Clauses
Clause 4
General Requirement
4.1 Impartiality
On an ongoing basis, the laboratory must identify risks to impartiality, including those arising from its activities or relationships or the relationships of its personnel.
4.1.5
The laboratory must be able to demonstrate how it minimises or eliminates the risks it identifies.
Clause 5
Structural Requirements
5.1 Laboratory as Legal Entity
The laboratory is to be a legal entity or a defined part of a legally entity and be legally responsible for its activities.
5.2 Management Responsible for Laboratory
Management who have overall responsibility for the laboratory need to be identified.
5.3 Scope of Accredited Laboratory Activities
The laboratory needs to define and document the range of activities which it claims conformity to the Standard. The range of activities cannot include externally provided laboratory activities on an ongoing basis.
5.4 Laboratory Requirements
Laboratory activities need to meet the requirements of the Standard, its customers, regulatory authorities and organisation providing recognition. It is responsible for activities at its permanent facilities, at sites away from its permanent facilities, mobile facilities or at a customer’s facility.
5.5 Laboratory Organisational Structure
The laboratory must:
a. define the organisation and management structure of the laboratory;
b. specify the responsibility, authority and interrelationship of all laboratory personnel whose work affects the laboratory results;
c. document its procedures to assure the consistent application of its activities and validity of results, to the extent necessary
5.6 Personnel Responsibilities and Authority
Laboratory personnel to have the authority and resources needed to carry out :
a. implementation, maintenance and improvement of the management system;
b. identification of deviations from the management system or procedures for laboratory activities;
c. actions to minimise deviations;
d. reporting on the management system;
e. ensuring the effectiveness of laboratory activities.
Clause 6
Resource Requirements
6.2 Personnel
6.2.2
The competence requirements for each function influencing the results of laboratory activities must be documented.
6.2.5
Procedures and records need to be maintained for personnel covering:
a. determination of competence requirements;
b. selection of personnel
c. training of personnel
d. supervision of personnel
e. authorization of personnel
f. monitoring of competence of personnel.
6.2.4
Duties, responsibilities and authorities shall be communicated to personnel.
6.2.6
Personnel must be authorised to perform specific activities including:
a. develop, modify, verify and validate methods;
b. analysis of results, statements of conformity and opinions / interpretations;
c. report, review and authorise results.
6.3 Facilities and environmental conditions
6.3.2
The requirements for suitable facilities and environmental conditions to perform laboratory activities shall be documented.
6.4 Equipment
6.4.3
A procedure for the proper handling, transport, storage, use and planned maintenance to ensure proper functioning of equipment and to prevent contamination must be maintained.
6.4.7
A calibration program shall be established, reviewed and adjusted as necessary, to ensure confidence in the status of calibrations.
6.4.10
A procedure is to be followed when intermediate equipment checks are necessary.
6.5 Metrological traceability
6.5.1
The laboratory must maintain metrological traceability of its measurement results by a documented unbroken chain of calibrations, each contributing to the measurement uncertainty, linking them to an appropriate reference.
6.6 Externally provided products and services
6.6.2
A procedure and records are required for:
a. defining, reviewing and approving externally provided products and services;
b. the criteria for evaluation, selection, monitoring and re-evaluation of external providers;
c. ensuring, prior to use or supply to customer, externally provided products and services conform to the laboratory’s established requirements or the Standard;
d. actions arising from evaluations, monitoring or re-evaluations of external providers.
Clause 7
Process Requirements
7.1 Review of requests, tenders and contracts
7.1.1
A procedure must be established for the review of requests, tenders and contracts, ensuring:
a.the requirements are defined, documented and understood;
b. the laboratory has the capability and resources to meet the requirements;
c. the customer being informed of the activities to be performed by external providers and approval from the customer obtained;
d. appropriate methods or procedures are selected which customer needs.
7.2 Selection, verification and validation of methods
7.2.1.1
Appropriate methods and procedures must be used for laboratory activities. This includes for the evaluation of measurement uncertainty and statistical techniques for analysis of data.
7.2.2.4
Validation records must include the following:
a. the validation procedure used;
b. specification of the requirements;
c. performance characteristics of the method;
d. results obtained;
e. a statement on the validity of the method for its intended use.
7.3 Sampling
7.3.1
The laboratory must have a sampling plan and method when it carries out sampling. The method shall address the factors to be controlled. The method and plan shall be available at the sampling site. The plan shall be based on statistical methods where reasonable.
7.3.3
Relevant sampling data that forms part of the testing or calibration performed is to be recorded and include:
a. reference to the sampling method;
b. date and time of sampling;
c. data to identify and describe the sample;
d. identification of the personnel performing sampling;
e. identification of the equipment used;
f. environmental or transport conditions;
g. diagrams or other means to identify the sampling location when appropriate;
h. deviations, additions or exclusions from the method or sampling plan.
7.4 Handling of test or calibration items
7.4.1
The laboratory must have a procedure for the transportation, receipt, handling, protection, storage, retention and disposal or return of test or calibration items. This includes provisions to protect the item, the interests of the laboratory and the customer.
7.7 Ensuring the validity of results
7.7.1
The laboratory shall have a procedure for monitoring the validity of results. The data is to be recorded in such a way as to allow trend analysis and where practical, statistical techniques are to be applied to review the results. Monitoring is to be a planned activity and must include, where appropriate:
a. use of reference materials or quality control materials;
b. use of alternative calibrated instrumentation providing traceable results;
c. functional checks of measuring and testing equipment;
d. use of check or working standards with control charts;
e. intermediate checks on measuring equipment;
f. replicate tests or calibrations;
g. retesting or recalibration of retained items;
h. correlation of results for different characteristics of an item;
i. review of reported results;
j. intralaboratory comparisons;
k. testing of blind sample(s)."
7.9 Complaints
7.91
The laboratory must have a documented process for receiving, evaluating and making decisions on complaints.
7.9.2
A description of the complaint handling process must be available to any interested party on request. Upon receiving a complaint, the laboratory must determine if it relates to the laboratory activities it is responsible for and if so, needs to deal with the complaint. The laboratory is responsible for all decisions in handling the complaint.
7.9.3
The complaints handling process must include:
a. a description of the process for receiving, validating, investigating the complaint, and deciding what actions are to be taken in response to it;
b. tracking and recording complaints, including actions taken to resolve them;
c. ensuring that any appropriate action is taken."
7.10 Nonconforming work
7.10.1
The laboratory must have a procedure for the addressing laboratory activities or results of these activities that do not conform with its own procedures or agreed customer requirements. The procedure must ensure that:
a. the responsibilities and authorities for the management of nonconforming work are defined;
b. actions are based upon the risk levels established by the laboratories;
c. an evaluation is made of the significance of the nonconforming work, including an analysis of the impact on previous work;
d. a decision is taken on the acceptability of the nonconforming work;
e. the customer is notified and work recalled, if necessary;
f. the responsibility for authorising the resumption of work is defined."
7.11 Control of data and information management
Clause 8
Management System Requirements
8.2 Management system documentation
8.2.3
The laboratory must provide evidence of commitment to the development and implementation of the management system and to continually improve its effectiveness.
8.3 Control of management system documents
8.3.1
Documents (both internal and external) that relate to the fulfilment of the requirements in the Standard must be controlled.
8.3.2
It must be ensured that:
a. documents are approved prior to issue by authorised personnel;
b. documents are periodically reviewed and updated;
c. changes and the current revision status of documents are identified;
d. relevant versions of documents are available and their distribution is controlled;
e. documents are uniquely identified;
f. unintended use of obsolete documents is prevented."
8.4 Control of Records
8.4.1
Legible documents must be retained to demonstrate fulfilment of the requirements in the Standard.
8.6 Improvement
8.6.2
Feedback must be sought from customers, analysed and used to improve the management system, laboratory activities and customer service.
8.7 Corrective actions
8.7.1
When a nonconformity occurs, the laboratory must:
a. react and take appropriate actions to control and correct the nonconformity and address the consequences;
b. evaluate the need for action to eliminate the cause(s) of nonconformity in order that it does not recur or occur elsewhere;
c. implement any action needed;
d. review the effectiveness of any corrective action taken;
e. update risks and opportunities determined during planning;
f. make changes to the management system, if required."
8.8 Internal audits
8.8.2
The laboratory must:
a. plan, establish, implement and maintain an audit programme which takes into account the importance of the laboratory activities concerned, changes affecting the laboratory, and the results of previous audits;
b. define the audit criteria and scope for each audit;
c. ensure that the results of the audits are reported to relevant management;
d. implement appropriate correction and corrective actions without undue delay;
e. retain records as evidence of the implementation of the audit program and the audit results."
8.9 Management reviews
8.9.1
Laboratory management must review its management system at planned intervals to ensure its continuing suitability, adequacy and effectiveness, including the stated policies and objective related to the fulfilment of the Standard.