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  Generic Quality Manuals & Quality Procedures in ISO/IEC 17025. Click here to view SAMPLE !


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Transition to ISO/IEC 17021:2011

The International Accreditation Forum (IAF), in consultation with the International Organization for Standardization (ISO), has set the date for implementation of ISO/IEC 17021:2011 as 1 February 2013. This is a two year transition from the date of publication.

ISO/IEC 17021 was revised and published on 1 February 2011. It incorporates new requirements for third-party certification auditing of management systems and the competence of personnel involved in the certification process. It also provides a framework for the further development of competence criteria as deemed appropriate by the relevant ISO Technical Committees.

ISO/IEC 17021:2011 includes the existing text of ISO/IEC 17021:2006 virtually unchanged and contains additional requirements for competence and the audit process and is applicable to the certification of all types of management systems and to the bodies providing these activities.

In setting this transition period of two years from the publication date of ISO/IEC 17021, IAF and ISO have taken into account the following:

  • Transition to ISO/IEC 17021 may require translations, changes to procedures, setting up new or amended training regimes, revision of software systems and the implementation of systems to demonstrate competence.

  • The identification by certification bodies of differences and the preparation of a transition plan to determine both the changes to their own QMS and the time frame required to execute them.

After publication, any new application for accreditation by certification bodies is expected to be to ISO/IEC 17021:2011. Any statement of conformity to ISO/IEC 17021:2006 after the transition period will no longer be valid.

Source: ISO website

 

The Importance of Standard Operating Procedures (SOPs)

All test methods should be written up as a clear and unambiguous set of instructions. The detailed method description is often referred to as a standard operating procedure (SOP). The aim of using SOPs in the laboratory is to ensure consistent application of test methods. Often analyses will be carried out by a number of different analysts; getting them all to follow the same SOP should improve the comparability of their results. Systems should be in place to control the number of copies of a particular SOP that are in circulation and to enable them to be recalled and updated if required. It is essential to ensure that only the most recent version of an SOP is being used.

When using SOPs follow these guidelines:

  • Make sure you have the most recent version of the SOP
    many laboratories have controls in place to prevent unauthorised photocopying/printing of methods – this makes it easier to manage and control the issuing of updates;
  • Make sure you have read the SOP and are familiar with all steps of the method before commencing work;
  • Follow the procedure exactly as it is described in the SOP
    - do not be tempted to take shortcuts or adapt the method in any way (even if you think it will speed up the analysis or ‘improve’ the results);
    - if you encounter any problems with the method or have any suggestions as to how the method might be improved/modified always discuss them with your supervisor/laboratory manager;
    - any changes will require the SOP to be revised and reissued. If the changes are significant then the method will require revalidation before at can be used for the analysis of test samples.

 

10 Good Things ISO Standards Do For SMEs 

1. Standards help you compete on a level playing field with bigger enterprises

2. Standards open up export markets for your products & services

3. Standards help you discover best business practices

4. Standards drive efficiency in your business operations

5. Standards add credibility and confidence for your customers

6. Standards open new business opportunities and sales

7. Standards give you the competitive edge

8. Standards make your brand name internationally recognised

9. Standards help your company grow

10. Standards enable a common "language" to be used across an industry sector

Adapted from ISO Focus+ September 2011 page 44

 

What is GLP?

Good Laboratory Practice (GLP) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. GLP practices are intended to promote the quality and validity of test data.

Published GLP regulations and guidelines have a significant impact on the daily operation of an analytical laboratory.

GLP is a regulation. It is not only good analytical practice. Good analytical practice is important, but it is not enough. For example, the laboratory must have a specific organizational structure and procedures to perform and document laboratory work. The objective is not only quality of data but also traceability and integrity of data. But the biggest difference between GLP and Non-GLP work is the type and amount of documentation.

For a GLP inspector it should be possible to look at the documentation and to easily find out

  • who has done a study, 
  • how the experiment was carried out,-
  • which procedures have been used, and
  • whether there has been any problem and if so
  • how it has been solved.

The key requirements of a GLP type works are

  • Responsibilities should be defined for the sponsor management, for study management and for the quality assurance unit.
  • All routine work should follow written standard operating procedures.
  • Facilities such as laboratories should be large enough and have the right construction to ensure the integrity of a study, for example, to avoid cross contamination.
  • Test and control articles should have the right quality and instruments should be calibrated and well maintained 
  • People should be trained or otherwise qualified for the job
  • Raw data and other data should be acquired, processed and archived to ensure integrity of data

The GLP requirements for proper planning, for controlled performance of techniques, for faithful recording of all observations, for appropriate monitoring of activities and for complete archiving of all raw data obtained, serve to eliminate many sources of error.

Whatever the industry targeted, GLP stresses the importance of the following main points:

1. Resources: Organisation, personnel, facilities and equipment;
2. Characterisation: Test items and test systems;
3. Rules: Protocols, standard operating procedures (SOPs);
4. Results: Raw data, final report and archives;
5. Quality Assurance: Independent monitoring of research processes.

 

World Accreditation Day 9 June 2010

World Accreditation Day 2010 – “Global Acceptance”

This year marks the 10th anniversary of the ILAC Mutual Recognition Arrangement (MRA) and the 12th anniversary of the IAF Multilateral Recognition Arrangement (MLA). The principle aim of these arrangements is as relevant today as it was when they were first established, and that is to support the freedom of world trade by eliminating technical barriers to trade. The creation of an international network among accreditation bodies removes the need for suppliers to have their products or services re-evaluated in each country they enter on a commercial basis. The key to the arrangements is that the results of accredited organisations are recognised as equivalent by signatory accreditation bodies. In this way, certificates issued by accredited organisations can therefore be accepted throughout the world.

‘Global Acceptance’ is therefore an apt theme for World Accreditation Day 2010, a worldwide initiative jointly established by the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC) to raise awareness of the importance of accreditation-related activities. June 9th 2010 will mark the day, which will see major national events and press campaigns carried out in more than 60 countries.

Internationally-agreed standards and accreditation play an important role in the support of competitive markets and cross-border trade. This is increasingly important as supply chains are ever-extending to new overseas markets as businesses seek to lower costs or satisfy contract terms, whilst maintaining a level of confidence that products are technically compatible, to specification, and safe.

In such complex markets, reassurance in the measurements, tests, inspections, and certification performed in another jurisdiction is essential. Without these standards, the free exchange of goods and services would be hampered by technical barriers, thereby increasing costs for importers and consumers.

Global acceptance of accredited certificates is a central pillar of accreditation as the harmonization of assessment requirements and processes at a worldwide level, provides businesses and regulators with confidence that products entering the market conform to specification, meet national legal and regulatory requirements, and will therefore serve to protect public interests in general.


Key Differences in ISO/TS 16949:2009

ISO/TS 16949:2009 introduces no new or changed requirements. The incorporated ISO 9001:2008 standard is based on clarifications or amendments to ISO 9001:2000 and those intended to improve consistency with ISO 14001:2004.

ISO/TS 16949 incorporates text from the ISO 9001 standard within boxed sections. The text unique to ISO/TS 16949 is included outside the boxed ISO 9001 sections. Most of the differences in ISO/TS 16949:2009, beyond those in the boxed ISO 9001:2008 text, were to:

1. Change from "product quality" to "conformity to product requirements" in multiple places for consistency with the same change made in ISO 9001:2008.
2. Change from "regulatory" requirements to "statutory and regulatory" requirements in multiple places for consistency with the same change made in ISO 9001:2008.
3. Modify the titles for clauses 6.2.2 and 7.6 to match the changed titles in ISO 9001:2008.
4. Replace "ISO 9001:2000" with "ISO 9001:2008" and "ISO 9000:2000" with "ISO 9000:2005".
5. Add new references in the Bibliography section and remove the withdrawn standards.



ISO, ILAC and IAF Streamline Quality Management Requirements for Medical Laboratories

Medical laboratories accredited to ISO 15189:2007 are recognized as meeting the management system principles of ISO 9001:2008.

The move was announced in a joint communique by ISO, ILAC and IAF in September 2009. The ISO-IAF-ILAC communique was issued to address the misconception in the market that medical laboratories accredited to ISO 15189:2007 do not operate a recognized management system.

Until now, accredited medical laboratories were often requested by their customers to undertake the additional step of certification to ISO 9001:2008 to demonstrate that they are in full control of their processes. Based on the new procedures, medical laboratories accredited to ISO 15189 will now be recognized as meeting the management system principles of ISO 9001:2008. Accredited medical laboratories that are part of a larger organization certified to ISO 9001 should only need to be assessed once according to ISO 15189, and these results should be accepted as meeting the principles of the management system requirements (ISO 9001:2008).

This recognition will reduce redundant, costly and time-consuming audits, at the same time, enable medical laboratories to better meet their customers' needs.

 

Tips on Applications of ISO/IEC 17025 Requirements

What is considered an "equivalent measure" for avoiding loss or change of original data that is stored electronically per Section 4.13.2.3?

"Electronic records" are considered to be records that exist in electronic form such as data stored on a computer hard drive, network or other storage media. Appropriate measures are to be implemented by the laboratory that safeguard against loss or change of the originally recorded data. Such measures may include:

  • Preventing the overwriting of an existing record, but saving a revision of the original record which includes the corrected or altered data;
  • Retaining a register of changes/revisions in electronic records that detail the changes made;
  • Limiting write access to electronic records to only authorized individuals;
  • Using revision control features of the application that is used to generate the electronic record (e.g. "track changes" in MS Word)

 
 

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Last Updated 22 July, 2016