What clause 8.9 requires
Clause 8.9 applies to laboratories running their management system under Option A. Laboratories under Option B (a system per ISO 9001) meet it through the ISO 9001 management review, but should still cover the laboratory-specific content of 8.9.
| Part | Content |
|---|---|
| 8.9.1 General | Management reviews the management system at planned intervals to ensure its continuing suitability, adequacy and effectiveness, including the policies and objectives related to fulfilling the standard |
| 8.9.2 Inputs | Records of review inputs, at least the items named in the standard (see below) |
| 8.9.3 Outputs | Records of decisions and actions related to: effectiveness of the management system and its processes, improvement of laboratory activities related to the requirements, provision of required resources, any need for change |
The standard names no fixed interval; “planned intervals” means you set it and justify it. In practice assessors expect at least one review a year and an additional one after significant changes.
The inputs under 8.9.2
The standard lists the inputs. It pays to assign each one a data source so that preparation does not start from scratch every year.
| Input | Typical source |
|---|---|
| Changes in internal and external issues relevant to the laboratory | Risk register, market monitoring, changes in law and standards |
| Fulfilment of objectives | Last year's target figures, e.g. turnaround time, on-time delivery, retests |
| Suitability of policies and procedures | Process reviews, feedback from daily work |
| Status of actions from previous management reviews | Action list of the previous review |
| Outcome of recent internal audits | Audit reports, open findings |
| Corrective actions | Deviation and action management |
| Assessments by external bodies | Accreditation body reports, customer audits |
| Changes in the volume and type of work and the range of laboratory activities | Order statistics, scope of accreditation |
| Customer and personnel feedback | Customer surveys, staff conversations |
| Complaints | Complaints log with handling status |
| Effectiveness of any implemented improvements | Effectiveness checks of closed actions |
| Adequacy of resources | Staff planning, utilisation, equipment |
| Results of risk identification | Risk assessment under clause 8.5 |
| Outcomes of the assurance of the validity of results | Proficiency testing, interlaboratory comparisons, internal quality control (7.7) |
| Other relevant factors, such as monitoring activities and training | Training plan, monitoring of personnel and equipment |
The management review in seven steps
- 1
Set date and participants
Laboratory management, quality manager and area owners. Put the interval and participants in the procedure, not just in the calendar.
- 2
Name a data source per input
A table like the one above, with an owner and a cut-off date. It replaces the yearly search for documents.
- 3
Compile the inputs
Figures with a prior-year comparison, open actions and findings. Numbers before opinions: the meeting should evaluate, not start collecting.
- 4
Hold the meeting and take minutes
Every input is discussed and assessed. The minutes record what was decided, not only what was discussed.
- 5
Derive actions
Per action: owner, due date, expected result. Resources and need for change need an explicit decision, even if it is “no change”.
- 6
Track implementation
The standard requires actions to be carried out within an appropriate time. Open items belong in ongoing action management, not in a folder.
- 7
Check effectiveness at the next review
The status of actions is itself an input to the next review, which closes the loop.
Typical assessment findings
- The review took place, but not at planned intervals, or the interval is not defined anywhere.
- Individual inputs are missing, mostly complaints, risks, outcomes of assuring the validity of results or personnel feedback.
- The minutes list topics but contain no decisions and actions.
- Actions without an owner or due date; no status in the following review.
- The review is made up shortly before the assessment, based on figures nobody collects regularly.
- Management was not involved: the minutes come from quality management alone.
The common denominator is a missing data basis. If deviations, actions, utilisation and reports are captured in one place during day-to-day work, preparation means analysing instead of searching.