8 Measurement, analysis and improvement Flashcards
8 Measurement, analysis and improvement
8.1 General
The organization shall:
8.1 General
The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed to:
a) demonstrate conformity of product;
b) ensure conformity of the quality management system;
c) maintain the effectiveness of the quality management system.
This shall include determination of appropriate methods, including statistical techniques, and the extent of their use.
- 2 Monitoring and measurement
- 2.1 Feedback
As one of the measurements of the effectiveness of the quality management system, the organization
shall:
8.2.1 Feedback
As one of the measurements of the effectiveness of the quality management system, the organization shall gather and monitor information relating to whether the organization has met customer requirements.
The methods for obtaining and using this information shall be documented.
The organization shall document procedures for the feedback process. This feedback process shall include provisions to gather data from production as well as post-production activities.
The information gathered in the feedback process shall serve as potential input into risk management for monitoring and maintaining the product requirements as well as the product realization or improvement processes.
If applicable regulatory requirements require the organization to gain specific experience from post-production activities, the review of this experience shall form part of the feedback process.
8.2.2 Complaint handling
The organization shall:
8.2.2 Complaint handling
The organization shall document procedures for timely complaint handling in accordance with applicable regulatory requirements.
These procedures shall include at a minimum requirements and responsibilities for:
a) receiving and recording information;
b) evaluating information to determine if the feedback constitutes a complaint;
c) investigating complaints;
d) determining the need to report the information to the appropriate regulatory authorities;
e) handling of complaint-related product;
f) determining the need to initiate corrections or corrective actions.
If any complaint is not investigated, justification shall be documented. Any correction or corrective action resulting from the complaint handling process shall be documented.
If an investigation determines activities outside the organization contributed to the complaint, relevant information shall be exchanged between the organization and the external party involved.
Complaint handling records shall be maintained (see 4.2.5).
8.2.3 Reporting to regulatory authorities
If applicable regulatory requirements require notification of complaints that meet specified reporting
criteria of adverse events or issuance of advisory notices, the organization shall:
8.2.3 Reporting to regulatory authorities
If applicable regulatory requirements require notification of complaints that meet specified reporting
criteria of adverse events or issuance of advisory notices, the organization shall document procedures
for providing notification to the appropriate regulatory authorities.
Records of reporting to regulatory authorities shall be maintained (see 4.2.5).
8.2.4 Internal audit
The organization shall:
8.2.4 Internal audit
The organization shall conduct internal audits at planned intervals to determine whether the quality management system:
a) conforms to planned and documented arrangements, requirements of this International Standard, quality management system requirements established by the organization, and applicable regulatory requirements;
b) is effectively implemented and maintained.
The organization shall document a procedure to describe the responsibilities and requirements for planning and conducting audits and recording and reporting audit results.
An audit program shall be planned, taking into consideration the status and importance of the processes and area to be audited, as well as the results of previous audits. The audit criteria, scope, interval and methods shall be defined and recorded (see 4.2.5).
The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
Records of the audits and their results, including identification of the processes and areas audited and the conclusions, shall be maintained (see 4.2.5).
The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results.
NOTE Further information can be found in ISO 19011.
8.2.5 Monitoring and measurement of processes
The organization shall:
8.2.5 Monitoring and measurement of processes
The organization shall apply suitable methods for monitoring and, as appropriate, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate.
8.2.6 Monitoring and measurement of product
The organization shall:
8.2.6 Monitoring and measurement of product
The organization shall monitor and measure the characteristics of the product to verify that product requirements have been met.
This shall be carried out at applicable stages of the product realization process in accordance with the planned and documented arrangements and documented procedures.
Evidence of conformity to the acceptance criteria shall be maintained. The identity of the person authorizing release of product shall be recorded (see 4.2.5). As appropriate, records shall identify the test equipment used to perform measurement activities.
Product release and service delivery shall not proceed until the planned and documented arrangements have been satisfactorily completed.
For implantable medical devices, the organization shall record the identity of personnel performing any inspection or testing.
- 3 Control of nonconforming product
- 3.1 General
The organization shall:
8.3.1 General
The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery.
The organization shall document a procedure to define the controls and related responsibilities and authorities for the identification, documentation, segregation, evaluation and disposition of nonconforming product.
The evaluation of nonconformity shall include a determination of the need for an investigation and notification of any external party responsible for the nonconformity.
Records of the nature of the nonconformities and any subsequent action taken, including the evaluation, any investigation and the rationale for decisions shall be maintained (see 4.2.5)
8.3.2 Actions in response to nonconforming product detected before delivery
The organization shall:
8.3.2 Actions in response to nonconforming product detected before delivery
The organization shall deal with nonconforming product by one or more of the following ways:
a) taking action to eliminate the detected nonconformity;
b) taking action to preclude its original intended use or application;
c) authorizing its use, release or acceptance under concession.
The organization shall ensure that nonconforming product is accepted by concession only if the justification is provided, approval is obtained and applicable regulatory requirements are met. Records of the acceptance by concession and the identity of the person authorizing the concession shall be maintained (see 4.2.5).
8.3.3 Actions in response to nonconforming product detected after delivery
When nonconforming product is detected after delivery or use has started, the organization shall:
8.3.3 Actions in response to nonconforming product detected after delivery
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. Records of actions taken shall be maintained (see 4.2.5).
The organization shall document procedures for issuing advisory notices in accordance with applicable regulatory requirements.
These procedures shall be capable of being put into effect at any time. Records of actions relating to the issuance of advisory notices shall be maintained (see 4.2.5).
8.3.4 Rework
The organization shall:
8.3.4 Rework
The organization shall perform rework in accordance with documented procedures that takes into account the potential adverse effect of the rework on the product.
These procedures shall undergo the same review and approval as the original procedure.
After the completion of rework, product shall be verified to ensure that it meets applicable acceptance criteria and regulatory requirements.
Records of rework shall be maintained (see 4.2.5).
8.4 Analysis of data
The organization shall:
8.4 Analysis of data
The organization shall document procedures to determine, collect and analyse appropriate data to demonstrate the suitability, adequacy and effectiveness of the quality management system.
The procedures shall include determination of appropriate methods, including statistical techniques and the extent of their use.
The analysis of data shall include data generated as a result of monitoring and measurement and from other relevant sources and include, at a minimum, input from:
a) feedback;
b) conformity to product requirements;
c) characteristics and trends of processes and product, including opportunities for improvement;
d) suppliers;
e) audits;
f) service reports, as appropriate.
If the analysis of data shows that the quality management system is not suitable, adequate or effective, the organization shall use this analysis as input for improvement as required in 8.5.
Records of the results of analyses shall be maintained (see 4.2.5).
- 5 Improvement
- 5.1 General
The organization shall:
8.5.1 General
The organization shall identify and implement any changes necessary to ensure and maintain the continued suitability, adequacy and effectiveness of the quality management system as well as medical device safety and performance through the use of the quality policy, quality objectives, audit results, postmarket surveillance, analysis of data, corrective actions, preventive actions and management review.
8.5.2 Corrective action
The organization shall:
8.5.2 Corrective action
The organization shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Any necessary corrective actions shall be taken without undue delay. Corrective actions shall be proportionate to the effects of the nonconformities encountered.
The organization shall document a procedure to define requirements for:
a) reviewing nonconformities (including complaints);
b) determining the causes of nonconformities;
c) evaluating the need for action to ensure that nonconformities do not recur;
d) planning and documenting action needed and implementing such action, including, as appropriate, updating documentation;
e) verifying that the corrective action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device;
f) reviewing the effectiveness of corrective action taken.
Records of the results of any investigation and of action taken shall be maintained (see 4.2.5).
8.5.3 Preventive action
The organization shall:
8.5.3 Preventive action
The organization shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be proportionate to the effects of the potential problems.
The organization shall document a procedure to describe requirements for:
a) determining potential nonconformities and their causes;
b) evaluating the need for action to prevent occurrence of nonconformities;
c) planning and documenting action needed and implementing such action, including, as appropriate, updating documentation;
d) verifying that the action does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device;
e) reviewing the effectiveness of the preventive action taken, as appropriate.
Records of the results of any investigations and of action taken shall be maintained (see 4.2.5).
