This Q&A Session covers the most frequently asked questions about ISO 9001. This standard is suitable for all organizations. Adopting an efficient Quality Management System based on ISO 9001 will help organizations save time and cost, improve their efficiency, and improve their customer relationships.
1. What is the purpose of ISO 9001?
The adoption of a quality management system based on ISO 9001 is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives.
2. Why is ISO 9001 the most used ISO standard?
In the recent report of ISO, the Quality Management System ISO 9001 is the most successful standard developed by ISO, with over one million organizations certified. In my view, one of the main reasons is that using ISO 9001 helps ensure that customers get consistent, good-quality products and services, which in turn brings many benefits to the business.
3. What are the 7 principles that ISO 9001 is based on and why are they important?
The seven Quality Management Principles (QMP) are:
QMP 1 – Customer focus
QMP 2 – Leadership
QMP 3 – Engagement of people
QMP 4 – Process approach
QMP 5 – Improvement
QMP 6 – Evidence-based decision making
QMP 7 – Relationship management
The importance of each principle differs based on organizations and can be modified over time. Additionally, there are different ways of applying these quality management principles.
The implementation of the principles is determined based on the nature of the organization and the specific challenges it is facing. Furthermore, setting up a quality management system based on these principles is found to be beneficial by many organizations.
4. Which are the most important clauses of ISO 9001?
Since Customer Focus is the most important principle of ISO 9001, clauses that address customer focus (clause 5.1.2) and customer satisfaction (clause 9.1.2) are emphasized throughout the document for organizations to know how important it is to meet customer requirements.
The scope of the management system (clause 4.3) forms the basis and structure to implement the quality management system. On the other hand, clause 10 Improvement describes the requirements for continual improvement in the quality management system by identifying nonconformities and taking corrective actions to prevent the nonconformity from recurring by eliminating the root cause of the non-conformance.
However, one should keep in mind that all the clauses are equally important and if one is not implemented successfully, it may have a direct impact on other clauses.
5. What is the Plan-Do-Check-Act cycle and how do ISO 9001 requirements fit into it?
In the ISO 9001:2015, the PDCA cycle is described as follows:
— Plan: establish the objectives of the system and its processes, and the resources needed to deliver results in accordance with customers’ requirements and the organization’s policies, and identify and address risks and opportunities;
— Do: implement what was planned;
— Check: monitor and (where applicable) measure processes and the resulting products and services against policies, objectives, requirements and planned activities, and report the results;
— Act: take actions to improve performance, as necessary.
6. What is documented information and how important is it?
The difference between documents and records has been removed from the ISO 9001:2015. Both are now called “documented information.” ISO defined the term “documented information” as information that must be controlled and maintained. Consequently, it is expected that organizations maintain and control the medium as well as the information. Furthermore, documented information is considered as evidence of conformance.
Documented information can be in any format and media, from any source, and can refer to:
- the management system and its associated processes;
- information created for the organization to operate (documentation);
- evidence of results achieved (records).
The reasons for retaining documented information include:
- Proving conformity to the standard;
- Communicating information in the organization;
- Maintaining organizational knowledge;
- Tracing back changes or measurements used;
- Keeping a reference for improvement.
7. Is the Quality Manual still a requirement from ISO 9001?
The short answer is that, under ISO 9001:2015, a quality manual will not be required. The ISO 9001:2015 standard does not specify a requirement for a formal quality manual.
However, many organizations that were certified under the previous version/s of the standard continue to make use of a Quality Manual. It could be very useful in terms of understanding the organization and its scope and providing a synopsis of the QMS.
8. Are organizations allowed to exclude requirements of ISO 9001?
In ISO 9001:2015 the applicability of its requirements to the organization’s quality management system cannot be excluded any longer. Nevertheless, an organization can determine the applicability of requirements. All the requirements in the standard, are intended to be applied.
An example of a set of requirements that are often excluded are the requirements for design and development (clause 8.3). If your organization does not do any design work but strictly works from designs given to you by a customer, then these requirements can rightly be determined to be not applicable to your organization.
9. What other ISO standards can ISO 9001 be aligned with?
ISO 9001 can be aligned with various other standards. Common standards that can be integrated are ISO 14001 and ISO 45001. Many organizations will refer to their management system as an Integrated SHEQ (ISO 45001, ISO 14001, and ISO 9001) Management System.
10. Which industries can benefit the most from the ISO 9001 and how?
The standard is generic, which means it can be used by any organization, large or small, regardless of its field of activity.
11. How does the certification audit against ISO 9001 help organizations?
The implementation of a QMS based on ISO 9001 helps organizations become more efficient and improve customer satisfaction. Organizations certified against ISO 9001 show that they:
- Place customers FIRST by consistently meeting their needs;
- Facilitate opportunities to enhance customer satisfaction;
- Address risks and opportunities associated with its context and objectives;
- Meet applicable statuary and regulatory requirements;
- Have a competitive advantage.
12. What are some tips and advice to get ready for a certification audit against ISO 9001?
Audits differ depending on the scope, the audit team, the maturity of the management system, the certification body, etc. However, there are general rules that apply to most audits and facilitate certification audits.
Communication prior to the certification audit is recommended. It is good practice for the top management to communicate some general information about the certification audit to all employees. It can include information about why the organization is undergoing a certification audit, the dates of the audit, and the audit scope. Depending on the organization, this can be communicated through email or meetings. Moreover, organizations should ensure that all documented information is readily accessible.
On the other hand, employees should be prepared to answer questions such as:
- Tell us about your role and responsibilities.
- What are the objectives of this process?
- What kind of resources are required for conducting this process?
- Do you retain documented information on this activity? How do you do it?
- If things do not go as planned, what do you do?
- How can you tell if your work is done correctly?
- Can you show me how you do it?
About the Responder
Riekie van den Berg specializes in Quality Management Systems (ISO 9001) and Environmental Management Systems (ISO 14001), and Occupational Health & Safety (ISO 45001) auditing, consulting, and training. She has more than 1500 official audit days, ISO Management Systems (MS) experience and has conducted MS Audits (1st, 2nd and 3rd Party) in various industry categories.
She has been conducting ISO 9001, ISO 14001, and ISO 45001 audits on behalf of MSECB since 2017.
Her passion is the empowerment of ISO Auditors and Candidate Auditors by adding value to the customer’s Management System. No “fault-finding”, only “fact-finding”.
MSECB is accredited by IAS to offer audit and certification services for a wide range of ISO Standards. If you are interested to certify your management systems start by getting a Free Quote.