Quality Documentation Services has now become

 QDS CORP.

Managing your quality systems.

Phone: (781) 270-9001; (207) 865-1544
Fax(781) 270-6204
QDS94@cs.com

1. Why do I need a Quality System like ISO 9001 or AS9100?

Companies need systems because the opposite of a system chaos disorder and confusion. This is far more difficult and costly method then maintaining systems. If one has no system for filing, for example, it can take hours and even days of sorting, hunting and searching to find records that you hope exist somewhere. When we look at business systems, the more customers, the more employees, the more part numbers, the more transactions and the more functions or processes a company has, the greater the need for systems. Many companies without systems are unable to grow and cannot be competitive.

Even a little disorder can go a long way to decreasing response time, multiplying inconsistencies and increasing disputes between well intentioned employees and managers.

Companies where Quality systems have been introduced have produced a better, more productive, happier work place where efficiencies and profits have increased.

ISO 9001 is a Business Quality System Standard for Business Managers who are interested in honest, more productive and good business practices.

The “requirements” that make up the ISO 9001 standard are sets of good business and management practices. To be against good systems and good practices is a non starter. The intent of the ISO 9001-2000 standard is to make companies stronger more dependable and reliable companies.

Companies that have bad, obsolete or poorly maintained systems are also the companies that complain about the “requirements” of the standard.

You, the company, get to decide how to implement the required concepts that are outlined (but not detailed) in the standard. If any concept in the ISO 9001 standard seems too cumbersome, there is always an easier way that better fits your circumstances. Often what companies end up doing as part of their of ISO 9001 or other Quality System is not even required.

For Example, ISO 9001:
o Provides a structure for management at all levels of the company
o Gives management the data essential for good decision making
o Will require that you focus on your customer’s needs and satisfaction
o Will ensure that your company improves its’ systems, communications and work processes.
o Will decrease the number of unexpected events that can be costly
o Requires monitoring of time and resource allocations
o Develops a focus for the company that can include goals such as increased profitability, efficiencies, and growth.
 

Only five areas of the standard require procedures or written work instructions. All of these may be covered in just a single Quality Manual.

So, as few as one document can cover all the requirements of the ISO 9001 standard. For small companies and companies with simple processes, few employees, and customers, this is adequate documentation.

Procedures are written where exact instructions are important, required, complex or numerous. If your system is difficult to maintain, you may need to simplify. One of the problems encountered by companies who pursue ISO 9001 is that they create a paperwork nightmare. Use the KISS principle (KEEP IT SIMPLE STUPID!)

Records are another area of documentation that too many companies suffer over. Only specific records are required. And many records only require a set of initials and date. Most of the required records make good sense, other records may be required, but record keeping must be manageable.

Also, plan on spending 5-10 hours a week during the implementation. Other people within the organization may also need to spend some time based on their level of responsibility.
 

Secondly, read the requirements which are located in Sections 4 through 8 of the standard.

If you are brand new to the standard, consider the services of a consultant or attending training classes. If you attend an ISO 9001 or AS9100 training class, consider also a follow up training class within 4 months of the initial training class. This will allow you to get answered some real company specific implementation questions.

Begin implementation with Section 7 (Product Realization). If you are managing the system, it will be helpful to understand each process as laid out in the standard.
 

One of the practical differences with recent revisions to the standard is that it cannot be implemented or maintained by one person. Responsibilities must be assumed, assigned, delegated and even subcontracted. Consider the following needs for resources:
 You will need someone committed to knowing (or learning) the ISO 9001 standard.
 You will need someone to create and maintain the required procedures and Quality Manual.
 You will need someone to maintain a Corrective Action system.
 You will need someone to manage the Internal Audit program, and auditors to perform the internal audits
 You will need someone to manage a Training program and perform the training
 You will need people to collect and analyze important company performance data such as On Time Delivery and Customer Satisfaction.

This may sound time consuming, but only if these tasks are not delegated or assigned to other capable individuals.
 

If you are considering the services of an ISO9001 or AS9100 consultant, for reasons of lack of knowledge, experience, resources, availability of time, then the best way to use a consultant is as a Project Manager.

he objective of achieving ISO or AS Registration should be given to the consultant in an agreed amount of time. Determine if the consultant or the company will be:
 Writing the internal procedures
 Writing the Quality Manual
 Provide training to key managers
 Training Internal Auditors
 Performing the Internal audits
 Providing other employee training
 

All registrars have auditors with the same required training. It will be more beneficial to make sure that the Auditor who will be performing your registration audit has not just the qualifications, but also the background in your specific industry.

Pricing may also be a factor as various registrars charge up to 30% more than other Registrars. When using a consultant, find out what Registrars the consultant has worked with. Having worked with 9 different Registrars, all Registrars will give you a good, honest audit. The individual Auditor will make the difference.
 

Once the system is in place, with responsibilities delegated as they should be, a guide you can use will be about twenty minutes per employee per week. Remember, systems are always easier to maintain than trying to work in an environment with no system or organization. .
 

or the critical material and services that suppliers and subcontractors provide, similar processes should be developed.

A screening process should be used for new suppliers. This might include a mail in survey (to determine capabilities), checking of references or on-site audits to ensure that they have systems in place to consistently meet your company’s requirements.

Suppliers and subcontractors should also be subject to a review process. Records of non-conformances and delinquent deliveries should be kept, reviewed and appropriate actions taken depending on your industry. Visiting your suppliers periodically to evaluate their systems will also be beneficial and can increase your success with your suppliers.
 

Contact QDS CORP. for quotes and more information:

QDS CORP.
25 Hillcrest Road
Burlington, MA 01803
Phone: 781-270-9001, 207-865-1544
Fax: 781-270-6204
QDS94@cs.com

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