Access the full ISO checklist template library on Safesite. With Safesite, you can conduct quality inspections from your mobile device or desktop for free. We're a group of safety and tech professionals united in our desire to make every workplace safer. We keep a pulse on the latest regulations, standards, and industry trends in safety and write about them here on our blog. Wherever practicable, validation shall be completed prior to the delivery or implementation of the product.
Records of the results of validation and any necessary actions shall be maintained. The changes shall be reviewed, verified, and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered.
Records of the results of the review of changes and any necessary actions shall be maintained. 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.
Criteria for selection, evaluation, and re- evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained. The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. Controlled conditions shall include, as applicable a the availability of information that describes the characteristics of the product, b the availability of work instructions, as necessary, c the use of suitable equipment, d the availability and use of monitoring and measuring devices, e the implementation of monitoring and measurement, and f the implementation of release, delivery, and post-delivery activities.
This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered. Validation shall demonstrate the ability of these processes to achieve planned results. The organization shall establish arrangements for these processes including, as applicable a defined criteria for review and approval of the processes, b approval of equipment and qualification of personnel, c use of specific methods and procedures, d requirements for records, see 4.
The organization shall identify the product status with respect to monitoring and measurement requirements. Where traceability is a requirement, the organization shall control and record the unique identification of the product see 4. Note: In some industry sectors, configuration management is a means by which identification and traceability are maintained. The organization shall identify, verify, protect, and safeguard customer property provided for use or incorporation into the product.
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. This preservation shall include identification, handling, packaging, storage, and protection. Preservation shall also apply to the constituent parts of a product. 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.
The organization shall establish processes 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. Where necessary to ensure valid results, measuring equipment shall: a 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; b - be adjusted or re-adjusted as necessary; c be identified to enable the calibration status to be determined; d be safeguarded from adjustments that would invalidate the measurement result; e be protected from damage and deterioration during handling, maintenance, and storage.
The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained see 4. 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. The organization shall plan and implement the monitoring, measurement, analysis, and improvement processes needed a to demonstrate conformity of the product, b to ensure conformity of the QMS, and c to continually improve the effectiveness of the QMS.
This shall include determination of applicable methods, including statistical techniques, and the extent of their use. The methods for obtaining and using this information shall be determined.
An audit program 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. The audit criteria, scope, frequency, and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process.
Auditors shall not audit their own work. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records see 4.
The management responsible for the area being audited shall ensure that 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 see 8. 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, to ensure conformity of the product.
This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements see 7. Evidence of conformity with the acceptance criteria shall be maintained.
Records shall indicate the person s authorizing release of product see 4. Product release and service delivery shall not proceed until all the planned arrangements see 7. 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 controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure. 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 by a relevant authority, and, where applicable, by the customer; c by taking action to preclude its original intended use or application.
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained see 4. When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use has started, the organization F The organization shall determine, collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the effectiveness of the QMS can be made.
This shall include data generated as a result of monitoring and measurement and from other relevant sources. The analysis of data shall provide information relating to a customer satisfaction see 8. Corrective actions shall be appropriate to the effects of the nonconformities encountered. Ask the persons being interviewed what documents are used in their work.
You may find documents and forms beyond those identified in your audit planning. See if the documents are adequately controlled and available for use. Refer to the documents to help you follow the work being shown. Verify the records described in the documents are being properly collected and controlled.
When you interview people and observe operations, you are determining how the process is currently being performed.
However, you also want to verify the process has been compliant since the last audit. The best way to evaluate prior practices is to examine the records from past operations. The facts uncovered using these methods should be carefully recorded in your audit notes.
Analyze this evidence to report the degree of conformity or nonconformity. Auditors cannot interview every person, observe every activity, look at every document, and evaluate every record. You should strive for representative samples that allow you to make informed judgments. Since audits are limited due to sampling, nonconformities may continue to exist in the system beyond those identified and reported.
You may have heard that ISO only specifically requires six procedures. Those required procedures by clause are:. ISO clause 4. Therefore, organizations should only develop the level of documentation they need based on the process complexity, personnel competence, and organization size. This means some processes may be defined and not documented. Auditors accustomed to relying upon a written procedure to use as the audit criteria may feel lost without them. However, ISO has never required every task to be documented.
There have always been cases where an organization could depend on the training, skills, and experience of the persons carrying out a defined process instead of having it written in a document.
With the requirement for fewer documented procedures, auditors will have to improve upon their interviewing techniques to understand and take notes on the defined process.
Ask the manager of the area if any documents exist to guide the people in their assigned activities. If not, ask the manager to explain the process. Auditors should always substantiate the evidence before making conformity judgements. This is especially important with an undocumented process. Review how the process is planned, people are trained, practices are deployed, conditions are controlled, results are achieved, records are maintained, and the process is improved.
Organizations with an existing internal audit program should review their results to ensure audit objectives are being met and to identify opportunities for improvement. Use the update of your internal audit process as an opportunity to take corrective and preventive actions. Look at past audit reports and see if you are satisfied with current practices and auditor consistency. Have training sessions with your auditors to go over previously written nonconformity statements and identify what clause references would have been used for ISO Of course, internal auditors must prepare audit forms and reports as prescribed by their own audit procedure.
Remind them to audit for conformity not nonconformity and to share some positive comments in their reports to encourage improved compliance. The purpose of an internal audit program schedule is to plan the type and number of audits, as well as, to identify and provide the necessary resources to conduct them. The auditors need to understand how the new clause structure and requirements will affect their audit plans. Instead of auditing by clause, the organization may decide to audit by functional area.
An earlier tip described the need to look at requirements from multiple clauses to fully assess a particular activity. Organizing audits by clause may limit the evaluation to just a subset of the planning, doing, checking, and acting requirements for a process. Scheduling audits by functional area will promote an examination of all the applicable requirements clauses for the specific process scope. If audit results indicate problems with a particular clause across multiple areas, a supplemental audit can be scheduled.
Another method of auditing is to trace customer orders downstream or shipping notices upstream through the flow to assess department interfaces and process handoffs. Audits can also be scheduled for a specific contract or project to only assess the involved areas. Remember that ISO requires audits to be planned based on the status and importance of the areas being audited, as well as, the results of prior audits.
Internal audits of critical areas or poorly performing ones must be scheduled more frequently. If the scope of your system has changed based on permissible exclusions see clause 1. For information on permissible exclusions and outsourcing, refer to Guidance on Clause 1. We hope you find these tips useful in setting up or revising your internal audit program for ISO Although registrars cannot consult on possible audit practices, you can ask them for their interpretation of the ISO requirements.
Best wishes for efficient and effective internal auditing!
0コメント