Quality management
ISO 9001: Quality management systems, requirements
The world's most widely used management system standard and the baseline expectation for industrial suppliers.
01Purpose
ISO 9001 specifies requirements for a quality management system that enables an organisation to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and to enhance customer satisfaction.
02Scope
It applies to any organisation, regardless of size or sector. It follows the harmonised structure common to ISO management system standards, which makes integration with ISO 14001 and ISO 45001 straightforward.
03Main requirements
- Understanding the organisation's context and interested parties
- Leadership commitment, quality policy and objectives
- Risk-based thinking and planning of changes
- Resources, competence, awareness and documented information
- Operational planning, customer requirements, design control where applicable
- Control of externally provided processes, products and services
- Production control, identification, traceability and release
- Control of nonconforming outputs
- Monitoring, measurement, internal audit and management review
- Corrective action and continual improvement
04Typical applications and industries
ISO 9001 certification is a common minimum requirement in supplier approval. It is also the base of sector standards such as IATF 16949 and AS9100, and is closely related to ISO 13485.
05Audit and inspection considerations
- Is the scope of certification relevant to the products being bought?
- Are supplier controls (clause 8.4) applied to the sub-suppliers that matter, such as heat treaters and platers?
- Do production controls exist at the workstation, not only in the manual?
- Are nonconformities recorded, analysed and corrected effectively?
- Is measuring equipment calibrated and traceable?
06Common nonconformities
- Certificate scope does not cover the purchased product or site
- Outsourced special processes not controlled
- Corrective actions without root cause analysis
- Internal audits that never find anything
- Calibration records incomplete or overdue
- Obsolete documents at workstations
07How QUALITAS TR can support
QUALITAS TR verifies how effectively a supplier's ISO 9001 system works for your product through second-party QMS audits and qualification audits, and helps suppliers close gaps through supplier development.