ISO 13485 certification

ISO 9001 and other standard Resources

CALISO has the pleasure to provide the following useful resources that will help you in your ISO 9001, ISO 13485, ISO 16949, ISO 14001 implementation efforts:


The following FAQ may also brings some helpful insight:

ISO 9001 related


How do you achieve ISO 9001 certification?
Very often people think that each individual employee of a company needs to be certified. The reality is is that it is a company certification, a good number of employees are audit by a 3rd party registration body BUT it is the company the gets certified. Employees need to be trained on this international standard. ISO 9001 training should be dispensed to at least top and middle-management of an organization. Registration organizations will verify training records and compliance with the company processes, which in turn need to be compliant with the various requirements of the ISO 9001 international standard. The requirements are set in the ISO 9001 document and are preceded by the word "shall": i.e. "The organization shall establish and maintain a quality manual that includes....". So in short an organization needs to train its employees, implement in its business practices all the necessary controls and process steps required by the standard, and then successfully pass an audit by a third party Registrar such as TUV, SGS, or UL.

What is the difference between the ISO 9000 and the ISO 9001 standards?

Both names are often used meaning the same thing. In reality ISO 9000 refers to a family of standards: ISO 9000 (contains vocabulary and definitions), ISO 9001:2008 (contains the actual requirements that an organization has to comply with to become certified), and ISO 9004 (contains guidelines on how to improve a quality management system). ISO 9001, the latest version being 2008, is a standard for quality management and sets requirements for all aspect of the operation of an organization (Sales, Purchasing, Manufacturing, service delivery, etc...). Compnay will seek ISO 9001 certification to prove to the world that their total product quality meets this international standard. Areas that are not covered specifically by this standard are: accounting, finance and personnel. Human resources such as hiring and training are within the scopr of this standard developed by the International Organization for Standards The purpose of this standard is to ensure that your organization will consistently provide products or services that meet customer and applicable regulatory requirements, and that your organization will enhance customer satisfaction by being effective in your operation and continually improving them.

Is Lead Auditor Training required for ISO 9001 implementation?

No, but it is highly recommended to have some key member within a company take this training so that they can manage and lead the required internal audits and eventually supplier audits. If the company chooses to outsource these activities, it is still a good idea to have ISO 9001 Lead Auditor training for the Quality Assurance Manager or QA Supervisor, so that he understands how to manage the internal audit program, and VERY IMPORTANT manage the 3rd party certification audits and surveillance audits by Registrars.

The ISO 9001 Lead Auditor training is also a very useful training for someone who wishes to drive the implementation of the international standard. The reason is that it gives useful insight on what auditors expects to find, it also takes the trainee through useful case studies that show all the different nuances in implementation for various industries whether they provide products or services.

How are internal Audits conducted for ISO 9001 compliance?

Conducting internal audit need to be conducted "at planned intervals to determine whether the quality management system (QMS) conforms to the planned arrangements and to the requirements of ISO 9001 and to the QMS requirements established by the organization, and is effectively implemented and maintained.

So, internal audits needs to be planned, with a schedule established that will ensure all areas of an organisation are audited, and all the requirements of ISO 9001 addressed. ISO 9001Auditor training needs to be provided to employees that will audit areas that they are independent from AND will be able have a grasp on how they operate. A production employee may have difficulty auditing a high-tech engineering departments.

At the end of the internal audit and closing meeting is conducted with all the department heads, stake holders and top management, to give an overview of the findings and opportunities for improvement uncovered during the audit.

Then an audit report is generated and promulgated among the key functions of the organization so that corrective actions can be taken.

What is the focus and benefits of ISO 9001 the international standard?

The international standard ISO 9001 is a quality management standard used by businesses that implement it to keep the most important aspects of running their operations and aligning business objectives with quality objectives. A company and all who partake in the daily activities of running the business will benefit from implementing ISO 9001 to ensure that all the proper steps and regulations are followed in all the most important areas, such as Sales, Operations and Purchasing. This way, they can ensure that the business and its employess are getting the most done in the most proficient manner and in a way that makes the business more efficient: the end result being a more profitable venture and a well-balanced, organization

Advantages of ISO 9001

The adoption of ISO 9001 by hundreds of thousands of companies worldwide is a good indicator on how advantageous it is to have ISO 9001. The number of certifications continues to grow and it is widely acknowledged that a QMS improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9001 are also sound, and give the following advantages:

1. Create a more efficient, effective operation

2. Increase customer satisfaction and retention

3. Reduce audits by customers

4. Enhance marketing ability

5. Improve employee motivation, awareness, and efficiency

6. Facilitate international trade

7. Increase profitability

8. Reduce nonconformities and increases productivity.

AS9100 related

How do you meet the training requirement for AS9100 the aerospace standard?

There are various organizations offering training programs on the AS9100 standard in itself. Even though the most important training is on the organization's compliant procedures and policy rather than on AS 9100. It is important that some key members of the organization have a very good grasp of the standard and eventually on how to audit or be audited to this standard. 5-Day seminars can be overkill in terms of employee immobilization and cost especially for small and medium businesses. A Web-based AS9100 Course may be the way to go. An employee can do it at its own rhythm and take the time to grasp the concepts. The cost-effectiveness of such course can be very appealing in order to train more employees. The thing to verify is the approvals granted by to such course providers. Registrar approval are a good indicator. RABQSA and IRCA approval are valuable but are more adapted for individuals who want to work for Registrars. They are usually costly approvals to have and the cost of individual courses suffer from it.

FDA, Medical Devices and Pharmaceuticals

  • Registering your device manufacturing facility with the FDA
  • Why is ISO 13485 necessary for CE marking of medical devices?
  • What facilities need Good Laboratory Practices (GLP)?
  • Registering your device manufacturing facility with the FDA

    Manufacturers registered with the FDA as medical device manufacturers have a differential advantage that they could leverage to increase sales. Very often, they do not have the choice. Either:

    -They are manufacturing a medical device, or -They are supplying a component to a manufacturer who makes a medical device, and their client wants them to register with the FDA to facilitate the FDA Approval of his own device.

    It is not that simple though. There are 3 scenarios:

    1/ The part or component manufactured is simply NOT a medical device. So the manufacturer CANNOT register with the FDA.

    2/ The part or component manufactured is considered as a low risk (Class 1) medical device. Then in this case the manufacturer of a Class I medical devices have the least amount of regulatory control because it presents minimal potential harm to the user. Class I devices are typically simple in design, manufacture and have a history of safe use. Examples of Class I devices include tongue depressors, arm slings, and hand-held surgical instruments. Most Class I devices are exempt from the premarket notification and may be exempt from compliance with the good manufacturing practices regulation. So the Manufacturer can self-declare and obtain a Device Manufacturer with the FDA.

    3/ The part or component manufactured is considered as a higher risk (Class 2 or 3), and in this case before being to obtain a facility registration, the manufacturer will need to obtain an FDA Clearance for the device through an FDA 510k approval process if similar devices exist already on the market (called predicate devices). Many controls are required such as compliance with the GMP, Special labeling requirements, Mandatory performance standards, both International and United States Postmarket surveillance, and FDA medical device specific guidance

    Class III medical devices have logically most stringent regulatory controls. They devices usually support or sustain human life, are of substantial importance in preventing impairment of human health, or present a potential unreasonable risk of illness or injury to the patient. Typically a Pre-Market Approval (PMA) submission to the FDA is required to allow marketing of a Class III medical device. And this precedes obtaining a facility registration for the manufacturer.

    Why is ISO 13485 necessary for CE marking of medical devices?

    In order to obtain CE approval and being able to market medical devices in the EU manufacturers have to comply with the EU Medical Device Directive. The MDD sets safety and efficacy requirements for medical devices. Among the requirements manufacturers have to have an effective quality management system in place. ISO 13485 is the most commonly chosen path for companies to meet this requirement in Europe. Even in Canada, Japan, Australia and other countries local regulations make it the simplest way to achieve compliance. Implementing ISO 13485 is voluntary for manufacturers selling in Europe, most companies opt to apply this standard to demonstrate compliance with the Directives. In Canada and Japan, ISO 13485:2003 is mandatory for most Class II, III and IV medical device manufacturers.

    Contrarily to the US, where the FDA is the only regulatory organization, notified bodies in Europe can thus ensure and enforce the quality management requirement of the MDD.

    What facilities need Good Laboratory Practices (GLP)?

    The Food and Drug Administration GLP is applicable and is extremely helpful for Pharmaceutical, Medical Device, Human Food, Neutraceuticals, or a non-regulated industry test or research laboratory. It provides very sound techniques to operate a laboratory in a controlled fashion. It is not required for Clinical Laboratory studies, but some elements of it are very useful in a clinical research environment lab.The GLP contains a set of principles that provides a framework for planning, performing, monitoring, recording, reporting and archiving laboratory studies. GLP is also used to assure regulatory authorities that the data submitted can be relied upon when making risk/safety assessments and are a true reflection of the results obtained during the study. GLP Training should be dispensed to all the Laboratory staff that performs studies or generate data by which the hazards and risks to users, consumers and third parties, including the environment, can be assessed for pharmaceuticals (only preclinical studies), agrochemicals, cosmetics, food additives, feed additives and contaminants, novel foods, biocides, detergents and so on.

    Useful documentation and videos can be accessed through this doumentation link in collaboration with YouTube.

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