ISO 9001: 2015 - Changes, structure, what has changed ...

The publication of ISO 9001 review: 2015 has significant changes, especially when compared to the review carried out in 2008. In this way, we intend, with the publication of this article, highlight the main aspects of those changes.

ANNEX SL - High-level structure

ISO 9001: 2015 has been restructured on the basis of Annex SL, a strategy that will gradually be applied to all ISO management system standards. In the future will have the same main text and common terms and definitions. This structure aims to maintain its relevance in the market allowing:

• Integrate with other management systems
• Provide an integrated approach to organizational management
• Provide a consistent basis for the coming years
• Reflecting environmental increasingly complex, wherein the act organizations
• Ensure that the new pattern reflects the needs of all potential users groups
• Strengthen the organization's ability to meet customer needs

O Appendix SL ISO DirectivesPart I has the following structure:

This new common framework, aims to help organizations integrate more easily the various management systems such as ISO 14001 (Environmental Management) or the future ISO 45001 (Health and Safety at Work Management)

ISO 9001 STRUCTURE: 2015

Clause 1: Scope

Establishes the desired results management system. The results are specific to the industry and should align with the organization's context (clause 4).

Clause 2: Normative References

It provides details of the reference standards or publications relevant to a particular standard.

Clause 3: Terms and Definitions

It provides details of the terms and definition applicable to the specific standard, in addition to any formal standard related definitions and terms.

Section 4: Organization Context

Clause 4 is composed of four sub-clauses:

4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of stakeholders

4.3 Determine the scope of the quality management system

4.4 quality management system and its processes

Arise in this review two new clauses (4.1 and 4.2) to give importance to the context in which it operates the certified organization and stakeholders, focusing on the need for context analysis in which it operates the organization as well as the identification of the parties interested and understanding their expectations.

As the basis of a management system, Clause 4, determines the environment in which the organization operates. As part of the answer to this question, the organization needs to identify internal and external issues that may have an impact on the desired results, as well as all stakeholders and their requirements. It is also necessary to document the scope and define the boundaries of the management system taking as a guideline the business objectives.

Clause 5: Leadership

Clause 5 is composed of three sub-clauses:

5.1 Leadership and commitment

5.2 Policy

5.3 Roles, responsibilities and organizational authorities

Esta é uma nova cláusula inteiramente dedicada à Liderança. É uma das mudanças mais significativas, colocando exigências sobre a gestão de topo, desaparecendo a ideia do “representante da gestão”. A gestão de topo tem uma maior participação na gestão do sistema devendo alinhar a política da qualidade e as metas estabelecidas com as orientações estratégicas da organização integrando os requisitos do sistema de gestão no processo do negócio. Há ainda um maior enfoque da gestão de topo na satisfação dos clientes através da identificação e tratamento dos riscos e oportunidades que a possam afetar. Neste contexto, a gestão de topo deve identificar, avaliar e analisar as forças e fraquezas das organizações e o impacto que estas podem ter no seu negócio.

Finally top management is responsible for communicating the importance of the management system and increase the awareness and involvement of its employees.

Clause 6: Planning

Clause 6 comprises three subclauses:

6.1 Actions to address risks and opportunities

6.2 Objectives of quality and planning to achieve them

6.3Planeamento of changes

A cláusula 6 personaliza o “risk thinking” na norma. Após a organização identificar riscos e oportunidades é necessário definir como estes serão geridos através do planeamento. A fase do planeamento define o quê, quem, como e quando estes riscos devem ser geridos. Esta abordagem pro-activa substitui a acção preventiva e reduz a necessidade de acções correctivas posteriormente. Podemos dizer agora que a acção correctiva corresponde a um risco não identificado, erroneamente qualificado ou mal gerido e a acção preventiva visa a antecipação ao risco.

It also placed a special focus on the objectives of the management system. These should be measured, monitored, communicated, aligned with the management system policy and updated when necessary.

Clause 7: Support

Clause 7 is composed of five sub-clauses:

7.1 Resources

7.2 Skills

Awareness 7.3

7.4 Communication

7.5 documented information

After addressing the context, commitment and planning, organizations will have to take into account the support they need to achieve their goals and objectives. This includes resources, internal and external communications directed and documented information that replace previously used terms such as documents, documentation and records.

Clause 8: Operationalizing

Clause 8 has seven sub-clauses:

8.1 Planning and operational control

8.2 Requirements for products and services

8.3 Design and development of products and services

8.4 Control of processes, products and services from external suppliers

8.5 Production and service provision

8.6 Release of goods and services

8.7 non-compliant output control

Most of the management system requirements are focused on this single clause. Clause 8 deals with both internal and external processes, while the total process management includes appropriate criteria to control these processes, as well as ways to manage planned and unintended change.

Clause 9: Performance Evaluation

Clause 9 is composed of three sub-clauses:

9.1 Monitoring, measurement, analysis and evaluation

9.2 Internal Audit

9.3 Management review

Here, organizations must determine what, how and when things are monitored, measured, analyzed and evaluated. An internal audit is also part of this process to ensure that the management system complies with the requirements of the organization as well as the standard, and is implemented and maintained in a successful manner. The final step, review management, notes that the management system is convenient, appropriate and effective.

Clause 10: Improvement

With three sub clause, Clause 10 points as nonconformities and corrective actions should be managed:

10.1 General

10.2 Non-compliance and corrective action

10.3 Continuous improvement

In a business world that changes every moment, not everything happens according to plan. Clause 10 points out ways to address non-conformances and corrective actions and strategies for improvement on an ongoing basis.

THE LEADERSHIP

ISO 9001: 2015 has an entire clause dedicated to leadership. This is one of the most significant changes.

This clause puts demands on top management, disappearing into the idea of ​​"representative of the management." This one has a greater stake in systems management must align the quality policy and targets with the strategic orientations of the organization. There is even a greater top management's focus on customer satisfaction by identifying and addressing the risks and opportunities that may affect.

OPENING AND EVOLVING SECTOR ORGANISATIONS

QUALITY MANUAL

QUALITY MANUAL

A ideia de um manual da qualidade está intimamente ligada à implementação de qualquer sistema de gestão da qualidade. Esta revisão da ISO 9001:2015, já não o exige, não obstante o requisito da documentação estar presente, “informação documentada”, ou seja é necessário documentar, manter e preservar as informações relevantes. Desse modo, um manual de qualidade continua a ser uma possibilidade para o cumprimento desse requisito, ainda que não seja a única solução. Esta alteração permite uma maior flexibilização na organização da informação, sendo possível estar em conformidade com a norma sem comprometer a agilidade do SGQ.

KNOWLEDGE AS A RESOURCE

Key terminology differences between ISO 9001: 2008 and ISO 9001: 2015

Key terminology differences between ISO 9001: 2008 and ISO 9001: 2015

RISK MANAGEMENT

The revision in the standard structure introduces a concept, Management RiskWhich enables organizations to have opted for this certification, achieving a new level of organization.

Esta abordagem, “risk thinking”, tem um papel central na nova publicação da norma ISO 9001:2015, focada na identificação, qualificação e gestão do risco. This approach, "risk thinking" has a central role in the new publication of ISO 9001: 2015, focused on the identification, qualification and risk management. Desta forma a qualidade resulta da gestão adequada desses riscos, que vão além do âmbito específico do produto ou serviço prestado. Thus the quality result of appropriate management of these risks, beyond the specific scope of the product or service. Em suma, qualidade não pode existir, a menos que, a organização possa fornecer aos seus clientes, um produto ou serviço em conformidade a longo prazo. In short, quality can not exist unless the organization can provide its customers with a product or service under the long term.

The risk is an additional concept and is not intended in any way to replace, but to complement the principles existing in the standard. The approach processes and PDCA (Plan-Do-Check-Act) remain two essential pillars now assisted by risk management, the purpose of continuous improvement.

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