Friday, June 24, 2016

Certification of Suppliers

If a Company is ISO 9001 certified,
is it mandatory for the Supplier of the materials to have the ISO 9001 in place or the Company’s certification is sufficient.

There are three available options.
1.    Option #1 – to evaluate supplier of a particular material in accordance with the Supplier evaluation methodology established in the the Organization at specified intervals, for example, annually.
2.    In case the Supplier becomes permanent by the decision of the Organization leadership to transfer the production process of a particular material to the external provider, the second and/or third options could be chosen.

2.1. Option #2 - conduct 2nd party annual audit of the supplier utilizing the resources of the Particular material production process Quality Assurance System internal auditors. This System should include the supplier processes that directly affect the quality of the particular material (this is – the 2nd party audit scope), such as:

  •  Production’, including the final inspection and preservation (the part relevant to the production process of a particular material).
  • Control of nonconforming output processes, products, and services’ (the part relevant to the production process of a particular material).
  • Design and development’ (part relevant to technological design of production process of a particular material).
  • Control of external processes, products and services’, (the part relevant to the purchase of equipment, raw materials, components, etc. for the production process of a particular material).
  • Control of Personnel’ (the part associated with the definition, provision and evaluation of the competence of personnel involved in the production of a particular material).
  • Control of documented information
  • Contract Analysis’ (the part associated with the particular material production process outputs definition and requirements analysis).
  • Customer communication’ (part of the ‘Marketing’ process relevant to the involvement of the organization to improve particular material production process outputs).

The requirements to the Supplier processes relevant to the Quality Assurance System of the particular material production (these are the 2nd party audit criteria):

  • definition of these processes inputs and outputs;
  • ensuring the interaction of these processes with each other;
  • ensuring the interaction of the outsourced process with the processes of the organization;
  • definition and implementation of criteria and methods (including monitoring, measuring and relevant operation parameters), necessary for the effective execution of these processes and their management;
  • determination of the resources needed for these processes, and ensuring their availability; allocation of responsibilities and authorities in relation to these processes;
  • addressing the risks and opportunities associated with the implementation of these processes;
  • evaluation of these processes and introduction of the necessary changes to ensure achievement of the planned process results;
  • carrying out actions for improvement of these processes;
  • maintenance of documented information necessary for the implementation of these processes; preservation of documented information to make sure that the processes are carried out as planned.

The requirements to the personnel involved in the production of a particular material should also be the criteria of the 2nd party audit:

  • definition of the required competence;
  • provision of competence;
  • evaluation of the effectiveness of measures to ensure competence;
  • preservation of competence evidence (basic education diplomas, training certificates, continuous education programs, internships, etc., letters of recommendation).

2.2. Option #3 – request the supplier to develop, implement and certify a Quality Management System in accordance with ISO 9001. It is also possible to recommend to the Supplier a Certification body (or bodies) that the Organization trusts.
From the standpoint of a good practice, option #3 is preferred because:
1) It reduces the ‘likelihood’ of the Supplier’s particular non-conformant material getting into the your Organization ‘Production’ process.
2) As a result of p. 1 (above), your Organization can reduce the amount of incoming control of the particular material or even waive the incoming inspection (if you highly approve the Supplier’s QMS, including ‘Product release’ sub process).
3) You have way less "headache".
4) It is absolutely convincing for the auditors of Your Organization QMS Certification body.

Friday, June 17, 2016

ISO 9001 based QMS Key Performance Indicators

ISO 9001:2015 requires to determine objects for monitoring and measuring to determine the performance and effectiveness of the QMS.

The term Key Performance Indicator (KPI) refers to the chosen measurements.

Some examples of commonly used KPIs are given in Mark Hammar's article How to define Key Performance Indicators for a QMS based on ISO 9001:
  • 'First Pass Yield: What percentage of your product or service is acceptable the first time it is created? If you have a high rework cost, a focus on this might help improve the processes of your QMS.
  • Downtime: Are there problems with equipment maintenance and unexpected service outages? Downtime could be useful for you to track and improve.
  • Reject Ratio: Like first pass yield this focuses on non-conforming product and if it is within an expected/acceptable rate. Many companies try to improve in this area, and understanding the performance is the first step.
  • Customer Satisfaction: One of the most important measures for a customer-focused business is how satisfied the customer is. There are many ways to measure this, but it is important for many businesses to understand how their customers see them.
  • Gross Margin: It is no surprise that most businesses are interested in how much profit they are making. Knowing the profit margin on your products and services can be a key indicator of how your QMS is performing.'

To help you better understand the ISO 9001:2015 requirements, learn practical tips, examples and guidelines that will help you with the transition of your QMS to the new version of the ISO 9001 - check our online course ISO 9001:2015 QMS Transition Workshop.
We issue Certificates that are accepted by IRCA and RABQSA as evidence of continual professional development.

More on ISO 9001:2015 including Quality Manual Template, quality system procedures, methodical materials in our ISO 9001:2015 documents and templates collection.

Tuesday, June 14, 2016

Using Knowledge as a Resource

New quality system procedure has been added to the ISO 9001:2015 documents and templates collection - Control of Organizational Knowledge.

QSP describes the organization activity to implement the new requirements of ISO 9001:2015 of using the knowledge as a resource for the QMS processes.

QSP regulates the implementation of the ‘Control of organizational knowledge’ process, which aims at transforming the internally and externally sourced information flows into the Organization’s knowledge bank.

The process involves four stages:
  • definition of the necessary knowledge
  • creation of the organization knowledge bank
  • maintaining and providing access to knowledge
  • QMS processes improvement through acquired knowledge. 

‘Control of organizational knowledge’ process model diagram is displayed in the diagram below.

Download a free PDF preview of the QSP that contains the Process model diagram and the detailed description of the Process inputs and outputs. 

Purchase the complete Control of Organizational Knowledge QSP from our Site.

More ISO 9001:2015 Documents and Templates