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) Each organization certified to ISO 9001 is required to have a “Customer focus” and a assigned role with responsibility and authority to ensure the promotion of customer focus throughout the organization.  Begin by describing your complaint and the steps you have taken so far directly with the person you are in contact 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 the needs and expectations of interested parties is an important principle in ISO 9001. Focus your discussion around the specifics of what you feel was not met. This may be a statement of commitment made on a website, a description of the product in a catalogue, an advertisement, or specific promises made by a salesperson that you feel are incorrect. Insist that you be provided with a product or service that meets the description.

2) Should your initial contact not provide an acceptable resolution to your concern, find out who within the organization has been assigned the responsibility and authority for customer focus and escalate your concern.  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 (5.1.2), Establishing the quality policy (5.2.1), Quality objectives and planning to achieve them (6.2), Customer communication (8.2.1), Requirements for products and services (8.2.2), Review of the requirements for products and services (8.2.3), Customer satisfaction (9.1.2), Nonconformity and corrective action (10.2).

3) ISO 9001 requires top management to demonstrate leadership and commitment to the organization’s quality management system. Section 5.1.1 requires that they take accountability for the effectiveness of the quality management system. 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 Quality Management System documentation is entirely up to you. You should select the method that adds the most value and is most easily used by your employees.
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 management system. This person will report directly to the CEO or they are the CEO.

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

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 how they are documented.

4. Train the Project Team on the requirements of ISO 9001.  This aids in developing leaders to create and sustain awareness. All members must learn so they understand and can explain.

5. Create and then publish the Quality Policy, Quality Objectives and Action Plan.

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

7. Involve employees in developing and improving the processes and closing gaps identified during the gap assessment. Through awareness sessions, flowcharting, team or peer reviews, experience and feedback.

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

9. Code all previously existing documentation in line with agreed coding procedure. Every document should belong to a process; remove redundant documents and create any newly identified ones.

10. Correlate all forms to processes. Every form should have a place, if not check completeness of processes.

11. Review processes/flowcharts for accuracy. By “accuracy” we mean what actually happens!

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

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

14. Create a document that describes your overall system (could be a quality manual). Keep it slim and simple for customers, all employees and suppliers.

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

16. Audit and improve your system to raise value and reduce avoidable costs.

17. Conduct a management review and document any resulting decisions and actions.

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, services, software and processed materials).

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
  • 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
  • Automotive – IATF 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?

ISO 9000:2015 – Quality management systems — Fundamentals and vocabulary provides the fundamental concepts, principles and vocabulary for Quality Management Systems.  It is the accepted “dictionary” for all management system standards.

How will a small organization be able to conform with the requirements of the standard? What flexibility is allowed?
The requirements of  ISO 9001 are applicable to all organizations of any size, either public or private which includes, but is not limited to:  sole-trader, company, corporation, firm, enterprise, authority, partnership, association, charity or institution.


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