Quality management system lifecycle (ISO 9001 and IATF 16949)

Deciding what the quality management system covers and why: the organisation's context, interested parties and their requirements, the sites, products and remote support functions in scope, the quality policy and objectives, and top management's commitment and accountability, including the customer specific requirements that will shape it when automotive customers are served.

LCLeadership commitment gateSAScope and policy approved gate

Comparing current practice with ISO 9001, and with IATF 16949 where automotive production parts are supplied, then planning the work to close the gaps: risks and opportunities, quality objectives with plans to reach them, resources, competence needs, the certification body choice and the timing of the certification audit.

QPQMS plan approved gate

Defining the processes of the system and how they interact, with owners, inputs, outputs, measures and risks for each: the process map and turtle diagrams or equivalent, the documented information the standard and the organisation need, document and record control, and the core tools procedures for APQP, PPAP, FMEA, MSA and SPC.

DRSystem documentation released gate

Running the processes as documented and producing the evidence that they work: training and competence records, calibration and measurement system records, supplier approvals and monitoring, control plans in use, nonconformance and corrective action records, and process measures reported against their targets.

IEImplementation evidence in place gate

Checking the system with planned audits by competent auditors who do not audit their own work: a risk-based audit programme covering every process, every shift and every site in scope, with process audits, product audits and, for automotive, layered process audits by managers at the point of work, and findings driven to root cause and correction.

ACInternal audit programme complete gate

Top management reviewing the system at planned intervals with the inputs the standard lists, such as audit results, customer satisfaction and scorecards, process and product performance, supplier performance, risks and the resources needed, and recording decisions and actions on improvement, changes and resources.

MRManagement review complete gate

The independent audit by an accredited certification body, in two parts: a first stage that checks readiness, documentation and scope, and a second stage at the sites that tests whether the system is implemented and effective, followed by the correction of any nonconformities within the timescale the scheme sets and the certification decision.

SOFirst stage audit passed gateCECertified gate

Running the certified system day to day and improving it: customer specific requirements kept current, complaints and returns handled with 8D or an equivalent disciplined method, layered process audits, supplier development, contingency plans tested, product safety handled, and continual improvement projects tied to the quality objectives.

PRPerformance and improvement review gate

The certification body's periodic surveillance audits between certification and recertification, which sample the system, follow up earlier findings, and check that the system still meets the standard and the customer requirements, with any nonconformities answered and closed to the scheme's rules.

SCSurveillance audit closed gate

Renewing the certificate before it expires with a recertification audit of the whole system, and handling transitions when a standard is revised, the scope changes, sites are added or removed, or the certification body changes.

RCRecertified gate