“What documents do we need to prepare?” this is often the first question you would ask yourself.
Identifying the required documentation is one of the first steps, and one of the most important, in building a Quality Management System. This should be assessed after the organisation identifies the ISO standard it wishes to comply with.
Good news: Following the most recent update, the ISO 15189 standard is now structurally aligned with ISO 17025, making it easier for users to navigate.
Navigating through the standards, specific terminology defines how the standard is implemented. In the standards, the word ‘shall’ indicates it is a requirement, and the organisation must consider how the requirement is fulfilled. ‘Should’ indicates it is a recommendation, where the organisation may consider the practicality of the requirement in the context of the organisation based on analysis of existing data, to decide if implementing that specific clause adds value to the organisation.
Knowing the definition of these two keywords gives the user a good idea of what process is a solid requirement and where the flexibilities are. We have curated lists of documents which should be considered during your ISO 17025:2017 and ISO 15189:2022 implementation. The organisation is still recommended to go through the standards and understand what detail is required, but this should give you a head start in your QMS journey:
Table 1: Documents to consider for ISO 15189:2022
| Documents | ISO15189:2022 | ||
| Required | Recommended | Clause | |
| Quality Manual | v | 8.2.1 | |
| Quality policies and objectives | V | 5.5 8.2.1-2 | |
| Patient POCT requirement procedure (if required) | V | 4.3 a-i | |
| Organogram | V | 5.4.1 a-c | |
| Risks and opportunities procedure | V | 5.6 a 8.5 8.6 | |
| Training, competence, authorisation procedure | V | 6.2 8.2.2 | |
| Laboratory facilities, environment and activities | V | 5.3 6.3 | |
| Equipment acceptance, use, maintenance procedure | V | 6.4.1-6.4.7 | |
| Equipment calibration and traceability procedure | V | 6.5.2-6.5.3 | |
| Management of reagents and consumable procedure | V | 6.6.1-6.6.7 | |
| Contracts and agreements procedure | V | 6.7.1 | |
| Management of externally provided products and services procedure | v | 6.8.3 a-e | |
| Pre-examination activities procedure – Consent and information for users – Examinations requests – Primary sample collection, transportation, handling – Sample reception and acceptance criteria | v | 7.2 | |
| Method verification and validation procedure | v | 7.3.2, 7.3.3 | |
| Measurement uncertainty evaluation | v | 7.3.4 | |
| Examination procedure | v | 7.3.6 a | |
| Results validity (IQC/EQA) procedure | v | 7.3.7.1-3 | |
| Results reporting procedure | v | 7.4.1 | |
| Sample retain and disposal procedure | v | 7.4.2 | |
| Nonconformity and corrective actions procedure | v | 7.5 a-g 8.7 | |
| Laboratory data and information management procedure | v | 7.6 | |
| Contingency plan | v | 7.6.4 7.8 | |
| Complaints procedure | v | 7.7.1-3 | |
| Document control procedure | v | 8.3 | |
| Records management procedure | v | 8.4 | |
| Quality indicators monitoring procedure | v | 8.8.2 | |
| Internal audit procedure | v | 8.8.3 | |
| Internal audit programme | v | ||
| Management review procedure | v | 8.9 | |
| Management review plan | v | ||
Table 2: Documents to consider for ISO 17025:2017
| Documents | ISO17025:2017 | ||
| Required | Recommended | Clause | |
| Quality Manual | v | 8.1.2 | |
| Quality Policies and objectives | v | 8.2.1 | |
| Training and competence procedure | v | 6.2.5 | |
| Facilities and environment procedure | v | 6.3.2 | |
| Organogram | v | 5.5 | |
| Equipment handling, operation, maintenance procedure | v | 6.4.3 | |
| Equipment Calibration procedure | v | 6.5.1 | |
| Management of externally provided products and services procedure | v | 6.6.2 | |
| Customer requirement and service | v | 7.1.1 | |
| Method Validation and verification | v | 7.2 | |
| Sampling procedure | v | 7.3.2 | |
| Handling of test or calibration items procedure | v | 7.4.1 | |
| Record management procedure | v | 7.5.1 8.4.1 | |
| measurement uncertainty procedure | v | 7.6.1 | |
| Measurement uncertainty evaluation | v | ||
| Results quality assurance procedure | v | 7.7.1 | |
| Results reporting procedure | v | 7.8 | |
| Complaints procedure | v | 7.9.3 | |
| Nonconformity and corrective actions | v | 7.10.1 8.7.1 | |
| Laboratory Information Management System procedure | v | 7.11.3 | |
| Document control procedure | v | 8.3.1 | |
| Risks, opportunities and improvement procedure | v | 8.5.2 | |
| Internal audit procedure | v | 8.8.2 | |
| Internal audit programme | v | ||
| Management review procedure | v | 8.9.1 | |
| Management review plan | v | ||