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Rather, it focuses on the most important requirements and the ones that need specific attention, according to the opinion and interpretation of the author.
To learn more about the package, click here Management requirements pertain to the operation and effectiveness of the quality management system within the laboratory.
The requirements are similar to ISO This clause is divided into fifteen chapters, described below. Organization This chapter ensures that the roles and responsibilities of the laboratory, the management, and key personnel are defined.
An organizational structure, as well as responsibilities and tasks of both management and staff should be defined. Examples include commercial marketing or financing departments. A quality assurance manager should be appointed. All personnel should be free from any commercial or financial pressure that could adversely impact the quality of calibration and test results.
Management System This chapter describes how to ensure that a management system is implemented, maintained, and continually improved. There should be policies, standard procedures and work instructions to ensure the quality of test results.
There should be a quality manual with policy statements that are issued and communicated by top-level management. The effectiveness of the management system should be continually improved Document Control Individual paragraphs in this chapter describe how to ensure that all documents related to the management system are uniquely identified and created, approved, issued, and changed following documented procedures.
All official documents should be authorized and controlled.
Documents should be regularly reviewed and updated if necessary. The review frequency depends on the document itself. Typical review cycles are between one and three years. Changes to documents should follow the same review process as for the development of initial documents.
Review of Requests, Tenders, and Contracts This chapter describes how to ensure that requirements of requests, tenders and contracts are well defined, reviewed, understood, and documented.
Changes in a contract should follow the same process as the initial contract. Subcontracting of Tests and Calibrations.
This chapter describes how to ensure that tests and calibrations subcontracted to third parties are performed according to the same quality standards as if they were done in the subcontracting laboratory. Purchasing Services and Supplies This chapter describes how to ensure that services and supplies delivered by third parties do not adversely impact the quality and effectiveness of laboratory operations.
Suppliers should be selected and formally evaluated to ensure that services and supplies are of adequate quality. Records of the selection and evaluation process should be maintained.
The quality of incoming material should be verified against predefined specifications. Service to the Customer This chapter describes how to ensure that the laboratory continually meets customer requirements.
The laboratory should communicate with customers to clarify requests and get customer input. The laboratory should have a formal program to collect feedback from customers on an ongoing basis.
The laboratory should allow customers to audit the laboratory. Complaints This chapter describes how to ensure that any customer complaints are documented, evaluated, and adequately followed up.
There should be a policy and procedure for the resolution of complaints received from customers. Records of complaints and all steps taken when resolving the complaint should be maintained.
This includes documentation of investigations and corrective actions. This chapter describes how to ensure that nonconforming test and calibration results are adequately followed up, and that corrections are initiated. There should be a policy and process that come into effect when results do not conform to procedures.
Corrective actions should be taken immediately to avoid recurrence. The significance of nonconforming work should be evaluated, for example, the possible impact on other testing or calibration work.
If necessary, customers should be notified. Continuous Improvement This chapter describes how to ensure that the effectiveness of the management system is continually improved.
Suggestions for improvements should be taken from audit reports, analysis of data, customer complaints and suggestions, corrective and preventive actions, and management reviews.QUOTE: “Google is “the biggest kingmaker on this Earth.” Amit Singhal, Google, A Mountain View spokesman once called the search engine ‘kingmakers‘, and that’s no lie.
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