Implementation Guideline for Clause 8 of ISO 9001 2015 Standard

Clause 8 of ISO 9001 2015 standard is identical with clause 7 of ISO 9001 2008 standard with change in titles, restructuring of clauses and inclusion of some minor requirements.

Clause 8 – Operation

8.1 – Operational planning and control

This clause focuses upon four key aspects

  1. Defining criteria for technical processes acceptance. Such as manufacturing / service technicality etc.
  2. Defining criteria for product acceptance,
  3. Change control management
  4. Outsourced process control.

This clause also requires documented information as demanded in clause 4.4.

8.2 – Requirements for products and services

With comparison to earlier standard ISO 9001 2008, this clause is restructured.

8.2.1 – Customer communication

Organization shall define customer communication mechanism for

  • Spreading product information
  • Getting inquiries, orders, amendments, complaints, feedbacks
  • Handling and controlling customer property, if applicable
  • Contingency actions when relevant. This is relevant for key customers who are giving good amount of business. Contingency actions shall be available to ensure business continuity for such key customers. Though such actions shall be available for all customers ideally. However for smaller organizations, where cost constraints are there for implementation of contingency actions, it shall be done for key customers.

8.2.2 – Determining requirements related to products and services

This clause requires determination of all products and service related requirements the organization is offering to customers. This includes quality, delivery, packaging, capacity, design, performance, service etc. related requirements. This also includes statutory and regulatory requirements. While specifying these requirements, organization should ensure that the requirements are correct enough to handle claims may be received after delivery of products/services.

8.2.3 – Review of requirements related to products and services

Organization shall review requirements of products and services before committing acceptance of requirements to customers. Review includes requirements specified by customers, not specified but necessary considering intended use or product/services, statutory and regulatory requirements, other requirements as necessary, any requirement which is differing from confirmed earlier. Organization shall confirm verbal requirements. Organization shall handle amendment in requirements effectively by communicating it to relevant persons.

 

8.3 – Design and development of products and services

8.3.1 – General

This clause requires that a process of design and development shall be established and implemented. Process shall be understood effectively.

8.3.2 – Design and development planning

Planning clause is as per ISO 9001 2008 standard with inclusion of following requirements

  • Inclusion of design review at planning stage
  • inclusion of customer involvement in planning stage
  • Inclusion of resources required for design and development in planning stage
  • Planning of records for design and development activity

ISO 9001 2008 version was requiring

  • Planning of stages for design and development
  • stage wise responsibilities
  • Plan and actual dates for each stage

8.3.3 – Design and development Inputs

ISO 9001 2008 version was requiring to determine following as design input requirements

  • Functional and performance requirements
  • statutory and regulatory requirements
  • requirements derived from previously similar designs

ISO 9001 2015 has following additional requirements

  • Any reference standard organization has committed to comply in its design
  • Design Failure modes / Potential consequences of failure of product and services

8.3.4 – Design and development Controls

This is an additional clause. However requirements were already defined in ISO 9001 2008 version.

It requires

  • To define design input ( results to be achieved )
  • To conduct design review at appropriate stages. To take actions on review output.
  • To do design verification at planned stages
  • To do design validation at planned stage

8.3.5 – Design and development Output

This clause of ISO 9001 2015 standard is as per ISO 9001 2008 version.

Requirement is

  • Design output shall meet design input
  • Shall reference execution of manufacturing / service provision activity with monitoring and measurement criteria
  • shall reference product inspection / testing activity with acceptance criteria
  • shall reference raw material specifications
  • shall reference material preservation guideline
  • shall reference safety guideline

8.3.6 – Design and development Changes

Requirement of this clause is,

  • Changes shall be reviewed and approved
  • consequences of changes shall be evaluated with prevention of unintended effects
  • Changes made and release details

 

8.4 – Control of externally provided processes, products & services

8.4.1 – General

This clause of ISO 9001 2015 standard requires that all suppliers and service providers shall be evaluated before their selection as approved supplier. Criteria for evaluation and selection shall be determined. Once suppliers are selected, they shall be periodically reevaluated for their performance suitable to organization’s requirement. Based on output of performance evaluation suitable actions shall be taken on suppliers for their improvement / discontinuation.

8.4.2 – Type & extent of control

Organization shall determine which controls shall it apply to suppliers and service providers so that organization can provide products and services to its customers consistently. Controls can be providing clear purchasing information to suppliers, supplier audits on frequent intervals, inspection and testing of products / services provided by suppliers at supplier end or at our end …. etc…. There may be other controls organization may apply to ensure its supply to customer do not get adversely affected.

8.4.3 – Information for external providers

Organization shall provide clear purchasing information to external providers / suppliers which provides all requirements necessary to avoid any miscommunication of purchasing information to supplier. Information may include product description, quantity, delivery, requirement of test certificate, method of product approval, how performance of supplier is evaluated, how organization will interact with supplier on various issues, how customer involvement would be there at supplier premises etc.

 

8.5 – Production & Service provision

8.5.1 – Control of production and service provision

This clause of ISO 9001 2015 standard requires that production and service provision activity shall be controlled by organization with following key control points.

  • All persons involved in production and service provision activity shall be competent for their job
  • Suitable machinery / hardware / software shall be provided to achieve required product characteristics
  • Suitable monitoring and measuring instrument shall be provided for monitoring of process characteristics
  • Required characteristics of product / resultant output shall be available at point of production and service provision for clear understanding of purpose.
  • Process characteristics and Product characteristics monitoring and measurement shall be implemented.
  • Validation shall be implemented for suitable processes output of which can not be measured/monitored
  • Up to extent possible, human intervention shall be controlled to prevent human errors.

8.5.2 – Identification and traceability

Till material / product remains in control of production / service provision function, it shall be identified suitably. Identification should include as suitable – name, specification, size etc. It can also includes ok/reject or accepted / rejected to products as suitable. Most importantly for tracing customer complaints to root cause stage, man/machine/material etc. method identification shall be given and records shall be maintained so that a traceability between customer to supplier stage can be established.

8.5.3 – Property belonging to external providers

Customer property / external providers property is any property which customer is sending for using / incorporating with end product or any property which is useful for providing product / service as per customer requirements. External provider property may include property which is not received from customers but received from associate companies / property taken on rent. All such properties shall be identified, verified, safeguarded and protected. If any of property is not found suitable for use then it shall be reported to external provider.

8.5.4 – Preservation

Preservation includes protection of product / service characteristics till it is delivered to customer. It includes handling, storage, packaging, protection, identification, contamination control and transportation control. All suitable controls amongst these shall be implemented to protect product / service characteristics.

8.5.5 – Post delivery activities

This clause of ISO 9001 2015 standard is a great clarification about responsibility of organization in terms of post delivery activities. Organization shall decide post delivery activities it should comply with depending upon product and service it providers. It may include maintenance of product till warranty claims, how customer can contact organization when it faces any problem while use of product / service, any statutory requirement organization should comply with in terms of disposal / usage of product, providing safety or maintenance manual, providing user manual, providing expiry details about product as applicable. etc.

8.5.6 – Control of changes

Any change in the production / service provision shall be reviewed for its consequences prior to implemented. Change shall be approved and released by authorised person only.

 

8.6 – Release of products & services

This clause of ISO 9001 2015 standard is same as 8.2.4 clause of previous version ISO 9001 2008 standard. It requires that organization shall verify / inspect / test products at various predefined stages with predefined parameters and acceptance norms. Product / service shall be released only if it complies with defined acceptance norms. If any deviations are there then they shall be approved by authorised person and in case of final product deviation – by customer. However we believe that product should not released to next stage if any non conformance is found against defined acceptance criteria.

 

8.7 – Control of non conforming output

This clause of ISO 9001 2015 standard is similar as per 8.3 clause of previous version ISO 9001 2008. This clause requires that non conforming output of any process ( depending upon its tangibility ) shall be segregated, identified and controlled for its unintended use / delivery. Organization may take one of more action on such non conforming outputs.

  • Taking action for eliminating non conformance. In such cases product / service shall be reverified / inspected / tested after resolution of non conformance.
  • Taking deviation approval from authorised person
  • Informing customer as necessary
  • Avoiding its original use. Scrapping.

 

Clause 8 of ISO 9001 2015 standard is key clause on implementation prospective. This clause covers almost every department. So it shall be implemented with utmost understanding and control.

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