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On this article we wolud review the ISO 13485 Standard requirements specified on chapter 1 - Scope and application.It may be boring and I bet that most of you did not even bother to look through but still... The information in this chapter can help a bit and ease the certification process. Give it a try. And as always, we would refer to the ISO 9001 Standard to make things clearer.
Chapter 1.1 - Scope This international standard specifies requirements for a quality management system where an organization: ISO 9001
| ISO 13485
| is required to demonstrate is ability to supply persistently product to meet specific requirements (customer's or regulatory). | is required to demonstrate is ability to supply persistently medical devices and/or related services to meet specific regulatory requirements and specific customer's requirements applicable for medical devices. | has a defined objective for achieving customer's satisfaction. This objective shall be achieved by implementing effectively a quality management system. The quality management system shall include:
- Continual improvement activities.
- Assurance of conformity to customer's requirements
- Assurance of conformity to regulatory requirements
| shall understand that the main objective of these standard requirements is to assist and to facilitate harmonizing regulatory requirements for medical devices and the requirements for a quality management system. Therefore the standard includes particular requirements that are not included within the ISO 9001 Standard. On a same scale, the ISO 13485 Standard excludes some requirements of the ISO 9001 Standard (which are not appropriate to this standard). |
Welcome to the ISO 13485 Standard. That is the meaning of chapter 1. You may already be familiar with the ISO 9001 Standard requirements, no one is questioning that. But his cousin, the ISO 13485 Standard is much more complex. First of all the objectives of these two standards are different. The ISO 9001 Standard is aiming to meet customer's satisfaction by fulfilling his requirements and international, national or/and regulatory requirements while performing a continual (documented) improvement. The ISO 13485 Standard has another objective. The ISO 13485 Standard puts the international, national or/and regulatory requirements for medical devices at the first priority. After these requirements come all the rest. So, his objectives (it's still a standard for quality management) is to harmonize regulatory requirements with quality management system requirements. Utopia!
What do they mean by harmonizing? To harmonize is to bring several things into harmony, or to make several things compatible. In the quality management case, you are required to bring the international, national or/and regulatory requirements into consonance with your quality management system: the main processes, the procedures, documentation requirements etc, are should be planned and performed according to the regulatory requirements. An explanation has been added as to how an applicable Medical Devices Regulations (MDR) requirement can be incorporated into the quality management system (QMS) documentation. How? This is the reason why you are reading this, isn’t it? To understand "how".
First, the ISO 13485 Standard includes more particular requirements that do not appear in the ISO 9001 Standard. The reason for the additional or different requirements is to support the main objective of this standard: harmonizing quality management requirements and regulatory requirements. That means (as specified in the ISO 13485 Standard) that organizations that their quality management system competes to the ISO 9001 Standard are not necessarily competing to the ISO 13485 Standard requirements and vice versa. These are two different standards and certification for each one is to be achieved separately. It's true that they are similar and very close, but still they are considered as two different standards.
While the ISO 9001 Standard puts customer's satisfaction and continual improvement at the main objectives of the standard, the ISO 13485 Standard eliminate (!!!) these objectives from its scope. Why? The ISO 13485 Standard regards the regulatory requirements as his main objective. Organization that implements quality management system according to the ISO 13485 Standard requirements must adopt other main objectives that customers' satisfaction or continual improvement. These objectives are to be maintained in a different manner according to different requirements of the ISO 13485 Standard. Chapter 1.2 – Application ISO 9001
| ISO 13485
| The requirements of this international standard are generic requirements that are appropriate applicable for all kinds and sizes of organizations and appropriate and applicable for any kind of product. | The requirements of this international standard are appropriate and applicable for all kind and sizes of organizations providing medical devices and/or related services.
| The organization may exclude some of this standard's requirements.
The organization can exclude requirements only from chapter 7 (product realization) and when it is beyond any doubt and provable that the exclusions do not affect the product's quality.
Exclusion are to be made, when such requirements are not applicable in the organization due to the nature of the organization or the nature his of products.
| Where regulatory requirements allow exclusions of design and development controls (as specified in chapter 7.3), the organization may exclude these requirements. In any case of exclusions, the regulatory requirements must provide alternative arrangements to the excluded requirements.
The organization may exclude some of this standard's requirements specified in chapter 7 (product realization) when such requirements are not applicable in the organization due to the nature of the organization or the nature of its medical devices.
For any exclusion, the organization is responsible to justify the exclusion with the relevant approval as specified in paragraph 4.2.2-a.
In the ISO 13485 Standard, some of the requirements are indicated as "if appropriate" or "where appropriate". These requirements are applicable in any case. In cases, when the organization can justify that these requirements are not applicable, it may exclude these requirements.
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Just to make it clear, standard application refers here, to whom, where, why and how these standard requirements are to be implemented. In other words, which organizations are suitable to implement these requirements.
The ISO 9001 Standard applies for all organizations regardless to their size, kind, product or service in any sector of activity whether it is a business enterprise, a public administration or a regional government department. The ISO 13485 Standard requirements, however, are applicable for all organizations regardless to their size, kind, product or service in any sector of activity, when such organizations provide medical devices and/or related products. The ISO 13485 Standard is planned to support quality management system to organizations producing medical devices. It would be easier for these organizations to implement the standard requirements.
When any requirement specified by the ISO 9001 Standard is irrelevant to the organization due to its nature or nature of its products, it may exclude this requirement with a reasonable explanation. Exclusions are allowed only for requirements appearing in chapter 7 – product realization. Any other requirements from any other chapters (1, 2, 3, 4, 5, 6 and 8) are obligatory in order to meet the standard's requirements – the organization cannot exclude them. When excluding any requirement, the organization must prove that this requirement is excluded due to the nature of the organization or the nature of the products. The organization must also, prove that the exclusion does not affect the quality of the product. Exclusions usually are mentioned during the quality manual.
The ISO 13485 Standard regards exclusions more seriously. First of all, the ISO 13485 Standard refers to design and development requirements. The ISO 13485 Standard requires that only when regulatory requirements allow exclusions of the requirements specified in chapter 7.3, they may be excluded. Before excluding anything, check the regulatory requirements or any other local or international directives, whether you may exclude anything at all. You might be surprised. But this is not all. The exclusion is permitted only when alternative arrangements for these requirements (chapter 7.3) are provided by the regulatory requirements. In other words, a developing organization for medical devices may exclude the requirements in chapter 7.3, only when regulatory requirements from its region (state country etc.) allow it and other requirements for controlling the design and the development are defined by this regulatory requirement and implemented by the organization. It is not that easy to exclude with the ISO 13485 Standard.
Like his cousin, the ISO 13485 Standard allows exclusions from chapter 7 – product realization only. Any exclusion from made chapter 7 must be justified by the organization (as specified in paragraph 4.2.2-a). It may be, that some processes required by the ISO 13485 Standard, would not be performed by the organization. In any case, the organization must include in its quality management system all the aspects of the organization's activities (those that are related to the medical devices and those that are not).
Some of the requirements in the ISO 13485 Standard are indicated as "if appropriate" or "where appropriate". These requirements are not applicable only when the organization can prove and justify that they are not appropriate. In these cases the organization may exclude these requirements from the scope. View our article about the ISO 13485 Standard terms and definitions requirements. |
