Portuguese Standard

NP 44572007

Management of Research, Development and Innovation (RDI) RDI management system requirements

Gestão da Investigação, Desenvolvimento e Inovação (IDI) Requisitos do sistema de gestão da IDI

Gestion de la Recherche, Développement et Innovation (RDI) Exigences du système de gestion de la RDI

English version

ICS 03.100.40 DESCRIPTORS Project; management; research; research work; research results; planning; organizations; definitions; bibliography CORRESPONDENCE

RATIFICATION Ratification Nr. 11/2007, 2007-01-29 PREPARED BY CT 169 (IPQ) EDITION January 2007 PRICE CODE X004

© IPQ reprodução proibida

Instituto Português da ualidade Rua António Gião, 2 PT – 2829-513 CAPARICA PORTUGAL

Tel. (+ 351) 21 294 81 00 E-mail: ipq@mail.ipq.pt Fax. (+ 351) 21 294 81 01 URL: www.ipq.pt

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Table of contents Page

Foreword

0 Introduction ...........................................................................................................................................4

0.1 Conceptual model of the Research, Development and Innovation process..........................................5

1 Scope.......................................................................................................................................................7

2 Normative reference..............................................................................................................................7

3 Terms and Definitions...........................................................................................................................7

4 Requirements .........................................................................................................................................7

4.1 General .................................................................................................................................................7

4.2 Management Responsibility .................................................................................................................8

4.3 Planning RDI........................................................................................................................................9

4.4. Implementation and Operation ............................................................................................................11

4.5. Evaluation of Results and Improvement .............................................................................................13

Bibliography .............................................................................................................................................15

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Foreword to the English translation This standard was published in Portuguese in January 2007 as a result of an Innovation Initiative “Corporate Innovation Sustainable Development” led by COTEC PORTUGAL, Associação Empresarial para a Inovação. The Portuguese Institute for Quality has created a Technical Commission (CT 169) that discussed, drafted and prepared the first set of the Portuguese “family” of innovation standards. A period of 60 days was allocated for public consultation and for the introduction of suggestions from stakeholders and interested parties.

Between the edition time and the moment of this translation, an accreditation scheme was developed, the first 13 organizations have been certified and a scientific paper on the model has been published. Thus, this translation benefited from the acquired knowledge on the model and on the application of the standard. In this translation the editorial group introduced some improvements with the objective of enhance clarity and concision, but respecting the requirements established in the initial Portuguese Version, that remains unchanged by this translation.

0 Introduction

Knowledge is the foundation of wealth creation in developed societies and research and development are the foundations of the production of such knowledge, but it is in innovation that a means to transform knowledge into economic development can be found.

This standard is based on an innovation model, supported by interfaces and interactions between the scientific and technological knowledge, the knowledge about the organization and the market and society as a whole. This standard articulates the emerging characteristics of the knowledge-based society, while it takes into account the role of the end users of innovation, whether they are consumers of new and improved products or new services, or citizens and users of public or private service.

The underlying innovation concept is used in this standard in its broad sense of a generating value mechanism, whose impact and usefulness results in benefit for both the organization and the society. Even though RDI aims to reach positive results, this does not always happen, because the intrinsic risk that comes from proof of new scientific hypothesis, the application of new technologies, the development of new products, processes, services, marketing or organisational methods and knowledge valorization, does not guarantee successful innovation. To fail and to start again is part of this process.

This standard aims to define the requirements of an effective management system for Research, Development and Innovation (RDI), allowing organizations that adopt this standard the definition of an RDI policy in order to reach their innovation objectives.

This standard does not intend to establish rigidity in the RDI system’s structure nor in its documentation. This Standard may be used for certification, self-assessment or assessment by any other interested party, with the objective of evaluating the organisation’s capacity to fulfill the requirements of RDI’s management system.

The RDI management system follows a PDCA approach – Plan-Do-Check-Act, directed to continuous improvement. This standard is aligned with ISO 9001:2000 “Quality Management systems – Requirements” and with ISO 14001:2004 “Environmental management systems – Requirements with guidance for use”, as well as other management systems standards, by the adoption of the compatibility concept developed together by both the Technical Committees ISO/TC 176 “Quality management and quality assurance” and

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ISO/TC 207 “Environmental management”. The implementation of this standard may be independent from or combined with other management systems standards.

This Standard can be used by organisations of any type in the management of their innovation processes. Innovation is understood in its broader sense, according to the OECD Oslo Manual (2005), including new products (goods or services), processes and new marketing or organisational methods. Thus, even though technology is one of the fundamental results of research and development, the Standard is not restricted to this area, i.e., it is also aimed at organisations that intend to innovate in other domains rather than only in the technological level. In all cases, innovation shall be favoured and carried out in a systematic and planned approach.

Thus, this present Standard aims to establish a normative framework that contributes to a better performance of the organization, focusing on their Research, Development and Innovation management system (RDI) as a fundamental method to create knowledge and transform it into economic and social wealth.

0.1 Conceptual model of the Research, Development and Innovation process

The reference model for this Standard (fig.1), the Chain linked interaction model, A model for innovation in the knowledge-based economy, 1was designed to allow organizations, of any size and type, the design, the alignment and the evaluation of the critical dimensions of the RDI process for the transition into the knowledge-based economy. The conceptual framework was developed based on three assumptions:

a) Generalize the classic and very influential Kline and Rosenberg chain-linked model, reviewed and updated for the knowledge-based economy;

b) Accommodate the concepts of the third edition (2005) of the OECD Oslo Manual;

c) Consider innovation in the industry sector (goods) as well as in services (intangible goods), as much in traditional sectors (low technology content) as in sophisticated sectors (high technology content);

Thus, the chain-interactive innovation model design stems from the known chain linked-model, as well as the scheme developed in the experimental AENOR Spanish standard for the management of RDI (a modified Kline and Rosenberg model). In these two models, only the scientific-based and technology-originated innovation, understood as product and process innovation, are considered. Therefore their application to high technology intensive sectors is straightforward. However, we know that innovation activities are not only limited to the technological scope, often occurring jointly, or even preceded, by organizational or marketing innovation. It is precisely these two types of innovation that were introduced in the third edition of the OECD Oslo Manual.

The chain-interactive innovation model offers three interfaces for an open innovation environment. These interfaces define the competence boundaries where the productive economic knowledge moves and transfers between the innovative activity and its environment. These interfaces are essential for an effective innovation management since they are fundamental for the entrepreneurial capability that is necessary to the development of innovation projects, and manage their linkage to the existing and the generated knowledge on the required domains. They allow the transformation of knowledge into applications useful to the markets and valued by the society. These interfaces, according to their dimension, level of technological intensity, market concentration, maturity of the organization, and other organization or sector other characteristics, may be materialized in innovation departments or otherwise be focused on innovation managers (or even the

1 Caraça, Ferreira, Mendonça (2006), Modelo de interacções em cadeia, Um modelo de inovação para a economia do conhecimento, Relatório COTEC, Outubro de 2006

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top management). They can also be shared under certain conditions with other organizations. The three interfaces do not necessarily have to be put in effect simultaneously or to embody separated entities.

Figure 1: Conceptual model of the innovation process in the knowledge economy,

- The chain-interactive model -

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1 Scope This Standard specifies the requirements for a research, development and innovation management system to allow an organisation to develop and implement an RDI policy aiming to increase the effectiveness of their innovation performance.

This Standard applies to any organisation that intends to:

a) establish, implement, maintain and improve an RDI management system;

b) assure the fulfilment of their innovation policy through checking their planned actions and evaluating their results or effects;

c) demonstrate compliance with this Standard through:

1) self-assessment or auto-declaration , or

2) assessment of compliance by an interested party, or

3) assessment of their auto-declaration by some external party, or

4) assessment of their RDI management system by a certification body.

All requirements in this Standard are applicable to organisations with Research, Development and Innovation activities, regardless of their dimension and complexity and the nature of their activities. This Standard is applicable to any innovation type: products (goods and services), processes, organisational, marketing or a combination of any of these.

The extension of these requirements’ application depends upon several factors such as RDI policy, dimension and complexity of the organisation and the sector in which it is set in.

2 Normative reference

NP 4456:2007 Management of Research, Development and Innovation (RDI) Terminology and definitions of RDI activities

3 Terms and Definitions

For the purpose of this standard, the terms and definitions given in NP 4456:2007 apply.

4 Requirements

4.1 General

The organisation shall establish, document, implement, maintain and continuously improve the effectiveness of a Research, Development and Innovation (RDI) management system in accordance with the requirements of this Standard.

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The organisation shall:

a) determine how it will fulfil these requirements;

b) define the scope of the research, development and innovation activities;

c) document the activities associated with the RDI management system, on a regular and up to date basis, independently of its organizational structure.

Where an organisation outsources any activity that may affect the RDI management system and its results, the organisation shall ensure control over such activities. Control of such outsourced activities shall be identified within the RDI management system.

4.2. Management Responsibility

4.2.1 RDI policy

The RDI policy shall define the intentions and principles of the organisation concerning its RDI activities, consistent with the RDI objectives and targets, having as an ultimate goal adding value to the organisation or to the users of their products (goods and services).

The RDI policy shall:

a) be documented and implemented;

b) be communicated and understood within the organisation;

c) provide a framework for establishing and reviewing the RDI objectives and targets;

d) be reviewed for continuing suitability and consistency with the changes in the environment within which the organisation is operating;

e) include a commitment to comply with the requirements of this Standard and continuously improve the effectiveness of the RDI management system.

The RDI objectives shall be verifiable.

4.2.2 Responsibility and authority

The RDI management system requires the involvement and the identification of responsibilities for the top management, for the management representative, and when appropriate for other management system participants. When appropriate, the organisation can establish permanent or temporary RDI structures, namely RDI groups, project teams or others.

Roles, responsibilities and authorities shall be defined, documented and communicated, in order to facilitate effective management.

4.2.2.1 Top management

Top management shall be responsible for:

a) establishing, approving and communicating the RDI policy within the organisation;

b) creating the conditions for the promotion of an innovative culture, for internal creativity and for knowledge management;

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c) appointing the management representative;

d) defining and reviewing the RDI objectives;

e) ensuring the availability of the necessary resources, including human resources and specialised skills, organizational infrastructure, technological and financial resources;

f) reviewing, at planned intervals, the RDI management system and their results.

4.2.2.2 Top management representative

Top management representative shall, irrespective of other responsibilities:

a) ensure that the RDI management system is established, implemented and maintained according to the requirements of this Standard;

b) follow regularly the RDI activities, checking that these carried out in accordance with the RDI policy and objectives;

c) ensure that the activities for the promotion of internal creativity and knowledge management are carried out;

d) report to top management on the performance of the RDI management system for review, including recommendations for improvement.

4.2.3 Management review

Top management shall review the organisation’s RDI management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes in the RDI management system, including their policy.

The input for the management review shall be documented and include necessary information on:

a) evaluation of research, development and innovation results;

b) internal audit and follow up actions results (see 4.5.2.);

c) follow up actions from previous management reviews;

d) changes in circumstances, and other relevant information that could affect the policy and the RDI management system;

e) recommendations for improvement.

The output from management system review shall be recorded and include any decisions and actions related to:

a) the improvement of the effectiveness of the RDI management system;

b) resource requirements; and

c) changes on policy, objectives and other elements of the RDI management system.

4.3 Planning RDI

4.3.1. Interface management and knowledge production management

The organisation shall define a process to manage the technological, organisational and market interfaces of the innovation process, to ensure the transfer of knowledge between the organisation’s innovative activity and its environment.

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The organisation shall:

a) analyse the external environment to identify which actors interact, or may interact, in the information exchange considered necessary by the organisation for the production of knowledge as well as the detection of opportunities and threats. This analysis shall address, as appropriate, the organisation’s micro-environment: suppliers, consultants, partners, distributors, customers, and competitors. It shall also address the macro environment: the education and training system, science and technology system, information infrastructure, regulators, finance, sectorial innovation systems;

b) define the elements in the organisation that ensure the communication flows and information exchange with the identified actors;

c) define mechanisms for the periodic review of the external micro and macro environment analysis and identification of external and internal actors of the interfaces;

d) identify and ensure that the activities of technological monitoring, technological cooperation and technological foresight, necessary for information exchange/knowledge production on scientific and technological knowledge, are planned, implemented, maintained and updated;

e) identify and ensure that the internal and external analysis’ activities, intellectual property and new customer analysis (observation and analysis on potential new customers and markets), necessary for information exchange/knowledge production on the market, their needs, values and preferences, are planned, implemented, maintained and updated;

f) identify and ensure that the internal creativity’s activities and knowledge management tools necessary to information exchange/knowledge production on organizational knowledge, are planned, implemented, maintained and updated;

g) determine and ensure the necessary resources;

h) assign and document responsibilities and authorities for the management of the different interfaces;

j) establish procedures to collect, record, process, analyse, communicate and value information.

Note: The three interfaces do not necessarily have to be put in effect simultaneously or to embody separated entities.

4.3.2 Ideas management and evaluation of opportunities

The organisation shall establish the procedures for generation, analysis, evaluation and pre-selection of ideas, in order to evaluate suitability to innovation opportunities;

The organisation shall consider, in this domain, the information obtained in the interface management process and the results on the identification of problems and evaluation of opportunities;

The evaluation and idea selection criteria shall be consistent with the Research, Development and Innovation (RDI) policy;

The organisation shall consider, when relevant, the evaluation of the potential market, the criteria of the techno-economical feasibility, and, when appropriate, the legal, social, economic, technological, financial risk factor requirements;

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4.3.3 Planning of RDI projects

For each selected project, the organisation shall establish a project plan. The RDI project shall consider, when relevant, the following provisions:

a) Invention, basic design or concept of the service;

b) Detailed design or prototyping;

c) Re-design, demonstration or test and production;

d) Commercialisation or implementation.

NOTE1: These phases are not necessarily sequential.

NOTE2: The organisation may develop the projects in cooperation with other entities, where some activities may be developed externally, and formalised through agreements, partnerships, alliances or other forms of cooperation.

Each project plan shall include:

a) project description, including identification of the problem to be solved, the improvement, the competitive advantage or the expected benefits;

b) team identification , needed resources and planned time limits for the project achievement, with special reference the expected milestones;

c) verification and validation of the activities, including, when appropriate, revision criteria, selection and result approval.

d) method for operation control;

e) identification of the expected results;

f) documentation concerning arrangements for protection of intellectual property.

4.4. Implementation and Operation

4.4.1. Research, Development and Innovation management activities

The organisation shall identify the necessary management activities for the RDI process, namely:

a) project portfolio management and coordination;

b) intellectual property management;

c) knowledge management;

d) identification and analysis of problems and opportunities;

e) creativity;

f) idea management;

g) analysis, evaluation, selection and project management;

h) any others identified by the organisation;

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For the management activities identified, the organisation shall, according to their complexity, risk and dimension, define the criteria and procedures in order to ensure that they are carried out under specified conditions, documented and recorded.

4.4.2 Competence, awareness and training

The organisation shall ensure that the personnel performing research, development and innovation activities, including the activities inherent to interface management, are competent on the basis of appropriate education, training and professional experience. The organisation shall retain the associated records.

The organisation shall determine the necessary competence for personnel performing and managing RDI activities. The organisation shall provide training or take other actions to satisfy these needs and shall retain the appropriate records.

Creativity shall be fostered within the organisation, promoting competence to abandon the usual structured channels and ways of thinking, in order to reach an idea that will allow solving a specific problem or exploit opportunities.

4.4.3 Communication

The organisation shall ensure the establishment of communication processes adequate for internal and external communication. When establishing these processes, the organisation shall take into account the communication needs identified as necessary for accessing and producing knowledge in clause 4.3.1, as well as the restrictions identified for the protection and exploitation of results.

RDI policy shall be internally communicated.

4.4.4 Documentation

The RDI management system documentation shall include:

a) RDI policy and RDI objectives;

b) scope of RDI activities;

c) description of the main elements of the RDI management system, their interactions, and references to related documents;

d) documents, including records, determined by the organization as necessary to ensure the effective planning, operation, and control of RDI processes and activities.

4.4.5 Control of documents and records

4.4.5.1 Control of documents

Documents required by the RDI management system and this standard shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.4.5.2

The organisation shall establish, implement and maintain one or more procedures:

a) to approve documents for adequacy prior to issue;

b) to review and update as necessary and re-approve documents;

c) to ensure that changes and the current revision status of documents are identified;

d) to ensure that relevant versions of applicable documents are available at points of use;

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e) to ensure that documents remain legible and readibily identifiable;

f) to ensure that the documents of external origin are identified and their distribution controlled, and;

g) to prevent the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose.

4.4.5.2 Control of records

The organisation shall establish and maintain the records necessary to evidence results, the conformity to the requirements of the RDI management system and to this standard.

Records shall remain legible, readily identifiable and retrievable.

The organisation shall establish, implement and maintain one or more procedures for the identification, storage, protection, retrieval, retention time and disposal of records.

4.5. Evaluation of results and improvement

4.5.1 Results Evaluation

The organisation shall define one or more procedures to document and assess, in a regular way, the RDI results: innovations in product, process, marketing or organisational, or a combination thereof. This evaluation shall consider, as appropriate, the financial aspects, the competitive advantages and the benefits achieved.

Procedures shall ensure:

a) evaluation of the innovation process results, including the results of interface management and knowledge production, idea management, opportunity evaluation and finished and ongoing projects;

b) planning, development and record of the evaluation activities at appropriate steps;

c) the identification and record of the gap between the real and the expected results;

d) when appropriate, the planning of the evaluation of results after commercialisation or implementation, namely:

1) non conformities and complaints;

2) assessment of interested parties’ perception;

3) impact evaluation;

4) others identified by the organisation.

The results of this assessment shall be considered in future RDI activities.

When the organisation uses measuring and monitoring devices in the evaluation of results, it shall ensure that these devices produce valid data.

4.5.2 Internal audits

The organisation shall conduct internal audits at planned intervals to determine whether the RDI management system:

a) conforms to the planned arrangements, to the requirements of this standard and to the RDI management system requirements established by the organisation.

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b) is effectively implemented and maintained.

The organisation shall plan, establish and maintain an audit programme. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work. The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow up activities shall include the verification of the actions taken and the reporting of the verification results.

The organisation shall maintain appropriate records of the planning, auditing and follow up activities.

4.5.3 Improvement

The organisation shall continually improve the effectiveness of the RDI management system through the use of the RDI policy and objectives, management review, the evaluation of results, audit results, and the internal and external communication.

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Bibliography

[1] Caraça, Ferreira, Mendonça (2006), Modelo de interacções em cadeia, Um modelo de inovação para a economia do conhecimento, Relatório COTEC, Outubro de 2006

[2] UNE 166002 EX:2002 Gestión de la I+D+I: Requisitos del Sistema de Gestión de la I+D+I

[3] UNE 166002:2006 Gestión de la I+D+i: Requisitos del Sistema de Gestión de la I+D+i

[4] ISO 9000:2005 Quality management systems – Fundamentals and vocabulary

[5] ISO 9001:2000 Quality management systems – Requirements

[6] ISO 14001:2004 Environmental Management Systems – Requirements with guidance for use