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ISO 9001QUALITY MANAGEMENT SYSTEM
ISO 9001: 2015
INTRODUCTION
Management systems standards undergo a periodic review for adequacy tothe globalized world, market trends and the application and / or availabilityof new technologies available.
The ISO 9001 standard is reviewed by the ISO technical committee, calledISO/TC176. More than 80 countries are direct participants, withprofessionals from the various branches of activity, such as consultingprofessionals, certification, industry, etc., all directly linked to a body fromtheir country of origin and / or authorized institution. In your portfolio,ISO/TC 176 has more than 20 published standards with the objective ofassisting organizations around the world in the implementation of a qualitymanagement system.
Since the last revision of ISO 9001 in 2008, ISO/TC176 was planned for therevision and publication of ISO 9001: 2015, established by the followingguidelines:
• Annex SL, called a high-level structure, a reference standard for harmonization of management system standards;• Seek greater clarity and simplicity of language use for better application of the Standard;• Online world survey with users obtaining more than 12,000 answers;• Review and adequacy of the principles of quality management;• Lessons learned from previous draft revisions to the Standard.
Based on all these inputs, ISO/TC 176 fostered discussion in the worldregarding the review of ISO 9001 and has established a comprehensivestandard to meet market's aspirations for continuous improvement. In2015, ISO has officially published the ISO 9001: 2015 standard, which aimsto remain active from 10 to 15 years as an international benchmark in theimplementation of quality management systems.
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ISO 9001: 2015
ANNEX SL - HIGH-LEVEL STRUCTURE
Annex SL is a document drawn up by the ISO to harmonize the structure ofstandards. The goal is to align standards with single structure and facilitatetheir integration.As an example, an organization certified in ISO 9001 and ISO 14001 mayeasily integrate your management system with the new requirementsstructure and classifications of Annex SL. The following is the structure ofannex SL for an easy comparison of recently published standards:
1 - Scope2 - Normative References3 - Terms and Definitions4 - Context of the Organization5 - Leadership6 - Planning7 - Support8 - Operation9 - Performance Evaluation10 – Improvement
The structure presented above is the same as that of ISO 9001:2015 andISO 14001:2015; the requirements converge between standards andintegration is extremely easy compared to previous versions. Soon, allnorms of management systems will obey this same structure, optimizingthe implementation processes for certified organizations.
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ISO 9001: 2015
DID YOU KNOW?
In 2012, Annex SL had its first published application in ISO 22301 - Business Continuity Management Systems.
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ISO 9001: 2015
QUALITY MANAGEMENT PRINCIPLES
ISO 9001:2015 is based on the principles of quality management describedin ISO 9000:2015 (Quality management systems -Fundamentals andvocabulary). It is recommended to read ISO 9001 for a better understandingof the definitions of new terminology and classifications, as well as theimplementation of the standard.
In the specific case of quality management principles, the descriptions ofthe ISO 9000 standard include the declaration of each principle, thejustification that the principle is important for organization, as well asexamples of benefits associated with the principle of actions to improve theperformance of organizations in their application.
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VERSION: 20081- Focus on the client;2- Leadership;3- Involvement of people;4- Process approach;5- Approach management system;6- Continuous improvement;7- Making decisions based on facts;8- Mutual benefits in relations with suppliers;
VERSION: 20151- Focus on the client; 2- Leadership; 3- Engagement of people; 4- Process approach; 5- Improvement; 6- Evidence-based decision making; 7- Relationship management;
In the figure above it is possible to compare the changes of the principles ofquality management in relation to the 2008 version of the standard, in thisupdate the main changes were:
ISO 9001: 2015
• In Clause 3, the word involvement has given rise to the word engagement.The term involves people intrinsically, the search for empowerment andimprovement of skills, in general the term also demonstrates the focus onpeople acting on behalf of the organization.
• Principles 4 and 5 have become only a Process Approach. The principleclarifies the interrelationship between processes to concentrate efforts onimprovement opportunities, aligned processes and demonstratingstakeholders on the consistency, effectiveness and efficiency of the qualitymanagement system.
• Principle 7 has been changed to manage stakeholder relationships withthe QMS, aiming at improving organizational performance throughresponses to opportunities and constraints with each stakeholder, commonunderstanding of goals and values, improvement in the ability to aggregatestakeholder value and effective supply chain management.
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ISO 9001: 2015
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0.1 General0.3 Process approach 0.3.2 Plan-Do-Check-Act cycle 0.4 Relationship with other management system standards 2 Normative reference 4 Context of the organization 4.2 Understanding the needs and expectations of interested parties4.4 Quality management system and itsprocesses 5.1 Leadership and commitment 5.1.2 Customer focus 5.2.1 Establishing the quality policy5.3 Organizational roles, responsibilities and authorities 6.1 Actions to address risks and opportunities 6.3 Planning of changes7.1 Resources 7.1.2 People 7.1.4 Environment for the operation ofprocesses 7.1.6 Organizational knowledge 7.3 Awareness 7.5 Documented information 7.5.2 Creating and updating 8 Operation8.2 Requirements for products and services 8.2.2 Determination of requirements for products and services 8.2.4 Changes in requirements for products and services services8.3.1 General 8.3.3 Design and development inputs 8.3.5 Design and development outputs 8.4 Control of externally provided processes, products and services8.4.2 Type and extent of control 8.5 Production and service provision8.5 .2 Identification and traceability 8.5.4 Preservation 8.5.6 Control of changes8.7 Control of nonconforming outputs 9.1 Monitoring, measurement, analysis and evaluation 9.1.2 Customer satisfaction 9.2 Internal Audit 9.3.1 General 9.3.3 Management review outputs10.1 General 10.3 Continuous improvement
0.2 Quality management principles 0.3.1 General 0.3.3 Risk mentality 1 Scope 3 Terms and definitions4.1 Understanding the organization and its context 4.3 Determining the scope of the quality management system 5 Leadership 5.1.1 General 5.2 Policy 5.2.2 Communicating quality policy 6 Planning 6.2 Quality objectives and planning to achieve them 7 Support 7.1.1 General 7.1.3 Infrastructure 7.1.5 Monitoring and measurement resources 7.2 Competence 7.4 Communication 7.5.1 General 7.5.3 Control of documented information 8.1 Operational planning and control 8.2.1 Customer communication8.2.3 Review of the requirements for products and services8.3 Design and development of products and services 8.3.2 Design and development planning 8.3.4 Design and development controls 8.3.6 Design and development changes8.4.1 General 8.4.3 Information for external providers8.5.1 Control of production and service provision 8.5.3 Property belonging to customers or external providers8. 5.5 Post-delivery activities 8.6 Release of products and services 9 Performance evaluation9.1.1 General 9.1.3 Analysis and evaluation 9.3 Management review9.3.2 Management review inputs10 Improvement 10.2 Nonconformity and corrective action
THE NORM 9001:2015 AND ITS STRUCTURE
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THE MAIN CHANGESIN RELATION TO THEPREVIOUS VERSIONS
ISO 9001: 2015
ISO 9001: 2015
1) REFORMATION
TO MAKE THE STANDARD MORE GENERIC WITH EASY UNDERSTANDING FOR THE SERVICE SECTOR:
The classifications of ISO 9001 have always been criticized by companiesthat do not work in the manufacturing area, the omission of the specificreference to the term "services" in previous versions of the Standard hasbecome unsustainable, so the applicability to the service sector has beenreinforced in several requirements.
The ISO 9001:2015 version uses the term "products and services", whichincludes all categories of outputs, as cited in Norma's own examples. Thesecategories can be: materials, machines, tools, services, software, processedmaterials, etc.
In the structure of requirements of the Standard shown above, the term"services" may be highlighted especially in the following clauses:
8.2 - Requirements for products and services8.3 - Design and Development of products and services8.5 - Production and provision of services
These clauses clearly demonstrate that ISO 9001:2015 brings the serviceindustry to the requirements of the standard, thus facilitating theunderstanding and consequently the implementation of the qualitymanagement system in all branches of activity.
For clause 8.3 - Design and Development of products and services, it isimportant to emphasize that this can also be applied to the service sector,organizations must evaluate its applicability, implement the necessaryrequirements of Design and Development and not simply dismiss therequirement as not applicable. This evaluation should be judicious to thepoint of a critical analysis of the organization's processes and context for acoherent definition.
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ISO 9001: 2015
DID YOU KNOW?
The Standard also describes what products and services can be usedtogether. That is because a product may have a service associated with it, such as a transporting a product to the end customer, and a service mayhave some associated product, a maintenance company that uses parts
that are incorporated into the final service.
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ISO 9001: 2015
2) CONTEXT
OF THE ORGANIZATION AND INTERESTED PARTIES:
The Annex SL - High Level Structure, explained at the beginning of this e-book, introduced two new sections regarding the context of theorganization:
4.1 - Understanding the organization and its context;4.2 - Understanding stakeholder needs and expectations.
Regarding the term "organization and its context", the standard establishesa clear determination of internal and external issues of the organization toachieve the requirements of the quality management system. In thisprocess, the implementation of the requirement may be aligned with thebasis of the company's strategic planning and / or process only with thequality management system in accordance with the requirements of theStandard.
The scope of this process is in accordance with the objectives of thecompany and the delimitation of the scope of the quality managementsystem, the standard establishes the minimum requirements of a qualitymanagement system and each organization must evaluate such impactwithin its purposes and organizational structure.
To determine the internal and external issues of the organization, severalmanagement tools can already be adapted and used for this purpose, oneof them is the SWOT analysis tool. This tool is essentially intended to beused for scenario analysis, in the case of item 4.1 of ISO9001: 2015, the toolcan be used for this purpose. This is illustrated in the figure below:
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ISO 9001: 2015
The Standard establishes resolution of the term "needs and expectations ofstakeholders”, and their respective requirements. However, theorganization must note that item 4.2 does not imply the extension ofrequirements beyond the scope of ISO 9001:2015 itself, as the standarditself warns, since such a term may lead to confusion regarding this process.The determination of stakeholders should be limited to the qualitymanagement system, scope of the organization and its context.
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ISO 9001: 2015
DID YOU KNOW?
The term SWOT stands for Strengths, Weaknesses, Opportunities, andThreats. The tool is credited to Albert Humphrey, who led a research
project at Stanford University in the United States in the 1960’s and 1970’s using large international corporations.
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ISO 9001: 2015
3) PROCESS APPROACH:
The ISO 9001:2008 standard promoted the inclusion of the processapproach for developing, implementing and improving the effectiveness ofthe quality management system. In ISO 9001:2015 this becomes moreexplicit in 4.4 with adoption of specific requirements considered essentialto the adoption of this approach.
By managing the interrelationship between the processes of the qualitymanagement system, the tendency is for the improvement to become moreevident to the organization when it achieves its intended results. In thisprocess, the Standard establishes the use of the PDCA cycle (Plan, Do,Check, Act) focused on risk management, aiming to identify opportunitiesand prevent undesirable results. The following figure represents thestructure of ISO 9001:2015 in the PDCA cycle.
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According to the above representation it is possible to identify Leadership(item 5) as the center of the quality management system. Comparing toprevious versions of the Standard the inputs are not limited to therequirements of the client, but also the needs and expectations of thestakeholders (item 4.2), the organization and its context (item 4.1).
ISO 9001: 2015
4) RISK-BASED THINKING:
Initially considered one of the major changes of the ISO 9001 standard, theconcept of risk-based thinking has always been present in previousversions, but implicitly, through planning requirements, critical analysis,corrective actions aimed at recurring non-conformities and preventiveactions. Item 6.1 specifies and clarifies this approach and defines planningrequirements for this, putting the prevention functionality as the mainpurpose of the quality management system.
According to the preventive purpose the ISO 9001:2015 does notdetermine a specific requirement as the "preventive action" as the previousversions, because this concept is expressed by the pervasive risk mentalityin the main requirements of the standard.
It is important to emphasize, as the Standard itself describes, there is nospecific requirement for formal risk analysis and management methodswithin the organization or even a documented process for this purpose, soorganizations can develop their own procedure, whether it be kept asinformation documented or not. The scope of the risk managementmethod to be implemented in the organization may vary according to thecomplexity of the company's activities, the scope of the managementsystem and the context of the organization.There are several process risk management tools that can be adapted tomeet ISO 9001:2015, or as highlighted above, the organization can developits own methodology, two examples below:
- Failure Mode and Effect Analysis (FMEA) or Failure Mode and EffectAnalysis, a method used for risk assessment in process and project failures,can be adapted to any risk management process;
- HAZOP (Hazard and Operability Study), method originally used to identifyand evaluate processes that may cause personal risk or equipment, as wellas the previous method, can be adapted for risk management of the QMS;
As the concept clause itself states, risk management in the organizationmust be disseminated as a mindset for the people acting on behalf of theorganization and can thus bring significant improvement results.
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ISO 9001: 2015
DID YOU KNOW?
The previous documents elaborated by ISO / TC176 cited ISO 31000 - Risk Management as a normative reference, but since ISO 9001:2015 does not
establish a formal method for risk management, this reference was withdrawn and inserted only in Bibliography.
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ISO 9001: 2015
5) DOCUMENTED INFORMATION
For alignment with Annex SL, quoted at the beginning of this e-book, theterm documented information has been included to replace the old terms"document" and "record". Throughout the norm the requirements wereadapted to this clause, establishing processes that need evidence as tomaintain and retain documented information.
In the ISO9001:2008 version the term "record" was used to refer todocuments required to provide evidence of compliance with requirements.In the ISO 9001:2015 version the term "withheld information" is used todenote the old record. In the case of the term "document" of the oldversion, the current ISO 9001:2015 version refers to this as "keepingdocumented information".
This alignment of Annex SL is due to the advent of new media to denote asdocument and / or registration, and the conflicting understanding of themarket between document and registry.
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ISO 9001: 2015
6) ORGANIZATIONAL KNOWLEDGE
ISO 9001:2015 addresses the issue of organizational knowledge,establishing the need to determine and manage the knowledge maintainedby the organization to ensure that it can achieve product and servicecompliance.
It is already notorious that companies may have losses of their know-howdue to the turnover of people acting on behalf of the organization and/ordeficiency in maintaining and sharing information through effectivecommunication. Due to these facts, one of the objectives of this item is tosafeguard the organization of losses of the now called ISO 9001:2015,organizational knowledge.
Another objective of this item, as mentioned in the Standard, is toencourage organizations to acquire knowledge, where it can be done indifferent ways with previous projects experiences, mentoring, courses,seminars, etc.
The requirement may initially appear generic but establishing ways tomaintain the knowledge already acquired and seeking alternatives toacquire additional knowledge will enter a knowledge cycle, which aims toprepare organizations for adverse situations impacting this process.
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ISO 9001: 2015
QMS VISION ABOUT ISO 9001:2015
We at QMS, as active participants in the revision of the previous version,believe that ISO 9001:2015 met the proposed objectives at the time of itsconception and we can conclude that:
• The text of the Standard is clearer and more objective thanprevious versions and has a more accessible language for betterapplication in companies in search of certification;
• The Standard can be used as a process management tool and theeffectiveness of the quality management system is most noticeableto top management and all employees who act on behalf of theorganization;
• The implementation and maintenance of the quality managementsystem can be directed together with the strategic planning of theorganization, provided that the organization has that objective;
• The easy adherence to implementation and consequently ISO9001:2015 certification of small and medium-sized enterprises, aswell as companies engaged in service activities, due to a betterunderstanding of the requirements of the regulations.
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ISO 9001: 2015
WHAT CAN QMS DO FOR YOUR COMPANY IN THIS PROCESS?
GAP ANALYSIS AUDITEvaluation of your QMS by specializedauditors to observe gaps for migration to ISO9001:2015.
IN-COMPANY TRAININGIn-house training with expert instructors onISO9001:2015.
CERTIFICATIONIf your company is not yet certified by QMS,transfer your certification or certify with usand experience the best service in the market.
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