Weights and Measures Regulations 1999

Schedule 7 Requirements for quality management system to be operated by accredited persons

r 17

Interpretation

1 Interpretation

(1)

In this schedule, unless the context otherwise requires,—

certification work means—

(a)

the examination and testing of measuring equipment:

(b)

the stamping of measuring equipment:

(c)

the issuing of certificates of accuracy

management representative means the person nominated in accordance with clause 4

measuring equipment means weights, measures, and weighing or measuring instruments

non-compliance, in relation to any measuring equipment, means the failure of that equipment to comply with the requirements of the Act or of these regulations; and non-complying has a corresponding meaning

operations, in relation to an accredited person, means the operations of that accredited person as they relate to the exercise or performance, by that accredited person, of the powers, duties, and functions of an accredited person under the Act or these regulations

quality management system means a system of operation for exercising or performing the powers, functions, and duties of an accredited person.

(2)

An accredited person who adopts a document (the ISO QMS document) containing a quality management system approved by the International Organization for Standardization and operates that system throughout the person’s operations is to be treated, for the purposes of this schedule, as complying with any requirement in this schedule to define or outline matters in a written document if the matters are contained in the ISO QMS document.

Schedule 7 clause 1(2): added, on 1 April 2010, by regulation 17(1) of the Weights and Measures Amendment Regulations 2009 (SR 2009/377).

Management of accredited persons

2 Quality policy

(1)

Every accredited person must define, in a written document, the policy of that accredited person in relation to quality as it relates to the operations of that accredited person.

(2)

Without limiting subclause (1), every written policy on quality must define—

(a)

the accredited person’s commitment to quality; and

(b)

the objectives of the accredited person as they relate to the attainment of quality.

(3)

Every accredited person must ensure that the accredited person’s policy on quality is understood, implemented, and maintained at all levels of that accredited person’s operations.

3 Responsibility and authority

Every accredited person must define, in a written document,—

(a)

the responsibilities and authority of each person who is employed or engaged by that accredited person to carry out any duties in relation to the operations of that accredited person; and

(b)

the relationship between each such person and every other person so employed or engaged by that accredited person.

4 Management representation

(1)

Every accredited person must nominate a member of that accredited person’s staff to be that accredited person’s management representative.

(2)

The management representative’s responsibilities must include responsibility for ensuring that the requirements of the Act and these regulations, as they relate to the operations of the accredited person, are complied with.

5 Resources and personnel

Every accredited person must define, in a written document,—

(a)

the resources that will be used in the accredited person’s operations; and

(b)

the procedures to be followed to ensure that those operations are carried out by competent personnel.

6 Review of quality management system

(1)

Every accredited person must ensure that the quality management system of that accredited person is reviewed, at regular intervals, in order to ensure its continuing suitability and effectiveness.

(2)

Every accredited person must ensure that adequate records are maintained of every review carried out in accordance with subclause (1) in relation to that accredited person’s quality management system.

7 Quality assurance systems

(1)

Every accredited person must establish and maintain an effective quality assurance system in relation to—

(a)

certification work; and

(b)

the checking of certification work.

(2)

Every such quality assurance system must include the maintenance of a written document outlining—

(a)

the procedures to be followed in carrying out certification work; and

(b)

the standard of workmanship to be attained; and

(c)

the records to be kept by personnel carrying out certification work.

(3)

The procedures referred to in subclause (2)(a)—

(a)

must be approved by the management representative before they are implemented by the accredited person; and

(b)

must be reviewed from time to time by the management representative in order to ensure their continuing suitability and effectiveness.

(4)

Every accredited person must establish document control procedures sufficient to ensure that personnel carrying out certification work do so in accordance with the written document referred to in subclause (2) that is for the time being in force in relation to that accredited person’s operations.

8 Corrective action

(1)

Every accredited person must establish and maintain procedures—

(a)

for investigating the cause of the non-compliance of any measuring equipment, where that non-compliance occurs during the currency of any certificate of accuracy issued, in respect of that equipment, by or on behalf of that accredited person; and

(b)

for formulating and implementing any corrective action necessary to prevent the recurrence of any such non-compliance; and

(c)

for the application of controls to ensure—

(i)

that such corrective action is taken; and

(ii)

that such corrective action is effective; and

(d)

for implementing and documenting any changes to certification work procedures, where those changes result from such corrective action; and

(e)

for analysing the operations of the accredited person (including certification work procedures, quality assurance records, and service reports), and customer complaints, in order to detect and eliminate potential causes of such non-compliance.

(2)

Every accredited person must ensure that the procedures referred to in subclause (1) are defined in a written document.

9 Internal quality audits

(1)

Every accredited person must establish and maintain procedures for the carrying out of internal quality audits—

(a)

to determine whether or not the operations of the accredited person are being carried out in accordance with the requirements laid down by that accredited person; and

(b)

to determine whether or not the quality assurance system established by that accredited person is effective.

(2)

Every accredited person must ensure that the procedures referred to in subclause (1) are defined in a written document.

(3)

Where an internal quality audit is carried out in respect of any of the operations of any accredited person, that accredited person must ensure—

(a)

that the findings of that audit are recorded in writing and brought to the attention of the personnel responsible for those operations; and

(b)

that timely corrective action is taken to remedy any deficiencies revealed by the audit.

10 Training

(1)

Every accredited person must ensure that personnel undertaking certification work have appropriate training and experience.

(2)

Every accredited person must ensure that written records of any training given by that accredited person are made and maintained.

Particular requirements in relation to certification work

11 Certification work

(1)

Every accredited person must ensure that the procedures established by that accredited person for the carrying out of certification work are followed by that accredited person’s personnel.

(2)

Every accredited person must ensure that adequate records are made and maintained in relation to certification work carried out by that accredited person’s personnel.

(3)

Without limiting the generality of subclause (2),—

(a)

the records referred to in that subclause must include, in relation to each stage of the examination and testing process undertaken in respect of any measuring equipment, the results of the examination and testing at each such stage; and

(b)

where any measuring equipment is examined and tested over a period of more than 1 day, the results of the examination and testing undertaken on each separate day in that period must be recorded on that day; and

(c)

the records referred to in that subclause must be legible and be readily identifiable with the measuring equipment to which they relate; and

(d)

all records relating to certification work carried out in relation to any particular measuring equipment must be retained by an accredited person for a period of not less than 5 years.

Schedule 7 clause 11(3)(d): amended, on 1 April 2010, by regulation 17(2) of the Weights and Measures Amendment Regulations 2009 (SR 2009/377).

12 Working standards and test equipment

(1)

Every accredited person—

(a)

must establish and maintain procedures for ensuring that the standards of measurement and other equipment used in certification work carried out by that accredited person’s personnel are sufficiently accurate to enable that work to be carried out satisfactorily; and

(b)

must ensure that records are maintained of the verification of such standards of measurement and such equipment, and of the results of that verification.

(2)

Every accredited person must ensure that the procedures referred to in subclause (1)(a) are defined in a written document.

13 Inspection and testing status

(1)

Every accredited person must ensure that while measuring equipment is under the control of the personnel of that accredited person, adequate procedures are adopted (whether by means of markings, stamps, tags, labels, physical location, or other suitable means) to identify the stage that the equipment has reached in the examination and testing process, in order to ensure that the equipment is stamped or, as the case may be, a certificate of accuracy is issued in respect of the equipment, only on the basis of examination and testing actually carried out on that equipment.

(2)

Every accredited person must ensure that, where measuring equipment is released from the control of the personnel of that accredited person, a record is kept of the identity of the person authorising that release.

(3)

Every accredited person must ensure that non-complying measuring equipment under the control of the personnel of the accredited person is clearly identified as such and, so far as practicable, is kept separate from other measuring equipment.

14 Protection of equipment

Every accredited person must ensure that all measuring equipment under that accredited person’s control is adequately protected against loss or damage.