ISO 9001: Frequently Asked Questions Answered

businessman writing on paperAs with any industry, medical device manufacturers are governed by industry standards and government regulations. Chief among these standards is ISO 9001—the international standard for quality management systems for companies, businesses, and organizations. ISO first published the standard in 1987. Updated versions were published in 1994, 2000, 2008, with the newest version being ISO 9001:2016.

The ISO 9001 quality management standard applies to a wide range of industries, suppliers, and services. A shortlist includes pharmaceuticals, oil and gas, mining, energy, electronics, steel, banking, health care, hospitality, utilities, biotechnology, and the manufacturing of medical devices.

With regard to the latter, many countries rely on ISO standards in regulating medical devices to develop similar quality system requirements internationally. Yet, does the ISO set inspection standards for medical devices with regulatory agencies globally? In the U.S. what role does the FDA play in medical device regulation and compliance? And what exactly is the ISO? And how does ISO 9001 affect the medical device industry? It can be confusing. Read on to answer these and other FAQ’s relating to ISO 9001:

What is the FDA?
The Food and Drug Administration (FDA) is a U.S. government agency responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological goods and products, blood products, and medical devices, as well as to ensure the safety of the food supply for people and animals, dietary supplements, cosmetics, and products that emit radiation. It is the regulatory body for the medical device industry.

What is the ISO?
ISO is the International Organization for Standardization. It is an independent, non-governmental international organization with a membership of 162 national standards bodies. It establishes guidelines, requirements and specifications for products, services and systems, to ensure quality, safety and efficiency. It also works to harmonize its standards with those of the regulatory agencies and bodies around the world.

What is ISO 9001?
ISO 9001 is the International Standard that promotes and defines the criteria for the development, implementation, and effectiveness of a quality management system for companies, businesses, and organizations. It is the only standard in the ISO 9000 series of standards of quality management guidelines and tools that is certifiable for companies and organizations. To date, over one million companies and organizations in over 170 countries have been certified to ISO 9001.

The standard focuses on seven customer-oriented quality management principles to ensure consistent, quality services and products for customers, that the implementation of will also, in turn, reward businesses with success. The ISO 9001 principles are customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management.

It is important to note that ISO 9001 is not a product standard, but a tool to control your processes and a quality system that your end product should meet. Also, ISO 9001 is not a membership group. A company or organization doesn’t ‘join’ ISO 9001. It must meet the criteria as defined in the certification requirements and pass the ISO audit. Once passed, the ISO registrar issues an ISO 9001 Certificate good for a three year period.

Why was ISO 9001 Developed?
Developing and establishing international standards provides a benchmark for quality management systems to meet. A consequence of bureaucratic regulation is a tendency toward a piecemeal approach to address evolving system requirements. Quite often, an overarching consistency is lacking, along with other inefficiencies, be it the private or public sector. ISO 9001 was developed to avoid such inconsistencies and to achieve a uniformity of objectives for quality management systems.

What is the influence of ISO 9001 on Medical Devices?
The entire scope of ISO 9001 is used by all companies that design, produce, manufacture, process, pack, label, and ship medical devices are required to comply with governmental regulations based either directly or indirectly on the ISO 9000 series. Most medical device manufacturers are ISO 9001 certified, along with other certifications.

Does the Medical Devices Industry Have an ISO?
The medical device sector follows the guidelines and requirements of ISO 13485. It is the international standard for quality management systems that established requirements for the medical device industry. ISO 13485 is designed and intended to function with other management systems around the world, and by doing so, work more efficiently and transparently with each other. The standard functions as a set of supplementary requirements used in conjunction with ISO 9001, which encompasses requirements specific to medical device manufacturers. Recently, the FDA announced its intention to use ISO 13485 as the basis for its quality system legislation.

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Plastic Products Catalog

BMP Medical is a quality manufacturer of plastic consumables and plastic products for research and medical diagnostic laboratories. Our products are manufactured to the highest quality standards. We offer a wide selection of products sold through the world’s premier laboratory distributors.

Non-Sterile and Sterile Centrifuge Bottles

  • Available with standard caps for low-speed work and sealing caps for high-speed applications
  • Caps have a built-in gripper to facilitate removal from the rotor
  • Extra thick walls for durability-resistant to most chemicals
  • Wide mouth design makes filling and decanting easier
These precision molded centrifuge bottles are available in polycarbonate or polypropylene. For low speed applications the bottles provide excellent value for large volume/large batch centrifugation procedures. For high-speed work, the easy-to-use Noryl® (Noryl® is a registered trademark of General Electric Company) sealing caps with silicone O-rings enable leak-free processing at high centrifugal forces over long durations. Bottles must be filled to 80% of capacity. Centrifuge bottles may be autoclaved at 121ºC at 15 psi for 20 minutes. Caps should be placed on the bottles without engaging the threads. Bottles are qualified to the rated g-forces using Sorvall® (Sorvall® is a registered trademark of Kendro Laboratory Products) and Fiberlite® (Fiberlite® is a registered trademark of Piramoon Technologies Inc.) high-speed rotors, tested at 20ºC, with bottles filled to 80% of capacity. Failure to use the correct rotor cushion or adapter will shorten the life of the bottle and may prevent achievement of the maximum rated RCF and/or bottle failure. Prolonged autoclaving and reuse may cause stress cracks, crazing or bottle discoloration.
centrifuge bottle
Sterile Centrifuge Bottles 
 
centrifuge bottle
Non-sterile Centrifuge Bottles

Cytology Funnels Category

BMP Medical Cytology Funnels for the Shandon CytoSpin® Centrifuge BMP Medical Cytology Funnels are the functional equivalent of the Thermo Shandon CytoFunnel®. Fully compatible with the Shandon CytoSpin Centrifuge, BMP Medical Cytology Funnels can be used to deposit a thin layer of cells in a clearly defined area of a microscope slide. The filter card absorbs any excess fluid. Operation is identical to those supplied by Shandon and easy-to-follow instructions are included in each pack. All products sold in case quantities only.


 

metal cytology funnel clip

Metal Cytology
Funnel Clips

Double Cytology Funnels

Double Cytology Funnels

Single Cytology Funnels

Single Cytology Funnels

Hemodrop Blood Dispenser

The Hemodrop is designed to reduce the risk of exposure to bloodborne pathogens in the Hematology laboratory. To prepare a manual differential smear, a drop of blood needs to be dispensed onto a glass slide from the specimen tube. Simply puncture the rubber stopper with the Hemodrop, and then invert and press gently onto the slide. A single drop of blood will be dispensed and the slide is ready. No more removing the stopper and manually putting a drop on the slide to test blood.  
hemodrop
Hemodrop

Multipurpose Containers

These high-quality non-graduated lab containers are designed for the collection, transport, and storage of specimens and samples. Tight fitting lids prevent leaks and odors. Ideal for storing biologically hazardous samples for terminal autoclaving before disposal. Molded from various materials. The stackable containers are resistant to freezing and boiling.


centrifuge
Translucent Multipurpose
Containers

Polypropylene Beakers

Resistant to most commonly used laboratory reagents, including a variety of strong acids, bases, and organic solvents, these high quality polypropylene beakers are the premier choice for scientific laboratory applications. All beakers are transparent for clear content visibility and graduated for easily estimating volumes. Molded-in pouring spouts, and a rolled lip, for a dripless working environment. Autoclavable to 121ºC ( 248ºF).
centrifuge
Polypropylene Beaker

Specimen Collection

For specimen collection and transport, this system provides disposable products for the convenient collection, delivery, and testing of urine specimens. A plastic cup is provided for specimen collection and the pressure sensitive patient identification labels have ample writing space. The lightweight transport rack is small and easy to carry yet provides space for up to 20 tubes with labels and caps. The tubes are made of sturdy polystyrene and are safe for centrifuging. The flared top permits the use of a midget urinometer ensuring a tight cap fit. 

centrifuge

Commode Specimen
Collection Systems

urine container

24 Hour Urine Containers

urine container

24 Hour Urine Containers with Spout

Tissue & Ultra Tissue Grinders

We offer two lines of tissue grinders for the clinical lab and research lab. The standard product is all plastic and is designed to grind softer tissues such as liver and spleen. The Ultra tissue grinder line has a vitrified tip and is designed for tougher material such as muscle or bone. Both lines are delivered sterile sealed Tyvek® (Tyvek® is a registered trademark of DuPont) package.

tissue grinder

Tissue Grinders

ultra tissue grinder

Ultra Tissue
Grinders

Urine Sedimentation System

BMP Medical, a manufacturer of diagnostic products, has a full line of urinalysis disposables. We offer the components separately, or in various kit sizes and configurations. The line is built around our 10-chambered Decislide which is made out of optically clear acrylic. It can take 10 individual samples on the same slide eliminating the need for a new slide for each sample.

 

Urine Sedimentation

Urine Sedimentation
System