Version 1.6.1
David Trew
Consulting Ltd
8.1 Resources
8.1.1 Review of Requests, Tenders and Contracts
Your laboratory needs to have evidence that customers’ requirements are clearly defined, recorded and understood and that any ambiguities are clarified before testing or calibration activities commence. If changes are made to requirements after work has started, there needs to be evidence that such changes are communicated to personnel.
You need to have records of all communications with your customers.
8.1.2 Methods
You need to have written copies of the methods you use for each test or calibration. These must be in sufficient detail to enable them to be performed consistently by different staff members over a long time.
You need to have objective evidence to convince an expert that your laboratory can properly perform each test or calibration evidence. This can include comparisons with other laboratories.
You need to have evidence of method validation If any of the methods you are using are non – standard methods or standard methods but used outside their scope or have been modified. Such evidence must provide a high level of confidence that the test can consistently deliver valid results. Also, such evidence must be convincing to an expert.
8.1.3 Sampling
If your laboratory carries out sampling activities, you need to have sampling plans and methods which must address the factors that need to be controlled to provide valid test or calibration results. You need to be able to explain how the controls you have implemented will address the factors and potential issues you have identified.
Also, you need to have records of all sampling operations you have carried out.
8.1.4 Handling of test or Calibration Items
You need to have records of all samples or calibration items received by your laboratory. You need to be able to explain how your sample or calibration item management system prevents sample or calibration items from being confused either physically or when referred to in records.
Further, you need to be able to explain how you prevent samples or calibration items from being damaged or contaminated and how you protect them from deterioration.
Also, you need to be ready to demonstrate your sample or calibration item handling procedure.
8.1.5 Technical Records
You can expect to be asked to show a sample of your records of testing or calibration.
8.1.6 Ensuring the Validity of Results.
You need to have a plan of activities to monitor the validity of the results you deliver. You should ensure that you have carried out all of the monitoring activities you have planned to undertake.
It is ILAC policy that a laboratory seeking accreditation for the first time must have carried out either a performance test or an interlaboratory comparison study for each test or calibration it is seeking accreditation. Also, laboratories must carry out at least one performance test or interlaboratory comparison study for each test or calibration for each test it is accredited for during each four-
However, the results from such performance tests or interlaboratory comparison studies must convince an expert that the laboratory is competent to perform the tests or calibrations. If the results show a questionable or unsatisfactory performance, further performance testing or interlaboratory comparison studies will be required.
The requirement is that you must have sufficient evidence from performance tests or interlaboratory comparison studies to convince an expert of your competency to perform the tests or calibration. Therefore, a single performance test or interlaboratory comparison might be sufficient for calibrating a meter by comparison with a primary calibration meter, but it probably would not be for the calibration of a primary pH calibration buffer using the Harned cell.
8.1.7 Complaints and Nonconforming Work
You will need to have records of all complaints you have received and nonconformities that have been identified. Although if you are seeking accreditation for the first time, it will be recognised that you might not have many complaints or nonconformities to report.
It is important that you do report all nonconformities identified. If a nonconforming event is identified during the onsite assessment that was not reported when it occurred, that is a nonconformity itself.
You will also need to have records of the corrective actions and be able to explain how those corrective actions will prevent the issue from reoccurring.
When any laboratory introduces new systems and working practices, mistakes will be made as staff become familiar with working in a new environment. Therefore, the assessors will be expecting you to have some nonconformities. Therefore, if you report having no nonconformities, it will probably mean you are not correctly identifying nonconforming events. Alternatively, you are not paying enough attention to the identification of nonconformities.
8.1.8 Control of Data and Information Management
You will need to have evidence that provides a high level of confidence that all computers and other information management systems used in connection with testing or calibration, such as computers controlling measuring equipment, can perform their assigned functions. If your systems have been in use for some time, you can use that fact as evidence. However, you will need to explain how you are using that evidence to support your conclusions.
Also, you will need to have evidence to show that your information management systems are;
1. Secure from unauthorised access
2. Protected against tampering and loss of data
3. Operated following provider and laboratory requirements
4. Maintained in a manner to assure the integrity of data and information stored
Further, you will need to have records of any system failures or outages, together with the corrective actions taken.
You will also need to have records to show that all calculations and data transfers are systematically checked.
8.2 Management System
8.2.1 Documents and Records
All your documents and records must be readily available and quickly retrievable. Generally, you should be able to supply any document or record within 30 minutes of it being requested, if the document is onsite, and within 24 hours if the document is offsite. However, it would be prudent to have all documents or copies of readily available during the onsite assessment
8.2.2 Management of Risks and Opportunities
You need to have records of the risks and opportunities you have identified, together with the actions you have taken to address them. In particular, this needs to include threats to the impartiality of laboratory operations.
8.2.3 Improvement
You need to have records of the customer feedback you have received and the analysis you have carried out, together with records of any actions you have taken. You need to have evidence of proactively seeking feedback from your customers.
8.2.4 Internal Audits
You need to have a schedule for internal audits. All planned audits must be carried out on time. You will need to have records of the audits that have been carried out, together with records of corrective actions that have been implemented. For a laboratory implementing a quality management system for the first time, it can be expected that mistakes will be made as staff adjust their working practices to working in the new environment.
8.2.5 Management Review
A laboratory seeking accreditation for the first time needs to have records of at least one management review. There need to be records of management reviews, including agendas and minutes, together with records of actions that need to be taken.