Barigazzi F.lli S.r.l. confirms the objectives described in its Quality-oriented Corporate Policy:

The goal of BARIGAZZI F.LLI S.r.l. is:

• The complete satisfaction of the Customer’s needs and expectations;
• The achievement and maintenance of a primary market position.
• The achievement and maintenance of high quality standards with respect to its product (pallet) and service.

To achieve these goals and improve them, the Company’s policy intends to follow the following general concepts:

• Compliance with applicable laws;
• Compliance with contractual regulations;
• Compliance with the chosen Quality Assurance standard: UNI EN ISO 9001:2015;
• Analysis and monitoring of available resources;
• Optimization of resource management costs;
• Defect prevention and correction;
• Involvement of all personnel with quality-related functions;
• Individual empowerment of employees in functions influencing product quality;
• Empowerment of supervisors regarding tasks influencing the quality of their employees;
• Training in quality disciplines and continuing education of all functions at all levels;
• Measurement of QS adequacy, compliance and effectiveness through internal and external audits;
• Availability and visibility of data records that constitutes objective evidence of product quality;
• Appointment of a management representative for everything related to Quality;
• Continuous search for new goals;

All of the above-described activity is based on specific documents (regulations, communiqués, contracts, etc…) that are kept available for interested functions to consult.

In order to fully meet the customer’s needs and further qualify its business, Barigazzi F.lli complements the inherent quality of the pallet produced with various services such as:

• Production and sale of products certified according to national and international standards (EPAL Pallets);
• Production and sale of customized pallets according to customer needs;
• Provision of specific logistics services (timely delivery, transportation to destination, storage c/o our warehouses of company-owned products);
• Provision of specific and innovative services for compliance with national and international regulations (drying, phytosanitary treatment, pallet capacity).
• Use and promotion of innovative materials (agglomerated wood, cardboard, plastic)

The Quality Policy is disseminated to all levels of the corporate organizational structure. It is therefore distributed to all holders of the Quality Manual and to all personnel-by posting on company premises-it is also included in staff training courses, particularly for newly hired staff.

ISO 9001:2015 standard

Barigazzi F.lli follows the requirements of the new ISO 9001:2015 “Quality Management Systems” standard.

The main changes in the new standard concern the structure of the new ISO 9001:2015 standard, which consists of 10 chapters according to an organization called HIGH LEVEL STRUCTURE. This change was introduced to enable the quality management system to be easily integrated with other management systems (environment, safety, information security, etc.).

1- Purpose and scope

The section clarifies the purpose and scope of the standard, i.e., the requirements for a quality management system that can support the delivery of a product or service through the implementation of effective and constantly improving systems, ensuring compliance with contractual requirements and applicable laws and increasing customer satisfaction.

2- Normative references

ISO 9000:2015, Quality management systems – Fundamentals and vocabulary is normatively referenced within ISO 9001:2015.

3- Terms and Definitions

The section recalls ISO 9000:2015.

4- Background of the Organization

The section defines the requirements for the organization to monitor high-level activity, taking into consideration the key internal and external factors that affect it and how it should manage them within a defined management system.

4.1 Understanding the organization and its context

This point requires the organization to consider a multitude of potential factors that may influence the management system, in terms of structure, purpose and scope, implementation and operation. The factors that impact the organization’s results can be internal or external and very diverse from each other:

• External factors: may be legal, technological, competitive, market, cultural or socio-economic in nature and may be at the international, national, regional or local level.
• Internal factors: may refer to the organization’s own values, culture, knowledge and performance.

4.2 Understand the needs and expectations of stakeholders

Section 4.2 asks the organization to determine the needs and expectations of “stakeholders,” internal and external. Interested parties could be:

• Employees
• Outside contractors
• Direct and end customers
• Suppliers
• Regulatory Bodies
• Shareholders
• Borders and neighboring communities
• Non-governmental organizations (NGOs)
• Motherhouse

It is clear that the context and stakeholders must be considered because of the relevance to the scope and purpose of the standard, and the assessment must be relevant and proportionate. Regarding the demonstration of compliance, ISO 9001 makes it clear that the organization:

“Must monitor and review information concerning such external and internal factors” (p. 4.1).

“Must monitor and review information concerning such stakeholders and their requirements” (p. 4.2).

The above implies that, in this regard, it will be necessary to keep documented information in some form to substantiate how internal and external factors and the views of stakeholders have been taken into account. Many methodologies and approaches can be used to document such inputs. As with any significant revision of standards, it is desirable that a set of reference methods and examples be developed.

Some topical examples:

Internal and external factors

-Substantial economic and market development: can affect the organization, which is probably well aware of the dynamics taking place in the markets but there is an opportunity to address them in a very focused way

– Innovations and technological development: this is a critical area for the company’s success, and is probably already being monitored and addressed at various levels

– Regulatory developments: a wide range of external regulations are monitored by your organization. Failure to comply could seriously undermine your business, while getting early guidance on content could enable you to better seize opportunities

– Political or other instability: if, for example, you are dependent on raw materials from a particular country that is going through a period of severe instability, your entire operation could be in jeopardy, as well as if there are serious doubts about the ethicality of sourcing specific materials or goods

– Organization culture and attitudes: an efficient and motivated workforce creates positive effects; many organizations solicit feedback from employees

Internal and external stakeholders

– Stakeholder engagement activities: already widespread for consultation with stakeholders and timely identification of concerns and issues; most often in use at large organizations engaged in corporate social responsibility initiatives.

– Consultative meetings with local stakeholders and NGOs on environmental issues, planning and industrial development: often organized by large factories with significant health, safety and environmental (HSE) risks.

– Meetings and relations with regulatory bodies: these may concern, for example, critical quality or compliance issues, but also the development of standards and definition of compliance requirements.

– Employee meetings, consultations and feedback: should already be held in the company, but perhaps this will solicit more engagement in an area at risk in the past of only formal compliance with ISO 9001:2008.

– Consultation and supplier relationship: many organizations are attempting to derive more mutual benefit from the supplier-customer relationship, which is critical to the success of both.

– Consultation and relationship management with direct and end customers: this is, of course, a building block in all standards and for success.

– It can happen that when it comes time to reflect on how the most important issues are being dealt with and how many stakeholders are already involved, one has nice surprises. Perhaps you are confronting only a limited number of internal or external parties-it is time to start thinking about whether it is enough and whether you are not missing valuable opportunities.

This can be documented in many ways, with the hope that improvements and new approaches will emerge from the application of this part of the standard. The results should contemplate:

• Summary information from the activities listed above (e.g., brief report)
• Summary information in documentation of risks and opportunities
• Records on simple spreadsheets
• Information uploaded and updated to database
• Information captured and verbalized in key meetings

These requirements ask organizations to think clearly and logically about what may affect their management systems internally and externally and to prepare to demonstrate that this information is being monitored and reviewed. Organizations are also urged to take the discussion to the highest levels, as being able to document all the above information is arduous without the involvement of senior management.

4.3 Determine the scope of the quality management system

This point should be familiar to most organizations, since ISO 9001:2008, in p. 4.2.2, calls for defining the scope of the management system. With ISO 9001:2015, this requirement becomes even more stringent, as it commits the organization to take into account the inputs of p. 4.1 and 4.2, as well as the products and services provided.

Once the scope of the quality management system has been defined, the organization should apply all the requirements of the standard, or provide a clear justification for the requirements it deems not applicable. The defined field must be documented and updated. The standard states, “Compliance with this International Standard may be declared only if the requirements determined as not applicable do not affect the organization’s ability or responsibility to ensure the conformity of its products and services and the enhancement of customer satisfaction.”

Clarity on how to define the purpose of the management system. Certifying bodies will continue, as in the past, to evaluate how scope is defined to ensure that it is appropriate and corresponds to what the system implements.

4.4 Quality management system and related processes

This item basically states that the organization must establish, implement, maintain and continuously improve a management system to provide the products, services and performance required by the scope. This, too, should be known to organizations implementing management systems to achieve compliance and improved results.

The point focuses specifically on asking organizations to better understand ‘breadth of processes relevant to the scope of the management system. The term process is defined as “series of interrelated and interacting activities that transform inputs into outputs.”

For those working on a management system that is of central importance to the company, it is likely that the above is already applied, however, it may be necessary to reexamine how effectively the processes are interrelated and to understand how they affect each other and how they affect the company’s results.

This should also increase the importance and value of the system to the company because it should lead to more meaningful analyses of key processes and their critical aspects. In practice, it will push the organization to analyze its processes more fully and gain a good understanding of their interactions, rather than running them as isolated procedures with no points of contact.

Section 4 introduces some significant innovations in the world of management systems and could pose a challenge to those organizations that have not hitherto considered management systems to be central to the business, because it takes the management system to a higher level and more centered on how the organization functions.

5- Leadership

The section contains a good deal of familiar requirements since the publication of ISO 9001:2008, but it also introduces some significant changes in leadership and engagement as a whole, as well as on the ‘expectation of greater participation of senior management on critical aspects of the quality management system.

5.1 Leadership and commitment

This item lays out a number of key activities for senior management if they intend to “demonstrate leadership and commitment to the management system.” Herein lies one of the innovations of the HLS common structure: senior management must show leadership toward the management system, rather than merely demonstrating commitment to it. The standard brings management system oversight to the highest level of management, making it a key component of the organization and its core processes and activities.

It does not mean that senior management should know policy by heart or be able to recite objectives and targets, but rather that internal or external stakeholders should feel empowered to relate to senior management about central and critical aspects of the company because they are at the heart of the management system. An additional goal of the requirement is to fully identify the needs and expectations of the market and end customers. This information serves as input to determine strategy, which, in turn, provides guidance and encourages the development of a management system that can satisfy the target market or clientele. This is an iterative process, which can be arrived at in many different ways. Although not specified in the standard, surveys, minutes of customer meetings, questionnaires and other forms of market research could be included as documented information.

The customer focus has remained largely unchanged from ISO 9001:2008, but has been expanded to include the determination of risks and opportunities that affect product and service compliance.

5.2 Policy

The Quality Policy is an important document because it acts as a driving force for the organization. Sets guidelines and formalizes goals and commitments. Senior management should ensure that policy is appropriate and compatible with strategic direction. The policy must be communicated to all employees, who must understand their role in its implementation.

ISO 9001:2015 calls for the policy to also be documented and, where appropriate, available to stakeholders.

5.3 Roles, responsibilities and authority in the organization

For a system to work, those involved must be fully aware of their roles. Senior management must ensure that the most relevant responsibilities and authorities are unambiguously defined and that everyone involved is clear about his or her role. Defining roles is functional for planning because it ensures that awareness is achievable through communication and training. Not infrequently, organizations employ job descriptions and procedures to define responsibilities and authority.

In ISO 9001:2015, senior management is more directly identified as the entity responsible for ensuring that these aspects of the system are properly assigned, communicated and understood.

The role of the Management Representative has been eliminated, while the standard still provides for all related key activities and responsibilities, which, however, are now more directly entrusted to the central structure of the organization, including senior management.

Section 5 covers many familiar contents, but with a greater emphasis on leadership and commitment and with the expectation that senior management will be more actively involved in the management system.

6- Planning

This is an excellent addition to ISO 9001:2015, introducing the concept of risk (and opportunity) within the HLS framework. DNV GL has been in the “risk” business for a long time: in fact, in addition to working together with our clients on risk management, we have been applying the Risk Based approach to our certifications since 2004. This innovative approach, is based on focusing audits around areas of risk relevant to the organization and investigates thoroughly to determine whether a given risk is being managed effectively.

6.1 Actions to address risks and opportunities

In essence, the point requires that the organization:

• Recognize risks and opportunities relevant to the purpose of the management system and define actions, objectives and plans to address them.
• In recognizing risks and opportunities, the organization uses the inputs it has identified to determine the context, as required in p. 4.1, and the views and inputs from stakeholders in p. 4.2.

A well-established and popular approach in many organizations is to compile a risk register, which, if well managed and implemented, can provide the data useful in effectively managing risks and opportunities in relation to different issues. There are also alternative approaches, some emerging from the different points, the depth and complexity of the approach will depend significantly on the size and complexity of the organization, as well as other factors, which could include the level of external standardization, existing data publication requirements, shareholder interests, public profile, and the number and type of customers and suppliers.

6.2 Objectives for quality and planning for their achievement

Within the planning process, senior management must define the objectives for quality that will contribute to the realization of the Quality Policy. Goals and plans for quality, must be clear, measurable, monitored, communicated, updated. Senior management must allocate the resources needed to achieve the goals.

There are many objectives that can be considered: market positioning and/or growth dynamics, process effectiveness and/or efficiency, increased staff awareness, retention of current positions, reduction of quality costs, improved product conformity and defect reduction, increased customer satisfaction, etc. Objectives must be implemented in relevant areas of the organization and must be meaningful to those entrusted with responsibility for their achievement or whose activities will contribute to them.

Documented information about goals should be kept, while it will be necessary to be able to substantiate the monitoring of achieved goals.

6.3 Change planning

The item defines requirements to ensure that changes that are necessary for the management system are planned, possible consequences are considered, and resources are available and roles and responsibilities are defined. Changes in the management system may be necessary in case of company acquisitions, introduction of new products or services, etc.

7- Support

An effective quality management system cannot be maintained and improved without adequate resources, which should be determined and made available based on what is planned. This is also applicable in the case of resources needed to manage specific contracts or projects. The item includes all aspects of management systems referable to “people, places and procedures.” Key points at the HLS level include:

• 1 Resources
• 2 Expertise
• 3 Awareness
• 4 Communication
• 5 Documented information

7.1 Resources

The main intent behind this general requirement is for those working within the quality management system to be competent in view of fulfilling their duties, supported by equipment and infrastructure suitable for the purpose. The availability of infrastructure, such as buildings, hardware, software, transportation facilities, etc., must be adequate. It is part of planning to determine how much is needed and what maintenance to schedule to ensure its continuous operation.

An organization’s work environment consists of a number of human and physical factors that can affect quality, effectiveness and efficiency. These factors need to be identified and managed, including, for example: protective equipment, ergonomics, heat, noise, lighting, hygiene, humidity, vibration, temperature, etc. Relevant factors vary, of course, depending on the product or service. As an example of a problem in a work environment, one might mention humidity control in a paint shop. Although not required to document these requirements, criteria applicable to the work environment often appear in procedures, contracts, specifications and professional codes. Compliance should be substantiated by documented information.

The organization must determine what kind of monitoring and measurements need to be undertaken and prove that they are being carried out with correct and reliable equipment. Regular calibration and maintenance (in addition to documented information kept) is one way to provide assurance of the validity of results.

Equipment for critical measurements (including software) must be available and its accuracy must be known to ensure that the product meets relevant requirements.

In ISO 9001:2015, the requirements for the provision of resources for the management system and the effective implementation of support activities are reformulated to reflect the fact that tools can be understood in a broader sense and not limited to equipment and hardware.

There is also a very interesting additional requirement called “organizational knowledge,” which states that the organization must demonstrate that it understands internal and external knowledge needs and must be able to demonstrate how they are managed. The requirement could also extend to resource knowledge management, efficient planning of staff alternation, and processes to document knowledge held by individuals or groups.

7.2 Expertise

In order to determine competence, relevant criteria must be established for each function that affects quality in order to assess existing competence and determine future needs. Where the criteria are not met, interventions should be implemented to fill the gaps, including also training and retraining. It is necessary to keep documented information to prove competence.

Recruitment and training programs, training plans, qualification verification and staff evaluations often provide evidence of competence and its evaluation. Competency requirements often appear in job advertisements and job descriptions.

7.3 Awareness

Personnel must be made aware of the importance of their activities, their contribution to the achievement of quality goals, and the effectiveness of the management system and the resulting performance of the organization. To this end, training programs and interviews with workers are often used.

7.4 Communication

Through the HLS, ISO 9001:2015 clearly emphasizes the importance of internal and external communication (the latter more than in the 2008 version of the standard).

The point emphasizes the need to plan and implement a communication process based on the usual principles: “who, what, when, how.”

Effective communication is so essential to a management system that senior management itself must ensure that mechanisms are in place to facilitate it. Of necessity, communication is bidirectional and should not only be about what is intended to be communicated, but also about what has been understood-in other words, what has been planned and what has been achieved. Changes in the quality management system should be communicated in defined ways to stakeholders (although in practice these are mainly internal stakeholders) and should identify appropriate levels of training updates. Communication mechanisms could include: meetings, bulletin boards, internal newsletters, awareness seminars, update talks, intranet, email, etc.

7.5 Documented information

For the most part, the text of ISO 9001:2015 does not present anything new, similarly reiterating the requirements of ISO 9001:2008, although there is a logically intended expansion to broaden the applicability of the requirements to electronic and web environments. It is worth pointing out that the standard no longer requires documented procedures to be drawn up, because the organization itself decides what is necessary. On several occasions, however, it specifies the need to maintain or preserve documented information to concretize, clarify and demonstrate that the system is up-to-date and effective. The term “documented information” replaces the previous terms: “documented procedure” and “documentation.”

Documented information can be in any format determined by the organization, as long as it provides evidence of compliance.

There are several subpoints in ISO 9001:2015 with respect to the 2008 standard, but they are mainly dictated by the need to ensure the faithful transposition of the content of the current ISO 9001:2008 to the most appropriate and consonant point in ISO 9001:2015.

In many areas, this point does not impose major changes, but some of the additional requirements require further thought, particularly when they relate to organizational knowledge. The changes introduced with the HLS regarding not requiring documented procedures are not actually a significant issue: organizations must determine where documented information (processes, procedures, data, records, and the like) is essential to management systems and their smooth operation.

8- Operational Activities

This requirement of the standard includes the planning and control aspects of operational processes, i.e., the “beating heart” of production. Many points are added to the basic HLS.

8.1 Operational planning and control

This point recalls the substantive elements of p. 4.4, where critical processes and their interaction were determined, and the actions in Sect. 6. Also defined are some additional requirements on change control, which are now made more explicit, as well as on the control of outsourced processes (previously covered in the purchasing section of ISO 9001:2008).

8.2 Requirements for products and services

It is necessary to activate a process to ensure that customer requirements and expectations are defined and that mandatory product requirements with respect to intended use are met.

Once determined, the requirements must be reviewed by the organization before committing in any way toward delivery to ensure that they have been understood, that any anomalies are resolved, and that the organization has the capacity to meet them. Rich is the case history of bids sent and followed by the acceptance of orders without any cognizance for the company of its ability to honor commitments. As far as documentary inputs are concerned, examples are requests for proposal, contract specifications and requests for clarification; as documentary outputs, there are quotations, contracts and proposals to contractors.

Communication must be planned to ensure that all necessary information is made available when needed, from both external and internal sources. Such information could also include customer feedback, more fully discussed in the customer satisfaction section (p. 9.1.2). Documented information related to communication is not specified, but typically may include contracts, specifications, drawings, e-mails, letters, faxes, meeting minutes, complaints, etc.

ISO 9001:2015 is enriched with content on communication with reference to customer rights and emergency action.

8.3 Design and development of products and services

A systematic approach to the control of design and development activities is indispensable, which presupposes their planning, complete with all phases of study, review, verification and validation. Although not required by ISO 9001:2015, a commonly drafted document is the project plan, which outlines its future management throughout the design and development process.

Design and development inputs can include customer specifications, mandatory requirements, information extracted from previous projects, budget considerations, etc. Each organization should decide how to develop the design, but the output must be checked against the input requirements of the design. Therefore, the output must be in a format that facilitates verification. Typical outputs include drawings, specifications, instructions, schedules, user manuals, etc.

At scheduled cadences, the design and development should be reviewed to ensure that the design is satisfactory and to solicit solutions to any problems encountered. Documented information on design and development reviews and related actions taken should be maintained. They could typically consist of: meeting minutes, revised drawings, sketches, formal approvals, etc.

Verification is basically a process during which design and development are screened to ensure that what is processed meets the input requirements. It may consist, for example, of checking design calculations to ensure that an air conditioner has the desired capacity. Results and actions required as an outcome of the verification process should be retained as documented information. They can typically consist of alternative calculations, approvals, reports on comparative studies, etc.

It is necessary to conduct validation to ensure that the product meets the basic design characteristics, for example, by testing a prototype of the air conditioner to ensure that it can maintain the desired temperature under the prescribed conditions of use before starting mass production. Whenever possible, validation should be completed before delivery. The results of the validation process and all actions must be kept as documented information. Typically they may include test results, feedback on prototypes, use tests, etc. Design and development requirements can be changed at any time and be the outcome of multiple factors, as well as can significantly affect the course of existing projects. Any resulting design changes must be reviewed, verified and validated where necessary. Variations to projects must be identified and kept as documented information.

This point follows ISO 9001:2008 almost in its entirety on p. 7.3, but according to a clearer structure and requirements for design and development planning, with greater attention to customer needs and starting with essential documenting information (p. 8.3.2); for design and development inputs, a broader set of inputs are provided, such as analysis on resources and potential consequences of failures (p. 8.3.3). It is necessary to maintain documented information for this process.

8.4 Control of externally supplied processes, products and services

The main purpose of this requirement is to ensure that the necessary externally supplied processes, products and services (e.g., the components of its product) enable the organization to ensure that its product/service meets the customer’s requirements.

First, it is necessary to trust the external supplier of the process, product or service. It is necessary to have instituted some form of initial assessment, keeping in mind that not all suppliers have the same impact on the final product or service. It is imperative to determine and apply criteria for selecting, evaluating, and re-evaluating suppliers; then decisions should be made and controls implemented on what is supplied from outside in light of the potential impact on the compliance of the final service product (risk management).

A second step in ensuring compliance of the externally purchased process, product, or service is to get all the necessary information to the supplier, who should not be forced to guess what is needed, as clarity is essential, not only in terms of product specifications, but also operator qualifications, quality control and assurance, documentation, lead times, etc.

Requirements specified at the time of purchase should also be checked for adequacy before being communicated to the external supplier. Typical documented information includes vendor quotes, purchase orders, contracts, and associated documented reviews.

A third step is to verify the process, product or service being procured. It is possible to do this in many ways, before shipment or upon receipt, such as by inspections of deliveries received or by recording tests performed, or by verification of a product’s certificate of conformity. Some organizations undertake audits of key suppliers or attend at the time of acceptance testing. Activities could include a joint audit with the supplier at its sites.

As a fourth step, it is necessary to reevaluate suppliers periodically (or continuously) against predefined criteria. Results of supplier evaluation and re-evaluation must be kept up-to-date and could consist of references, test orders, product specifications, audit findings, performance or defect data, etc.

Although not required by the standard, some organizations choose to compile a list of approved providers for ease of reference.

With regard to outsourced processes, products and services, ISO 9001:2015 considers a much broader scope than the purchasing section of ISO 9001:2008 and clarifies the criteria for applying the requirements.

8.5 Production and delivery of services

The requirement aims to ensure that production activities and operations are planned and conducted under controlled conditions; the requirement may also extend to operations that take place at customer sites, such as installation.

There are different ways to achieve controlled conditions; methods may include control of processes, procedures, drawings, specifications, operating instructions, quality plans, operating and process criteria.

As for products that cannot be truly tested until the time of use (e.g., a match, for which the only effective test is to light it), the company must trust in the ability of its process to consistently perform as intended. Through validation, processes may also need to be re-validated from time to time because conditions, personnel, and materials may change. Documented information related to process validation is required to be kept, consisting, for example, of documentation on operator qualifications, materials and methods used, working environment, etc.

In almost every organization, there is a need to formally identify the product or service and determine its status or level of completion at any time. There may also be a need to maintain traceability of a product or service (e.g., for legal compliance).

In some industries, traceability is a requirement that applies to all processing steps and thereafter to facilitate any recall actions. In such cases, the unique identification of the product must be the subject of controls and records. There are many ways in which products and/or services can be identified and tracked; these include: lot numbers, production dates, inspection reports, color coding by labels, confined warehouses, barcodes on packages, service reports, job codes, project/report number, part numbers, configuration information, etc.

Some organizations use products or intellectual property (e.g., patents) provided by the client. In such cases, it is necessary to ensure that what is provided is suitable for the intended application and, thereafter, that it is used appropriately and protected from loss or damage. For this purpose, records of receipt, inspection, use, loss, damage, or return can be kept (again, there are clear requirements for the return of documented information).

The product must be preserved from the raw material during receipt, storage, processing of the finished product and up to the point of delivery, with the aim of constantly ensuring fitness for use. In the tertiary sector, preservation of data or reports on electronic media could also be included. In planning for product preservation, the needs of customers and regulators and the requirements for identification, handling, storage and protection must be assessed. The type of product will impose natural choices about the necessary infrastructure and controls.

Documented information may also cover storage procedures and criteria, records of receipt or shipment, attestations of legal compliance, deadlines, damaged or lost goods, etc.

8.6 Release of products and services

The organization must monitor and measure product characteristics to verify that requirements have been met, evidence of compliance with requirements must be retained, and the person who authorized the release of the product for delivery to the customer must be indicated.

8.7 Control of non-conforming outputs

The requirement is intended to prevent nonconforming products from being further processed, used or delivered. Once identified, regardless of when this happens (e.g., during the production process or after delivery), any nonconforming product should initiate a process whereby an authorized and competent party should decide what to do: discard, supply as an exception, allocate to alternative uses, rework or recall the product, and the like.

9- Performance Evaluation

9.1 Monitoring, measurement, analysis and evaluation

Collection and analysis of relevant data are necessary to measure the suitability and effectiveness of the management system and identify opportunities for improvement. The goals and objectives of the company should be taken into account when deciding what to analyze and comment on.

Methods of analysis vary widely in terms of applicability and complexity. For some activities, simple histograms will suffice, while for others Statistical Process Control (SPC) must be enabled: it is important that the method chosen is no more complex than necessary. At a minimum, analysis should be done in relation to customers, product compliance, and process and supplier performance.

Return information from the customer is an excellent indicator of the performance of the management system and the company. Since there are many ways to collect customer feedback, companies should consider alternatives to simply questionnaires or complaints, including, for example, interviews, customer meetings and surveys. The purpose is to capture the customer’s perception of the product and/or service and improve satisfaction.

The item deals with content already known in relation to customer satisfaction analysis and evaluation, but compared to ISO 9001:2008 it insists on analytical evidence and evaluation of salient performance data as the foundation of factual decision making.

9.2 Internal Audit

Internal audits have always characterized ISO 9001 as an aid to evaluating the effectiveness of the quality management system. An auditing program should be established to ensure that all processes are audited internally as frequently as necessary and with a focus on those that are most critical to the business. To ensure that internal audits are consistent and comprehensive, a clear objective and scope should be defined for each.

This will facilitate the selection of the auditor with a view to his or her objectivity and impartiality. For best results, auditors should have a working knowledge of the object to be audited, while management must act on the audit findings. Often we are limited to corrective actions in the face of detected nonconformities, but other outcomes can be leveraged to pursue prevention and improvement.

It would be appropriate to verify that the action taken as a result of the audit findings is effective.

The point appears to be identical to the corresponding one in ISO 9001:2008.

9.3 Management review

The main purpose of management review is to ensure the continuing suitability, adequacy and effectiveness of the quality management system and its alignment with the organization’s strategic direction. The goal can only be achieved if the review is carried out with adequate frequency (remember that one meeting a year may not be enough for management review), providing complete information (the standard defines minimum inputs) and ensuring that the right people are involved.

Input for management review should include information on:

(a)Advancement of the actions of previous reviews.

(b)Internal or external changes of significance to the quality management system.

(c) Performance and effectiveness of the management system.

(d)Adequacy of resources

(e) Effectiveness of actions taken against risks and opportunities.

(f) Opportunities for improvement

The output of the management review should include decisions and actions related to opportunities for improvement, the need for changes in the quality management system, and resource requirements.

Documented information related to management review is required to be kept, usually in the form of minutes.

This point is largely unchanged from ISO 9001:2008, but provides greater depth on some issues, in line with the new concept of risks and opportunities and the context of the organization.

10- Improvement

10.1 Generalities

The item summarizes what is required in terms of improvement from to ISO 9001:2015, a comprehensive approach that requires reviewing the processes, products, services, and results of the quality management system to select opportunities for improvement and define each action to improve customer satisfaction.

10.2 Nonconformities and corrective actions

The primary purpose of corrective actions is to eliminate the causes of problems so as to prevent them from occurring again. This is a reactive process, in that it is triggered after an unwanted event (e.g., detection of nonconforming product). In essence, it is based on the principles of root cause analysis: an elementary approach to problem solving is the study of the causal relationship, which must lead to the elimination of the cause itself. The action taken must be appropriate to the impact of the problem (risk). Once the process has begun, it is necessary to ascertain and ensure that the action taken is effective.

This point in the new standard is very similar to the corresponding one in ISO 9001:2008, although the item “preventive action” has been removed from the requirements (however mentioned elsewhere in the context of risk-based thinking), since the new HLS framework is based on the fundamental principles of risk management, which involves a fully preventive approach to identifying and managing risks and aims at their elimination or mitigation.