Quality management (ISO)

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• 1-800-463-8220(Ottawa)
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• All your processes are evaluated, standardized and explained to the personnel
• Training new employees is made much easier
• Problems are detected more quickly and solutions/results are improved
• Improved customer satisfaction
• Better understanding of customer needs
• Better perception of your company
• Suppliers become more like partners
• Overall communication is improved
• Better knowledge of your company by employees
• Improved participation of employees

• Observation
• Minor non-compliance
• Major non-compliance

• Procedures are evaluated, defined and understood by everyone
• Employee training is faster
• Problems are identified faster and effective solutions are implemented
• Improved customer satisfaction
• Better understanding of customer needs
• Improved company image
• Improved relationship with partners (sub-contractors)
• Better communications
• Employees have a better understanding of the company's role
• Increased employee participation
• Cost reduction

• All parties involved must adhere to the methods established
• Minimal increase in documentation

• Audits qualité internes (Internal Quality Audits)
• Assurer le passage à la norme iso 9001 version 2000
• Guide d'interprétation des normes iso 9000 (Guide to understanding ISO 9000 Standards)
• La certification qualité dans les services (Quality certification in the service industry)
• Mode d'emploi pour pme iso 9001 (ISO 9001-a practical guide for small businesses)
• Comprendre les normes iso900 version 2000 (Understanding ISO 9000 Standards, 2002 Edition)

Q. We want to get ISO certification for our information technology company, what are the costs and steps that need to be undertaken for our operational processes.

A. First, lets look at the steps that need to be taken to prepare your organization for a successful ISO Certification.

1. Document your management system:
   • Identify your core or business processes
   • Develop documentation that is useable and meets your business needs (i.e. policy statements, objectives, manuals, procedure's work instructions, job descriptions, forms etc.)
   • Encourage the participation of employees with the development of documentation to create ownership of the processes and increase awareness of the management system
   • Review, approve and distribute the documentation to those who need access to the information
2. Implement your System:
   • Ensure procedures are being performed as you have described in your documentation
   • Ensure employees are trained properly for the tasks they are performing
   • Create effective reporting systems (inspection, testing, corrective actions, preventive actions, management review meetings, monitoring of objectives, statistical techniques, etc.)
   • Measure the effectiveness of your processes through the use of measurable data where possible
   • Review and take action to improve in the areas required.
3. Verify that your system is effective:
   • Plan internal auditing activities (scheduling, review of documentation, creation of checklists, notification of personnel)
   • Conduct the audit – review the processes and system for compliance and effectiveness (observe, interview people, sample records)
   • Identify and report strengths and weaknesses of the management system
   • Take corrective or preventive action as required
4. Registration:
   • Select appropriate auditing body for external registration
   • Submit your Management System documentation for review to ensure compliance to the applicable standard
   • Prepare for review by external auditor to confirm the requirements of the management system are being satisfied and that the management system is implemented effectively.

The costs for developing and registering a formal Management System vary depending on the size and complexity of the organization and the internal processes however, there are some considerations one can make with respect to costs:

• First, there is the developmental costs (these costs would be in terms of resource time spent on the documentation and implementation of the system).
• Second, there would be costs associated with training internal employees in the skills necessary to prepare the necessary documentation and to plan and conduct effective internal audits and,
• Finally, there is the cost of registration. This cost includes such things as conducting the audit, registering the Management System and is dependent on the number of locations; the scope of work, number of shifts etc.

Using external support in the preparation and development of the Management System and training of employees can reduce some of the developmental costs in that there is much less chance of "starting down the wrong path", or missing critical requirements of the standard however, these tasks can be performed "in-house" if you have the resources available.

Some general guidelines for organizations, using external support, are that from inception to registration usually takes 8 months (minimum) to 18 months, with the average size organization taking about 12. This time is required to allow the sufficient collection of data to demonstrate that the system is effectively implemented prior to registration. Depending on the maturity of the current management system, the size and complexity of the organization and the scope of registration, costs to implement a formal Management System will range from approximately $12,000.00 to $50,000.00 plus the costs of the registration audits. These audits will again vary in costs for the same reasons as mentioned above from approximately $2000.00 per year to $30,0000.00.

Q. What's the difference between ISO and HACCP?

A. There are probably more similarities between ISO and HACCP than there are differences however; the main difference is that the HACCP system is intended for the food industry while ISO is applicable to all industries. Hazard Analysis Critical Control Point or HACCP is a Food Safety Enhancement Program built on seven key principles:

1. Conduct a hazard analysis.  Potential hazards may be biological, such as a microbe; chemical, such as mercury or a toxin; or physical, such as ground glass.
 
2. Identify the Critical Control Points (CCPs) in the process where the elimination or prevention of any contaminates would occur.

3. Establish critical limits for preventive measures associated with each identified CCP.

4. Establish monitoring requirements and procedures for using the results of monitoring to adjust the process and maintain control.

5. Establish corrective actions to be taken when monitoring indicates that there is a deviation from an established critical limit.

6. Establish effective record-keeping procedures that document the HACCP system.

7. Establish procedures for verification that the HACCP system is working correctly.

HACCP has become a mandated system for processors of seafood, meat, dairy, honey, maple syrup, processed fruits and vegetables shell eggs and processed egg and poultry hatchery sectors of the food industry.

While HACCP focuses primarily on control within the production processes, ISO is broader in nature and takes into account all of the supporting processes as well.  Both systems require the implementation of formal documented processes for such things as addressing corrective and preventive actions, training, maintenance of equipment, internal auditing, etc. and therefore, from a documentation perspective, it is relatively easy to combine the systems into one overall Management System that meets both the requirements for ISO 9000 and the requirements for HACCP.

Both HACCP and ISO are internationally recognized systems that will enhance consumer confidence when dealing with organizations that have implemented these systems and remain committed to the process and certified through third party registrars.     

Q. Can you provide me with a simple explanation and difference between being labeled ISO 9001, 9002, etc.

A. When the first ISO 9000 Quality Management System standard was published in 1984, it was determined that although the standard was intended to be applicable to all types of organizations in all types of different industries, there were some elements that were not applicable.  For example, certain businesses such as those involved in warehousing, or those in the service industry do not have design as part of their mandate therefore the requirements to control design and development are not applicable and so on. 

To accommodate all of these different organizations, three standards were published; ISO 9001, ISO 9002 and ISO 9003.  Organizations implementing a formal quality management system were instructed to select the standard applicable to their specific operation.  For example, an organization that had a responsibility for design and development, or control over design changes, would implement and register to ISO 9001 whereas an organization that assembled and sold a product that was designed by someone else and had no authority or responsibility to change the design would implement and register to ISO 9002.  The ISO 9003 standard was intended for those organizations that had no input or involvement in some of the more complex elements such as design and development, or perhaps controlling monitoring and measuring devices etc. such as a warehouse operation.  This standard was seldom used as both ISO 9002 and ISO 9003 were found to be very similar.

The three separate standards, although revised and refined in 1987 and 1994, remained in effect until 2000 when they were replaced with a new standard ISO 9001:2000.  As of December 2004, the registration to ISO 9001-94, ISO9002-94 or ISO 9003-94 is no longer valid. 

The ISO 9001:2000 standard underwent some drastic changes from the previous ISO standards one of which was to eliminate the need for three separate standards.  In ISO 9001:2000, an organization that does not include any part of the requirements specified in section 7 of the standard in their operational processes can simply exclude that requirement from their system provided the rationale for exclusion can be supported.     

Q. I want to open a coffee shop selling products made in Quebec. I would also like to be able to offer salads and sandwiches. Do I need a permit and what are the standards for food products?

A.  Opening a coffee shop can be a rewarding venture, but any public food establishment is not without red tape. With proper planning and a few telephone calls, you can avoid some very costly mistakes.

First, recognize that there are standards available for food services. In a coffee house/tea room setting, the ISO 22000 Standard and HACCP principles could apply, but this would be a stretch to the intent of the standard. These standards are written for agriculture, food processors, etc., not necessarily in a restaurant/retail environment.  ISO 9001 is applicable for every type of business, however, again, in a restaurant setting, becoming ISO registered would not be a priority during business start up. As with any business, perhaps, once you have become established and put best business practices in place with a trained staff, this could be a future consideration, especially if you wished to expand.

Your question was with regards to permits and standards. One area of rules and regulations that all new businesses must comply with is that of licenses and regulations. When creating a business, the entrepreneur must contact the municipality involved, along with the provincial and federal governments. Every business will need a Business Number, which is your business tax ID number.

Each municipal government has the authority to issue its own business licenses within its jurisdiction. Since there is no uniformity throughout the country regarding municipal licenses for businesses, you should consult with the appropriate local officials to determine whether your business will be affected by local regulations and licensing requirements.

On the provincial government side, a call to the provincial Department of Health and Department of Agriculture will assist you with any required applications. There are certain standards for refrigeration and safe food handling, smoking regulations, etc.  All public-eating establishments must be constructed and operated in accordance with these standards. Anyone considering establishing a public eating establishment must submit a plan to the local authority and receive approval. In order to begin business operations, the establishment must pass a mandatory health inspection. On site visits will be required by food inspectors to ensure ongoing compliance.

You will be required to comply with the provincial Occupational Health and Safety regulations, so you will need to establish a H&S program depending on the number of employees you intent to hire. This includes First Aid Training, the number of inspection fire extinguishers on site, etc. 

The specific regulations vary from province to province so be sure to thoroughly investigate your requirements. Contacts for local, provincial and federal governments can be found in the government listings of your telephone directory.

If this seems overwhelming, just know that there is help. There are many different industry associations available to provide information. In Quebec, you may also wish to contact Info Entrepreneurs, a member of the Canada Business network providing one stop shopping for new business orResources Enterprises.

Remember regardless of the type of business to be established, as an entrepreneur, there are four main areas of professional services with which you may consult: lawyer, insurance broker, accountant, and finally your banker - for tips and pointers on dealing with your financial institution. BDC is able to offer consulting. Contact your local BDC office for more information.