Quality Management System Registration 

ISO 9001, ISO 14001, ISO 13485, OHSAS 18001, TS 16949

Medical Device:

ISO 15883, MDD 93/42/EEC, ISO 14971, ISO 15223

Water pollution prevention:

EN 1717, WRAS, DWG W540, KTW W270, NSF 61

ISO 9000

ISO9000 is an internationally recognized standard for business management which ensures that businesses are
operating to the same standards of meeting customers’ requirements. There are many benefits for the business
certified to ISO 9001. The major benefit is a significant competitive edge over competitors. ISO 9001 can also be a
cost-effective way to demonstrate customers that quality assurance is of paramount importance to your organization
and through proper preventive measures you can save waste that can be passed on to your customers.

ISO 14001

ISO14001 is an internationally recognized Standard for evaluating how an organization manages its environmental
matters. ISO14001 certification means complying with environmental legislation. Many customers and other
stakeholders may require their suppliers to be accredited.

ISO 13485

It is the regulatory standard for medical devices. It is based on ISO 9001 but has some additional requirements
typical for medical device industry. It is required by legislation. Canada, EU and other countries require the
manufacturers and distributors to be ISO 13485 certified. In order to sell medical devices internationally, it is a must
for organizations to have ISO 13485 certification: It is mandatory for CE mark and Canadian Medical Device Licence.

OHSAS 18001

This is a safety standard, to enable businesses to measure and demonstrate their commitment to Occupational
Health and Safety. OHSAS 18001certification confirms that safety procedures are within the requirements of the law,
the business operates to accepted high standards of safety, ensures legal and regulatory compliance, reduces the
probability of workplace accidents, and helps control insurance premiums.

We will assist you throughout the process, while making the system simple: Say what you do, do what you say, prove that you do what you say. We understand your needs and adjust the process of certification to your needs:

• Conduct gap analysis to ascertain present position.

• Plan for establishment and implementation of relevant systems.

• Set up simple policy statement and objectives.

• Train the workforce and Internal Auditors.

• Develop documentation structure.

• Assist Internal Auditors conduct internal audits.

• Assist with selection of Registrar.

• Assist to maintain the system on regular basis.

• Plan for quality.

o Sample plans.

o Statistical techniques.

o Inspections.

o Calibration.

o Selection of instruments.

o Selection of personnel.

Improving efficiencies

• Strategic business planning with analysis of strengths and weaknesses.

• Developing short and long term business goals.

• Developing business plans.

• Introducing lean manufacturing concepts in processes.

• Developing job descriptions & hiring the right personnel.

• Developing performance-based evaluation of work force.

• Enabling management to synchronize energy of the organization behind a shared vision.

• Building strategic management capacity.

• Developing a better understanding of the business environment with analysis of threats and opportunities.

• Developing an alignment between the plan and the team.

Training

Training is an integral part of developing workforce to meet new challenges and it is necessary to determine the

needs for training and to provide the staff the necessary tools to implement continuous improvement strategies. In close cooperation with the management, we provide training in the following aspects:

• Understanding management systems.

• Documentation and quality records development.

• Internal auditing techniques.

• Statistical techniques.

• Improving communication.

Regulatory affairs

We assist the Medical Device companies in Canada in meeting FDA requirements and preparing technical files for

Health Canada, European Union and other countries in regulatory submissions and staff training.

Regulatory submissions

• US FDA 510(k).

• US FDA PMA.

• Health Canada (Medical Device Licence).

• Health Canada (Establishment Licence).

• Medical device supplier & internal audits.

• Establishment registration & licensing.

• Registration to industry standards.

• Due diligence.

On & off-site training for employees & supervisors

• Regulatory Processes

• Document Control

• Internal Audits

Business consulting

Preparing an effective business plan is a foundation for a reliable business start and development. We will discuss your specific needs and present an achievable plan to become a partner in your success by reducing unnecessary waste of resources and creating synergies in your processes and personnel. In case you want to know more, please do not hesitate to contact us for initial discussion.