Audit Checklist for Laboratories-ISO 9001 Certification

 

A review checklist is a crucial element for conducting or preparation for an ongoing process audit. Taking into consideration the demands for ISO 9001 standard, a review checklist is a tool consisting of questions obtained from the quality management system demands, work performance criteria associated with the procedure while the paperwork created for the method that will be audited. Now, in terms of auditing a laboratory process, there are specific requirements that an auditor should think about while planning the audit checklist.

 

Laboratory review checklist preparation

Typically, laboratories are based on two working principles: either it works in every organization to perform tests and analysis on particular items, manufacturing procedures, or functions, or even the laboratories work individually as an event that is third party examinations and evaluation on offered examples from clients/customers.

 

Whichever criteria have been used in any laboratory, specific process flow steps tend to be followed: 

1) Getting test examples

2) Classification of test examples

3) Planning for examination (conditioning, equipment planning, or any other pre-requisites)

4) Performing test evaluation

5) Generation of test reports

 

Also, Check >>>> ISO 9001 Certification in India

 

In carrying out these five basic businesses, there are lots of things that should be taken care of to produce efficient test results. They can add documents of test treatments, the competence of workers examinations which can be doing physical fitness of testing equipment, environment in which examinations are being performed, dimension traceability of test outcomes, and input/output requirements for carrying out test analysis.

 

You can find few constituents which are to be are listed below that should be included in an ISO 9001 Laboratory audit checklist:

1) Risks and opportunities associated with laboratory functions (if applicable)

2) Objectives and targets regarding the preparation and laboratory to produce them (if applicable)

3) Resource requirements and their provision to do laboratory operations (machinery and manpower)

4) Competence of personnel test

5) Fitness record files for screening equipment (Calibration records)

6) Documentation maintained for laboratory processes

7) Sample-taking criteria, retained category and information of samples and their recognition

8) Retained information for test outcomes

9) Control of non-conforming test results

 

The concerns associated with those demands and requirements can be expected through review checklists during an audit if there are certain demands for process operations defined in the laboratory’s documented procedures.

 

Because these concerns are based on the guidelines of ISO 9001, an auditor has a collection of questions which are considering a laboratory’s specialized functions. The questions becoming expected will depend on the type of tests becoming carried out.

 

How to use audit checklist

The audit is a process, considering systematic activities which are carried out to examine or measure the conformity of any procedure. The auditor utilizes a checklist to collect research showing that the process satisfies the requirements defined within the criteria so that you can audit any process. The instance checklist overhead is specific for just one laboratory. The audit criteria will include two major things while conducting a laboratory audit. One is the defined process demands the laboratory that is certainly additionally the other would be the ISO 9001 standard needs for a process.

 

The auditor should be taking a look at process tasks predicated on ISO9001 Certification standard needs if the laboratory won't have defined documentation for the procedures. Find out more about an ISO 9001 Certification review, when you look at the article how exactly to prepare for an audit, is certainly internal.

 

The review checklist would aim to review the effectiveness of the process

To audit a laboratory’s conformity with ISO 9001 Certification, auditors use checklists to find proof that laboratory procedures meet the needs of ISO 9001 requirements. Where the laboratory has not yet maintained procedure documents, an auditor will use ISO that is basic 9001 requirements to examine the method, like in clause 8. Something that should always be recognized is that the reason for utilizing an audit checklist for a laboratory will be to review the potency of the procedure, and also to make certain that non-conformities don't happen.

 

The idea isn't just to search out non-conformities; the aim of the ISO 9001 Audit checklist for a Laboratory would be to review the process that the records offer evidence that the procedure meets its requirements. The auditor only raises problems about a corrective action plans for correct occasions when the process does not meet needs.