcare setting.

This is being done through various medical simulation centers in the state. Simulation is still fairly new in medical training and preparation. However, many medical schools across Arizona are adopting this new practice in hopes of producing better trained physicians.

Simulation centers vary from facility to facility, but they typically involve mannequins that enable students, practitioners and residents to learn how to deal with many different aspects of medical care and treatment.

Innovation abounds

The Banner Simulation Medical Center’s 55,000-square-foot simulation center is one of the largest simulation centers in Arizona, where trainees can fully experience a hospital-like atmosphere.

The center is nestled in a decommissioned, hospital where students can immerse themselves in simulations at an intensive care unit, surgery center, operating rooms and training labs. Students learn how to take blood samples, utilize proper sanitary measures and more, says Karen Josey, senior director of simulation at Banner Health.

“Simulation is all about patient safety,” Josey says. “Simulation goes from simple training such as putting in an IV, to the more complex tasks and scenarios, such as a chest tube insertion.”

The center also offers a day in the life of a nurse, where students are assigned a number of patients that they must watch, prioritize and care for throughout the day. This is followed by hours of debriefing on what needs to be improved and what was done correctly.

The University of Arizona currently has two simulation labs. One located in Tucson — which will open in May of 2018 — and one in Phoenix.

The Phoenix simulation center consists of three wings, 14 hospital rooms, two surgical stations, nine debriefing rooms, six onsite training rooms, three scrub sinks, ultrasound machines, 3-D models of the brain and eyes and a virtual reality simulation.

All of this is in hopes of accomplishing the UA’s “mission of providing the best training to students, residents and fellows, but it also helps recruit and expand our pipeline of students who might consider entering careers in medical fields,” says Guy Reed, dean of the University of Arizona College of Medicine – Phoenix.

Midwestern University is also home to a simulation lab. Its lab is made up of 19 exam rooms and extends to seven veterinary-based exam rooms. Also, there’s an ICU, emergency/trauma room, a pediatric floor, maternal fetal simulator, operating rooms and more.

Arizona is filled with simulation labs, including two more with Mayo Clinic. Mayo’s facility contains about six fully equipped exam rooms that are identical to those in the Mayo Clinic Cancer Center, and another simulation center within its hospital.

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Health Education England launches online workshop on improving digital readiness

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Health Education England is launching an online workshop to gather views on digital readiness.

The organisation is working in collaboration with Digital Health and innovation and crowdsourcing agency Clever Together on the online workshop, which forms part of the Building a Digital Ready Workforce programme.

It will be launched on 22 November in partnership with BCS Health and Care, the Federation of Informatics Professionals in Health and Social Care, and the Faculty of Clinical Informatics.

James Freed, chief information officer at Health Education England, told Digital Health the exercise was a chance to gather the views of those who already have a strong voice as well as those who are less commonly heard.

“In almost all technological programmes I have seen, our efforts are mostly about technology and very little about process, and the process redesign, and almost none on people,” he explained. He hopes the new online workshop will address that.

Andy Kinnear, chair of BCS Health and Care, added the aim was to hear from “digital experts; the wider group of people involved in the digital space such as nurses, doctors and care professionals; and the entire health and social care workforce”.

The online workshop will run for about three weeks and its results will form the basis for how the BRDW programme will prioritise and invest £6m over the next four years. Its findings will be extensively covered by Digital Health.

You can register now for the online workshop. Our feature article gives more detail – including interviews with James Freed and Andy Kinnear. Keep an eye on Digital Health over the next few weeks for ongoing coverage.