SOP / QMS Console
TemplatesCompliance Consultancy Ltd
← FARLA MEDICAL SUPPLIES LTD

Edit FARLA MEDICAL SUPPLIES LTD

Client details

Warehouse / distribution site

The site actually holding/moving stock — this is what a GDP inspection covers, and may differ from the registered office above.

Licensed scope

Tick what applies — these drive which clause blocks and terms are allowed to appear in this client's documents, so ticking (not typing) keeps them matching exactly.

Standard

Each client is licensed under exactly one framework — no dual certification.

Activities
Temperature conditions

Leave unticked if not relevant to this client.

Regulatory regime

Which market(s) this client's devices are placed on — a client can hold both if they sell into the UK and EU. This tells the AI review what to check for beyond the ISO 13485 clauses themselves (UDI, technical documentation, PRRC, vigilance/PMS reporting). Shown because ISO 13485 is ticked above — ISO-only, never relevant for a GDP client.

ISO 13485 clause applicability

Every clause applies by default — only tick "Excluded" for a clause this client's QMS genuinely doesn't cover, and say why (e.g. a design-only "virtual manufacturer" excludes 7.5.3 Installation). Shown because ISO 13485 is ticked above — ISO-only, never relevant for a GDP client.

4. Quality Management System
4.1 General requirementsalways applicable
4.2 Documentation requirementsalways applicable
5. Management Responsibility
5.1 Management commitmentalways applicable
5.2 Customer focusalways applicable
5.3 Quality policyalways applicable
5.4 Planningalways applicable
5.5 Responsibility, authority and communicationalways applicable
5.6 Management reviewalways applicable
6. Resource Management
6.1 Provision of resourcesalways applicable
6.2 Human resourcesalways applicable
6.3 Infrastructurealways applicable
6.4 Work environment and contamination controlalways applicable
7. Product Realization
7.1 Planning of product realizationalways applicable
7.2 Customer-related processesalways applicable
7.3 Design and development
7.4 Purchasingalways applicable
7.5.1 Control of production and service provisionalways applicable
7.5.2 Cleanliness of product and contamination control
7.5.3 Installation activities
7.5.4 Servicing activities
7.5.5 Particular requirements for sterile medical devices
7.5.6 Validation of processes for production and service provision
7.5.7 Validation of processes for sterilization and sterile barrier systems
7.5.8 Identificationalways applicable
7.5.9 Traceabilityalways applicable
7.5.10 Customer property
7.5.11 Preservation of productalways applicable
7.6 Control of monitoring and measuring equipmentalways applicable
8. Measurement, Analysis and Improvement
8.1 Generalalways applicable
8.2 Monitoring and measurementalways applicable
8.3 Control of nonconforming productalways applicable
8.4 Analysis of dataalways applicable
8.5 Improvementalways applicable

Saving scope changes opens a new scope version (the old one is kept for audit history) — this may affect which documents pass their conformance check.

Branding

Doc-ID prefix, numbering, and heading style are configured separately per document type (SOPs, Forms, Work Instructions, Policies) on the client page — the logo below applies once, across all of them.

Document templates

Each document type can use its own template — assign one of the shared master designs, or upload this client's own Word document and its header/footer will be used exactly as designed.

Standard Operating Procedures

Current: Double Line Style · has a Word header/footer

from shared master template

Forms

Current: (unnamed)

from shared master template

Work Instructions

No template set up yet.

Policies

Current: Standard Policy

from shared master template

Manuals

No template set up yet.

Records

No template set up yet.