The first edition of the ISO 9001 standard was published in 1987. Since its publication, the requirements and characteristics for a quality system that defines this standard have been revised three times.
In 1994, the series standards were revised, keeping the requirements practically unchanged, but some elements were added (to facilitate application) and some paragraphs (to avoid ambiguities).
Subsequently, in the year 2000 the second modification occurs. In this case, it was a profound change in the content and focus of the standards. Since this revision, a single standard for certification purposes was consolidated: ISO 9001. Until then, three standards were used for certification, ISO 9001, ISO 9002 or ISO 9003, depending on the characteristics of the quality system to be certified.
In 2008, a new review was carried out mainly focused on clarifying the application of some requirements, facilitating their application, improving their compatibility with other standards such as ISO 14001 on environmental management and increasing their consistency with other standards in the ISO 9000 family, maintaining the initial structure, sections and requirements of the previous version.
New changes were published in September 2015. These changes are noticeable in: principles, in structure, in terms and definitions. New concepts and requirements are incorporated and others are expanded, among which we can mention: organizational context, risk-based thinking, operations, documented information, knowledge management, people competence, among others. We begin to talk about the environment for the operation of the processes, suppliers and services provided externally, external suppliers and other changes associated with the terminology of the standard.
Reference to the terms documented procedure and records is no longer made and the term "documents" is passed. No mention is made of the management representative for the quality management system, the quality manual, or preventive actions. The current change in structure aids compliance with the ISO Directives that all Management Systems standards published or revised by ISO must follow an identical structure. In fact, the new standards of Business Continuity Management Systems (ISO 22301: 2012) or Road Safety (ISO 39001: 2013) already follow this structure. It ensures that there is at least 30% common text between each management system standard and is achieved through promoting it.
For all the above, the existence of interesting changes that can motivate important changes in the conception of the current quality management system in organizations is appreciable. So we are faced with the need to ask ourselves, are there many documents that we will need to meet the requirements of the new version of the ISO 9001: 2015 standard? Many think so, while others do not have the same answer to the problem. I am in the second group, of which we think there are not so many.
Documentation required by the requirements of the standard
There is a widespread belief that a procedure must be developed for each process identified in the organization. The new version of the ISO 9001: 2015 standard makes this task somewhat easier, makes it somewhat easier, is more liberal in terms of documentation requirements, which means that there are no longer six mandatory procedures as in the previous version of the 2008. In any case, the current version identifies many records that must be kept, which are generated by the processes of the Quality Management System.
Next, to focus on the objective stated in the title of the work, I will mention the "information", documented or not, and which must be "maintained" and "kept" by the organization on a mandatory basis, at least from my interpretation of the standard. It is appropriate to specify that in order to reach such conclusions it is important to take into account what is stated in the same regarding the use of the verbal forms contained therein. The norm says in this sense:
- "Must" indicates a requirement; "Should" indicates a recommendation; "May" indicates a permission, a possibility, or a capability.
So, I will make some comments that perhaps make it easier to clarify and understand the concepts associated with "information" and "documented information" addressed in the standard. As a first aspect it should be specified that when referring to "information", there is no requirement that such information has to be documented. In such situations, the organization can decide whether it is necessary or not, or if it is appropriate to maintain documented information for certain specific purposes or the fulfillment of some other requirements derived from legal or regulatory requirements, from interested parties or other institutions related to the organization..
When referring to “documented information” it is used for all document requirements, and refers to the information that an organization has to control and maintain, and the medium that contains it and that can be in any format and medium, being able to come from any source. Documented information may refer to the management system, including related processes, the information generated for the organization to operate (documentation) and evidence of the results achieved (records).
When reference is made to "maintaining documented information", it denotes those documents that specify who does what, how, when, where and with what, that is, what we called the procedure in the previous version. On the other hand, when referring to “keeping documented information” it denotes the documents necessary to provide evidence of compliance with the requirements, that is, what in the previous version were recognized as records. Both are mandatory.
| information | ISO 9001: 2015 clause |
| Understanding the organization and its context | 4.1 |
| Understanding the needs and expectations of stakeholders | 4.2 |
| Communication with the customer | 8.2.1 |
| Information for external providers | 8.4.3 |
| Customer satisfaction | 9.1.2 |
| Analysis and evaluation | 9.1.3 |
| Management review inputs (performance and effectiveness of the quality management system) | 9.3.2 |
| Documented Information | ISO 9001: 2015 clause |
| Creation, updating and control of documented information | 7.5.3.1; 7.5.3.2 |
| Control of production and service provision | 8.5.1 |
| Maintain Documented Information | ISO 9001: 2015 clause |
| Support the operation of the processes | 4.4.2 |
| Quality politics | 5.2 |
| Objectives and improvement plans | 6.2 |
| Retain Documented Information |
ISO 9001: 2015 clause |
| The processes are carried out as planned; planning and operational control | 4.4.2; 8.1 |
| Maintenance and Calibration | 7.1.5.1; 7.1.5.2 |
| Competences | 7.2 |
| Review of product or service requirements | 8.2.3 |
| New product or service requirements | 8.2.3 |
| Input data in the Design | 8.3.3 |
| Controls in Design | 8.3.4 |
| Output data in the Design | 8.3.5 |
| Design changes | 8.3.6 |
| Supplier Evaluation | 8.4.1 |
| Control of outsourced processes, products and services (outsourced processes) | 8.4.1 |
| Product or service sheets | 8.5.1 |
| Identification and traceability | 8.5.2 |
| Changes in customer needs | 8.5.3 |
| Changes in production planning | 8.5.6 |
| Evidence of product conformity | 8.6 |
| Nonconformities | 8.7.2, 10.2.2. |
| Supervisions | 9.1.1 |
| Internal audits | 9.2.2 |
| Management review | 9.3 |
| Nonconformities and corrective actions | 10.2.2 |
It is important to understand and interpret that a requirement to "maintain" documented information does not exclude the possibility that the organization may also need to "retain" the same documented information for other purposes or purposes of particular interest to the organization, or even some interested parties..
Of all those shown are mandatory in the quality management system under the ISO 9001: 2015 standard, those that are recognized as "maintaining" or "conserving" documented information, but it is also true that our objective is not only to strictly comply with the standard, but to have a system as a tool for work and continuous improvement of the management of our company. And for this, as demonstrated by the daily and daily practice in the operation of an organization, it will be necessary to develop in more detail and rigor the quality management system with the use of more documents and records, than those presented here and which are identified as necessary by the organization itself.
In this sense, it is appropriate to mention a suggestion of the standard itself in which it is stated that the length of the documented information for a quality management system may vary from one organization to another, due essentially to the size of the organization. and its type of activities, processes, products and services; the complexity of the processes and their interactions and the competence of the people.
My professional experience of more than 25 years related to the subject has shown me that the less competent the people associated with the system and its application, the greater the number of documents required by the organization to guarantee its proper functioning.
Anyway, I dare to offer you personal advice…..care !! with the documentary syndrome. If the standard gives us the possibility of not filling ourselves with documents, then we take advantage of, or at least keep in mind, that option and that flexibility in the documentary design of the system, without losing sight, of course, of those that are mandatory. Also based on my professional experience, I dare to suggest something that personally has brought me very positive dividends for the better understanding and acceptance of the system documentation and has been very useful for me, consisting of including in a single document several requirements which can help reduce system documentation.
BIBLIOGRAPHY.
- ISO 9000: 2015, Quality management systems. Foundations and vocabulary. Fourth edition. 2015-09-15ISO 9001: 2008, Quality management systems - ISO 9001: 2015 requirements, Quality management systems - Requirements. Fifth edition. 2015-09-15 Luis, A. “The future of ISO 9001: 2015. Preparing for change. ” Master Conference given at the National Workshop on Quality Management. Escambray Marketing Company. Havana. Cuba. May 2014. Luis, A. “ISO 9001: 2015. "Projection, changes and perspectives until 2025". Master Conference given at the National Business Management Workshop. Agrarian University of Havana. Cuba. April 2014. Luis, A.; Gretel, Dopico Leyva; Miriam Celeste, Benítez Rivera; Camilo, Company Azcuy:“A perspective view of the new version of ISO 9001: 2015. Preparing for change. ” Escambray Marketing Company. Havana. January 2015.
