ISO 9001

Quality Management System

What comes to your mind when you hear the word ‘Quality Management’? Probably you will think of ISO, documentation, audit or other thoughts, which trigger different feelings in different actors in the economic sphere. Our mandate is to turn quality management into a useful, value adding tool for your organisation.


ISO 9001:2015 – Frequently asked questions (FAQ)

1Why was a new revision of the ISO 9001 standard necessary?

The creators review the standards regularly to align them to the requirements of the age and technical solutions as much as possible.

The issue of the ISO 9001:2015 is the result of such a revision. The creators of international standards update the requirements of general management systems also to make them more user-friendly and effective in regarding the results.

2What kind of changes are implemented in the ISO 9001:2015 standard?

The standard is user-friendly and adapted better to the users' needs. It clearly expresses its relevance to both 'product' and 'service' on the level of terms.

The standard redefines the context of the organization. It highlights the importance of risk assessment to identify risks and opportunities.

It expands the tasks and responsibilities of the top management. Organizations shall continue to define their operations with their processes in focus.

Additionally, the standard introduces the High Level Structure (HLS) to ensure the uniformity of all management standards. As a result of the new requirements, the ISO 9001:2015 standard has become more practical.

3What is 'High Level Structure'?

'High Level Structure' (HLS) means a new basic structure to provide a uniform composition to the management system standards.

The purpose of the new basic structure is to simplify the future integration of different management systems.

One of the most common examples is the integrated application of the standards ISO 9001:2015 and ISO 14001:2015, but now ISO 45001 and ISO 27001 follows the same structure.

4Is the international standard only suitable for productive sectors?

No. The certification can be obtained also by companies in the service sector. The text of the standard uses the 'products and services' terms.

5Does the ISO 9001:2015 standard refer to the PDCA cycle too?

Yes. PDCA (Plan, Do, Execute, Check, Act) remains a fundamental part of all quality management systems.

Every quality management system shall be planned, operated, verified, and adjusted. With the introduction of the High Level Structure, the PDCA cycle is incorporated directly into the standard.

6Are there exclusions in the ISO 9001:2015 standard, such as Clause 7.3 in the ISO 9001:2008 standard?

No. There are no exclusions in the ISO 9001:2015 standard. All chapters of the standard applied to the customer shall be included in the system.

If the organization does not apply individual clauses of the standard (for example, the activity does not include development), these clauses are not applicable in the management system either. In this case, the party to be certified shall justify its decision.

7How does the ISO 9001:2015 standard take the interested parties into more prominent consideration?

Interested parties are various persons or groups that affect the life and operation of the organization. Any organization applying the standard shall define which interested parties it considers relevant.

According to the standard, these interested parties may be social, cultural, or economic groups, customers, competitors, legislators, but authorities, wholesalers or retailers, end-users, and the standard regards partners as interested parties too.

The definition of interested parties shall always be the subject of the organization's responsibility and decision.

8Shall all business processes be integrated into the quality management system?

No. The business processes may include processes - such as finance - out of the scope of the quality management system.

9How shall the processes be described?

There is no explicit requirement to describe the processes. Perhaps, the most important rule is that the content is the point, and the organization is free to choose the format.

For example, turtle models, flow charst, instructions for procedures, administrative and corporate management systems, images, and pictograms - among many others.

10Are there any further requirements for the organization's mission and vision?

No. The standard does not contain a clear definition of the company's mission or vision but the organization shall use the corporate strategy as input for defining the objectives and shall communicate them on every level.

11What is the concept of risk assessment?

The ISO 9001:2015 standard applies a risk-based approach and requires risk identification and assessment in corporate processes and taking appropriate measures to leverage opportunities.

This thinking and approach increases the value-adding ability of the certificate for the user. The standard does not determine the methodology of risk assessment. All organizations are free to apply the approach that fits their unique needs.

Possible risk assessment models include the SWOT (strengths, weaknesses, opportunities, threats) analysis, FMEA (failure mode and effect analysis), Ishikawa diagram, or other techniques applicable to quality management.

12What should companies pay attention to when assessing risks?

Companies shall systematically raise awareness of risks and opportunities. Companies shall detect and assess the risks inherent in processes and determine whether they need to take measures and - if so - what actions are necessary.

13What positive factors may hide behind the risks?

In the previous ISO 9001 standard, the clause of preventive measures regulated the possible risks, but the organizations rarely applied this clause consistently.

Consequently, the creators of the standard decided to discard the concept of 'preventive measure' from the standard requirements because performing a risk assessment is already part of the preventive measures.

14Why isn't there quality manager in the ISO 9001:2015 standard?

According to the ISO 9001:2015 standard, the top management has more responsibility than before, as reflected in the management review.

Although the standard does not mention the function of the quality manager, according to Clause 5.3, the top management shall assign responsibilities and authorities to the relevant roles.

Since the duties of the former quality manager remain, the management can assign them to any relevant manager depending on the organization's decision. In this sense, the quality manager can continue to monitor and improve the quality management system.

15Are there any specific (new) requirements regarding the externally provided processes?

Yes. The standard explicitly requires the verification and the control of the externally provided processes, products, and services. The organization shall determine and apply criteria for assessing, selecting, controlling the performance and reassessing external service providers.

16What does 'post-delivery activities' mean (Clause 8.5.5)?

Examples of this include repairing or replacing products during warranty, as well as a follow-up of the services.

17There were six (6) mandatory requirements of 'documented procedures' in the ISO 9001:2008 standard. What does ISO 9001:2015 require in this regard?

The ISO 9001:2015 standard does not determine mandatory procedures. It focuses on the requirements described as 'documented information' instead.

The bottom line is that the organization shall verify the fulfillment of the requirement in some way wherever this term appears in the standard. Regarding the method of documentation, the standard accepts any form available at the current level of development.

You can consider digital documentation, image and audio files, shared documents, photos, administrative dashboards, and databases - among others. The organization is free to establish a suitable and convenient level of documentation.

18Does the ISO 9001:2015 standard require compiling a quality handbook?

The ISO 9001:2015 does not require to have a quality handbook. The key is that the information platform describing the organization's operation should meet the standard requirements and the organization's needs.

According to our experience, the handbook - as a basic document - is still prepared and available to the employees of the organizations.

19Do the employees of the companies have to participate in training related to the transition?

We advise to learn and practice the new knowledge every time the standard is modified. We also recommend this type of training for the most relevant people - for example, internal auditors - who can pass the knowledge on to the other levels of the organization.