Clause

ISO 13485

SoftExpert Compliance Evidence

4

Quality management system

4.1

General requirements

4.1q1

The organization shall establish, document, implement and maintain a quality management system and maintain (continually improve) its effectiveness in accordance with the requirements of this International Standard.

SE Document minimizes risks and costs associated with a growing number of regulatory compliance and corporate governance processes such as those related to the ISO 9000 Quality Guidelines. It ensures compliance with electronic documents and signatures, revision control and audit trails.

4.1q2a

The organization shall a) identify the processes needed for the quality management system and their application throughout the organization (see 1.2),

The Organization identifies the processes needed for the QMS and their application throughout the organization at the SE Process.

4.1q2b

The organization shall b) determine the sequence and interaction of these processes,

The Organization determines the sequence and interaction of QMS processes at the SE Process.

4.1q2c

The organization shall c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective,

The criteria and methods used to ensure that operation and control of QMS processes are effective are published at the SE Document.

4.1q2d

The organization shall d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes,

The Organization provide information needed to support the operation and monitoring QMS processes making documents available at the SE Process

4.1q2e

The organization shall e) monitor, measure and analyze these processes,

The Organization monitor, measure and analyze QMS Processes by establishing indicators at the SE Performance

4.1q2f

The organization shall f) implement actions necessary to achieve planned results and maintain the effectiveness (continual improvement) of these processes.

The Organization implement actions and maintain the effectiveness of processes needed for QMS by following the policies and processes established at the SE Document and SE Process. The preventive actions and corrective actions are managed at the SE Action.

4.1q3

These processes shall be managed by the organization in accordance with the requirements of this International Standard.

The concepts and features provided by SE Process meet all requirements established by international standards and regulations.

4.1q4

Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes.

The Organization control outsourced process by establishing policies and processes at the SE Document and SE Process. The indicators are controlled at the SE Performance.

4.1q5

Control of such outsourced processes shall be identified within the quality management system (see 8.5.1). 

The controls of outsourced processes that affect product conformity with requirements are identified at the SE Process.

4.2

Documentation requirements

4.2.1

General

4.2.1q1a

The quality management system documentation shall include
a) documented statements of a quality policy and quality objectives,
b) a quality manual,
c) documented procedures required by this International Standard,
d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and
e) records required by this International Standard (see 4.2.4).
f) any other documentation specified by national or regional regulations.
Where this International Standard specifies that a requirement, procedure, activity or special arrangement be “documented”, it shall, in addition, be implemented and maintained.
For each type or model of medical device, the organization shall establish and maintain a file either containing or identifying documents defining product specifications and quality management system requirements (see 4.2.3).
These documents shall define the complete manufacturing process and, if applicable, installation and servicing.

The Organization documents statements of a quality policy and quality should be published at the SE Document.
The quality manual, procedures required by ISO 9001:200/13485:2003 should be documented at the SE Document.
The Organization ensures the effective planning, operation and control by establishing adequate documents and policies at the SE Document.
All documentation required by ISO9001:2000 should be published at the SE Document including any other documentation specified by national or regional regulation.
Documentations for each type or model of medical device containing or identifying documents with product specifications and QMS requirements should be published and maintained at the  SE Document or SE Asset.
Documentations regarding the complete manufacturing process and, if applicable, installation and servicing should be published and maintained at the SE Document.

4.2.2

Quality manual

4.2.2q1a

The organization shall establish and maintain a quality manual that includes
a) the scope of the quality management system, including details of and justification for any exclusions and/or non-application (see 1.2),
b) the documented procedures established for the quality management system, or reference to them, and
c) a description of the interaction between the processes of the quality management system.
The quality manual shall outline the structure of the documentation used in the quality management system.

The quality manual should be published at the SE Document and it should contain details of and justification for exclusions and/or requirements that don’t apply the scope of QMS.
The quality manual should also contain or reference the documented procedures established for the QMS and should include a description of the interaction between the processes of the QMS.
The quality manual should contain the outline of the structure of the documentation used in the quality management system.

4.2.3

Control of documents

4.2.3q1

Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.

SE Document automates document management processes, such as document change requests and document review and approval processes, to ensure that they are carried out accurately and efficiently.

4.2.3q2

A documented procedure shall be established to define the controls needed

1. to review and approve documents for adequacy prior to issue,
2. to review and update as necessary and re-approve documents
3. to ensure that changes and the current revision status of documents are identified
4. to ensure that relevant versions of applicable documents are available at points of use
5. to ensure that documents remain legible and readily identifiable
6. to ensure that documents of external origin are identified and their distribution controlled
7. to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for a0ny purpose.

The documented procedure that defines the controls needed for the QMS should be published and maintained at the SE Document.

4.2.4

Control of records

4.2.4q1

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system.

The records that provide evidence of conformity to requirements and the effective operation of the QMS should be legible, readily identifiable, retrievable and published and maintained at the SE Document.

4.2.4q2

Records shall remain legible, readily identifiable and retrievable.

4.2.4q3

A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.

Documented procedure defining the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records should be published and maintained at the SE Document.

Clause

ISO 13485

SoftExpert Compliance Evidence

5

Management responsibility

5.1

Management commitment

5.1q1a

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and maintaining (continually improving) its effectiveness by
a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements,
b) establishing the quality policy,
c) ensuring that quality objectives are established,
d) conducting management reviews, and
e) ensuring the availability of resources.

SE Document automates document management processes, such as document change requests and document review and approval processes, to ensure that they are carried out accurately and efficiently.

SE Document automatically routes documents to multiple authors, reviewers and approvers before being ready for general distribution.

5.2

Customer focus

5.2q1

Top management shall ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction (see 7.2.1 & 8.2.1).

SE Request ensures that new demands on services or products are managed properly according to customer’s new specifications or requirements.

5.3

Quality policy

5.4.1q1

Top management shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the organization.

The quality objectives at relevant functions and levels within the organization should be established at the SE Performance.

5.4.1q2

The quality objectives shall be measurable and consistent with the quality policy.

Measures to ensure that the quality objectives are consistent with the quality policy should be published and maintained at the SE Performance.

5.4.2

Quality management system planning

5.4.2q1

Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and
b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

SE Performance includes activities to ensure that goals are consistently being met in an effective and efficient manner.  
SE Project contains the quality baseline that sets the criteria that specify the quality objectives for the project and thereby makes the basis for measuring and reporting quality performance. It defines quality metrics and quality checklist.

5.5

Responsibility, authority and communication

5.5.1

Responsibility and authority

5.5.1q1

Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization.

The responsibilities and authorities should be documented at the SE Document. It automates document distribution process allowing authorized users to register and email documents directly from/to team members, partners, suppliers, or customers. A permanent record of all distribution tasks is maintained for each version of each document.

5.5.2q1a

Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes

• ensuring that processes needed for the quality management system are established, implemented and maintained,
• b) reporting to top management on the performance of the quality management system and any need for improvement (see 8.5), and
• ensuring the promotion of awareness of regulatory and customer requirements throughout the organization.

The management representative should be designated by the top management and his responsibilities and authority should be published and maintained at the SE Document.

5.5.3

Internal communication

5.5.3q1

Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.

SE Document improves meaningfully communication and teamwork within the organization.

5.6

Management review

5.6.1

General

5.6.1q1

Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness.

The organization’s quality management system shall be reviewed by top management at planned intervals. This schedule should be published and maintained at the SE Document.
This documented procedure should contain what kind of information should be reviewed in management reviews.

5.6.1q2

This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

5.6.1q3

Records from management reviews shall be maintained (see 4.2.4).

5.6.2

Review input

5.6.2q1

The input to management review shall include information on

• results of audits,
• customer feedback,
• process performance and product conformity,
• status of preventive and corrective actions,
• follow-up actions from previous management reviews,
• changes that could affect the quality management system, and
• recommendations for improvement, and
• new or revised regulatory requirements.

Results of audits could be easily accessed at the SE Audit, that simplifies the planning and running of any type of audit.
Customer feedback, the preventive status and corrective actions, follow-up actions from previous management reviews, changes that could affect the quality management system, recommendations for improvement and revised regulatory requirements  could be found at the SE Action

5.6.3

Review output

5.6.3q1

The output from the management review shall include any decisions and actions related to
a) improvement needed to maintain the effectiveness of the quality management system and its processes,
b) improvement of product related to customer requirements, and
c) resource needs.

The SE Action offers total flexibility for the organization, including the following actions:

• Planning (5W2H) and approval of action plan.
• Implementation of the corrections (disposition/ contention/ immediate) actions, implemented to mitigate the impacts of the nonconformity.
• Implemented actions verification.
• Reviewing the effectiveness of the actions taken, including verification, standardization and communication, in order to verify if the same are appropriate for treating the real and potential nonconformities encountered and their impacts, avoiding repetition and/or occurrence.

Clause

ISO 13485

SoftExpert Compliance Evidence

6

Resource management

6.1

Provision of resources

6.1q1

The organization shall determine and provide the resources needed
a) to implement (and maintain) the quality management system and maintain (continually improve) its effectiveness, and
b) to meet regulatory and (enhance customer satisfaction by meeting) customer requirements.

SE Suite helps to determine and provide resources needed to implement the quality system and to  meet regulatory and customer requirements as follow:
SE Project provides features to select and allocate resources with the required skills and verify availability to implement the quality management system within the organization.
SE Action provides features to maintain and continually improve its effectiveness.
SE Training provides features to maintain the knowledge of the organization updated
SE Asset was designed to help with this key task by maintaining a record of all the assets that the organization wants to monitor. Hold detailed records of their service schedules, localization, verification, usage, maintenance, and much more.
SE Maintenance manages all maintenance tasks, helping the organization to reduce unplanned downtime and reactive maintenance. It allows the organization to quickly transition from crisis mode into planning mode.

6.2

Human resources

6.2.1

General

6.2.1q1

Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.

SE Competence offers different management indicators for measuring effectiveness in terms of human resource qualification, which display the level of adequateness of the organization's different areas, indicating those with the highest lack of qualification.
SE Training guarantees the verification of effectiveness, including the recording of the assessment method and objective evidence to prove such effectiveness and the verification of pending training and assessments per employee or company area, including notification of the same.
SE Training also guarantees the maintenance of the company’s talent database, displaying the employees who have completed certain training and/or have proven competencies.

6.2.2

Competence, awareness and training

6.2.2q1

The organization shall
a) determine the necessary competence for personnel performing work affecting product quality,
b) provide training or take other actions to satisfy these needs,
c) evaluate the effectiveness of the actions taken,
d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and
e) maintain appropriate records of education, training, skills and experience (see 4.2.4).

SE Competence offers different management indicators for measuring effectiveness in terms of human resource qualification, which display the level of adequateness of the organization's different areas, indicating those with the highest lack of qualification.
SE Training guarantees the periodic planning of the training required at the company, including the monitoring of costs resulting from internal and external training, as well as the reservation of training rooms and audiovisual materials, thereby optimizing the available resources at the company.
SE Training guarantees the verification of effectiveness, including the recording of the assessment method and objective evidence to prove such effectiveness and the verification of pending training and assessments per employee or company area, including notification of the same.
SE Training also guarantees the maintenance of the company’s talent database, displaying the employees who have completed certain training and/or have proven competencies.

6.3

Infrastructure

6.3q1

The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable
a) buildings, workspace and associated utilities,
b) process equipment (both hardware and software), and
c) supporting services (such as transport or communication).

All assets appropriate to meet product requirements are maintained by SE Asset and SE Maintenance.
SE Asset was designed to help with this key task by maintaining a record of all the assets that the organization wants to monitor. Hold detailed records of their service schedules, localization, verification, usage, maintenance, and much more.
SE Maintenance manages all maintenance tasks, helping to reduce unplanned downtime and emergency maintenance. It allows the organization to quickly transition from crisis mode into planning mode. All documented requirements should be published and maintained at the SE Document.

6.4

Work environment

6.4q1

The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
The following requirements shall apply.

1. The organization shall establish documented requirements for health, cleanliness and clothing
2. Of personnel if contact between such personnel and the product or work environment could adversely affect the quality of the product (see 7.5.1.2.1).
3. If work environment conditions can have an adverse effect on product quality, the organization shall establish documented requirements for the work environment conditions and documented procedures or work instructions to monitor and control these work environment conditions (see 7.5.1.2.1).
4. The organization shall ensure that all personnel who are required to work temporarily under special environmental conditions within the work environment are appropriately trained or supervised by a trained person [see 6.2.2 b).
5. If appropriate, special arrangements shall be established and documented for the control of contaminated or potentially contaminated product in order to prevent contamination of other product, the work environment or personnel (see 7.5.3.1).

The work environment required achieving conformity to product requirements and how it is managed and maintained should be published and maintained at the SE Document.

SE Training manages the necessity for training for all personnel who are required to work temporarily under special circumstances.

Clause

ISO 13485

SoftExpert Compliance Evidence

7

Product realization

7.1

Planning of product realization

7.1q1

The organization shall plan and develop the processes needed for product realization.

SE APQP automates the methods for managing the development and products changes. It serves as a guide in the product development process, while also standardizing the methods of sharing results between suppliers and manufacturers.

7.1q2

Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1).

SE PDM manages on a single repository all the information specified by the QMS compared to product realization, through the documents and processes added, promoting a free environment of duplicate and conflicting.

7.1q3

In planning product realization, the organization shall determine the following, as appropriate:

1. quality objectives and requirements for the product;
2. the need to establish processes, documents, and provide resources specific to the product;
3. required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
4. records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).

SE APQP helps ensure simple and effective control in the new products development. It also helps to comply with the requirements established both by quality standards and individual customers. Reports are generated and stored throughout the entire process.
SE APQP generates company-defined checklists and schedules of product quality planning and automatically sends pending tasks to assigned users, this ensures that both the realization processes and the product meet requirements.
SE APQP provides a Quality Plan (Control Plan) which is the output of the process and is used to deploy product realization. The Control Plan must include product details and control characteristics; process sequence and process control parameters; specific resources needed to make, verify and deliver product; product and process monitoring and measurement controls; plans to control and correct any product or process nonconformities; reference to support processes; documents needed (such as work instructions or engineering specifications, etc.) and details of records to be kept.

7.1q4

The output of this planning shall be in a form suitable for the organization's method of operations.
The organization shall establish documented requirements for risk management throughout product realization.
Records arising from risk management shall be maintained (see 4.2.4).

The product realization planning produces tangible outputs that show how product realization processes will be carried out: process plans (SE APQP-PPAP, SE PDM, SE Process), resource plans, work instructions, process documentation, control plans, verification or inspection and test plans (SE Document).
SE FMEA, calculates risks priority and examines potential failures in products or processes. It helps improve designs for products and processes, resulting in higher reliability, better quality, increased safety, enhanced customer satisfaction and reduced costs. All documents are kept and made available for viewing and use, each with their respective permissions and change controls.

7.2

Customer-related processes

7.2.1

Determination of requirements related to the product

7.2.1q1a

The organization shall determine
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,
b) requirements not stated by the customer but necessary for specified or intended use, where known,
c) statutory and regulatory requirements related to the product, and
d) any additional requirements determined by the organization.

SE APQP helps to comply with the requirements established both by quality standards and individual customers by providing a centralized characteristic database aligned to product datasheet. Any other requirements including statutory and regulatory requirements are controlled by SE APQP.

7.2.2

Review of requirements related to the product

7.2.2q1

The organization shall review the requirements related to the product. This review shall be conducted prior to the organization's commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that
a) product requirements are defined and documented,
b) contract or order requirements
c) the organization has the ability to meet the defined requirements.

SE APQP offers a series of documents gathered in one specific location called the "PPAP Package". The PPAP package is a series of documents which need a formal approval by the supplier and customer. The form that summarizes this package is called PSW (Part Submission Warrant). The approval of the PSW indicates that the supplier responsible person (usually the Quality Engineer) has reviewed this package and that the customer has not identified any issues that would prevent its approbation.

7.2.2q2

Records of the results of the review and actions arising from the review shall be maintained (see 4.2.4).

SE APQP guarantees the storage of all records and information relating to the product requirement review.

7.2.2q3

Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance.

SE APQP manages approval of the PSW indicates that the supplier responsible person (usually the Quality Engineer) has reviewed this package and that the customer has not identified any issues that would prevent its approbation.

7.2.2q4

Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

SE APQP ensures an effective change control, following the applicable requirements of the APQP methodology for assessing verifying and validating product realization changes before implementing. The change control process includes a powerful tool called team workflow which organizes all the steps and activities like evaluation, verification and validation, frequency, timing, method, communication, training, documentation, update of affected activities and documents, implementation, use of multi-disciplinary approach, checklists, etc.

7.2.3

Customer communication

7.2.3q1

The organization shall determine and implement effective arrangements for communicating with customers in relation to
a) product information,
b) enquiries, contracts or order
c) customer feedback, including customer complaints (see 8.2.1), and
d) advisory notices (see 8.5.1).

SE APQP provides to the customer ways to interact with the process by being notified and asked for approval by a powerful tool called team workflow which organizes all the steps and activities like evaluation, verification and validation, frequency, timing, method, communication, training, documentation, update of affected activities and documents, implementation, use of multi-disciplinary approach, checklists, etc.

7.3

Design and development

7.3.1

Design and development planning

The organization shall establish documented procedures for design and development.

Documented procedures should be published and maintained at the SE Document.
SE PDM manages on a single repository all the information related to product realization, through the documents and processes added, promoting a free environment of duplicate and conflicting.

7.3.1q1

The organization shall plan and control the design and development of product.

SE PDM considers all aspects of the product and product realization processes to ensure its conformity to requirements. This includes product identification, handling, packaging, storage and protection during internal processing and delivery to the customer.

7.3.1q2

During the design and development planning, the organization shall determine a) the design and development stages,
b) the review, verification, validation and design transfer activities (see Note) that are appropriate to each design and development stage, and
c) the responsibilities and authorities for design and development.

SE APQP specifies the design and development stages, activities and tasks, responsibilities, timeline and resources, specific tests, validations and reviews, and outcomes.

7.3.1q3

The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.

SE APQP is a fully integrated web-based solution that provides a collaborative environment including methods to communicate information, responsibilities, results, discussions, reviews and resources.

7.3.1q4

Planning output shall be documented, and updated as appropriate, as the design and development progresses (see 4.2.3).

SE APQP provides ways to identify, document and review planning outputs during the design and development progresses

7.3.2

Design and development inputs

7.3.2q1a

Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include:

1. functional, performance and safety requirements, according to the intended use,
2. applicable statutory and regulatory requirements,
3. where applicable, information derived from previous similar designs, and
4. other requirements essential for design and development, and
5. output(s) of risk management (see 7.1).

SE APQP provides ways to identify, document and review design inputs requirements for function, performance, safety, regulatory, quality, reliability, durability, life, timing,  maintainability, cost, identification, traceability, packaging, special or safety characteristics (from the customer or regulatory body), and other requirements essential to the product. 
All documents are kept and made available for viewing and use, each with their respective permissions and change controls.
SE FMEA calculates risks priority and examines potential failures in products or processes. It helps improve designs for products and processes, resulting in higher reliability, better quality, increased safety, enhanced customer satisfaction and reduced costs.

7.3.2q2

These inputs shall be reviewed for adequacy and approved.

SE APQP manages approval of the PSW indicates that the supplier responsible person (usually the Quality Engineer) has reviewed this package and that the customer has not identified any issues that would prevent its approbation.

7.3.2q3

Requirements shall be complete, unambiguous and not in conflict with each other.

SE APQP manages on a single repository all input requirements for adequacy and completeness and ensures that requirements are complete, clear and consistent with each other promoting a free environment of duplicate and conflicting information.

7.3.3

Design and development outputs

7.3.4q1a

At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1)

1. to evaluate the ability of the results of design and development to meet requirements, and
2. to identify any problems and propose necessary actions.

Reviews to evaluate if the results meet requirements are managed by SE APQP that specifies the design and development stages, activities and tasks, responsibilities, timeline and resources, specific tests, validations, reviews, and outcomes.
SE Action provides record of occurrence using world-class methods as PDCA, 8 Disciplines and MASP, where it is possible to associate criticality, items, attributes, images, other occurrences, suppliers, documents and process, and send them for user, function or responsible department approval.

7.3.4q2

Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed, as well as other specialist personnel (see 5.5.1 and 6.2.1).

SE Action provides record of occurrence using world-class methods as PDCA, 8 Disciplines and MASP, where it is possible to associate criticality, items, attributes, images, other occurrences, suppliers, documents and process, and send them for user, function or responsible department approval.

7.3.4q3

Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).

7.3.5

Design and development verification

7.3.5q1

Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development outputs have met the design and development input requirements.

SE APQP maintains records of the verification results  and any necessary actions including product design verification, design reviews, comparing the new design to a similar proven design, performing alternate calculations, performing tests and simulations, reviewing the design documents before release, etc.

7.3.5q2

Records of the results of the verification and any necessary actions shall be maintained (see 4.2.4).

SE APQP maintains records of the results of verification and any necessary actions including product design verification, design reviews, comparing the new design to a similar proven design, performing alternate calculations, performing tests and simulations, reviewing the design documents before release, etc.

7.3.6

Design and development validation

7.3.6q1

Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use.

SE APQP ensures product and manufacturing process validation including design reviews, comparison between customer requirements and  internal development plans, d & d validation against customer requirements and d & d input requirements, corrective action and lessons learned from documented process failures and product nonconformities

7.3.6q2

Wherever practicable, validation shall be completed prior to the delivery or implementation of the product.

SE APQP provides a form that summarizes product and manufacturing information that is called PSW (Part Submission Warrant). The approval of the PSW indicates that the supplier responsible person (usually the Quality Engineer) has reviewed this package and that the customer has not identified any issues that would prevent its approbation.

7.3.6q3

Records of the results of validation and any necessary actions shall be maintained (see 4.2.4).

SE APQP provides a form that summarizes product and manufacturing information that is called PSW (Part Submission Warrant). The approval of the PSW indicates that the supplier responsible person (usually the Quality Engineer) has reviewed this package and that the customer has not identified any issues that would prevent its approbation.

7.3.7

Control of design and development changes

7.3.7q1

Design and development changes shall be identified and records maintained.

SE APQP provides a powerful change control process which ensures that follows appropriate steps planned (define plan, have inputs and outputs, verify and validate)are controlled, identified and kept to the extent necessary to meet customer requirements and control product, quality and business risks

7.3.7q2

The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation.

SE APQP provides a powerful change control process which ensures that follows appropriate steps planned (define plan, have inputs and outputs, verify and validate)are controlled, identified and kept to the extent necessary to meet customer requirements and control product, quality and business risks

7.3.7q3

The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. 

SE APQP provides tools to perform DFEMA, PFMEA and risk matrix in order to evaluate the impact of the change addressed to actions of nonconformance treatment.

7.3.7q4

Records of the results of the review of changes and any necessary actions shall be maintained (see 4.2.4).

SE APQP provides tools to perform DFEMA, PFMEA and risk matrix in order to evaluate the impact of the change addressed to actions of nonconformance treatment.

7.4

Purchasing

7.4.1

Purchasing process

7.4.1q1

The organization shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements.

Documented procedures to ensure that purchased product conforms to specified purchase requirements should be published and maintained at the SE Document.
The type and extent of control applied to supplier and the purchased product should also be published and maintained at the SE Document.

7.4.1q2

The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.

Documented procedures to ensure that purchased product conforms to specified purchase requirements should be published and maintained at the SE Document.
The type and extent of control applied to supplier and the purchased product should also be published and maintained at the SE Document.

7.4.1q3

The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization's requirements.

SE Inspection evaluates suppliers based on their receiving history and quality index. The evaluation uses variables such as number of approved and rejected receiving’s number of non-conformities, checklist evaluations, % of conformity, packaging quality, delivery dates and amount received.

7.4.1q4

Criteria for selection, evaluation and re-evaluation shall be established.

SE Inspection evaluates suppliers based on their receiving history and quality index. The evaluation uses variables such as number of approved and rejected receiving’s number of non-conformities, checklist evaluations, % of conformity, packaging quality, delivery dates and amount received.

7.4.1q5

Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).

SE Inspection evaluates suppliers based on their receiving history and quality index. The evaluation uses variables such as number of approved and rejected receiving’s number of non-conformities, checklist evaluations, % of conformity, packaging quality, delivery dates and amount received.

7.4.2

Purchasing information

7.4.2q1

Purchasing information shall describe the product to be purchased, including where appropriate 
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.

Requirements for qualification of personnel, for quality management system and for approval of product, procedures, processes and equipments shall be published and maintained at the SE Document.

7.4.2q2

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

SE Inspection manages product requirements individually for each supplier, ensuring that all product receiving are adequate and meet specifications.

To the extent required for traceability given in 7.5.3.2, the organization shall maintain relevant purchasing information, i.e. documents (see 4.2.3) and records (see 4.2.4).

Relevant purchasing information documents could be demonstrated by SE Document. Records of purchases and their traceability should be demonstrated by the organization´s ERP.

7.4.3

Verification of purchased product

7.4.3q1

The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

SE Inspection provides the capability to plan the inspection of incoming materials and outgoing products.
The receiving inspection system - through skip lot inspection capabilities and based on part inspection results - allows to prevent out-of-spec supplied materials from entering into the production environment.

7.4.3q2

Where the organization or its customer intends to perform verification at the supplier's premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.

Product verification at supplier’s site should contain verification arrangements and method of product release published and maintained at the SE Document. The records of onsite verification also should be published and maintained.

7.5

Production and service provision

7.5.1

Control of production and service provision

7.5.1q1

The organization shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable:

1. the availability of information that describes the characteristics of the product,
2. the availability of documented procedures, documented requirements, work instructions, and reference materials and reference measurement procedures as necessary,
3. the use of suitable equipment,
4. the availability and use of monitoring and measuring devices,
5. the implementation of monitoring and measurement, and
6. the implementation of release, delivery and post-delivery activities, and
7. the implementation of defined operations for labeling and packaging.

SE APQP / SE PDM / SE PLM provides for each product or part family, work instructions and control plans which cover all production process steps from - receipt of materials, production, packaging, storage, delivery and even post-delivery activities such as installation or training. SE APQP also controls the current engineering level/date, customer or  special characteristics, inspection and test instructions with acceptance criteria, material identification and disposition instructions, operation name and number keyed to the process flow diagram, part name, number and family, reaction plans, relevant engineering and manufacturing standards, required tools, gages and other equipment, revision dates and approvals, SPC and other process monitoring requirements, tool-change intervals and set-up instructions, and others.

The organization shall establish and maintain a record (see 4.2.4) for each batch of medical devices that provides traceability to the extent specified in 7.5.3 and identifies the amount manufactured and amount approved for distribution.

Records for each batch of medical devices that provides traceability to the extent and identifies the amount manufactured and amount approved for distribution should be published and maintained at the SE Document.

7.5.1.2

Control of production and service provision — Specific requirements

7.5.1.2.1

Cleanliness of product and contamination control

The organization shall establish documented requirements for cleanliness of product if
a)  product is cleaned by the organization prior to sterilization and/or its use, or
b)  product is supplied non-sterile to be subjected to a cleaning process prior to sterilization and/or its use, or
c)   product is supplied to be used non-sterile and its cleanliness is of significance in use, or
d)  process agents are to be removed from product during manufacture.

Documented requirements for cleanliness of products should be published and maintained at the SE Document.
Processes regarding agents that should be removed from products during manufacture should be managed by SE Process.

If product is cleaned in accordance with a) or b) above, the requirements contained in 6.4 a) and 6.4 b) do not apply prior to the cleaning process.

Documented requirements for cleanliness of products should be published and maintained at the SE Document.
Processes regarding agents that should be removed from products during manufacture should be managed by SE Process.

7.5.1.2.2

Installation activities

If appropriate, the organization shall establish documented requirements which contain acceptance criteria for installing and verifying the installation of the medical device.

Documented requirements which contain acceptance criteria for installing and verifying the installation of the medical device should be published and maintained at the SE Document.
The installation activities could be managed by the integration of SE Request, SE Process and SE Document.

If the agreed customer requirements allow installation to be performed other than by the organization or its authorized agent, the organization shall provide documented requirements for installation and verification.

Documented requirements for installation and verification if installation is performed by outside organization should be published and maintained at the SE Document.

Records of installation and verification performed by the organization or its authorized agent shall be maintained (see 4.2.4).

Records of installation and verification performed by the organization or its authorized agents should be published and maintained at the SE Document.

7.5.1.2.3

Servicing activities

If servicing is a specified requirement, the organization shall establish documented procedures, work instructions and reference materials and reference measurement procedures, as necessary, for performing servicing activities and verifying that they meet the specified requirements.

Documented procedures, work instructions, reference materials and reference measurements procedures should be published and maintained at SE Document.

Records of servicing activities carried out by the organization shall be maintained (see 4.2.4).

Records of servicing activities carried out by the organization could be maintained at the SE Document or SE Maintenance.

7.5.1.3

Particular requirements for sterile medical devices

The organization shall maintain records of the process parameters for the sterilization process which was used for each sterilization batch (see 4.2.4).

The sterilization traceability and records of the process parameter for sterilization process should be published and maintained at the SE Process.

Sterilization records shall be traceable to each production batch of medical devices (see 7.5.1.1).

The sterilization traceability and records of the process parameter for sterilization process should be published and maintained at the SE Process.

7.5.2

Validation of processes for production and service provision

7.5.2.1

General requirements

7.5.2q1

The organization shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered.

Production or service processes where the resulting output cannot be verified later should be managed at the SE Process.

7.5.2q2

Validation shall demonstrate the ability of these processes to achieve planned results.

The validation of the ability of processes to achieve planned results should be demonstrated at the SE Process.

7.5.2q3a

The organization shall establish arrangements for these processes including, as applicable

1. defined criteria for review and approval of the processes,
2. approval of equipment and qualification of personnel,
3. use of specific methods and procedures
4. requirements for records (see 4.2.4), and
5. revalidation.

SE Process allows organizations to documented processes in some common, easy-to-use and understandable format and language. Allows business people to easily describe and document their processes.

The organization shall establish documented procedures for the validation of the application of computer software (and changes to such software and/or its application) for production and service provision that affect the ability of the product to conform to specified requirements. Such software applications shall be validated prior to initial use.

Documented procedures for validation of computer software should be published and maintained at SE Document.

7.5.2.2

Particular requirements for sterile medical devices

The organization shall establish documented procedures for the validation of sterilization processes. Sterilization processes shall be validated prior to initial use. Records of validation of each sterilization process shall be maintained (see 4.2.4).

Documented procedures for validation of sterilization processes should be published and maintained at the SE Document.

7.5.3

Identification and traceability

7.5.3.1

Identification

7.5.3q1

When appropriate, the organization shall identify the product by suitable means throughout product realization, and shall establish documented procedures for such product identification.

Documented procedures for product identification should be published and maintained at the SE Document.

The organization shall establish documented procedures to ensure that medical devices returned to the organization are identified and distinguished from conforming product [see 6.4 d)].

Documented procedures to ensure that medical devices returned to the organization are identified and distinguished from conforming product should be published and maintained at the SE Document.

7.5.3.2

Traceability

7.5.3.2.1

General

The organization shall establish documented procedures for traceability.

Documented procedures for traceability should be published and maintained at the SE Document.

Such procedures shall define the extent of product traceability and the records required (see 4.2.4, 8.3 and 8.5).

7.5.3q3

Where traceability is a requirement, the organization shall control and record the unique identification of the product (see 4.2.4).

SE PLM provides a centralized product development database that helps companies eliminate records duplication for products requiring traceability by maintaining other product information such as costs, characteristics, specifications and development status in a single place.

7.5.3.2.2

Particular requirements for active implantable medical devices and implantable medical devices

In defining the records required for traceability, the organization shall include records of all components, materials and work environment conditions, if these could cause the medical device not to satisfy its specified requirements.
The organization shall require that its agents or distributors maintain records of the distribution of medical devices to allow traceability and those records are available for inspection.
Records of the name and address of the shipping package consignee shall be maintained (see 4.2.4).

Records of all components, materials and work environment conditions and related information should be published and maintained at the SE Document.

7.5.3.3

Status identification

7.5.3q2

The organization shall identify the product status with respect to monitoring and measurement requirements.
The identification of product status shall be maintained throughout production, storage, installation and servicing of the product to ensure that only product that has passed the required inspections and tests (or released under an authorized concession) is dispatched, used or installed.

SE PLM provides a centralized product development database that helps companies eliminate effort duplication by maintaining other product information such as costs, characteristics, specifications and development status in a single place.

7.5.4

Customer property

7.5.3q2

The organization shall identify the product status with respect to monitoring and measurement requirements.
The identification of product status shall be maintained throughout production, storage, installation and servicing of the product to ensure that only product that has passed the required inspections and tests (or released under an authorized concession) is dispatched, used or installed.

SE PLM provides a centralized product development database that helps companies eliminate effort duplication by maintaining other product information such as costs, characteristics, specifications and development status in a single place.

7.5.4

Customer property

7.5.4q1

The organization shall exercise care with customer property while it is under the organization's control or being used by the organization.

SE PLM ensures customer-owned property controls which may be managed in product realization processes through product quality plans, work instructions and other specific documentation.

7.5.4q2

The organization shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product.

SE PLM ensures customer-owned property controls which may be managed in product realization processes through product quality plans, work instructions and other specific documentation. Access controls on customer information, where only those with permission can access certain information.

7.5.4q3

If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained (see 4.2.4).

Templates of reports to the customer could be published and maintained at the SE Document.

7.5.5

Preservation of product

7.5.5q1

The organization shall establish documented procedures or documented work instructions for preserving the conformity of product during internal processing and delivery to the intended destination.

Documented procedures or working instructions for preserving should be published and maintained at the SE Document.

7.5.5q2

This preservation shall include identification, handling, packaging, storage and protection.

Working instructions should be published and maintained at the SE Document.

7.5.5q3

Preservation shall also apply to the constituent parts of a product.
The organization shall establish documented procedures or documented work instructions for the control of product with a limited shelf-life or requiring special storage conditions.
Such special storage conditions shall be controlled and recorded (see 4.2.4).

Working instructions should be published and maintained at the SE Document.

7.6

Control of monitoring and measuring devices

7.6q1

The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements (see 7.2.1).

SE EAM provides an easy way to perform asset verification from time to time. Through this verification the organization is able to know what assets are available for usage, are in good operational condition, are in need of repair and/or maintenance, as well as the ones that complete their life-cycle and needs retirement. SE EAM supports management of calibration activities by incorporating features to integrate documentation, validation, applicable standards and tolerances, and traceability data for all calibrated assets.

7.6q2

The organization shall establish documented procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.

Documented procedures to ensure that monitoring and measurement can be carried out should be published and maintained at the SE Document.

7.6q3a

Where necessary ensure valid results, measuring equipment shall

1. be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;
2. be adjusted or re-adjusted as necessary;
3. be identified to enable the calibration status to be determined;
4. be safeguarded from adjustments that would invalidate the measurement result;
5. be protected from damage and deterioration during handling, maintenance and storage.

SE Calibration is one of the most comprehensive web-based software available for scheduling, documenting, planning, analyzing, and managing calibrations on the organization gages, test equipment, devices, and measurement standards.
SE Calibration provides many ways to define the frequency and method of calibration for each type and level (shop floor; laboratory or standard). Also it's possible identify what standard the organization used for calibration and show traceability of the standards the organization use at the  facility to national or international standards.
SE Calibration defines the measurement and monitoring required and the type of Monitoring and Measuring Devices needed for it, including the frequency of measurement, acceptance criteria, Type A and Type B measurement uncertainties, and others parameters.

7.6q4

In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements.

SE Calibration supports appropriate correction action to contain and re-verify the product affected, to the extent practical. This is in addition to containing, repair and recalibration of the defective Monitoring and Measuring Devices.

7.6q5

The organization shall take appropriate action on the equipment and any product affected.

7.6q6

Records of the results of calibration and verification shall be maintained (see 4.2.4).

Records of the results of calibration and verification are stored at the SE Calibration.

7.6q7

When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.

SE SPC, SE Calibration and SE MSA provide tools to simulate measurements and confirms/reconfirms the ability of computer software to satisfy the intended application.

Clause

ISO 13485

SoftExpert Compliance Evidence

8

Measurement, analysis and improvement

8.1

General

8.1q1

The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed

1. to demonstrate conformity of the product,
2. to ensure conformity of the quality management system, and
3. to improve  the effectiveness of the quality management system.

SE Performance provides tools to the organization to plan and implement the monitoring, measurement, analysis, improvement processes needed and the extent of their use.

8.1q2

This shall include determination of applicable methods, including statistical techniques, and the extent of their use.

SE Performance provides tools to the organization to plan and implement the monitoring, measurement, analysis, improvement processes needed and the extent of their use.

8.2

Monitoring and measurement

8.2.1

Customer satisfaction

8.2.1q1

As one of the measurements of the quality management system performance, the organization shall monitor information relating to customer satisfaction. The methods for obtaining and using this information shall be determined.

SE Action records of occurrence using world-class methods as PDCA, 8 Disciplines and MASP, where it is possible to associate criticality, items, attributes, images, other occurrences, documents and process, and send them for user, function or responsible department approval.
SE Performance manages the organization business performance practically and effectively, provides a simple way to gain control over performance indicators from individual business units to the overall corporate management strategy.

The organization shall establish a documented procedure for a feedback system [see 7.2.3 c)] to provide early warning of quality problems and for input into the corrective and preventive action processes (see 8.5.2 and 8.5.3).
If national or regional regulations require the organization to gain experience from the post-production phase, the review of this experience shall form part of the feedback system (see 8.5.1).

Documented procedure for a feedback system to provide early warning of quality problems and for input into the corrective and preventive action processes should be published and maintained at the SE Document.

8.2.2

Internal audit

8.2.2q1

The organization shall conduct internal audits at planned intervals to determine whether the quality management system
a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and
b) is effectively implemented and maintained.

SE Audit simplifies the planning and running of any type of audit. The workflow-enabled functionality drives the audit process and automates corrective actions derived from audit findings. This minimizes the audit administration costs and offers extensive management reports to build a platform for business improvement.
SE Audit is a flexible, complete and robust solution that integrates the different steps (planning, preparation, execution, conclusion and monitoring) required to ensure a successful quality audit.

8.2.2q2

An audit programmed shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits.

SE Audit simplifies the planning and running of any type of audit. The workflow-enabled functionality drives the audit process and automates corrective actions derived from audit findings. This minimizes the audit administration costs and offers extensive management reports to build a platform for business improvement.
SE Audit is a flexible, complete and robust solution that integrates the different steps (planning, preparation, execution, conclusion and monitoring) required to ensure a successful quality audit.

8.2.2q3

The audit criteria, scope, frequency and methods shall be defined.

The audit criteria, scope, frequency and methods shall be documented and published and maintained at the SE Audit and SE Document.

8.2.2q4

Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process.  Auditors shall not audit their own work.

The criteria of selection of auditors and the conduct of audits and objectives should be published and maintained at the SE Document.

8.2.2q5

The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in a documented procedure.

The internal audit procedure should be published and maintained at SE Document, the records of internal QMS audits should be demonstrated at the SE Audit and SE Action.

8.2.2q6

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes.

SE Action offers total flexibility for the organization and reviewing the effectiveness of the actions taken, including verification, standardization and communication, in order to verify if the same are appropriate for treating the real and potential nonconformities encountered and their impacts, avoiding repetition and/or occurrence.

8.2.2q7

Follow-up activities shall include the verification of the actions taken and the reporting of verification results (see 8.5.2).

SE Action automates the execution of implemented CAPA’s to avoid the repetition of the nonconformities and their verification.

8.2.3

Monitoring and measurement of processes

8.2.3q1

The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes.

The methods used to monitor and measure the QMS processes should be published and maintained at the SE Document.

8.2.3q2

These methods shall demonstrate the ability of the processes to achieve planned results.

Comparing objectives to actual results is easy with SE Performance. It generates a variety of performance analysis views and reports, as well as managerial charts. With just one central database, all data and documents are available to team managers for evaluation. And, it goes further, by helping to identify the problems that may be keeping the company from hitting performance targets.

8.2.3q3

When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product.

SE Action is a software solution that manages all stages of nonconformity treatment and CAPAs, from the initial record to review of the effectiveness of the action, since it includes tools for organizing, sorting and searching

8.2.4

Monitoring and measurement of product

8.2.4.1

General requirements

8.2.4q1

The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met.

SE APQP provides sample worksheets where not only specifies the acceptance criteria as well as evaluates the samples and the results of capability.
SE Inspection provides the inspection of finished products.
SE SPC uses control charts as a primary tool for statistical process control. Control charts are used to determine whether a manufacturing or business process is in a state of statistical control or not. They are also used with product measurements to analyze process capability and for continuous process improvement efforts.

8.2.4q2

This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements (see 7.1) and documented procedures (see 7.5.1.1).

Documented procedures for monitoring and measurement of product should be published and maintained at the SE Document.

SE APQP helps ensure simple and effective control in the development of new products. It also helps to comply with the requirements established both by quality standards and by individual customers. Reports are generated and stored throughout the entire process.
SE SPC uses control charts as a primary tool for statistical process control. Control charts are used to determine whether a manufacturing or business process is in a state of statistical control or not. They are also used with product measurements to analyze process capability and for continuous process improvement efforts.

8.2.4q3

Evidence of conformity with the acceptance criteria shall be maintained.

SE APQP demonstrates the evidence of conformity with the acceptance criteria by providing sample worksheets where not only specifies the acceptance criteria as well as evaluates the samples and the results of capability.

8.2.4q4

Records shall indicate the person(s) authorizing release of product (see 4.2.4).

SE PDM provides functions that enable users to become active participants in product development, design reviews, engineering change orders, approvals and other product-related processes. Automatic notifications prompt users on actions required at specific stages.

8.2.4q5

Product release and service delivery shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed.

SE APQP provides sample worksheets where not only specifies the acceptance criteria as well as evaluates the samples and the results of capability.

8.2.4.2

Particular requirement for active implantable medical devices and implantable medical devices

The organization shall record (see 4.2.4) the identity of personnel performing any inspection or testing.

Records of the identity of personnel performing any inspection or testing are made available at the SE APQP that keep tracks of the responsible of each stage of the process. Studies and tests performed during the project activities / APQP are properly identified and signed by officials, which are allocated according to their skills controlled by SE HDM.

8.3

Control of nonconforming product

8.3q1

The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.

SE Process provides ways to controls and prevents unintended use or delivery of not conform products

8.3q2

The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.

Documented procedures defining the controls for dealing with nonconforming products should be published and maintained at the SE Document.

8.3q3

The organization shall deal with nonconforming product by one or more of the following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorizing its use, release or acceptance under concession
c) by taking action to preclude its original intended use or application.

SE Process provides ways to the organization deal with nonconforming products by establishing a process to taking action to eliminate the detected nonconformity, by authorizing its use, release or acceptance under concession or by taking action to preclude its original intended use or application.

8.3q4

Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).

Records of nonconformities material and any actions taken should be published and maintained at the SE Action.

8.3q5

When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements.

At SE Action actions taken should be re-verified to ensure it conforms to requirements.

8.3q6

When nonconforming product is detected after delivery or use has started, the organization shall take action appropriate to the effects, or potential effects, of the nonconformity.
If product needs to be reworked (one or more times), the organization shall document the rework process in a work instruction that has undergone the same authorization and approval procedure as the original work instruction.
Prior to authorization and approval of the work instruction, a determination of any adverse effect of the rework upon product shall be made and documented (see 4.2.3 and 7.5.1).

Nonconforming product detected after delivery or his use shall be documented and maintained at the SE Action.
Rework work instructions approved by same authority as the original work instruction should be published and maintained at theSE Document.
Records of determination of adverse effects of rework should be published and maintained at the SE Document.

8.4

Analysis of data

8.4q1

The organization shall establish documented procedures to determine collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made.  This shall include data generated as a result of monitoring and measurement and from other relevant sources.

The data that should be collected and analyzed to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of its effectiveness should be documented, published and maintained at the SE Document.
SE Performance manages the organization´s business performance practically and effectively, provides a simple way to gain control over performance indicators from individual business units to the overall corporate management strategy.

8.4q2a

The analysis of data shall provide information relating to
a) customer satisfaction
b) conformity to product requirements (see 7.2.1),
c) characteristics and trends of processes and products including opportunities for preventive action, and
d) suppliers.

SE Action provides record of occurrence using world-class methods as PDCA, 8 Disciplines and MASP, where it is possible to associate criticality, items, attributes, images, other occurrences, suppliers, documents and process, and send them for user, function or responsible department approval.
SE Request ensures that new demands on services or products are managed properly according to customer’s new specifications or requirements.

8.5

Improvement

8.5.1

Continual improvement

8.5.1q1

The organization shall identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

SE Performance manages the organization´s business performance practically and effectively, provides a simple way to gain control over performance indicators from individual business units to the overall corporate management strategy.
The Organization implement actions and maintain the effectiveness of processes needed for QMS by following the policies and processes established at SE Document and SE Process. The preventive actions and corrective actions are managed at the SE Action.
Results of audits could be easily accessed at the SE Audit, that simplifies the planning and running of any type of audit.
Customer feedback, the status of preventive and corrective actions, follow-up actions from previous management reviews, changes that could affect the quality management system,

The organization shall establish documented procedures for the issue and implementation of advisory notices.
These procedures shall be capable of being implemented at any time.

Documented procedures should be published at the SE Document.

Records of all customer complaint investigations shall be maintained (4.2.4).
If investigation determines that the activities outside the organization contributed to the customer complaint, relevant information shall be exchanged between the organizations involved (see 4.1).
If any customer complaint is not followed by corrective and/or preventive action, the reason shall be authorized (see 5.5.1) and recorded (see 4.2.4).

Records of all customer complaint investigation shall be maintained at the SE Action.

If national or regional regulations require notification of adverse events that meet specified reporting criteria, the organization shall establish documented procedures to such notification to regulatory authorities.

Documented procedures related to notification to regulatory authorities should be published and maintained at the SE Document.

8.5.2

Corrective action

8.5.2q1

The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence.

At SE Action the cause analysis, the identification and addressing of issues are performed using tools such as Ishikawa Diagrams, 6M, 5 W’s and 5 Steps Method.

8.5.2q2

Corrective actions shall be appropriate to the effects of the nonconformities encountered.

SE Action provides CAPA’s management and corrective actions should be appropriate to the effects of the nonconformities encountered.

8.5.2q3

A documented procedure shall be established to define requirements for

1. reviewing nonconformities (including customer complaints),
2. determining the causes of nonconformities,
3. evaluating the need for action to ensure that nonconformities do not recur,
4. determining and implementing action needed, including, if appropriate, updating documentation (see 4.2),
5. records of the results of any investigation and of action taken (see 4.2.4), and
6. reviewing the corrective action taken and its effectiveness.

Documented procedures defining requirements for reviewing nonconformities, determining the causes of nonconformities, evaluating the need for action to ensure that nonconformities do not recur, determining and implementing action needed, records of the results of any investigation and of action taken and reviewing the corrective action taken and its effectiveness should be published and maintained at the SE Document.

8.5.2q4

1. records  of the results of any investigation and of action taken (see 4.2.4)

Records of investigation and corrective actions taken should be published and maintained at the SE Action.

8.5.3

Preventive action

8.5.3q1

The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence.

AT SE Action the cause analysis, the identification and addressing of potential nonconformities are performed using tools such as Ishikawa Diagrams, 6M, 5 W’s and 5 Steps Method. The preventive actions taken should prevent their occurrence

8.5.3q2

Preventive actions shall be appropriate to the effects of the potential problems.

AT SE Action the cause analysis, the identification and addressing of potential nonconformities are performed using tools such as Ishikawa Diagrams, 6M, 5 W’s and 5 Steps Method. The preventive actions taken should prevent their occurrence

8.5.3q3

A documented procedure shall be established to define requirements for

1. determining potential nonconformities and their causes,
2. evaluating the need for action to prevent occurrence of nonconformities,
3. determining and implementing action needed,
4. records of the results of any investigation and of action taken (see 4.2.4), and
5. reviewing preventive action taken and its effectiveness.

Documented procedures defining requirements for determining potential nonconformities and their causes, evaluating the need for action to prevent occurrence of nonconformities, determining and implementing action needed, recording if the results of any investigation and of action taken and reviewing preventive action taken and its effectiveness should be published and maintained at the SE Document.

8.5.3q4

1. records of the results of any investigation and of action taken (see 4.2.4), and

Records of preventive actions taken should be published and maintained at the SE Action.