If I am unhappy with an ISO 9001 certified organization, what recourse do I have?
How should I format my ISO 9001 documents?
What are the basic steps in gaining ISO 9001 certification?
My organization provides services. How are the ISO standards applicable to us?
What is ISO 9001?
What is ISO 9000?
How will a small organization be able to comply with the requirements of the standard? What flexibility is allowed?
If I am unhappy with an ISO 9001 certified organization, what recourse do I have?

People doing business with an organization that is certified to ISO 9001 sometimes ask what they can do if they are unhappy with the products or service they are receiving. Escalate your complaint, completing each of the following steps in order:

1) Begin by discussing the problem directly with the person you are disappointed with. This may be a sales person, service person, customer representative, or person actually performing the service or providing the product. Be specific about what you expected, why you expected it, and why you are disappointed. Fulfilling contracts is an important principle in ISO 9001. Focus your discussion around the contract you feel was not carried out. This may be a description of the product in a catalogue, an advertisement, or specific promises made by a sales person that you feel are incorrect. Insist that you be given a product that meets the description. You may have used a purchase order or other purchasing documents to obtain the product or service. Refer to the specific language in the purchasing documents you feel are not being met.

2) Each organization registered to ISO 9001 is required to have an ISO 9001 “Management Representative.” This person is authorized by top management to ensure that the requirements of ISO 9001 are being met. If step one does not provide a resolution, contact the organization’s ISO 9001 Management Representative and ask for help. Begin by describing your complaint and the steps you have taken so far. In addition, remind the representative that you are the customer and you expect your requirements to be understood and met. ISO 9001 has the following requirements that may be helpful to refer to in this communication. Describe how you believe the organization is failing to meet these requirements: Customer Focus (5.2), Quality Policy (5.3), Quality Objectives (5.4.1), Internal Communication (5.5.3), Resource Management (6), including competence, awareness, and training (6.2.2), determining requirements (7.2.1), review of requirements (7.2.2), customer communication (7.2.3), design and development validation (7.3.6), purchasing information (7.4.2), control of production and service processes (7.5.1), preservation of product (7.5.5), monitoring customer satisfaction (8.2.1), control of nonconforming product (8.3), corrective action (8.5.2), and preventive action (8.5.3).

3) ISO 9001 requires top management to take responsibility for the organization’s quality management system. Section 5.1 requires management commitment to specific quality management activities. Contact the top manager of the organization and describe your problem and expectations. If the organization has stock that is publicly traded, then the names of the top managers are publicly available.

4) If you still have not been satisfied, organizations that are certified to ISO 9001 have a certificate issued by a Certification Body. You can find out what firm issued the certificate by searching a list of certified companies. Contact the Certification Body with a description of your complaint.

The ISO organization itself develops and publishes standards, but cannot take any role in enforcement. Do not contact them for help in resolving a dispute.

How should I format my ISO 9001 documents?
ISO does not specify a document format. How you format your ISO 9001 documents is entirely up to you. You should select the method that adds the most value and is most easily used by your employees. However, ISO does expect you to control your ISO 9001 documents.
What are the basic steps in gaining ISO 9001 certification?

The following list of typical steps reflects the accumulated wisdom of hundreds of successful certification projects using the process approach now specified in ISO 9001:

1. Make a senior person responsible for your integrated system. This person will report directly to the CEO and will receive any required training.

2. Form a Project Team and consider need/role of an advisor/consultant. Select no more than eight personnel from a cross section of grades and functions.

3. Conduct a self-assessment or gap assessment using ISO 9001 and report on the results. Report will identify the adequacy of as-is processes and any identified need for new processes as well as report on any existing practices that appear to meet the requirements of the standard regardless of documentation.

4. Publish Quality Policy, Objectives and Action Plan. Policy and Objectives must be established and driven by Top Management and from the Project Team.

5. Develop leaders to create and sustain employee awareness. All leaders and the Project Team must learn so they understand and can explain.

6. Define organizational structure and responsibilities. Keep this up-to-date with names and job titles as a formal document.

7. Involve employees in developing and improving the system. Through awareness sessions, flowcharting, team reviews and experience feedback.

8. Decide on the document coding procedure. Use this from day one of developing system documentation.

9. Flowchart key processes showing all interfaces. Start with core processes and then tie in the support processes.

10. Code all forms in line with agreed coding procedure. Every form should belong to a process; remove redundant forms and create any newly identified forms.

11. Correlate all forms to flowcharts. Every form should have a place, if not check completeness of flowchart.

12. Review flowcharts for accuracy. By “accuracy” we mean what actually happens!

13. Develop and use flowcharts to document processes. The flowchart can become the procedure; always include process objective(s)/performance expectations.

14. Review, reconcile, approve and issue as-is procedures. Involve everyone and do not ignore comments. Process owners should approve procedures prior to release.

15. Prepare new procedures and train staff to implement them. These will come from the ISO 9001 self-assessment / gap assessment (see action 3) of your existing system.

16. Approve and issue new procedures and pilot quality plans. Quality planning is essential for customer driven teams eliminating waste.

17. Describe your overall system in your quality manual. Keep it slim and simple for customers, all employees and suppliers.

18. Launch the system and respond quickly to revision requests. Throw a party – you deserve it! Invite continual improvement ideas.

19. Audit and improve your system to raise value and reduce avoidable costs. Your trained audit team will come from action 15 which covers suppliers too.

20. Conduct pre-audit at least two months before the certification body / registrar is scheduled to audit the system. Use a Registered Lead Auditor and ensure that all corrective action records are up-to-date.

My organization provides services. How are the ISO standards applicable to us?

The standards are applicable to all types of organizations including all sectors and all services. The language in the standard continues to be simplified and made more user-friendly with less manufacturing bias with each revision.

(Note: the definition of the term ‘product’ within ISO 9000 includes hardware, software, processed goods and services).

What is ISO 9001?

ISO 9001 Quality Management Systems – Requirements, is the standard that outlines the essential characteristics of an ISO 9001 Quality Management System (QMS). It is used as the basis for QMS certification. This is the document that contains the actual requirements that must be fulfilled in order for an organization’s QMS to be certified.

The requirements within the Standard do not contain any industry specific or special requirements. It describes good management practice but does not state how an organization is to be controlled or operated. This will vary from one organization to another. The Standard recognizes the variation in Organizational structures, processes, products and procedures, and as such can be applied to very small and very large organizations alike.

In the current version of the ISO 9000 series, ISO 9001 is a generic requirements standard, applicable to any type of organization.

ISO 9001 is a tool that helps a company manage their business with a quality focus. The following are the main benefits of implementing an ISO 9001 Quality Management System:

  • Consistency in process and activity
  • Alignment, synergy
  • Synthesis of the focus of strategic management and the discipline of Quality * Assurance
  • Enhanced ability to drive improvement
  • Measurement
  • Improved Communication (internal & external)

There are several variants of ISO 9001 addressing specific industry sectors, better known as Technical Specifications. The most popular of these are:

  • Aviation – AS 9100
  • Food – ISO 22000
  • Medical Devices – ISO 13485/88
  • Automotive – ISO/TS 16949
  • Telecommunications – TL 9000 (SW, HW, FW and Service)
  • Laboratories for test and metrology – ISO/IEC 17025
  • Certification of individuals – ISO/IEC 17024
  • Information technology – ISO 27001
What is ISO 9000?

The ISO 9000 series is a set of generic management system standards. They can be applied to any organization, regardless of size and product (i.e. service or processed material) or activity (i.e. private, public or government).

“Management System” as mentioned above refers to what an organization does to manage its processes or activities. Simply put, a Management System is a method by which an organization can effectively control and improve its activities.

ISO 9001 unlike its many counterparts (e.g. ISO 14001—Environmental Management System Standard) is specifically concerned with “quality management”. This is what an organization does to enhance its customer satisfaction by meeting customer requirements and continuing to improve its performance.

ISO 9001 has become an international reference for quality requirements in business-to-business dealings, with over 1,000,000 certificates issued worldwide.

Key documents within the ISO 9000 family include ISO 9000:2005 – Quality management systems — Fundamentals and vocabulary; ISO 9001:2008 – Quality management systems — Requirements and ISO 9004:2009 – Managing for the sustained success of an organization – A quality management approach.

How will a small organization be able to comply with the requirements of the standard? What flexibility is allowed?
The requirements of the revised ISO 9001 are applicable to small, medium, and large organizations alike. ISO 9001 provides some flexibility, through clause 1.2 “Application”, on the exclusion of certain requirements for specific processes (i.e. those covered by clause 7, such as design activities) that may not be performed by the organization. However, the individual organization will still need to be able demonstrate its capability to meet customer and applicable statutory or regulatory requirements for its products, and will need to consider this when determining the complexity of its quality management system.