ISO 9001:2015 Quality Management System Operations

Key Requirements:

  • Plan, implement and control processes need to meet requirements for products and services
  • Ensure requirements for products and services are defined and claims for products and services offered are met
  • Establish, implement and maintain an appropriate design and development process
  • Ensure externally provided processes, products and services conform to requirements
  • Production and service provision must be under controlled conditions (identification, verification and validation identification)
  • Products and services are not to be releases until planned arrangements are completed
  • Nonconforming outputs are to be identified and controlled

Section 8 Operation

Section 8.1: Operational planning and control

As with previous versions of the standard, ISO 9001:2015 requires that the quality planning is used in ongoing organizational management. This section on operational management is one of the longest in the standard and requires:

  • Documentation of requirements for each of the organization’s specific products or services
  • An equally specific benchmark for measuring all operational processes and resulting product/service suitability or “acceptance”
  • An assessment of required resources to achieve the above
  • Meeting product/service prerequisites through all actions
  • Proof of resulting product/service consistency
  • The result of any quality management process be applicable to all the organization’s actions, such that both anticipated and unanticipated changes can be dealt with – whether under direct or indirect organizational control (as when subcontractors or subassembly suppliers are used)

Section 8.2: Requirements for Products and Services

Expanding on the need for specification of product/service needs, the standard breaks down the process of requirement determination into the following:

  • Having a system for robust, ongoing customer dialog for general information, order/change orders, measuring performance, complaint/discrepancy handling and use/care of customer-supplied assets – including a plan for dealing with any out-of-bound or unsatisfactory results
  • Definition of product/service needs must include requirements based on laws, regulations or even organizational dictates – and that these requirements can be met
  • A formal review must be conducted to determine if the above product/service requirements can be met before making any type of supply commitment
  • The above review results be documented, especially any customer requirement changes, and that the proper personnel be made aware of any changes in this area

Section 8.3: Design and Development of Products and Services

The standard specifies a formal product/service development process that addresses:

  • The situation, time-frame, intricacy, steps involved, need for review/validation
  • Who is responsible both internally and externally for product/service design/development/improvement, and what resources they need
  • The level, type, frequency and means of communication and control between those personnel and entities involved in design/development, including customers/users
  • What formal requirements result from the initial design specification stages and, at the end of the process, how prove that those specifications have been met by the design/development process

Delving more deeply into how to define a specific product/service design, ISO 9001:2015 creates a process for gathering relevant guidance including:

  • How the service is supposed to work (and how well), using information from similar design/development cycles
  • Influences on product/service requirements including legal, regulatory and ethical, codes and standards
  • Scope and type of outcomes and effects of failing to adhere to product/service performance expectations, as well as a process for resolving any conflicts or contradictions in these stated design/development expectations
  • And of course, the need to document and retain the outcomes of the above process

Managing the design/development process is crucial under this standard, so it requires that:

  • First, there be a delineation of what the process needs to achieve
  • Next, reviews/verification/validation be performed to be sure that design/development expectations and results are aligned including application/use and performance
  • And that any deviations that result from these assessments be corrected and all of the above activities are correctly documented

Detailing the results of the design/development planning process (as part of the QMS), the standard dictates that:

  • Design/development planning results (i.e. specifications, other outputs) meet the requirement definition phase in a workable way for product/service delivery – including any critical aspects (i.e. for safety, longevity or performance)
  • These results are measured against agreed upon expectations and are again documented properly

Special emphasis is accorded to design/development revisions during this process to ensure that:

  • These changes don’t compromise the original requirements
  • This phase be subjected to acceptable documentation practices and rigor to include design/development revisions, formal authorization of design change, design review outcomes and any compensatory actions taken to prevent problems as a result of the change(s)

Section 8.4: Control of Externally-Provided Processes, Products and Services

The ISO 9001 standard requires the same oversight for products, services and supporting methodologies procured outside the organization including:

  • Externally purchased products/services must come under QMS control:
    • When they are incorporated (in part or in full) into the organization’s own products/services
    • When they are delivered directly to the organization’s customers
  • There must be a process, determined by the organization, for assessing, choosing, reviewing, improving and replacing these external suppliers against stated expectations.
  • These review/adjustment processes must also be documented properly

When engaging in outsourcing, there must be a process to react to problems caused by external suppliers that preclude the organization from delivering upon commitments to its customers including:

  • Making sure the organization maintains effective controls over that supplier that are delineated, include a means for accurate evaluation and are tested for effectiveness over time
  • The supplier must be made by the organization to understand fully:
    • What it is to provide (including supporting methods, materials and equipment used to produce those products/services)
    • How those products services will be watched and assessed to be acceptable or unacceptable (including on-site assessments)
    • Any special skills, certifications, performance expectations expected of the supplier’s personnel
    • How the supplier and organization are to engage one another

Section 8.5: Production and Service Provision

Requiring management and accountability in how a service/product is produced, the standard calls for:

  • Clear and documented definitions for product/service specifications, needed activities and results
  • Effective step-by-step data collection and measurement to ensure that expectations are being consistently met or, if a process’ stages cannot be measured accurately, then ongoing evaluation of the outputs of that process be made
  • Acceptable support and surroundings for production, including selection/empowering of skilled, qualified personnel and formal methods to prevent errors caused by those personnel
  • Execute actions that ensure quality during and after production/provision of services according to the QMS

With specific emphasis on key performance criteria determination and tracking, the standard requires a method for determining, tracking, tracing and controlling key performance criteria associated with service/product provision.

Whether owned by a customer or external supplier, there needs to be a method for taking care of assets (such as materials, components, tools, equipment, facilities, data and intellectual property) when they are under the organization’s control, including asset identification, working status/condition, security/protection or location – and provide up to date documentation reflecting this care.

“After sale” operational support (such as warranties, agreed upon performance criteria, repair, recycling, etc.) shall be provided as required legally, by applicable regulation and customer dictates/communication in a manner suitable for the product/service application and life cycle, while considering any negative outcomes.

Operational support shall also include periodic evaluation and management of needed service/product offering changes to stay in compliance with customer/regulatory/legal expectations, including a documentation stream including change review results and authorizations.

Section 8.6: Release of Products and Services

Before releasing a product or service, there must be a process to ensure that customer expectations have been met at each stage of product/service production, including documentation of formal customer approval that agreed upon product/service needs were met.

Section 8.7: Control of Nonconforming Outputs

There must be a process to detect and correct non-compliant services/products before their delivery or use including a means to correct the problem, separate and return the offending product/service, communicate the issue to customers/users, and by gaining authorization to verify and address the non-conformity.

Non-conformance documentation must include a full description of the problem, corrective actions, any agreed upon compromises/adjustments reached with the customer, and who authorized and accepted the remedies.

Please note that certain text from the ISO 9001 standard is only used for instructional purposes. Standard Stores recognizes and respects the International Organization for Standardization (ISO) copyright and intellectual property guidelines.

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