Relationship of ISO/TS 9002: 2016 with ISO 9001: 2015

4.1: Understanding the organization and its context

– aware that external and internal issues can change

– Sources of issues: Meetings, national & international press, websites, government departments, professional & technical publications, conferences, customers and relevant interested parties and professional associations

– External issues could be Economic, social, political, technology, market and legal

– Internal issues could be organization performance, resources, human aspect and governance

a) the interested parties that are relevant to the quality management system.

b) the requirements of these interested parties.

The organization shall monitor and review information about these interested parties and their relevant requirements.

– Consider its external and internal issues BEFORE

– Interested parties: Customer, end-user, franchisor, shareholder, banker, union, supplier, employee, legal bodies, competitor, neighbour, local community

– Method to know needs and expectations: Order received, legal compliance, benchmarking, market surveillance, supply chain relationship, customer survey and satisfaction

– Relevant interested party’s requirements include Customer requirements, pricing, delivery, contracts, industry standards, MOU, protocol, code of practice, policies, environmental committees, Legal body  

The organization shall plan:

a) actions to address these risks and opportunities.

b) how to:

     1) Integrate and implement the actions into its QMS processes

     2) evaluate the effectiveness of these actions.

– Example of Risk: QMS will not achieve its objectives including the failure of processes, products and services to meet their requirements, or the organization not achieving customer satisfaction.

–Example of Opportunities: Potential to identify new customers, to determine the need for new products or services and to bring them to market, or to determine the need for revising or replacing a process by the introduction of new technology to become more efficient.

– Techniques to determine Risk and opportunities: SWOT or PESTLE, Failure Mode and Effects Analysis (FMEA); Failure Mode, Effects and Criticality Analysis (FMECA); or Hazard Analysis and Critical Control Points (HACCP). Simpler approaches include brainstorming, Structured What If Technique (SWIFT) and consequences/probability matrices.

– Action to address the Risk: Avoid it, eliminate it, take the risk, share the risk, no action

a) on what it will communicate.

b) when to communicate.

c) with whom to communicate.

d) how to communicate.

e) who communicates.

– Different communication methods are often required for different situations

– formal communication such as reports, specifications, invoices or service level agreements for external relevant interested parties.

– For internal communication, methods such as daily contact, regular department meetings, briefing sessions, email or an intranet. 

– To  be effective, the organization’s communication processes should provide it and its persons with    the ability to:

–          transmit and receive information quickly and act on it.

–          build trust amongst each other.

–          transmit the importance of customer satisfaction and process performance.

– Identify opportunities for improvement.

When the property is lost, damaged or otherwise found to be unsuitable for use,  report & retain documented information

– Property can be tangible or intangible (material, tools, customer premises, intellectual property or personal data).

– Examples: Instrument for measurement, vehicle for service or repair, component for PCB, packaging for finished goods, financial or personal data

– Protection of customer property: Password protection, specific location to store intellectual property like drawing, software, Limited access, system for storage and deletion

Take appropriate action based on the nature of the nonconformity in one or more of the following ways:

a) correction.

b) segregation, containment, return or suspension.

c) informing the customer.

d) Obtaining authorization

– Different ways to deal with NC products: Correcting- determining that the wrong meal has been prepared and providing the correct one before delivery.

Segregating: Type of physical label or location

Informing customer: Recall, suspension or withdrawal of affected parts, reprocessing

-Nonconformance detected after delivery: An example might involve an airline providing assistance, food and/or accommodation as a result of a flight delay, until the flight can depart or until the passenger has been rebooked on another flight.

expectations have been fulfilled. Determine the methods for obtaining, monitoring & reviewing this information.

– Determine the customers for taking customer satisfaction feedback and how it will monitor the information

– Determine the degree of customer satisfaction after the results are analysed and evaluated and take action

– Input to management review to improve customer satisfaction

– conforms to:
1) the organization’s requirements

2) The requirements of this International Standard

effectively implemented and maintained

– Audit methods should include direct observation of the process, interviews with relevant persons, examination of internal procedures, drawings, specifications, standards; customer requirements; and statutory and regulatory requirements.

– where the organization has multiple sites, set up an audit programme for each specific location

– The audit programme to indicate the frequency of conducting audits (e.g., monthly, quarterly, annually).

– Criteria to plan the audit include

importance of the processes, managerial priorities, performance of the processes, changes affecting the organization, results from previous audits, trends in customer complaints, statutory and regulatory issues

-For a smaller organization, the person can audit their work but results reviewed by a peer or a manager, to ensure results are impartial

– obtaining resources from an external provider like an external auditor, or another organization

– to conduct combined audits to reduce redundancy.

– Audit results include audit reports, evidence of corrections or corrective actions taken (e.g., training, updated documented information).