8.0 Operation

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8.6 Release of Products and Services

This requirement is comparable to ISO 9001:2008 Clause 8.2.4 Monitoring and Measurement of Processes. Your organization must show evidence that a process (method, techniques, formats, etc.) is in place to monitor and measure the characteristics of product to verify that requirements are being met. This must be accomplished at appropriate stages of the design and development process. The auditor will verify that records are maintained to provide evidence of conformity and indicate the person(s) authorizing the release of products.

The release of product or delivery of service must not be completed until the planned requirements defined in 8.1 have been met. The release of product may include, according to product planning and the verification stages; release to the next operation, release to an internal customer, or release to final customer, etc.

Planned arrangements can include design verification and design validation, which can inviove modelling, simulations, experiments, trials, prototypes, functional testing, performance testing; inspections comprising, in-process, first article and final inspection; thorough examination through destructive and non-destructive testing; customer acceptance testing, product certification/qualification, third party qualification from a regulator, recognized society, or independent testing body etc.

For product release or service delivery, the planning requirements may be waived, but must be approved by relevant authority and by the customer as appropriate. Monitor and measure product characteristics to ensure they are able to demonstrate:

  1. Product characteristics are continually met;
  2. Evidence of conformity with product requirements.

Retain records to provide evidence that acceptance criteria have been met might include: e.g. certificate of conformity, release certificate, regulatory certificate. Ensure traceability to the person(s) authorizing the release such as name, authorized signatories, user identification, stamp impression etc., including their authority status (release signatory, certifying staff, scope of authorization etc.).

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Planning

4.1 Understanding Context 5.1 Leadership and Commitment 6.1 Address Risk and Opportunity
4.2 Interested Parties 5.2 Policies 6.2 System Objectives and Planning
4.3 Determining Scope 5.3 Roles, Responsibility and Authority 6.3 Planning for Change
4.4 Management System Processes    
 

Doing

7.1 Resources 8.1 Operational Planning and Control 8.6 Release of Products and Services
7.2 Competence 8.2 Requirements for Products and Services 8.7 Non-conforming Outputs
7.3 Awareness 8.3 Design & Development of Products and Services 8.8 Emergency Preparedness and Response
7.4 Communication 8.4 Control of Externally Provided Products and Services 8.9 Accident and Incident Investigation
7.5 Documented Information 8.5 Product and Service Provision  
 

Checking and acting

9.1 Monitor, Measure, Analyse and Evaluate 10.1 General
9.2 Internal Audit 10.2 Non-Conformity and Corrective Action
9.3 Management Review 10.3 Continual Improvement

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