ISO 9001:2008 Frequently Asked Questions

What is ISO 9001:2008?

  • ISO 9001:2008 is a term for a set of international quality standards developed by the International Organization of Standards in Geneva, Switzerland. This organization has a membership of 110 standards groups representing 110 countries. The American National Standards Institute (ANSI) is the United States representative.
  • Over 140 countries recognize the standard.
  • Over 8,500 companies are certified in the United States, over 90 companies certified in Iowa.
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What is the history of ISO 9001:2008?

  • Mil-Q-9858 was adopted by NATO (AQAP-1)
  • British Standard (BS) 5750 evolved from the NATO standard and was adopted by the British Standards Institute in 1979.
  • ISO 9001:2008 was created the International Organization of Standards in 1987 primarily based on BS 5750.
  • ISO 9001:2008 standards are reviewed and revisions are adopted every five years. The second edition of the standard was issued in 1994.
  • ISO 9001:2008 activity in the United States is governed by ANSI and the American Society of Quality
  • (ASQ). Standards issued are titled ANSI/ISO/ASQ.
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What is a quality system?

  • It represents the quality of the product or services developed and supplied by your company under a set of documented procedures and work instructions known as the ISO 9000 quality system.
  • ISO 9001:2008 is a model/standard that lists requirements for a system to manage quality assurance; not a strict set of rules but a series of common sense guidelines.
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What are the parts of the standard?

With the advent of ISO 9001-2000, document resources have been pared to the following principle resources:

  • ANSI/ISO - Q9000-2000 - Quality Management Systems - Fundamentals and Vocabulary.
  • ANSI/ISO - Q9001-2000 - Quality Management Systems - Requirements.
  • ANSI/ISO - Q9004-2000 - Quality Management Systems - Guidelines for Performance Improvements.
  • ANSI/ISO - Q10011-1-1994;
                     Q10011-2-1994;
                     Q10011-3-1994 - Guidelines for Auditing Quality Systems.

(ISO 9001:2008 and ISO 9004 are designed to increase the understanding of the use of the standards.)

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What are the ISO 9001:2008 system requirements?

There are a number of ways ISO 9001:2008 is separate from other quality and management processes and systems. Notable are:

  • Visible, meaning documented, commitment by management.
  • Documentation to support all processes that affect product/service integrity.
  • Unique verification by audit process to confirm that those who claim to have adopted the standard have in fact done so.
  • Increase in Quality Management System effectiveness (Emphasis on Management added to stress that ISO is, more and more, a management system).

Take a tour of the quality system requirements of ISO 9001:2008.

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What are the benefits of adopting ISO 9001:2008?

One company's reported benefits were visible and recognized in all operations:

  • Employees said that job work instructions allowed them to carry out work without asking supervision.
  • Increased awareness of the value of quality in all operations.
  • Engineering department reported that design control improved communication and added to engineering project effectiveness.
  • Export sales have risen from nothing to 5% of sales with a projected increase to 15%.
  • The company was able to improve its customer market mix dramatically due to new market opportunities.
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How much does ISO 9001:2008 cost?

  • Costs vary dramatically depending on the degree of existing documentation and training currently in place.
  • Existing documentation requirements for FDA or for HACCP, can usually be adapted.
  • Registrar costs are, for most smaller firms, one of the largest individual costs. Registrars will quote in a flexible format to assist in controlling costs.
  • A three year Registrar contract for a smaller firm may be possible at a range of $15,000 to $20,000 for the three year period.
  • It is not unusual for cost savings to far outweigh this expense.
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What is the role of the Registrar?

  • The Registrar is an auditor certified to national standards with qualifications to review a firm's QMS system for correctness, usage, and effectiveness.
  • The Registrar first certifies that an applicant company meets the requirements of ISO 9001, then periodically follows up with surveillance audits to ensure continuity of the QMS system.
  • In this regard, the Registrar acts to police a company's QMS system to satisfy all potential customers that the company is capable of producing to their requirements.
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What documentation is required and needed for compliance with ISO 9001:2008?

  • Documentation to ensure a common understanding of quality policies and procedures.
  • Documentation sufficient to effective operation of the quality system and achievement of product quality.
  • Documentation only for the standard.
  • Key: Say what you do; Do what you say.
  • A common sense standard.
  • See documentation structure.
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What steps need to be taken for a successful implementation?

A small manufacturing company should allow 18 months for implementation before the certification audit is scheduled. An actual implementation schedule for an 80 employee company is reported in Carver Pump earns ISO 9001:2008 Certification, CIRAS News, Summer, 1995.

  • Management decision and commitment, (Absolute prerequisite)
  • Appoint a steering group and select management representative.
  • Create a steering group and select management representative.
  • Communicate ISO 9001:2008 implementation to entire organization.
  • Provide training as required.
  • Establish implementation teams.
  • Assess current quality systems status.
  • Accept, improve and develop necessary documentation.
  • Perform internal audits.
  • Select and apply for assessment from a registrar (if desired).
  • Take corrective actions.
  • Pre-assessment audit.
  • Correct deficiencies.
  • On-site assessment.
  • Registration.
  • Continuous improvement.
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Are there pitfalls to an effective implementation?

  • Lack of CEO and management commitment
  • Failure to involve everyone in the process
  • Failure to monitor progress and enforce deadlines
  • Failure to get input into documentation from the people involved in the process
  • Not setting an adequate time goal
  • Not actively using the system created
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How do you begin?

  • The first step is to decide for whatever reason that achieving ISO 9001:2008 certification is important to the company.
  • Next, appoint someone to receive education on ISO 9001:2008, preferably the person who will lead the company through the implementation phase. A one day introductory seminar is best. This person typically becomes the ISO 9001:2008 coordinator.
  • The ISO 9001:2008 coordinator meets with the management of the company to discuss what will be required to become certified.
  • If the company is still committed to the process, the top management official announces to everyone that the company will become certified to the ISO 9001:2008 standard.
  • The ISO coordinator attends a week long lead assessor course to learn about ISO 9001:2008 documentation, about internal auditing and about the ISO 9001:2008 standards.
  • The ISO 9001:2008 coordinator assists management in forming the ISO 9001:2008 steering committee charged with implementing ISO 9000. The committee receives two to eight hours of training about ISO 9001:2008. A target date for certification is established.
  • An implementation schedule is established.
  • The documentation team and implementation team are provided training on the twenty elements of ISO 9001:2008.
  • Documentation training is provided for the documentation team.
  • Begin documentation activities.
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Do you have an example of the ISO 9001:2008 documentation structure?

Diagram of the 3 levels of the ISO 9001 documentation structure.  Level 1, Quality Manual. The quality manual is a series of policy statements for each of the elements of the ISO 9001:2008 quality standard.  Level 2, Procedures. Procedures define the policy in terms of who, what, and where. Responsibilities and actions are outlined.  Level 3, Instructions. Work instructions define specific steps to accomplish tasks.

 
 

Engage. Educate. Embed.

Last updated: 7/31/2013