Management system guidance

8.2 Requirements for Products and Services

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8.2.2 Determining Requirements for Products and Services

This new requirement replaces ISO 9001:2008 Clause 7.2.1 - Determination of Requirements Related to Product Requirements. You should seek and record evidence that your organization has implemented a process to determine the requirements for the products and services that it intends to offer to customers.

This may also include the requirements from interested parties and also statutory and regulatory requirements relating to the product. You should determine how your organization was proactive in evaluating if there were any additional requirements for the product or service’s intended use.

If the organization determined there were not any additional requirements, this should be evident in associated records. If there were additional requirements, then evidence should be present how they were addressed in the affected process i.e. design, purchasing, manufacturing. The objective here is to set up a process to make sure that however an order is accepted, all the requirements for that order are determined. You will need to identify the following:

  1. Customer’s requirements;
  2. Those defined by the product’s purpose;
  3. Legal and statutory obligations;
  4. Organizational objectives;
  5. Appropriate records.

More information on PDCA

Planning

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

Doing

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

Checking

   
9.1 Monitor, Measure, Analyse and Evaluate 9.2 Internal Audit 9.3 Management Review

Acting

   
10.1 Improvement - General 10.2 Non-Conformity and Corrective Action 10.3 Continual Improvement
 

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