Version 1.6.1
David Trew
Consulting Ltd
6 Preliminary Assessment
Many accrediting bodies will offer applicants an optional preliminary assessment of their laboratory management system before the accreditation assessment. Preliminary assessments are not required for ISO/IEC 17025:2017 accreditation and are strictly optional, depending upon a laboratory’s needs. The extent of the preliminary assessment is also up to the laboratory.
The principal advantage of a preliminary assessment is that it allows the laboratory to identify and correct any potential problems before the accreditation assessment begins. A preliminary assessment also enables the accrediting body to recognise, in advance, any weaknesses that may exist in the laboratory quality management system.
During the preliminary assessment, the accrediting body will send an assessment team to the applicant’s laboratory. This team comprises competent assessors and will assess the laboratory’s QMS, records and other documentation, alerting the applicant to any concerns that may interfere with a successful accreditation assessment.
7 Stage 1 Review – Laboratory Management System Documentation
The first phase in the assessment consists of reviewing the documentation associated with the quality management system. Consisting of, at a minimum, a review of:
1. Quality manual
2. Quality policies
3. Quality Procedures
However, depending on your selected accrediting body, the following may also be reviewed:
1. Internal audit schedule
2. Plan of activities to ensure the validity of test or calibration results
3. Test or calibration methods
4. Method validation or verification reports
This review will determine that your QMS meets the ISO/IEC 17025:2017 International Standard requirements, together with any policies established by the accrediting body or relevant mutual recognition agreements. Any deficiencies discovered during the stage 1 review will be reported to you, and you will need to correct these before the onsite assessment.
8 Preparation for an onsite assessment
Before your onsite assessment, you should ensure you have sufficient records available, as evidence, to show that your laboratory is operating following your quality management system and the ISO/IEC 17025:2017 International Standard. In particular, you should have the following evidence available.
8.1 General Requirements
8.1.1 Impartiality
You should have evidence to show that you have endeavoured to identify threats to your laboratory’s impartiality. This could be in the form of a list of potential threats you have considered, including:
1. Ownership
2. Governance,
3. Management,
4. Personnel,
5. Shared resources,
6. Finances,
7. Contracts,
8. Marketing (including branding),
9. Payment of a sales commission or other inducement for the referral of new customers
10. Limited customer base
11. Product value is dependent on the content of an analyte
You need to be able to explain how your management is structured to safeguard the laboratory’s impartiality.
Where a threat to the laboratory’s impartiality has been identified, you need to have records of the actions taken to eliminate or minimise such risk
8.1.2 Confidentiality
You should have copies of example contracts or other legally enforceable documents available as evidence that you can ensure customer information can be kept confidential
You should be able to show how you protect your customer’s confidentially interests and how you confidentially ensure your staff work. This could include evidence of training activities which you provide for your staff.
It is also recommended you take steps to protect your customers’ confidentiality interests when storing and working on customer samples.
8.2 Structure
Your laboratory’s legal nature, together with the management structure and the interrelationships between personnel, should have been discussed in the quality manual submitted with the application and, therefore, would not be expected to be addressed during the onsite assessment.
8.3 Resources
8.3.1 General Requirements
You need to have records to show that you have identified the resources necessary for the laboratory to achieve its objectives. This needs to include:
1. Personnel
2. Accommodation
3. Equipment
4. Facilities
5. Utilities
8.3.2 Personnel
All personnel need to know their respective responsibilities, duties and authorities. This information needs to be communicated to staff, for example, in the form of a job description.
You need to have records to show that you have identified competency requirements for each role within your laboratory. This needs to include education, skills, training and experience. You also need to have a documented training program and have training records that are up to date.
You also need to identify the activities for which specific authorisation is required, criteria for authorisation and records to show who has been authorised to carry out these activities.
8.3.3 Facilities and Environmental Conditions
You need to have written records describing your laboratory’s accommodation and utility requirements. You also need to identify any environmental conditions that could affect the results or calibrations delivered by the laboratory and have the means to control, measure, monitor and record these
You need to have appropriate security controls, together with adequate contamination control, such as removing waste and arrangements to clean surfaces.
You also need to show an adequate separation of incompatible activities.
8.3.4 Equipment
You need to have a set of user, functional and operational requirements, including specifications for the accuracy and uncertainty, for each item of measuring equipment in the laboratory, together with evidence that the equipment meets those specifications. These needs include records of activities carried out when commissioning new equipment, together with calibration and maintenance records, together with a calibration and maintenance plan.
Also, you need to have evidence that all equipment can achieve the accuracy and precision required to provide accurate results. This needs to include records of period checks carried out on equipment and where appropriate evidence, such as equipment suitability or quality or control checks, which are carried out as an integral component of a test or calibration, to support the validity of the results provided by the equipment.
In particular, you need to pay specific attention to the following:
1. Purified water supply needs to conform to, and be operated following, the requirements of ISO 3696 Water for analytical laboratory use —Specification and test methods4.
2. Volumetric glassware needs to conform to and be operated following the requirements of the UKAS guidance document Lab 15 Traceability: Volumetric Apparatus5
3. Laboratory balances need to conform to and be operated following the requirements of the UKAS guidance document Lab 14 Guidance on the calibration of weighing machines used in testing and calibration laboratories (Edition 6, October 2019)6
Also, you will need to have the following records available, where applicable:
1. The identity of equipment, including software and firmware version;
2. The manufacturer’s name, type identification, and serial number or other unique identification;
3. Evidence of verification that equipment conforms with specified requirements;
4. The current location;
5. Calibration dates, results of calibrations, adjustments, acceptance criteria, and the due date of the next calibration or the calibration interval;
6. Record relating to reference materials, results, acceptance criteria, relevant dates and the period of validity;
7. The maintenance plan and maintenance carried out to date, where relevant to the performance of the equipment;
8. Details of any damage, malfunction, modification to, or repair of, the equipment
8.3.5 Externally Provided Products and Services
You need to have records of appropriate specifications for all critical products or services.
You should have evidence to show that you have evaluated all your suppliers who provide critical products or services, together with records of ongoing evaluation of suppliers and, where appropriate, actions taken as a result of continuing performance evaluation.